Title 53 Food, Drugs And Cosmetics

Chapter 1 Tennessee Food, Drug and Cosmetic Act

Part 1 General Provisions

§ 53-1-101. Administration — Short title.

This chapter shall be administered by the state department of agriculture and shall be known and may be cited as the “Tennessee Food, Drug and Cosmetic Act.”

§ 53-1-102. Chapter definitions.

As used in this chapter, unless the context otherwise requires:
1. (1) “Advertisement” means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or that are likely to induce directly or indirectly, the purchase of food, drug, devices or cosmetics;
2. (2) “Alcohol” means:
  1. (A) Rubbing alcohol compound;
  2. (B) Isopropyl alcohol; or
  3. (C) Any product manufactured with any specially denaturing properties, and represented to be a rubbing alcohol compound, or a rubbing alcohol, or an alcohol made especially for massaging or toilet purposes;
3. (3) “Antiseptic.” The representation of a drug, in its labeling or advertisement, as an “antiseptic” shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or other use that involves prolonged contact with the body;
4. (4) “Catfish” means any species within the family Ictaluridae or the family Anarchichadidae;
5. (5) “Catfish product” means any product capable of use as human food that is made wholly or in part from any catfish or portion of catfish, except products that contain catfish only in small proportions or historically have not been, in the judgment of the commissioner, considered by consumers as products of the United States commercial catfish industry and that are exempted from definition as a catfish product by the commissioner under conditions that the commissioner may prescribe to assure that the catfish or portions of catfish contained in the product are not adulterated and that the products are not represented as catfish products;
6. (6) “Certificate of free sale” means a certificate issued by the department that certifies that the manufacturer of the food, nonprescription drugs, or cosmetics listed in the document is duly authorized to manufacture the products and either that:
  1. (A) The products may be sold freely to the public in the United States, and the manufacturer is in substantial compliance with this chapter as determined by an inspection conducted by the department; or
  2. (B) The manufacturer has provided the department with a complete copy of the report of the most recent inspection conducted by the United States food and drug administration for each Tennessee location where the foods, nonprescription drugs or cosmetic products for which the certificate is being sought are manufactured; and that, based on the inspection report or reports, it is evident that the manufacturer is authorized to sell the products freely in the United States;
7. (7)
  1. (A)
    1. (i) “Color additive” means a material that:
      1. (a) Is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral or other source; and
      2. (b) When added or applied to a food, drug or cosmetic, or to the human body or any part of the human body, is capable, alone or through reaction with other substances, of imparting color to the food, drug or cosmetic, or to the human body or any part of the human body;
    2. (ii) “Color additive” does not include any material that the commissioner, by regulation, determines is used, or intended to be used, solely for a purpose or purposes other than coloring;
  2. (B) “Color” includes black, white and intermediate grays;
  3. (C) Nothing in this subdivision (7) shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest;
8. (8) “Commissioner” means the commissioner of agriculture;
9. (9) “Contaminated with filth” applies to any food, drug, device or cosmetic not securely protected from dust, dirt, and, as far as possible, from all foreign or injurious contamination;
10. (10) “Cosmetic” means:
  1. (A) Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part of the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance; and
  2. (B) Articles intended for use as a component of the articles listed in subdivision (10)(A), except that “cosmetic” does not include soap;
11. (11) “Delivered” means transferred to the consumer, either immediately upon sale or at a time thereafter;
12. (12) “Department” means the department of agriculture;
13. (13) “Device,” except when used in subdivision (26) and in §§ 53-1-103(a)(7), 53-1-105(a)(6), 53-1-109(a)(3), and 53-1-112(3), means instruments, apparatus and contrivances, including their components, parts and accessories, intended:
  1. (A) For use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; or
  2. (B) To affect the structure or any function of the body of humans or other animals;
14. (14) “Drug” means articles, not including devices or their components, parts or accessories, that are:
  1. (A) Recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any supplement to any of them;
  2. (B) Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals;
  3. (C) Intended, other than food, to affect the structure or any function of the body of humans or other animals; and
  4. (D) Intended for use as a component of any article specified in subdivisions (12)(A)-(C);
15. (15) “Farm to consumer distribution point” means a temporary or permanent location, that is not open to the general public, where a farmer or the farmer's agent delivers food, produced by the farmer and previously sold under an agreement entered into between the farmer and the consumer, directly to the consumer or the consumer's agent;
16. (16) “Federal act” means the federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended;
17. (17) “Food” means:
  1. (A) Articles used for food or drink for humans or other animals;
  2. (B) Chewing gum; and
  3. (C) Articles used for components of any article listed in subdivisions (17)(A) and (B);
18. (18) “Food additive” means any substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food; and including any source of radiation intended for any such use, if the substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use; except that “food additive” does not include:
  1. (A) A pesticide chemical in or on an agricultural commodity;
  2. (B) A pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw agricultural commodity;
  3. (C) A color additive;
  4. (D) Any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, pursuant to the federal Food, Drug and Cosmetic Act; or
  5. (E) Any substance used in food prior to January 1, 1958, that has been shown through either scientific procedures or experience based on common use in food to be safe under the conditions of its intended use;
19. (19) “Homemade food item” means a food item, including a non-alcoholic beverage, which is produced and, if packaged, packaged at the private residence of the producer;
20. (20) “Immediate container” does not include package liners;
21. (21) “Imported catfish” means catfish that is produced in a nation other than the United States, either according to the usual and customary techniques of aquaculture or in the freshwater lakes, rivers or streams or the marine or estuarine waters of the foreign nation;
22. (22) “Imported catfish product” means any product capable of use as human food that is made, wholly or in part, from any imported catfish or portion of catfish;
23. (23) “Intrastate commerce” means any and all commerce within the state and subject to the jurisdiction of the state, and includes the operation of any business or service establishment;
24. (24) “Label” means a display of written, printed, or graphic matters upon the immediate container of any article, and a requirement made by or under authority of this chapter, that any word, statement, or other information appearing on the label shall not be considered to be complied with unless the word, statement or other information also appears on the outside container;
25. (25) “Labeling” means all labels and other written, printed or graphic matter:
  1. (A) Upon any article or any of its containers or wrappers; or
  2. (B) Accompanying the article;
26. (26) “Misleading.” If an article is alleged to be misbranded because the labeling is “misleading,” or if an advertisement is alleged to be false because it is “misleading,” then in determining whether the labeling or advertisement is “misleading,” there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device, sound, or in any combination of statement, word, design, device, sound, but also the extent to which the labeling or advertisement fails to reveal facts material in the light of the representation or material with respect to consequences that may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement of the article or under conditions of use that are customary or usual;
27. (27) “New drug” means:
  1. (A) Any drug the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended or suggested in the labeling of the drug; or
  2. (B) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety for use under the conditions described in subdivision (27)(A), has become so recognized, but that has not, otherwise than in those investigations, been used to a material extent or for a material time under those conditions;
28. (28) “Non-time/temperature control for safety food” means food that does not require time or temperature control for safety to limit the rapid and progressive growth of infectious or toxigenic microorganisms, including categories of foods in Rules of Tennessee Department of Agriculture, Rule 0080-04-09-.01(116);
29. (29) “Official compendium” means the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any supplement to any of them;
30. (30) “Person” includes an individual, partnership, corporation and association;
31. (31) “Pesticide chemical” means:
  1. (A) Any substance or mixture of substances, including disinfectants, intended for preventing, destroying, repelling or mitigating any insects, rodents, nematodes, fungi, bacteria, weeds or other forms of plant or animal life or viruses, except viruses on or in living humans or other animals, that the commissioner declares to be a pest; and
  2. (B) Any substance or mixture of substances intended for use as a plant regulator, defoliant or desiccant;
32. (32) “Produce” means to prepare a food item by cooking, baking, drying, mixing, cutting, fermenting, preserving, dehydrating, growing, raising, or other process;
33. (33) “Producer” means a person who produces a homemade food item;
34. (34) “Raw agricultural commodity” means any food in its raw or natural state, including all fruits that are washed, colored or otherwise treated in their unpeeled natural form prior to marketing;
35. (35) “Salvageable merchandise” means any food, drug, cosmetic, device or other item listed in this chapter or any regulations promulgated under this chapter that can be reconditioned, labeled, relabeled, repackaged, recoopered, sorted, cleaned, culled or by any other means be salvaged to meet the requirements of this chapter or those regulations;
36. (36) “Seller” means a person who sells a homemade food item to a consumer;
37. (37) “Selling.” This chapter regarding the “selling” of food, drugs, devices or cosmetics shall be considered to include the manufacture, production, processing, packing, exposure, offer, possession, and holding of those articles for sale, and the supplying or applying of those articles in the conduct of any food, drug or cosmetic establishment. “Selling” does not include infrequent casual sales of honey or the selling or packing of less than one hundred fifty gallons (150 gals.) of honey per year; and
38. (38) “State” means the state of Tennessee and its political subdivisions.

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§ 53-1-103. Prohibited acts — Penalties — Exceptions.

(a) The following acts, and the causing of the following acts, within the state are prohibited:
1. (1) The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device or cosmetic that is adulterated or misbranded;
2. (2) The adulteration or misbranding of any food, drug, device or cosmetic;
3. (3) The receipt of any food, drug, device or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of any food, drug, device or cosmetic that is adulterated or misbranded for pay or otherwise;
4. (4) The sale, delivery for sale, holding for sale, or offering for sale of any article in violation of § 53-1-110, § 53-1-201, § 53-1-203, § 53-1-204, or any rule promulgated thereunder;
5. (5) The dissemination, in any manner or by any means or through any medium, of any false advertisement or for any advertising medium to knowingly publish false or misleading advertising;
6. (6) The refusal to permit:
  1. (A) Entry or inspection, or refusal to permit the taking of a sample, as authorized by § 53-1-203; or
  2. (B) Access to or copying of any record as authorized by § 53-1-203;
7. (7) The giving of a guaranty or undertaking, which guaranty or undertaking is false, except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of the person residing in the United States from whom this person received in good faith the food, drug, device or cosmetic;
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  - 53-1-102(13)
8. (8) The removal or disposal of a detained or embargoed article in violation of § 53-1-201;
9. (9) The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device or cosmetic, if the act is done while the article is held for sale and results in the article's being misbranded;
10. (10) The forging, counterfeiting, simulating or falsely representing, or without proper authority using any mark, stamp, tag, label or other identification device authorized or required by regulations promulgated under this chapter;
11. (11) The using, on the labeling of any drug or in any advertisement relating to the drug, of any representation or suggestion that an application with respect to the drug is effective under § 53-1-110, or that the drug complies with § 53-1-110;
12. (12) The sale of alcohol in violation of rules and regulations adopted by the United States treasury department, alcohol tax division, or by the department of revenue or the alcoholic beverage commission;
13. (13) The sale by vending machines of any drugs that are capable of causing physical or mental harm if taken internally in overdoses;
14. (14) The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device or cosmetic that contains any level of radiation or any amount of pesticide residue, food additive, color additive or other substance, in excess of the amount adopted or prescribed by regulation of the commissioner under authority of § 53-1-107; or
15. (15) The sale, delivery, holding, processing, or offering for sale any salvageable merchandise in violation of this chapter or any regulation promulgated under this chapter.
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- 53-1-201(e)
(b)
1. (1) Any person who violates subsection (a) commits a Class C misdemeanor.
2. (2) No person shall be subject to the penalties of subdivision (b)(1) for having violated subdivision (a)(1) or (a)(3) if the person established a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom the person received in good faith the article, to the effect that the article is not adulterated or misbranded within the meaning of this chapter.
(c) No publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, shall be liable under this section by reason of the dissemination by the publisher, licensee, agency or medium of the false advertisement unless the publisher, licensee, agency or medium has refused, on the request of the commissioner, to furnish the commissioner with the name and post office address of the manufacturer, packer, distributor, seller or advertising agency, who caused the publisher, licensee, agency or medium to disseminate the advertisement.

§ 53-1-104. Food deemed adulterated.

A food shall be deemed to be adulterated if:
1. (1)
  1. (A) It bears or contains any poisonous or deleterious substance that may render it injurious to health; but in case the substance is not an added substance, the food shall not be considered adulterated under this subdivision (1)(A) if the quantity of the substance in the food does not ordinarily render it injurious to health;
  2. (B) It bears or contains any added poisonous or added deleterious substance that is unsafe within the meaning of § 53-1-107;
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    53-1-107(a)
    53-1-107(b)(1)(A)
  3. (C) It consists, in whole or in part, of a diseased, contaminated, filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;
  4. (D) It has been produced, prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered diseased, unwholesome or injurious to health or if it is a potentially hazardous food, which would consist of meat, poultry, liquid eggs and partially cooked egg products, fish, milk and milk products, shellfish, partially cooked bakery products, such as cream filled pies, but not including standard fully cooked bakery products, and other ingredients capable of supporting rapid and progressive growth of infectious or toxigenic micro-organisms and is transported, stored or offered for sale at a product temperature in excess of forty-five degrees Fahrenheit (45° F) if a cold food, or below one hundred forty degrees Fahrenheit (140° F) if a hot food; provided, that a food that is offered for sale in a frozen state must be stored, transported and displayed at zero degrees Fahrenheit (0° F). However, a ten degree Fahrenheit (10° F) product temperature is acceptable for defrosting or recycling periods;
  5. (E) It is the product of a diseased animal or an animal that has died otherwise than by slaughter, or that has been fed upon the uncooked offal from a slaughterhouse; or
  6. (F) Its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health;
2. (2)
  1. (A) Any valuable constituent has been, in whole or in part, omitted or abstracted from the food;
  2. (B) Any substance has been substituted, wholly or in part, for the food;
  3. (C) Damage or inferiority has been concealed in any manner; or
  4. (D) Any substance has been added to the food or mixed or packed with the food so as to increase its bulk or weight, or reduce its quality or strength or make it appear better or of greater value than it is;
3. (3) It is confectionery and it bears or contains any alcohol or nonnutritive article or substance, except harmless coloring, harmless flavoring, harmless resinous glaze not in excess of four-tenths of one percent (0.4%), harmless natural gum, and pectin; provided, that this subdivision (3) shall not apply to any confectionery by reason of its containing less than one-half of one percent (0.5%) of volume of alcohol derived solely from the use of flavoring extracts, or to any chewing gum by reason of its containing harmless nonnutritive masticatory substances;
4. (4) It bears or contains a coal-tar color other than one from a batch that has been certified under the federal act; or
5. (5) The food has been made to appear of better quality than the product actually is through the use of any form of illumination that, by type, color, density, or by other means, alters the appearance of the food product; or if packaging or other materials are used that impart a misleading color or appearance to the food. However, the mere keeping of freshly cooked or prepared foods or liquids warmed pending their being served for consumption, through the use of heat generating lamps of any color, shall not constitute an adulteration.

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53-1-107(a)

§ 53-1-105. Food deemed misbranded.

(a) A food shall be deemed to be misbranded if:
1. (1) Its labeling is false or misleading in any particular;
2. (2) It is offered for sale under the name of another food;
3. (3) It is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation,” and immediately thereafter, the name of the food imitated;
4. (4) Its container is so made, formed or filled as to be misleading;
5. (5) In package form, unless it bears a label containing:
  1. (A) The name and place of business of the manufacturer, packer or distributor; and
  2. (B) An accurate statement of the quantity of the contents in terms of weight, measure or numerical count; provided, that under this subdivision (5) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the commissioner;
6. (6) Any word, statement or other information required by this chapter to appear on the label or labeling is not prominently placed on the label or labeling with such conspicuousness, as compared with other words, statements, designs or devices, in the labeling, and such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
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  - 53-1-102(13)
7. (7) It is not subject to [former] subdivision (a)(7), unless its label bears:
  1. (A) The common or usual name of the food, if there is one; and
  2. (B) In case it is fabricated from two (2) or more ingredients, the common or usual name of each ingredient; except that spices, flavorings and colorings, other than those sold as spices, flavoring and colorings, may be designated as spices, flavorings and colorings, without naming each; provided, that to the extent that compliance with the requirements of this subdivision (a)(7)(B) is impractical or results in deception or unfair competition, exemption shall be established by regulations promulgated by the commissioner. The requirements of this subdivision (a)(7)(B) shall not apply to any carbonated beverage, the ingredients of which have been fully and correctly disclosed, to the extent prescribed by this subdivision (a)(7)(B), to the commissioner in an affidavit;
8. (8) It purports to be or is represented for special dietary uses, unless its label bears information concerning its vitamin, mineral and other dietary properties that the commissioner determines to be, and by regulations prescribes, as necessary in order to fully inform purchasers as to its value for special dietary uses; or
9. (9) It bears or contains any artificial flavoring, artificial coloring or chemical preservatives, unless it bears labeling stating that fact; provided, that to the extent that compliance with the requirements of this subdivision (a)(9) is impracticable, exemptions shall be established by regulations promulgated by the commissioner. This subdivision (a)(9) with respect to artificial coloring shall not apply in the case of butter, cheese or ice cream.
(b)
1. (1) Any poultry, poultry product, meat, or meat food product offered for sale, sold, or distributed in this state and labeled or advertised as “Tennessee-raised” or by a similar designation is misbranded if the poultry or animal was not raised in this state.
2. (2) The commissioner may waive a determination that poultry, a poultry product, meat, or a meat food product is misbranded under subdivision (b)(1) upon application of the producer or processor, if the commissioner finds that a waiver is warranted due to economic factors, including, but not limited to, the proximity of processing facilities to the producer and the availability of processing facilities in this state.
3. (3) As used in this subsection (b):
  1. (A) “Meat”, “meat food products”, “poultry”, and “poultry products” have the same meanings as defined in § 53-7-202; and
  2. (B) “Tennessee-raised” means:
    1. (i) For poultry and poultry products, that the poultry was raised solely in this state from no later than the seventh day after hatching and processed solely in this state; and
    2. (ii) For meat and meat food products, that the animal was born, raised, and processed solely in this state.

§ 53-1-106. Certain food exempted from affirmative labeling requirements.

Food that is, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at an establishment other than the establishment where it was originally processed or packed is exempt from the affirmative labeling requirement of this chapter while it is in transit in intrastate commerce from one establishment to the other, if the transit is made in good faith for those completion purposes only; but the food is otherwise subject to all the applicable provisions of this chapter.

§ 53-1-107. Poisonous or deleterious substance — Regulations as to use.

(a) Any poisonous or deleterious substance, which shall include, but not be limited to, pesticide chemicals, food additives, color additives and radiation sources, added to any food pursuant to § 53-1-104, to any drug or device pursuant to § 53-1-108, or to any cosmetic pursuant to § 53-1-111, shall be deemed unsafe for the purposes of application of §§ 53-1-104(1)(B), 53-1-108(1) and 53-1-111(1), except where the substance:
1. (1) Is required in the production of the food;
2. (2) Cannot be avoided by good manufacturing practice; or
3. (3) Has been shown by competent scientific evidence, acceptable to the commissioner, to be useful in the interest of the health of the consumer.
(b)
1. (1)
  1. (A) When the substance is required, cannot be avoided or has been shown to be in the interest of the health of the consumer, as provided in subsection (a), the commissioner may promulgate regulations limiting the quantity in or on the foods, drugs, devices or cosmetics to the extent that the commissioner finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall be deemed unsafe for the purposes of application of §§ 53-1-104(1)(B), 53-1-108(1) and 53-1-111(1).
  2. (B) The commissioner may adopt without hearing any regulations identical with regulations limiting the quantity of any substance in or on foods, drugs, devices or cosmetics adopted under authority of the federal act.
2. (2) In determining the quantity of the added substance to be tolerated in or on different articles of foods, drugs, devices or cosmetics, the commissioner shall take into account the extent to which the use of the substance is required or cannot be avoided in the production or manufacture of the article and the other ways in which the health and economic interests of the consumer may be affected by the same or other poisonous or deleterious substances.

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§ 53-1-108. Drugs or devices deemed adulterated.

A drug or device shall be deemed to be adulterated if:
1. (1)
  1. (A) It consists, in whole or in part, of any filthy, putrid or decomposed substance;
  2. (B) It has been produced, prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;
  3. (C) It is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health; or
  4. (D) It is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch certified under the authority of the federal act;
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  - 53-1-107(a)
  - 53-1-107(b)(1)(A)
2. (2)
  1. (A)
    1. (i) It purports to be or is represented as a drug, the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in the compendium;
    2. (ii) The determination as to strength, quality or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence or inadequacy of those tests or methods of assay, those prescribed by the United States department of agriculture;
  2. (B) No drug defined in an official compendium shall be deemed to be adulterated under this subdivision (2) because it differs from the standard of strength, quality or purity for the drug set forth in the compendium, if its difference in strength, quality or purity from the standard is plainly stated on its label;
  3. (C) Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia, unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the Homeopathic Pharmacopoeia of the United States;
3. (3) It is not subject to subdivision (2) and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess; or
4. (4) It is a drug and any substance has been:
  1. (A) Mixed or packed with the drug so as to reduce its quality or strength; or
  2. (B) Substituted wholly or in part for the drug.

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53-1-107(a)

§ 53-1-109. Drugs or devices deemed misbranded — Exemptions.

(a) A drug or device shall be deemed to be misbranded:
1. (1) If its labeling is false or misleading in any particular;
2. (2) If in package form, unless it bears a label containing:
  1. (A) The name and place of business of the manufacturer, packer or distributor; and
  2. (B) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that, under this subdivision (a)(2)(B), reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the commissioner;
3. (3) If any word, statement or other information required by or under the authority of this chapter to appear on the label or labeling is not prominently placed on the label or labeling with such conspicuousness, as compared with other words, statements, designs or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
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  - 53-1-102(13)
4. (4) If it is for use by humans and contains any quantity of the narcotic or hypnotic substance alpha eucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, or sulphonmethane, or any chemical derivative of those substances, which derivative has been found by the commissioner after investigation to be, and by regulations promulgated under this subdivision (a)(4) designated as habit forming; unless its label bears the name and quantity of proportion of the substance or derivative and in juxtaposition the statement “Warning — May be habit forming”;
5. (5) If it is a drug and is not designated solely by a name recognized in an official compendium, unless its label bears:
  1. (A) The common or usual name of the drug, if there is a common or usual name; and
  2. (B) In case it is fabricated from two (2) or more ingredients, the common or usual name of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, aminopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any of those substances contained in the drug; provided, that to the extent that compliance with the requirements of this subdivision (a)(5)(B) is impracticable, exemptions shall be established by regulations promulgated by the commissioner;
6. (6) Unless its labeling bears:
  1. (A) Adequate directions for use; provided, that where any requirement of this subdivision (a)(6)(A), as applied to any drug or device, is not necessary for the protection of the public health, the commissioner shall promulgate regulations exempting the drug or device from the requirements; and
  2. (B) Adequate warning against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in a manner and form that are necessary for the protection of users;
7. (7) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packed and labeled as prescribed in the compendium; provided, that the method of packing may be modified with the consent of the commissioner. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling, unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia;
8. (8) If it has been found by the commissioner to be a drug liable to deteriorate, unless it is packaged in a form and manner, and its label bears a statement of precautions that the commissioner requires by regulations as necessary for the protection of public health. Regulations shall not be established for any drug recognized in an official compendium until the commissioner has informed the appropriate body charged with the revision of the compendium of the need for the packaging or labeling requirements, and the body has failed within a reasonable time to prescribe the requirements;
9. (9) If it is a drug and:
  1. (A) Its container is so made, formed or filled as to be misleading;
  2. (B) It is an imitation of another drug; or
  3. (C) It is offered for sale under the name of another drug;
10. (10) If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended or suggested in the labeling of the drug; or
11. (11) If it is a drug sold at retail for use by humans, and contains any quantity of aminopyrine, barbituric acid, cinchophon, dinitrophenol or sulfanilamide, or their derivatives, when used in the dosage, or with the frequency or duration prescribed, recommended or suggested in the labeling of the drug, unless it is sold on a written prescription authorized by a member of the medical, dental or veterinary profession who is licensed by law to administer the drugs, and its label bears the name and place of business of the seller, the serial number and date of the prescription, and the name of the member of the medical, dental or veterinary profession.
(b)
1. (1) A drug sold on a written prescription signed or authorized by a member of the medical, dental or veterinary profession, except a drug sold in the course of the conduct of a business of selling drugs pursuant to diagnosis by mail, shall be exempt from the requirements of this section if:
  1. (A) The member of the medical, dental or veterinary profession is licensed by law to administer the drug; and
  2. (B) The drug bears a label containing the name and place of business of the seller, the serial number and date of the prescription, and the name of the member of the medical, dental or veterinary profession.
2. (2) A drug or device that is, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at an establishment other than the establishment where it was originally processed or packed, is exempt from the affirmative labeling and packaging requirements of this section, while it is in transit in intrastate commerce from the one establishment to the other, if the transit is made in good faith for those completion purposes only; but it is otherwise subject to all applicable provisions of this chapter.

§ 53-1-110. Sale of new drugs.

(a) No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless an application with respect to the drug has become effective under § 505 of the federal act.
(b) This section shall not apply to:
1. (1) A drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs; provided, that the drug is plainly labeled “For Investigational Use Only”; and provided, further, that all reports of investigations that are being made and that have been made to show whether or not the drug is safe for use, and whether the drug is effective in use are furnished upon request to the commissioner;
2. (2) A drug sold in this state at any time prior to February 15, 1941, or introduced into interstate commerce at any time prior to the enactment of the federal act; or
3. (3) Any drug that is licensed under the Virus-Serum-Toxin Act (21 U.S.C. § 151 et seq.).

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§ 53-1-111. Cosmetics deemed adulterated.

A cosmetic shall be deemed to be adulterated if:
1. (1) It bears or contains any poisonous or deleterious substance that may render it injurious to users under the conditions of use prescribed in the labeling or advertisement of the cosmetic, or under conditions of use that are customary or usual; provided, that this subdivision (1) shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed on the label: “Caution — This product contains ingredients that may cause skin irritation on certain individuals and a preliminary test according to accompanying direction should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness”, and the labeling of which bears adequate direction to the preliminary testing. For the purpose of this subdivision (1), hair dye does not include eyelash dye or eyebrow dyes;
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  - 53-1-107(a)
  - 53-1-107(b)(1)(A)
2. (2) It consists, in whole or in part, of any filthy, putrid or decomposed substance;
3. (3) It has been produced, prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
4. (4) Its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health; or
5. (5) It is not a hair dye and it bears or contains a coal-tar color other than one from a batch that has been certified under the federal act.

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53-1-107(a)

§ 53-1-112. Cosmetics deemed misbranded.

A cosmetic shall be deemed to be misbranded if:
1. (1) Its labeling is false or misleading in any particular;
2. (2) In package form, unless it bears a label containing:
  1. (A) The name and place of business of the manufacturer, packer or distributor; and
  2. (B) An accurate statement of the quantity of the contents in terms of weight, measure or numerical count; provided, that under this subdivision (2)(B) reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by the commissioner;
3. (3) Any word, statement or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed on the label or labeling with such conspicuousness, as compared with other words, statements, designs, or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; or
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  - 53-1-102(13)
4. (4) Its container is so made, formed or filled as to be misleading.

§ 53-1-113. False advertising.

(a) An advertisement of a food, drug, device or cosmetic shall be deemed to be false if it is false or misleading in any particular.
(b) For the purpose of this chapter, the advertisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright's disease, cancer, carbuncles, cholocystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis or infantile paralysis, prostate gland disorder, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia, or venereal disease, shall also be deemed to be false; provided, that no advertisement not in violation of subsection (a) shall be deemed to be false under this subsection (b) if it is disseminated only to members of the medical, dental, pharmaceutical or veterinary professions, or appears only in the scientific periodicals of these professions, or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of the drugs or devices; provided, further, that, whenever the commissioner determines that an advance in medical science has made any type of self-medication safe as to any of the diseases listed in this subsection (b), the commissioner shall by regulation authorize the advertisement of drugs having curative or therapeutic effect for the disease, subject to conditions and restrictions that the commissioner may deem necessary in the interests of public health; provided, further, that this subsection (b) shall not be construed as indicating that self-medication for diseases other than those listed is safe or efficacious.

§ 53-1-114. Exemptions from labeling requirements.

Notwithstanding any law or rule to the contrary, a food item, including, but not limited to, biscuits, sandwiches, salads, slaw, cookies, candy and other desserts, shall be exempt from the labeling requirements of this chapter if the food item is:
1. (1) Made on site;
2. (2) Sold at retail to consumers on site; and
3. (3) Made from products that are commercially available.

§ 53-1-115. Use of the term “catfish” — Enforcement — Rules and regulations — Violations — Penalties — Hearing.

(a)
1. (1) The term “catfish” shall not be used as a common name or brand name or used to advertise, distribute, or label any fish or fish product, except for those species within the definition of catfish set out in § 53-1-102.
2. (2) It is a violation of this section to use the term “catfish” in the advertisement, distribution, processing, labeling, or wholesale or retail sale of any of those species within the family of Siluridae, Clariidae and Pangasiidaae or any other species of fish not included within the definition of catfish set out in § 53-1-102.
(b) This section shall apply only to the advertisement, distribution, processing, labeling, or wholesale or retail sale of:
1. (1) Unprepared or packaged imported catfish and imported catfish products; and
2. (2) Unprepared or packaged fish and fish products described in subsection (a).
(c) The commissioner shall enforce the requirements of this section and is authorized to promulgate rules and regulations pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, to implement this section.
(d) In the event of a violation of this section, the commissioner is authorized to:
1. (1) Order the processor, distributor, wholesaler or retailer to cease the distribution or sale of imported catfish or imported catfish products that are not labeled or are labeled in violation of this section;
2. (2) Order the processor, distributor, wholesaler or retailer to cease the advertisement, distribution, labeling or sale of all other fish or fish products that are being advertised, distributed, labeled or sold in violation of this section;
3. (3) Seek injunctive relief to stop practices that are in violation of this section; and
4. (4) Order the processor, distributor, wholesaler or retailer to comply with this section or any rule or regulation promulgated pursuant to this section.
(e) Any person who violates this section shall be subject to a civil penalty of not more than one thousand dollars ($1,000) for each violation. Each day of continued violation constitutes a separate violation.
(f) Any person aggrieved by an order or civil penalty imposed by the commissioner shall be entitled to a hearing in accordance with the Uniform Administrative Procedures Act.

§ 53-1-116. Labeling of imported catfish.

Any food service establishment, as defined in § 68-14-302, that sells imported catfish or imported catfish products, as defined in § 53-1-102, shall label such catfish or catfish products as “imported” on its menus.

§ 53-1-117. No criminal or civil liability in the absence of gross negligence or intentional misconduct for feminine hygiene product donation.

(a) The good faith donor of an apparently usable feminine hygiene product to a bona fide charitable or nonprofit organization for free distribution to persons in need of the product is not subject to criminal penalty for violation of unfair trade practice laws or civil damages arising from the nature, age, packaging, or condition of an apparently usable feminine hygiene product.
(b) A bona fide charitable or nonprofit organization that in good faith receives an apparently usable feminine hygiene product and distributes the product to persons in need is not subject to criminal penalty for violation of unfair trade practice laws or civil damages arising from the nature, age, packaging, or condition of an apparently usable feminine hygiene product.
(c) Subsections (a) and (b) do not apply when a good faith donor or bona fide charitable or nonprofit organization's actions constitute gross negligence or intentional misconduct that results in injury or death to a person who uses the apparently usable feminine hygiene product.
(d) As used in this section:
1. (1) “Apparently usable” means that a product meets all quality and labeling standards imposed by federal and state laws and regulations even if the product may not be readily marketable;
2. (2) “Bona fide charitable or nonprofit organization” has the same meaning as defined in § 57-4-102; and
3. (3) “Feminine hygiene product”:
  1. (A) Means a product used for a female's menstruation or other genital-tract secretions; and
  2. (B) Includes tampons and sanitary napkins.

§ 53-1-118. Exemption for production and sale of homemade food items.

(a) Notwithstanding part 2 of this chapter, or another law to the contrary, except as provided in this section, the production and sale of homemade food items under this chapter are exempt from all licensing, permitting, inspecting, packaging, and labeling laws of this state, except when the department of health is investigating a reported foodborne illness.
(b) The exemption under subsection (a) only applies if the following conditions are satisfied:
1. (1) Non-time/temperature control for safety food homemade food items must be sold either by:
  1. (A) The producer to the consumer, whether in person or remotely, including, but not limited to, a sale by telephone or internet; or
  2. (B) An agent of the producer or a third-party vendor, such as a retail shop or grocery store, to the consumer;
2. (2) Non-time/temperature control for safety food homemade food items must be delivered either by:
  1. (A) The producer to the consumer; or
  2. (B) An agent of the producer, a third-party vendor, or a third-party carrier to the consumer;
3. (3) The following information must be provided to the consumer, in the format required by subdivision (b)(4):
  1. (A) The name, home address, and telephone number of the producer of the homemade food item;
  2. (B) The common or usual name of the homemade food item;
  3. (C) The ingredients of the homemade food item in descending order of predominance; and
  4. (D) The following statement: “This product was produced at a private residence that is exempt from state licensing and inspection. This product may contain allergens.”; and
4. (4)
  1. (A) The information required by subdivision (b)(3) must be provided:
    1. (i) On a label affixed to the package, if the homemade food item is packaged;
    2. (ii) On a label affixed to the container, if the homemade food item is offered for sale from a bulk container;
    3. (iii) On a placard displayed at the point of sale, if the homemade food item is neither packaged nor offered for sale from a bulk container; or
    4. (iv) On the webpage on which the homemade food item is offered for sale, if the homemade food item is offered only for sale on the internet; and
  2. (B) If the homemade food item is sold by telephone or custom order, the seller need not display the information required by subdivision (b)(3), but the seller shall disclose to the consumer that the homemade food item is produced at a private residence that is exempt from state licensing and inspection, and may contain allergens. The seller shall have the information required by subdivisions (b)(3)(A)-(C) readily available and provide it to the consumer upon request.
(c) This section does not:
1. (1) Impede the department of health in an investigation of a reported foodborne illness;
2. (2) Preclude the production or sale of food items otherwise authorized by law;
3. (3) Change the regulation of other goods and services where homemade food items are also produced or sold;
4. (4) Exempt producers or sellers of homemade food items from any applicable tax law; or
5. (5) Apply to sales other than intrastate sales made within this state.
(d) This section preempts county, municipal, and other political jurisdictions from prohibiting and regulating the production and sale of homemade food items.

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Part 2 Enforcement

§ 53-1-201. Marking of article as detained or embargoed upon probable cause to believe that food, drug, device, or cosmetic is adulterated or misbranded — Petition for order of condemnation — Destruction — Condemnation or destruction of perishable articles — Injunctive relief.

(a) Whenever an agent of the commissioner has probable cause to believe that any food, drug, device, or cosmetic is adulterated or so misbranded as to be dangerous or fraudulent, the agent shall mark the article as “detained” or “embargoed”. It is a violation of this chapter for any person to remove or dispose of the detained or embargoed article by sale or otherwise without permission of the agent or the court.
(b) When an article detained or embargoed under subsection (a) has been found by the agent to be adulterated or misbranded, the agent shall petition the judge of a circuit or chancery court in whose jurisdiction the article is detained or embargoed for an order of condemnation of the article. If, however, the agent subsequently finds that an article so detained or embargoed is not adulterated or misbranded, or if the agent fails to petition for an order of condemnation within fifteen (15) days of the detainer or embargo, the agent shall remove the marking.
(c) If the court finds that a detained or embargoed article is adulterated or misbranded, the article must, after entry of the decree, be destroyed at the expense of the claimant of the detained or embargoed article, under the supervision of the agent, and all court costs and fees, and storage and other proper expenses, shall be taxed against the claimant of the article, unless the adulteration or misbranding can be corrected by proper labeling or processing of the article, in which case the court, after entry of the decree, and after the costs, fees, and expenses have been paid, may, by order, direct that the article be delivered to the claimant of the article for the labeling or processing under the supervision of an agent of the commissioner, with the expense of the supervision to be paid by the claimant.
(d) Whenever the commissioner or any of the commissioner's authorized agents find, in any room, building, vehicle of transportation, or other structure, any meat, seafood, poultry, vegetable, fruit, or other perishable articles that are unsound, or contain any filthy, decomposed, or putrid substance, or that may be poisonous or deleterious to health or otherwise unsafe, the meat, seafood, poultry, vegetable, fruit, or other perishable articles being declared to be a nuisance, the commissioner or the commissioner's authorized agent shall immediately condemn or destroy the meat, seafood, poultry, vegetable, fruit, or other perishable articles or in any other manner render the meat, seafood, poultry, vegetable, fruit, or other perishable articles unsalable as human food.
(e) In addition to the remedies provided elsewhere in this chapter, the commissioner is authorized to apply to a court of competent jurisdiction, and the court shall have jurisdiction upon hearing and for cause shown, to grant a temporary or permanent injunction restraining any person from violating § 53-1-103(a), regardless of whether or not there exists an adequate remedy at law.

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§ 53-1-202. Promulgation of rules.

The commissioner may promulgate rules for the efficient enforcement of this chapter. The rules must be promulgated in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.

§ 53-1-203. Access to factories, warehouses, or establishments, or vehicles, for purpose of inspection and securing samples — Access to, and copying of, records.

(a) The commissioner or the commissioner's agent shall have free access at all reasonable hours to any factory, warehouse, or establishment in which foods, drugs, devices, or cosmetics are manufactured, processed, packed, or held for introduction into commerce, or to enter any vehicle being used to transport or hold the foods, drugs, devices, or cosmetics in commerce, for the purpose of inspection and securing samples.
(b) Carriers engaged in intrastate commerce, and persons receiving food, drugs, devices, or cosmetics in intrastate commerce or holding those articles, shall permit an agent of the commissioner, at reasonable times, to access and copy all records showing, during or after the movement in intrastate commerce, the quantity, shipper, and consignee of the food, drug, device, or cosmetic.
(c) Carriers shall not be subject to the other provisions of this chapter by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, or cosmetics in the usual course of business as carriers.

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§ 53-1-204. License requirements — Issuance — Expiration — Fees.

(a)
1. (1) Except as provided in § 53-1-118, a person shall not manufacture, process, pack, or hold food for introduction into commerce unless the person holds a valid license issued by the commissioner.
2. (2)
  1. (A) Applicants for licensure shall apply for the license on forms provided by the commissioner.
  2. (B) The commissioner may issue a license to an applicant only upon receipt of the proper license fee and an inspection of the applicant's facility that indicates the applicant is in compliance with the requirements of this chapter and the rules promulgated thereunder.
  3. (C) Licenses issued under this section expire on July 1 of each year, or as the commissioner may otherwise provide by rule.
  4. (D) The commissioner shall set annual fees for licenses issued under this section by rule pursuant to § 43-1-703.
(b) The commissioner shall set, by rule under § 43-1-703, a fee for a certificate of free sale.
(c) [Deleted by 2022 amendment.]
(d) [Deleted by 2022 amendment.]

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Part 3 Produce Safety

§ 53-1-301. Part definitions.

As used in this part:
1. (1) “Administration” means the United States food and drug administration;
2. (2) “Department” means the department of agriculture; and
3. (3) “Standards” means the standards for the growing, harvesting, packing, and holding of produce for human consumption (21 CFR Part 112).

§ 53-1-302. State cooperation with United States food and drug administration.

(a) The department is authorized to cooperate with the administration under the standards.
(b) In furtherance of its responsibilities under this part the department may:
1. (1) Conduct inspections and take other actions reasonably necessary to assist the administration in enforcing the standards;
2. (2) Enter into cooperative agreements with the administration to implement provisions of the standards; and
3. (3) Promulgate rules to effectuate the purposes of this part, in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.

§ 53-1-303. Use of state funds — Funds limited to those provided to state by federal government.

(a) No state funds shall be expended for the purposes of enforcing the standards against agricultural producers that only make sales of produce to:
1. (1) The consumer of the produce; or
2. (2) A restaurant or retail food establishment that is located in this state or not more than two hundred seventy-five (275) miles away from the farm where the produce was produced.
(b) The department shall not expend more funds to cooperate with the administration under the standards than the amount of funds that are provided to this state by the federal government for such purposes.

§ 53-1-304. [Repealed]

Chapter 2 Tennessee Egg Law [Repealed]

§ 53-2-101. [Repealed]

§ 53-2-102. [Repealed]

§ 53-2-103. [Repealed]

§ 53-2-104. [Repealed]

§ 53-2-105. [Repealed]

§ 53-2-106. [Repealed]

§ 53-2-107. [Repealed]

§ 53-2-108. [Repealed]

§ 53-2-109. [Repealed]

§ 53-2-110. [Repealed]

§ 53-2-111. [Repealed]

§ 53-2-112. [Repealed]

§ 53-2-113. [Repealed]

§ 53-2-114. [Repealed]

§ 53-2-115. [Repealed]

§ 53-2-116. [Repealed]

Chapter 3 Dairy Law of the State of Tennessee

Part 1 General Provisions

§ 53-3-101. Short title.

This chapter shall be known and may be cited as the “Dairy Law of the State of Tennessee.”

§ 53-3-102. Construction of chapter.

(a) The word “shall” is mandatory, and the word “may” is permissive.
(b) Wherever a tolerance is allowed, it shall apply only to a tolerance as to composition and not to weight, unless specifically stated.
(c) Whenever any reference is made to any section in this chapter or to any other law, the reference shall apply to all amendments and additions to the section or other law.

§ 53-3-103. Chapter definitions.

As used in this chapter, unless the context otherwise requires:
1. (1) “Commissioner” means the commissioner of agriculture or the person authorized to enforce this chapter;
2. (2) “Dairy products” means pure, clean and wholesome milk, cream, pure milk fat, butter, buttermilk, cheese, ice cream, ice cream mix, ice milk, ice milk mix, ice or ice sherbet, evaporated milk, skimmed milk, condensed milk, sweetened condensed milk, condensed skimmed milk, sweetened condensed skimmed milk, dried milk, dried skimmed milk, any derivatives of milk or combination of products made from milk;
3. (3) “Dairy products plants” means all places where dairy products are packaged, processed or manufactured;
4. (4) “Department” means the Tennessee department of agriculture;
5. (5) “Official methods of analysis” means, for the purpose of determining the bacteriological, chemical or physical constituents in milk, dairy products and trade products as well as organoleptic tests and examinations for extraneous matter or direct and indirect additives and for enforcing the requirements of this chapter, The Methods of Analysis – Tenth Edition, and subsequent editions adopted by the Association of Official Analytical Chemists and Standard Methods for the Examination of Dairy Products – Twelfth Edition, and subsequent editions adopted by the American Public Health Association, and approved methods in a journal of these associations published prior to publication in the book of methods or other methods the commissioner may approve;
6. (6) “Person” includes an individual, firm, corporation, company or association;
7. (7) “Receiving plant” means all places where dairy products or milk products not in consumer packages are received on consignment or otherwise, stored or transported, but where packaging, processing or manufacturing does not occur;
8. (8) “Sell” includes “offer for sale,” “expose for sale,” “have in possession for sale,” “exchange,” “barter,” or “trade”;
9. (9) “Trade products” means any products made in semblance of dairy products that may be used as a substitute for dairy products; and
10. (10) “Trade products plants” means all places where trade products are packaged, processed or manufactured.

§ 53-3-104. Authority and powers of the commissioner — Special provisions for trade products — Rules and regulations.

(a)
1. (1)
  1. (A) The commissioner has the authority to define all varieties and types of dairy products and trade products.
  2. (B) The commissioner is further empowered to inspect and establish rules and regulations governing the production, storing, transportation, handling, processing, packaging and labeling of any and all dairy products and trade products.
2. (2) The product name for any trade product shall include the word “imitation” followed immediately by the name of the dairy product in semblance of which the trade product is made; further, the word “imitation” shall be in print of the same size as the name of the dairy product it precedes.
(b) The commissioner is further authorized to delegate the commissioner's authority under subsection (a) to any individual the commissioner deems qualified to assist the commissioner in the administration of this chapter.
(c) In the performance of the commissioner's official duties, the commissioner is authorized and empowered to enter during business hours all creameries, cheese factories, milk depots, milk plants, ice cream factories, milk condensaries, and similar plants processing or manufacturing trade products for the purpose of executing this chapter.
(d) The rules and regulations promulgated by the commissioner under the authority of this chapter shall comply with the following requirements:
1. (1) A copy of the proposed rules and regulations shall be mailed to every licensed processor and manufacturer of dairy products or trade products and all milk producer cooperatives operating within the state;
2. (2) The notice shall specify a time, no sooner than fifteen (15) days after the date of the notice, and the place for a hearing and shall allow for written objections to be filed five (5) days prior to the hearing;
3. (3) After the hearing, based on the evidence, any proposed rules and regulations shall be submitted by the commissioner to the attorney general and reporter for approval as to form and legality;
4. (4) Once the rules and regulations have been officially adopted and filed with the secretary of state, they shall become enforceable thirty (30) days after adoption and filing, and a copy of the official rules and regulations shall be mailed to all licensed processors and manufacturers of dairy products or trade products, and all milk producer cooperatives operating in the state. Also, copies shall be mailed to all registrants and licensed distributors of dairy products or trade products in the state;
5. (5) Proposals to promulgate rules and regulations may be made by the commissioner or by any other interested person. If any interested person other than the commissioner proposes rules and regulations, the person shall file an application in writing with the commissioner, giving the person's proposed rules and regulations, together with a brief statement of the reasons and needs for promulgating the rules and regulations. The commissioner may institute a hearing, as provided in this chapter, when the commissioner deems, after investigation and consideration of the proposal submitted by another interested person, that the proposal seems reasonable and justified or notify the person that the person's application has been denied and the grounds for the denial; and
6. (6) Any revision, amendment or termination of existing rules and regulations shall follow the same procedure as set forth in this section.
(e)
1. (1) Notwithstanding any rule promulgated under subsection (a) and except as provided in subdivision (e)(2), the department shall not regulate the production of unpasteurized butter provided that it is produced:
  1. (A) In a facility separate from production of pasteurized products;
  2. (B) Solely for intrastate commerce; and
  3. (C) By a person licensed by the department as a dairy plant.
2. (2) Any unpasteurized butter sold pursuant to this subsection (e) must bear the following warning on the principal display panel or panels of the label:
  1. WARNING: This product has not been inspected by the Department of Agriculture. Raw (unpasteurized) butter may contain disease-causing micro-organisms. Persons at highest risk of disease from these organisms include newborns and infants; the elderly; pregnant women; those taking corticosteroids, antibiotics, or antacids; and those having chronic illnesses or other conditions that weaken their immunity.

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53-3-201(6)

§ 53-3-105. Samplers and testers licenses.

(a) Samplers License and Fee. Every person receiving or buying milk or cream on the basis of its chemical or physical constituents shall be, or have in the person's employ, in or on each milk transport tank truck, a licensed milk sampler or tester. Application to become a licensed sampler shall be made to the commissioner on forms the commissioner may prescribe. The license shall expire on July 1 of each succeeding year. In order to qualify for a license, the applicant shall satisfy to the commissioner, either by a written examination or otherwise, that the applicant is honest and competent to do sampling work. An identification card stating the applicant's name and address and bearing the same number as the applicant's license shall be issued to the applicant at the time the applicant's license is issued and shall be carried on the applicant's person at all times while on duty. The annual license fee for a sampler shall be set by rule pursuant to § 43-1-703.
(b) Milk Testers License and Fee. Every person receiving or buying milk or cream on the basis of its chemical or physical constituents shall be, or have in the person's employ, a licensed milk tester to make the official analysis; and no other person shall be allowed to make the tests in any creamery, cheese factory, milk depot, milk plant, ice cream factory, cream station, milk condensery, or similar plant where milk or cream is bought or received on a basis of its chemical or physical constituents. Application to become a licensed milk tester shall be made to the commissioner on forms the commissioner may prescribe. If the applicant is found upon examination to be qualified and competent, the commissioner shall issue a license to the applicant. Licenses issued in accordance with this section shall be posted conspicuously in the tester's place of business. Licensed testers are also qualified and permitted to act as samplers. The annual license fee for a tester shall be set by rule pursuant to § 43-1-703.

§ 53-3-106. Manufacturer, plant and distributor licenses.

(a)
1. (1) Frozen Dessert Manufacturer's License. For purposes of licensing under this chapter, a dairy products plant that manufactures or packages frozen desserts, such as ice cream, ice cream mix, ice milk, ice milk mix, ice, or ice sherbets, or any trade product made in semblance of these products or that may be used as a substitute for these products, shall be licensed as a frozen dessert manufacturer. Any person making frozen dessert for sale shall be required to procure from the commissioner an annual frozen dessert manufacturer's license for each location or plant where frozen dessert is manufactured. The license fee for a frozen dessert manufacturer's license shall be set by rule pursuant to § 43-1-703.
2. (2) Dairy Plant or Trade Products Plant License, or Both. A dairy products plant or trade products plant that manufactures, processes, or packages any dairy products or trade products other than those listed as frozen desserts in subdivision (a)(1) shall be required to have a dairy plant license. Every person buying or receiving milk, cream, or dairy products from another for manufacturing, processing, or packaging shall be required to procure from the commissioner an annual dairy plant or trade products plant license for each location where milk, cream, dairy products, or trade products are received for the purpose of manufacturing, processing, or packaging. The license fees for a plant license shall be set by rule pursuant to § 43-1-703.
3. (3) Receiving Plant License. Any plant where fluid milk or cream not in consumer packages is received on consignment or otherwise, stored, or transported, but where packaging, processing, or manufacturing does not occur, shall be required to have an annual receiving plant license for each location or plant where milk or cream is received. The license fee for a receiving plant license shall be set by rule pursuant to § 43-1-703.
4. (4) Distributor's License. Every person buying or receiving from another person dairy products or frozen desserts or trade products, as defined in this chapter for the purpose of resale, shall be required to procure from the commissioner an annual distributor's license; provided, that no distributor's license shall be required of any license holder, licensed under this section, that delivers or distributes its own products. No distributor's license shall be required of any person who sells dairy products or trade products in hotels, restaurants, retail stores, or supermarkets if the dairy products or trade products have been delivered to the location of the hotel, restaurant, retail store, or supermarket by a licensed frozen dessert manufacturer, licensed dairy plant or trade product plant operator, or licensed distributor. No distributor's license shall be required of a receiving plant. The license fee for a distributor's license shall be set by rule pursuant to § 43-1-703.
(b)
1. (1)
  1. (A) Application for the license provided for in this section shall be made on forms prescribed by the commissioner and shall be accompanied by the required fee.
  2. (B) The license is to be issued by the commissioner after inspection and approval by the commissioner of the sanitary conditions of the place of business of the applicant.
  3. (C) Persons buying or receiving milk or cream from another, for sale or manufacture on the basis of the chemical or physical constituents in the milk or cream, or manufacturing or offering for sale dairy products or trade products as defined in this chapter, shall comply with and be governed by this chapter and all rules and regulations issued by the commissioner under authority of this chapter.
  4. (D) All licenses provided for in this section shall become due on July 1 of each year, and shall not be transferable.
2. (2) The commissioner, in issuing or renewing a license, shall give equal consideration to the location and person requesting the license, and the commissioner shall refuse to issue a license if, for any reason, in the commissioner's opinion, the location is unsatisfactory or the person is unqualified.

§ 53-3-107. [Reserved.]

§ 53-3-108. Revocation of licenses and registrations — Reissuance.

(a) The commissioner has the authority to revoke any license or registration certificate for violation of any section of this chapter. Upon information received, the commissioner shall, by written notice, establish a hearing for the licensee or registrant. The hearing shall be held within fifteen (15) days from the date of the mailing of the notice. If, after the hearing, the commissioner revokes the license, then the right of appeal is reserved to the licensee or registrant. The commissioner has the power to subpoena any persons or records incident to the hearing and further to administer oaths to those giving evidence. In case of contumacy or refusal to obey a subpoena issued to any person, any circuit or chancery court of this state within the county in which the investigation is carried on, or in which the person guilty of contumacy or refusal to obey is found or resides or transacts business, or has the person's principal place of business, upon application by the commissioner, shall have jurisdiction to issue to the person an order requiring the person to appear before the commissioner at a specified time and place and then and there produce evidence, if so ordered, or there to give testimony touching the matter under investigation or subject of inquiry, or answer any question, and any failure to obey the order of the court may be punished by the court as a contempt of the order as provided by law. A court reporter shall be in attendance at all revocation hearings other than testers or samplers.
(b) The action of the commissioner may be reviewed by petition for common law writ of certiorari addressed to the circuit or chancery court of Davidson County, and the petition shall be filed within ten (10) days from the date of the order of revocation issued by the commissioner. Upon the grant of the writ of certiorari, the commissioner shall certify to the court a complete transcript of the proceedings instituted before the commissioner. This certified transcript shall constitute the whole record, and no additional proof or evidence shall be considered by the circuit or chancery court of Davidson County. The decision of the commissioner shall remain final until the matter has been finally resolved by the courts.
(c) If, after revocation of the licensee's or registrant's license or registration, the licensee or registrant complies with the requirements of the law as provided and makes manifest, in writing, the licensee's or registrant's intentions to immediately observe the law, upon payment of the cost of the hearing, the commissioner may reissue a new license or registration certificate upon payment of the required fees. Reapplication may be made on forms provided by the commissioner, except in no case will reissuance of a license or registration certificate be allowed where fraudulent manipulation of tests or records is shown.
(d) It is the expressed intent of this section to preserve any appeal set forth in parts 2 and 3 of this chapter and to leave the appeal set forth in parts 2 and 3 of this chapter unaffected.

§ 53-3-109. Duties of licensees and registrants.

(a) Every person subject to a license or registration certificate under this chapter shall annually, on February 1, report to the commissioner, on blanks furnished by the commissioner, the location of the business and description of the premises, the name of the owner and manager, the amounts of the different dairy products or trade products processed, manufactured or distributed by the person during the year ending December 31 preceding, and other reasonable information the commissioner may prescribe.
(b)
1. (1) Every person licensed to buy milk and cream under this chapter shall keep, for a period of three (3) years, a legible record of all purchases made at the place where purchases are made, showing the weight of the purchases and test of the milk and cream at the place of purchase on the chemical or physical constituents and the total amount paid for the milk and cream.
2. (2) When a patron or producer is paid for milk or cream, a record shall be given the patron or producer showing the total amount paid and all factors, including gallons or weight, test, and price per unit used in arriving at the total amount paid to the patron or producer. This record shall also show any and all deductions made in determining the patron's or producer's net settlement. A duplicate copy of the record required by this subsection (b) or a duplicate of the check, where the required information is carried on the check, shall be kept on file for a period of three (3) years.
3. (3) If and when grades of milk and cream are established, the grades of the milk and cream shall be included in the purchase report and patron's and producer's record.
4. (4) It is unlawful not to keep these records or to falsify them.

§ 53-3-110. Only approved standard scales, weights, measures and tests to be used.

(a) Every person or agent for any person, buying milk or cream on the basis of its weights or chemical or physical constituents, as determined by an approved test, shall use only standard scales and measures approved by the commissioner and only standard weights and tests, bottles and pipettes approved by the commissioner.
(b) It is unlawful for any person to sell the articles listed in subsection (a) to anyone to be used for the purposes stated in subsection (a), unless they have been approved, as required in subsection (a), by the commissioner.

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59-8-111(c)(10)

§ 53-3-111. Tests to settle disputes between buyers and sellers.

(a) The commissioner is authorized and empowered to make tests that are necessary to settle disputes when called on by either a buyer or seller of milk, cream, or other dairy products, or trade products where disputes arise over dissatisfaction regarding weights or tests of dairy products.
(b) The tests made by the commissioner shall be prima facie correct, and shall be taken as a basis of settlement in the disputes.

§ 53-3-112. Inspection of products and establishments — Local regulations.

(a) At times the commissioner deems proper, the commissioner shall cause to be inspected all places where dairy products or trade products are made, stored or served as food for pay, and all places where cows are kept by persons engaged in the sale of milk or cream, and shall require the correction of all unsanitary conditions and practices found in those places.
(b)
1. (1) The governing authority of any municipal corporation, by ordinance, and any board of health, by regulation, may provide for the inspection of dairy products or trade products sold within its limits, dairy products or trade products plants and dairies and dairy herds kept for the production of milk or cream, and may prescribe the methods by which dairy products or trade products shall be handled, and may fix penalties for violation of ordinances and regulations; but no ordinance shall conflict in any way whatsoever with any law of this state, or any regulation promulgated by the commissioner, or interfere with any power or duty of the commissioner.
2. (2) It is unlawful for any political subdivision, agency or department of any political subdivision in this state to impose, collect or accept an inspection fee upon or from any person or firm in the state by reason of the fact the person or firm is a producer, transporter or a processor of dairy products.
3. (3)
  1. (A) Any Grade A milk, milk products or dairy products produced in a political subdivision of the state shall be accepted without further inspection in all other political subdivisions of the state or their police jurisdictions, if the products are produced or pasteurized under regulations that are substantially equivalent to the latest United States public health service recommended Grade A pasteurized milk ordinance, and that have been awarded an acceptable milk sanitation rating made by a state department of agriculture laboratory certifying officer and milk sanitation rating officer certified by the United States public health service, and acceptable to the commissioner.
  2. (B) All ungraded milk, whether used for manufacturing purposes or otherwise, shall be accepted in any political subdivision of this state without further inspection if produced in accordance with the regulations promulgated by the commissioner, setting out minimum standards for operation of manufactured milk product plants.

§ 53-3-113. Out-of-state products to meet requirements — Reciprocal inspection authorities and agreements.

(a) It is required that all dairy or trade products shipped into this state from another state shall meet the sanitary standards, definitions and requirements of the law, and the rules and regulations promulgated by the commissioner.
(b) The commissioner is authorized to establish acceptable reciprocal inspection authorities, interstate and intrastate, to properly enforce and administer this chapter in accordance with specifications and regulations adopted by the commissioner.
(c) A reasonable fee shall be charged for all out-of-state inspections where reciprocal inspections are not available and cannot be negotiated.

§ 53-3-114. Tagging and detention or destruction of products.

(a) Whenever a duly authorized agent of the commissioner finds or has good cause to believe that any dairy product or trade product is sold or offered for sale by any person contrary to this chapter or regulations established as authorized in this chapter, a tag or appropriate marking shall be affixed to the product giving notice that the product is not being sold in accordance with this chapter, and that no person shall remove or dispose of the product by sale or otherwise until permission for removal or disposal is given by the commissioner or the commissioner's duly authorized agent.
(b) In the event the product is unfit for human consumption, the commissioner or the commissioner's duly authorized agent may destroy it or authorize its disposal in a manner that is not a menace to public health.

§ 53-3-115. Violation of this part a misdemeanor — Penalty.

Any violation of this part, either doing acts prohibited by this part or failing to do the acts required by this part, including regulations adopted in accordance with this part, is a Class C misdemeanor.

§ 53-3-116. District attorney general to investigate and prosecute.

It is the duty of the district attorney general of the judicial district in which the commissioner reports a violation of this chapter, to investigate, prefer and prosecute charges if and when the district attorney general in the exercise of a sound discretion deems such action to be proper.

§ 53-3-117. Disposition of funds.

(a) All licenses, registration and inspection fees collected under this chapter shall be paid into the state treasury.
(b) The fees are appropriated exclusively to the department to be used solely and specifically in carrying out this chapter.

§ 53-3-118. Filing of a corporate surety bond by processors and distributors.

(a) Any processor or distributor required to be licensed under, or whose product is required to be registered under, the dairy law of this state, compiled in this chapter, who acquires or receives, on consignment or otherwise, market or fluid milk from producers or cooperative associations composed of producers, shall file with the commissioner a corporate surety bond payable to the state, for the use and benefit of any aggrieved person and in the form prescribed by the commissioner and conditioned for the payment by the processor or distributor of all amounts due for market or fluid milk purchased or otherwise acquired from producers or cooperative associations of producers by the processor or distributor.
(b) The bond shall be in an amount equal to the total purchases of market or fluid milk by the processor or distributor during the month of May of the preceding year, or if the processor or distributor was not engaged in business during the month of May of the preceding year, the bond shall be in an amount fixed by the commissioner. The bond required shall not, in any event, exceed fifty thousand dollars ($50,000).
(c) Any producer or cooperative association of producers aggrieved by reason of a processor's or distributor's failure or refusal to pay any amount of money due for purchases of market or fluid milk shall have a right of action to sue in its own name upon the bond and against the surety in any court of law or equity of this state having jurisdiction.
(d) The processor or distributor shall, at the time of paying the annual license or registration fees, file a corporate surety bond as provided in this section, which shall cover the term of the license or registration.
(e) If any applicant for the license or registration fails to file the corporate surety bond as required in this section, the commissioner may refuse to issue or renew the applicant's license or registration, or the commissioner may issue the license or registration conditioned upon the applicant's paying cash for all the applicant's market or fluid milk purchases; provided, that the applicant furnishes the commissioner with the names and addresses of all persons from whom the applicant purchases milk.

§ 53-3-119. Use of milk from hoofed mammal for owner's personal consumption or use — Safe milk-handling course — Cooperative agricultural extension funding — Records — Penalty.

(a) As used in this section:
1. (1) “Department” means the department of health; and
2. (2) “Farm owner” means a farm owner who tends to one (1) or more hoofed mammals for the purpose of producing milk to be consumed or otherwise used by an independent or partial owner of the hoofed mammal as authorized by subsection (b).
(b) Notwithstanding any law, an independent or partial owner of a hoofed mammal may use the milk from the mammal for the owner's personal consumption or other personal use in compliance with this section.
(c) A farm owner is encouraged to complete a safe milk-handling course offered by the University of Tennessee Agricultural Extension Service.
(d) If a farm owner complies with this section, then the farm owner may participate in the cooperative agricultural extension fund, created by § 49-50-103, for the purpose of receiving cooperative agricultural extension funding for dairy equipment and processing equipment that promotes public health, including, but not limited to, equipment for pasteurizing, testing, and bottling milk.
(e) In order to operate in a herd share program, a farm owner shall:
1. (1) Maintain a list of the names, addresses, phone numbers, and email addresses, if applicable, of all partial owners of a hoofed mammal;
2. (2) Maintain a contract on file between the farm owner and the partial owner of the hoofed mammal with clear terms of ownership and the rights resulting from that ownership; and
3. (3) Maintain a contract as described in subdivision (e)(2) that includes the following warning label:
  1. WARNING: Milk produced at this farm has not been inspected by the Department of Agriculture. Raw (unpasteurized) milk may contain disease-causing micro-organisms. Persons at highest risk of disease from these organisms include newborns and infants; the elderly; pregnant women; those taking corticosteroids, antibiotics, or antacids; and those having chronic illnesses or other conditions that weaken their immunity.
(f) A farm owner shall retain the records described in subsection (e) for each partial owner of a hoofed mammal for at least three (3) years following the end of the contract with that partial owner. A farm owner shall allow the department to inspect the records maintained according to subsection (e) upon request by the department.
(g) If a contamination event occurs on a farm owner's farm, then the farm owner shall:
1. (1) Allow the department access to the farm within twenty-four (24) hours following the contamination event to investigate on the farm and to complete lab testing;
2. (2) Cease all distribution of milk pursuant to this section until the investigation is completed and the cause of the contamination is determined and remedied to the satisfaction of the department; and
3. (3) Notify all partial owners of hoofed mammals by email, text message, or phone and provide a list of those partial owners to the department.
(h) If a farm owner violates this section, then the farm owner is subject to a civil penalty of five hundred dollars ($500).
(i) All moneys collected pursuant to this section must be transferred to the University of Tennessee Agricultural Extension Service for the sole purpose of offsetting the cost to farm owners for completing a course described in subsection (c).

§ 53-3-120. “Local Tennessee Milk”.

Any milk sold in this state may be labeled as “Local Tennessee Milk”, or a statement that indicates the milk is Tennessee milk, if the milk contains only milk produced in this state.

Part 2 Unfair Trade Practices

§ 53-3-201. Part definitions and general provisions.

As used in this part, unless the context otherwise requires:
1. (1) “Bulk milk” means milk in bulk form that is furnished to a processor for the purpose of processing and manufacturing into milk products;
2. (2) “Commissioner” means the commissioner of agriculture;
3. (3)
  1. (A) “Cost to the processor or distributor” means the actual cost of bulk milk and other ingredients, plus the cost of doing business properly allocable to each item covered by the term “milk products,” which cost of doing business includes, but is not limited to, labor, employee salaries, rent, maintenance and depreciation on real and personal property, shrinkage, interest, power, supplies, advertising, transportation and delivery costs, credit losses, all permits and license fees, all taxes, insurance and any and all other overhead expenses;
  2. (B) In the absence of proof to the contrary, the actual cost of bulk milk shall be presumed to be the cost as established by a federal marketing order effective in the area, or, if higher, the price established by a producer cooperative; or, in the absence of either, then the price that is effective in the nearest marketing area covered by a federal marketing order; and
  3. (C) The profit derived from the sale of one (1) product, whether the product is one of those included in the term “milk products,” or some other product, shall not be utilized in cost computations as a credit to, or deductions from, the cost of doing business properly allocable to any product embraced by the term milk products, so as to subsidize or lower the cost of doing business with respect to the milk products;
4. (4)
  1. (A) “Cost to the retailer” means the invoice price paid by the retailer for milk products, plus that portion of the retailer's overhead or cost of doing business properly allocable to the milk products, which cost of doing business shall include the same items of expense as are enumerated in the definition of cost to the processor or distributor in subdivision (3);
  2. (B) In the absence of specific evidence, the cost of doing business of a retailer shall be presumed to be ten percent (10%) of the invoice price, this cost to be calculated to the nearest whole cent on each sales unit; and
  3. (C) The cost of doing business of a retailer includes the fair value of any concession, of any kind whatever, that has the effect of reducing the actual sales price or increasing the cost of the goods delivered for the price stated in the invoice, including, but not limited to, the cost to the retailer of trading stamps or redeemable coupons;
5. (5) “Distributor” means any person engaged in the business of selling or offering for sale within the state milk products for consideration, where the property is sold for the purpose of resale or further processing, or is to be used or consumed by the purchaser and not resold or used for the purpose of further processing;
6. (6) “Milk products” means all or any one (1) of the following: market milk, pasteurized milk, vitamin-D milk, homogenized milk, flavored milk or flavored milk drinks, sweet cream, whipping cream, homogenized cream, skim milk, cottage cheese, buttermilk, and cultured buttermilk, as those products are defined by the commissioner under § 53-3-104, bulk milk as defined in this section, and all other products offered for sale by a milk processor or distributor, derived, in whole or in part, from milk, and frozen desserts, as described and defined by the commissioner under § 53-3-104;
7. (7) “Person” means and includes one (1) or more individuals, partnerships, associations, incorporated, unincorporated or cooperative, corporations, legal representatives, trustees in bankruptcy, receivers, or any other business unit, or any combination of these, except where the context otherwise requires;
8. (8) “Processor” means any person engaged in the business of processing or packaging bulk milk and other materials into milk products; and
9. (9) “Retailer” means any person, whether or not a processor or distributor, engaged in the business of selling or offering for sale within the state milk products for a consideration, where the milk products are to be used or consumed by the purchaser and are not to be resold or used for the purpose of manufacture or further processing.

§ 53-3-202. Prohibited practices.

(a) The prohibited practices described in this section are declared to be unfair trade practices and are prohibited and made unlawful when done with the intent or with the effect of injuring a competitor, of destroying competition or of creating a monopoly.
(b) No processor or distributor shall do, nor shall any retailer accept the benefit of, any of the following:
1. (1) Advertise, offer to sell or sell within the state, at wholesale or retail, any milk product for less than cost to the processor or distributor;
2. (2) Discriminate in price in the sale of any milk product between any of the towns or counties of this state; provided, that different prices that reflect actual transportation cost from point of processing to point of sale, or the actual transportation cost from point of purchase to point of resale, shall not be construed as discriminatory; or
3. (3) Give or offer to give any retailer or prospective retail customer of a processor or distributor, or of their agents or employees, any free service or any other thing of value, including, but not limited to, the following, which, together with any similar practices, are declared to be unfair trade practices when conducted with the intent of committing any of the acts outlined in this section: advertising allowance; brokerage fees or payments, or sales commissions, a part or all of which are passed on by the ostensible recipient of the fees, payments or commissions to the customer; compensation for jointly used advertising space; advertising displays of any kind, including, but not limited to, newspaper advertising, hand bills, booklets, television or radio advertising, and signs in or outside of the customer's place of business; furnishing of hosts or hostesses or demonstrators in stores to make sales to the store's customers; donations directly or indirectly made, whether by way of money, goods, labor or services; free equipment; cleaning and servicing of equipment; or rent on space used by retailer for storing or displaying processor's or distributor's merchandise. However, nothing in this subdivision (b)(3) shall be construed as prohibiting the furnishing, free of cost by a processor or distributor to a retailer, at the retailer's place of business, printed advertising material, such as recipes and informational materials for the promotion of the sale of the processor's or distributor's products.
(c) No retailer shall advertise, offer to sell or sell within the state any milk product for less than cost to the retailer.
(d) No person shall advertise, offer to sell or sell any milk product with any other commodity or service at a combined price that is less than the aggregate of the prices for which the milk product and the other commodity or service is separately offered for sale.
(e) In all proceedings brought to enforce this section, proof of consistent or repeated advertisements, offers to sell or sales of milk products at less than cost, as defined in this part, the advertisements, offers to sell and sales forming a pattern of sales below cost, shall be prima facie evidence of the intent to injure competitors and destroy or lessen competition.

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53-3-204

§ 53-3-203. Penalty for violations — Enforcement procedures — Regulations — Delegation of duties and powers by commissioner.

(a) Any person, or any trade association that is a representative of the person, claiming to be injured by reason of a violation of this part is authorized to file a written complaint with the commissioner, setting forth evidence the person may have, alleging that milk or milk products are being sold or offered for sale in violation of this part to the injury of the petitioner or injury to competition. Upon the filing of the complaint, the commissioner shall, with reasonable notice, require the person accused of violating this part to appear and answer the complaint and show cause why penalties provided in this part should not be imposed.
(b) Upon the finding by the commissioner that a violation of this part has occurred, the commissioner may:
1. (1) Revoke or suspend any license or permit issued by the department to the person found in violation of this part;
2. (2) Seek injunctive relief in any court of competent jurisdiction to enjoin any violation of this part;
3. (3) Impose civil penalties of up to one thousand dollars ($1,000) each day that a violation occurs; or
4. (4) Recover any and all expenses for investigation and prosecution of violations of this part from any person found in violation.
(c) The commissioner, any aggrieved person, or any trade association that is a representative of the person, may file an original injunction in the chancery court of the county in which the person who violates this part resides, to enjoin further violations of this part.
(d) The commissioner has the additional powers and duties to:
1. (1) Issue rules and regulations for the enforcement of this part, in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5; and
2. (2) Conduct hearings in accordance with the Uniform Administrative Procedures Act, and has the authority to issue subpoenas duces tecum, and have access to the records of those persons regulated by this part that are necessary and reasonable for the enforcement of this part.

§ 53-3-204. Exemptions.

Section 53-3-202 shall not apply to advertisements or offers to sell, or sales, where:
1. (1) The sales are made in an isolated transaction and not in the usual course of business, including, but not limited to, date commemoration, promotional events, grand openings and other temporary price reductions not intended to injure a competitor or injure or destroy competition. The isolated transactions shall not exceed three (3) days per month and, in any event, shall not exceed a total of fifteen (15) days in a twelve-month period;
2. (2) The merchandise is damaged;
3. (3) The items are sold upon the final liquidation of any business;
4. (4) The items are sold or given away for any charitable purposes;
5. (5) Bids are made in response to invitations from federal, state, county or municipal institutions and agencies, and contracts and deliveries pursuant to responses to invitations;
6. (6) The items are sold by an officer acting under the direction of any court;
7. (7) The price of the items is made in good faith to meet competition; provided, that the prices shall not be cut more than once, nor, in any event, cut below the price of competition;
8. (8) The items are sold for consumption on the premises where sold; or
9. (9) The items are sold within twenty-four (24) hours of the expiration or sell-by date imprinted on the item.

Part 3 Dairy Farmers Prosperity Act

§ 53-3-301. Short title.

This part shall be known and may be cited as the “Dairy Farmers Prosperity Act.”

§ 53-3-302. Category Tennessee prime milk established.

Notwithstanding any provision of law to the contrary, there is established a category of milk to be known as Tennessee prime milk and to be certified as such by the department for sale at retail.

§ 53-3-303. “Tennessee prime milk” — Defined.

For the purposes of this part, “Tennessee prime milk” means a quantity of milk obtained by the milking of one (1) or more healthy cows, not less than eighty percent (80%) of which quantity of milk is produced in this state.

§ 53-3-304. Certification.

Processors electing to have their milk certified as Tennessee prime milk shall make application to the department for such purpose and submit to all inspections deemed necessary by the department to attain such certification.

§ 53-3-305. Standards.

Tennessee prime milk sold at retail shall meet the following standards:
1. (1) Reduced fat milk shall contain at least ten percent (10%) milk solids not fat (SNF);
2. (2) Non-fat or skim milk shall contain at least nine percent (9%) milk solids not fat (SNF);
3. (3) Whole milk shall contain at least eight and one-half percent (8.5%) milk solids not fat (SNF);
4. (4) Milk set out in subdivisions (1)-(3) shall only contain milk or any other product that is produced in the United States; and
5. (5) Milk set out in subdivisions (1)-(3) shall only be packaged, bottled or processed in the United States.

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§ 53-3-306. Labeling.

The milk solids not fat (SNF) content and butterfat content shall be included on the labeling of all quantities and containers of Tennessee prime milk sold at retail.

§ 53-3-307. Documentation — Monthly analysis — Product samples — Costs.

(a) Only those products meeting the standards established in § 53-3-305 shall be labeled and sold as Tennessee prime milk.
(b) Dairy processors certified by the department to offer for sale Tennessee prime milk shall maintain documentation from a qualified laboratory acceptable to the department, such documentation to reflect monthly analyses of each product labeled Tennessee prime milk to ensure compliance with the standards established in § 53-3-305.
(c) All such documentary records, as well as all milk procurement and milk processing records, shall be made available to the commissioner upon request.
(d)
1. (1) In addition to the monthly analyses required by subsection (b), the commissioner may obtain samples of products for analyses to ensure compliance with the standards established in § 53-3-305, at the commissioner's discretion.
2. (2) The cost of performing such analyses and shipment to a qualified laboratory of such samples shall be borne by the appropriate processor.

§ 53-3-308. Sale of milk to dairy or trade products plant.

In order to facilitate the production and sale of Tennessee prime milk, dairy cooperatives doing business in Tennessee shall sell any reasonable quantity of milk to a dairy products plant or trade products plant that processes or packages Tennessee prime milk at the request of any such plant.

§ 53-3-309. Rules and regulations.

The commissioner of agriculture shall promulgate rules and regulations to effectuate the purposes of this part. All such rules and regulations shall be promulgated in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.

Chapter 7 Meat Inspection and Regulations

Part 1 Horsemeat

§ 53-7-101. Horsemeat sold or offered for sale to be denatured.

All horsemeat sold, offered for sale or exposed for sale shall be denatured with at least two percent (2%) charcoal or other similar inert ingredient and shall be in package form, and so labeled as to show that it contains horsemeat that has been denatured with at least two percent (2%) charcoal or other similar inert ingredient.

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§ 53-7-102. Enforcement — Rules and regulations.

The commissioner of agriculture or the commissioner's duly authorized representative is authorized to enforce § 53-7-101, and the commissioner is further authorized to adopt and promulgate rules and regulations for the enforcement of § 53-7-101.

§ 53-7-103. Penalty for violation of § 53-7-101.

Each person, firm or corporation violating § 53-7-101 commits a Class C misdemeanor.

Part 2 Tennessee Meat and Poultry Inspection Act

§ 53-7-201. Short title.

This part shall be known and may be cited as the “Tennessee Meat and Poultry Inspection Act.”

§ 53-7-202. Part definitions.

As used in this part, unless the context otherwise requires:
1. (1) “Adulterated” applies to any livestock, deer, or poultry carcass, part of any livestock, deer, or poultry carcass, meat food product or poultry product under one (1) or more of the following circumstances:
  1. (A) If it bears or contains any poisonous or deleterious substance that may render it injurious to health. In cases where the substance is not an added substance, the article shall not be considered adulterated under this subdivision (1) if the quantity of the substance does not ordinarily render it injurious to health;
  2. (B) If it bears or contains any added poisonous or added deleterious substance, unless the substance is permitted in its production or unavoidable under good manufacturing practices as may be determined by rules and regulations prescribed by the commissioner; provided, that any quantity of the added substances exceeding the limit so fixed shall also be deemed to constitute adulteration;
  3. (C) If any substance has been substituted, wholly or in part, for the livestock, deer, or poultry carcass, part of any livestock, deer, or poultry carcass, meat product or poultry product;
  4. (D) If damage or inferiority has been concealed in any manner;
  5. (E) If any valuable constituent has been, in whole or in part, omitted or abstracted from the livestock, deer, or poultry carcass, part of any livestock, deer, or poultry carcass, meat product or poultry product; or
  6. (F) If any substance has been added, mixed or packed with the livestock, deer, or poultry carcass, part of any livestock, deer, or poultry carcass, meat product or poultry product, so as to increase its bulk or weight, to reduce its quality or strength, or to make it appear better or of greater value than it is;
2. (2) “Bait” or “bait and switch” advertising is an alluring or fantastic offer or false and misleading offer that is not a bona fide offer to sell, but that is a means of attracting the prospective customer, the purpose being to sell or switch to some other product;
3. (3) “Carcass” means all parts, including viscera of a slaughtered animal, that are capable of being used for human food;
4. (4) “Commissioner” means the commissioner of agriculture, or any person authorized to act in the commissioner's stead;
5. (5) “Container” and “package” include any box, can, tin, cloth, plastic, or any other receptacle, wrapper or cover;
6. (6) “Custom slaughterer” means a person engaged for profit in this state in the business of slaughtering or dressing animals for human consumption that are not to be sold or offered for sale through a commercial outlet, and may include the boning or cutting up of carcasses of such animals and the grinding, chopping and mixing of the carcasses of animals;
7. (7) “Federal Meat Inspection Act” means the act of congress approved March 4, 1907, as amended and extended, compiled in 21 U.S.C. § 601 et seq., and the imported meat provisions of the Tariff Act of 1930, § 306(b) and (c), as amended (19 U.S.C. § 1306(c) [repealed] and 21 U.S.C. § 620);
8. (8) “Federal Poultry Products Inspection Act” means the act of congress approved August 28, 1957, as amended, compiled in 21 U.S.C. § 451 et seq.;
9. (9) “Immediate container” means any consumer package, or any other container in which an article, not consumer packaged, is packed;
10. (10) “Inspection service” means the official government service within the department of agriculture of this state designated by the commissioner as having the responsibility for carrying out this part;
11. (11) “Inspector” means an employee or official of this state authorized by the commissioner to inspect the operation and facilities of any custom slaughterhouse or meat or poultry processing establishment;
12. (12) “Intrastate commerce” means commerce within this state;
13. (13) “Label” means any written, printed, or graphic material upon the shipping container, if any, or upon the immediate container, including, but not limited to, an individual consumer package, of an article, or accompanying the article;
14. (14) “Livestock” means cattle, sheep, swine, goats or rabbits;
15. (15) “Meat” means the edible part of the muscle of cattle, deer, sheep, swine or goats that is skeletal or that is found in the tongue, in the diaphragm, in the heart, or in the esophagus, with or without the accompanying and overlying fat, and the portions of bone, skin, sinew, nerve and blood vessels that normally accompany the muscle tissue and that are not separated from it in the process of dressing. It does not include the muscle found in the lips, snout or ears;
16. (16) “Meat by-product” means any edible part other than meat that has been derived from one (1) or more cattle, deer, sheep, swine, goats or rabbits;
17. (17) “Meat food product” means any article of food, or any article intended for or capable of use as human food, that is derived or prepared, in whole or in part, from any portion of any livestock or deer, unless exempted by the commissioner upon the commissioner's determination that the article:
  1. (A) Contains only a minimal amount of meat and is not represented as a meat food product; or
  2. (B) Is for medicinal purposes and is advertised only to the medical profession;
18. (18) “Official establishment” means any establishment in this state, as determined by the commissioner, at which inspection of the slaughter of livestock or poultry or the processing of livestock, deer, or poultry carcasses or parts of livestock, deer, or poultry carcasses, meat food products, or poultry products, is maintained under the authority of this part;
19. (19) “Official inspection mark” means any symbol, formulated pursuant to rules and regulations prescribed by the commissioner, stating that an article was inspected and passed;
20. (20) “Person” means any individual, partnership, corporation, association, or any other business entity;
21. (21) “Poultry” means any live or slaughtered domesticated bird;
22. (22) “Poultry product” means any poultry that has been slaughtered for human food from which the blood, feathers, feet, head and viscera have been removed in accordance with rules and regulations promulgated by the commissioner, any edible part of poultry, or any human food product consisting of any edible part of poultry separately or in combination with other ingredients. However, any human food product may be exempted from this subdivision (22) by the commissioner upon the commissioner's determination that the product:
  1. (A) Contains only a minimal amount of poultry and is not represented as a poultry product; or
  2. (B) Is used for medicinal purposes and is advertised only to the medical profession;
23. (23) “Processor” means a person who engages for profit in this state in the business of packing or packaging carcasses, meat, meat food products or meat by-products, or poultry or poultry products, for human consumption, or a person engaged for profit in the business of curing, salting, processing or other preparing of carcasses, meat, meat food products or meat by-products for human consumption;
24. (24) “Shipping container” means any container used or intended for use in packaging the article packed in an immediate container;
25. (25) “Unwholesome” means:
  1. (A) Unsound, injurious to health, containing any biological residue not permitted by rules and regulations prescribed by the commissioner, or otherwise rendered unfit for human food;
  2. (B) Consisting, in whole or in part, of any filthy, putrid or decomposed substance;
  3. (C) Processed, prepared, packed or held under unsanitary conditions whereby any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass or any meat food product or poultry product may have become contaminated with filth or may have been rendered injurious to health;
  4. (D) Produced, in whole or in part, from livestock or poultry that is diseased, dead, dying or disabled and that has died otherwise than by slaughter;
  5. (E) Produced, in whole or in part, from deer that is diseased, dying, or disabled and that has died otherwise than by lawful harvest; or
  6. (F) Packaged in a container composed of any poisonous or deleterious substance that may render the contents injurious to health; and
26. (26) “Wholesome” means sound, healthful, clean and otherwise fit for human food.

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§ 53-7-203. Ante mortem and post mortem inspections — Quarantine, seizure, tagging, and destruction or reprocessing — Procedures.

(a)
1. (1) For the purpose of preventing the entry into or movement in intrastate commerce of any livestock or poultry carcass, part of any livestock or poultry carcass, meat food product or poultry product that is unwholesome or adulterated and is intended for or capable of use as human food, the commissioner shall, where and to the extent considered by the commissioner necessary, cause to be made by inspectors ante mortem inspection of livestock and poultry in any official establishment where livestock or poultry are slaughtered for intrastate commerce.
2. (2) For the purpose stated in subdivision (a)(1), the commissioner, whenever slaughtering or other processing operations are being conducted, shall cause to be made by inspectors post mortem inspection of the carcasses and parts of carcasses of each animal and bird slaughtered in any official establishment, and shall cause to be made by inspectors an inspection of all meat food products and poultry products processed in any official establishment in which meat food products or poultry products are processed for intrastate commerce.
(b)
1. (1) The commissioner shall cause, at any time, quarantine, seizure, segregation, and reinspection of livestock and poultry, livestock and poultry carcasses and parts of livestock or poultry carcasses, meat food products and poultry products in official establishments that the commissioner deems necessary to effectuate the purposes of this part.
2. (2) Whenever a duly authorized agent of the commissioner finds, or has probable cause to believe, that any livestock or poultry carcasses or part of livestock or poultry carcasses, processed meat food products or poultry products, in an official establishment or in other trade channels where the product is held or offered for sale, is adulterated or misbranded so as to be fraudulent or has been prepared, packed, processed or held under conditions whereby it may have become contaminated within the meaning of this part, the agent shall affix to the article a tag or other appropriate marking, giving notice that the article is, or is suspected of being, adulterated or misbranded and has been detained or quarantined, and warning all persons not to remove or dispose of the article by sale or otherwise until permission for removal or disposal is given by the agent or the court. It is unlawful for any person to remove or dispose of detained or quarantined articles by sale or otherwise without permission.
3. (3) All livestock and poultry carcasses and parts of livestock or poultry carcasses, meat food products, and poultry products found by an inspector to be unwholesome or adulterated in any official establishment or other trade channels where the product is held or offered for sale, shall be condemned and shall, if no appeal be taken from the determination of condemnation, be destroyed for human food purposes under the supervision of an inspector; provided, that articles that may, by reprocessing, be made not unwholesome and not adulterated need not be so condemned and destroyed if so reprocessed under the supervision of an inspector and thereafter found to be not unwholesome and not adulterated or not misbranded. If any appeal is taken to the commissioner from the determination, the articles shall be appropriately marked and segregated pending completion of an appeal inspection, which appeal shall be at the cost of the appellant if the commissioner determines that the appeal is frivolous or without merit. If the determination of condemnation is sustained, the articles shall be destroyed for human food purposes under the supervision of an inspector.
(c) One (1) inspector may be assigned to two (2) or more establishments where few animals are slaughtered or where small quantities of carcasses, meat or poultry or meat food products and poultry products are processed. When inspector assignments are made, the commissioner shall designate the days and hours when slaughtering and processing will be done.
(d) The licensee shall pay for devices and supplies used for marking and stamping and for carcass and meat containers and labels. The devices and supplies shall be under the control of the inspector.

§ 53-7-204. Inspection and sanitary standards for official establishments for slaughtering or processing of livestock or poultry.

(a)
1. (1) Each official establishment at which livestock or poultry are slaughtered or livestock, deer, or poultry carcasses or parts of livestock, deer, or poultry carcasses, meat food products, or poultry products are processed for intrastate commerce shall have the premises, facilities and equipment, and be operated in accordance with sanitary practices required by rules and regulations prescribed by the commissioner for the purpose of preventing the entry into and movement in commerce of carcasses, parts of carcasses, meat food products, and poultry products that are unwholesome or adulterated.
2. (2) Nothing in subdivision (a)(1) shall be construed as permitting the sale of deer.
(b) No livestock, deer, or poultry carcasses or parts of livestock, deer, or poultry carcasses, meat food products or poultry products shall be admitted into any official establishment, unless they have been prepared only under inspection pursuant to this part or the federal Meat Inspection Act (21 U.S.C. § 601 et seq.), or the federal Poultry Products Inspection Act (21 U.S.C. § 451 et seq.), or their admission is permitted by rules and regulations prescribed by the commissioner under this part.
(c) Each establishment licensed under this part that freezes meat or poultry carcasses, parts of meat or poultry carcasses or meat food products or poultry products must be equipped to quick or sharp freeze at ten degrees below zero Fahrenheit (-10°F) and otherwise be equipped to process, store and deliver frozen foods according to official regulations.
(d) The commissioner shall refuse to render inspection to any establishment whose premises, facilities or equipment, or the operation of the premises, facilities or equipment, fail to meet the requirements of this section.

§ 53-7-205. Official inspection marks and required labeling — Conforming products acceptable for intrastate commerce — False or misleading labels.

(a)
1. (1) Each shipping container of any meat, meat food product, or poultry product inspected under the authority of this part and found to be wholesome and not adulterated, shall, at the time the product leaves the official establishment, bear, in distinctly legible form, the official inspection mark and the approved plant number of the official establishment in which the contents were processed.
2. (2)
  1. (A) Each immediate container of any meat, meat food product or poultry product inspected under the authority of this part and found to be wholesome and not adulterated, shall, at the time the product leaves the official establishment, bear, in addition to the official inspection mark, in distinctly legible form, the name of the product, a statement of ingredients, if fabricated from two (2) or more ingredients, including a declaration as to artificial flavors, colors or preservatives, where the food additives are permitted by this part or regulations, the net weight or other appropriate measure of the contents, the name and address of the processor and the approved plant number of the official establishment in which the contents were processed.
  2. (B) The name and address of the distributor may be used in lieu of the name and address of the processor if the approved plant number is used to identify the official establishment in which the article was prepared and packed.
3. (3) Each livestock carcass and each primal part of a livestock carcass and meat by-products as hearts and livers shall bear the official inspection mark and approved plant number of the establishment when it leaves the official establishment.
4. (4) The commissioner may by rules and regulations require additional marks or label information to appear on livestock or poultry carcasses or parts of livestock or poultry carcasses, meat food products or poultry products when they leave the official establishments or at the time of their transportation or sale in this state, and the commissioner may permit reasonable variations and grant exemptions from the marking and labeling requirements of this subsection (a) in any manner not in conflict with the purposes of this part.
5. (5) Marks and labels required under this subsection (a) shall be applied only by, or under the supervision of, an inspector.
(b) Properly marked and labeled meat food products, poultry food products and carcasses or parts of livestock and poultry shall be acceptable for intrastate movement, and the products shall be acceptable for both public and institutional purchase.
(c)
1. (1) The use of any written, printed or graphic matter upon or accompanying any livestock or poultry carcass, or parts of livestock or poultry carcasses, meat food product, or poultry product inspected or required to be inspected pursuant to this part or the container of the livestock or poultry carcass, or parts of the livestock or poultry carcass, meat food products, or poultry products, that is false or misleading in any particular is prohibited.
2. (2) No livestock or poultry carcasses or parts of livestock or poultry carcasses, meat food products, or poultry products inspected or required to be inspected pursuant to this part shall be sold or offered for sale by any person, firm or corporation under any false or deceptive name. Established trade names that are usual to the articles and that are not false or deceptive and that are approved by the commissioner are permitted.
3. (3)
  1. (A) If the commissioner has reason to believe that any label in use or prepared for use is false or misleading in any particular, the commissioner may direct that the use of the label be withheld, unless it is modified in a manner the commissioner may prescribe so that it is not false or misleading.
  2. (B) If the person using or proposing to use the label does not accept the determination of the commissioner, the person may request a hearing, but the use of the label shall, if the commissioner so directs, be withheld pending hearing and final determination by the commissioner.
  3. (C) The determination by the commissioner shall be conclusive unless, within thirty (30) days after the receipt of notice of the final determination, the person adversely affected by the determination appeals the decision of the commissioner to the circuit court pursuant to the provisions for appeals provided in § 53-7-217.

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53-7-217(c)

§ 53-7-206. Prohibited acts.

The following acts or the causing of the following acts within this state is prohibited:
1. (1) The processing for, or the sale or offering for sale, transportation, or delivery or receiving for transportation, in intrastate commerce, of any livestock carcass or part of any livestock carcass, meat food product, or poultry product, unless the article has been inspected for wholesomeness, and unless the article and its shipping container and immediate container, if any, are marked in accordance with the requirements under this part or the federal Meat Inspection Act (21 U.S.C. § 601 et seq.), or the federal Poultry Products Inspection Act (21 U.S.C. § 451 et seq.);
2. (2) The sale or other disposition for human food of any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product, or poultry product that has been inspected and declared to be unwholesome or adulterated under this part;
3. (3) Falsely making or issuing, altering, forging, simulating, or counterfeiting, or using without proper authority any official inspection certificate, memorandum, mark, or other identification, or device for making the mark or identification, used in connection with inspection under this part, or causing, procuring, aiding, assisting in, or being a party to, the false making, issuing, altering, forging, simulating, counterfeiting, or unauthorized use, or knowingly processing, without promptly notifying the commissioner or the commissioner's representative, uttering, publishing, or using as true, or causing to be uttered, published, or used as true, any falsely made or issued, altered, forged, simulated, or counterfeited official inspection certificate, memorandum, mark, or other identification, or device for making the mark or identification, or representing that any article has been officially inspected under the authority of this part when the article has in fact not been so inspected, or knowingly making any false representation in any certificate prescribed by the commissioner in rules or regulations under this part or any form resembling the certificate;
4. (4) Using in intrastate commerce a false or misleading label on any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product, or poultry product;
5. (5) Engaging in or abetting another in bait and switch tactics in promoting for sale and selling livestock and poultry carcasses or parts of any livestock or poultry carcass, or meat products or poultry products and using false or misleading advertisements or for any advertising medium to knowingly publish false or misleading advertising;
6. (6) Using any container bearing an official inspection mark, except for the article in the original form in which it was inspected and covered by the mark, unless the mark is removed, obliterated or otherwise destroyed;
7. (7) Refusing to permit access by any duly authorized representative of the commissioner, at all reasonable times, to the premises of an establishment in this state at which livestock or poultry are slaughtered or livestock, deer, or poultry carcasses or parts of livestock, deer, or poultry carcasses, meat, meat food products, or poultry products are processed for intrastate commerce, upon presentation of appropriate credentials;
8. (8) Refusing to permit access to and the copying of any record as authorized by § 53-7-208;
9. (9) Using by any person to the person's own advantage, or revealing, other than to the authorized representatives of any government agency in their official capacity, or to the courts when relevant in any judicial proceeding, any information acquired under the authority of this part, concerning any matter that is entitled to protection as a trade secret;
10. (10) Holding, delivering, receiving, transporting, selling, or offering for sale or transportation in intrastate commerce, for human consumption, any uneviscerated slaughtered poultry, or any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product or poultry product that has been processed in violation of any requirements under this part, except as may be authorized by and pursuant to rules and regulations prescribed by the commissioner;
11. (11) Holding, delivering, receiving, transporting, selling, or offering for sale or transportation in intrastate commerce any livestock or poultry carcass or part of any livestock or poultry carcass, meat food product, or poultry product exempted under § 53-7-209 that is unwholesome or adulterated, and is intended for human consumption;
12. (12) Applying to any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product, or poultry product, or any container of any livestock, deer, or poultry carcass or any part of any livestock, deer, or poultry carcass, meat food product or poultry product, any official inspection mark or label required under this part, except by, or under the supervision of, an inspector;
13. (13) Refusing to make application for a license and refusing to pay, or operating a plant without payment of all license and inspection fees;
14. (14) Removing or selling any article detained or embargoed by an inspector;
15. (15) Violating any rule or regulation as authorized by this part;
16. (16) Disposing of or selling any dead, dying, diseased or disabled animals or poultry or carcasses or parts of any carcasses, except in a manner as prescribed by regulations of the commissioner; and
17. (17) The continued operation of any custom or commercial slaughterhouse or meat or poultry processing establishment that is in an unsanitary condition or that fails to comply with the specifications and standards that have been established by regulation by the commissioner.

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53-7-210(a)

§ 53-7-207. Compliance with law required for operation.

Subject to § 53-7-214(a), no establishment in this state shall slaughter any livestock or poultry or process any livestock, deer, or poultry carcasses, or parts of any livestock, deer, or poultry carcasses, meat food products, or poultry products, for human consumption, except in compliance with the requirements of this part.

§ 53-7-208. Records required — Inspection — Retention.

(a) For the purpose of enforcing this part, persons engaged in this state in the business of processing for intrastate commerce or transporting, shipping or receiving in intrastate commerce livestock or poultry slaughtered for human consumption, or meat, meat food products or poultry products, or holding the articles so received, shall maintain records the commissioner, by regulation, may require, showing, to the extent that they are concerned with the receipt, delivery, sale, movement or disposition of such articles, and shall, upon the request of a duly authorized representative of the commissioner, permit the duly authorized representative at reasonable times to have access to and to copy all the records.
(b) Any record required to be maintained by this section shall be maintained for a period of two (2) years after the transaction that is the subject of the record has taken place.

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§ 53-7-209. Exemptions.

(a) The commissioner shall, by regulation and under conditions as to labeling, and sanitary standards, practices, and procedures that the commissioner may prescribe, exempt from specific provisions of this part:
1. (1) Livestock producers and poultry producers with respect to livestock and poultry carcasses and parts of livestock and poultry carcasses, meat food products, and poultry products, processed by them from livestock or poultry of their own raising on their own farms, for their own consumption, the excess of which may be sold directly to consumers;
2. (2) Retail dealers with respect to meat and meat food products sold directly to consumers in individual retail stores; and retail dealers with respect to poultry products sold directly to consumers in individual retail stores, if the only processing operation performed by the retail dealers with respect to poultry is the cutting up of poultry products on the premises where the sales to consumers are made;
3. (3) Any person engaged in slaughtering livestock or poultry or processing livestock or poultry carcasses or parts of livestock or poultry carcasses, meat food products, or poultry products for intrastate commerce, and the articles so processed by the person, whenever the commissioner determines that it would be impracticable to provide inspection and the exemption will aid in the effective administration of this part;
4. (4) Persons slaughtering livestock or poultry or otherwise processing or handling livestock or poultry carcasses or parts of livestock or poultry carcasses, meat food products, or poultry products, that have been or are to be processed as required by recognized religious dietary laws, to the extent that the commissioner determines is necessary to avoid conflict with the requirements while still effectuating the purposes of this part;
5. (5) Poultry producers and growers acting in compliance with exemptions established in the federal Poultry Products Inspection Act (21 U.S.C. § 451 et seq.); and
6. (6) Livestock producers acting in compliance with exemptions established in the federal Meat Inspection Act. The department of agriculture shall maintain on its website information for livestock producers concerning the federal exemptions for livestock slaughter and processing to provide guidance as to the requirements for each federal exemption and its limitations.
(b) The commissioner may by order suspend or terminate any exemption under this section with respect to any person whenever the commissioner finds that the suspension or termination will aid in effectuating the purposes of this part.
(c) This part shall not apply to or affect the slaughter of swine or cattle or the processing of swine, deer, or cattle by or for individuals for their consumption at custom processing plants.
(d) The department of agriculture shall maintain on the website of the department information for poultry producers and growers concerning the federal exemptions for poultry slaughter and processing. Such information shall provide guidance as to the requirements for each exemption and the limitations thereto.

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§ 53-7-210. Violations — Injunctive action.

(a) Any violation of §§ 53-7-206 — 53-7-209, or of the rules and regulations duly promulgated by the commissioner pursuant to this part is a Class C misdemeanor; provided, that no carrier or warehouseman shall be subject to the penalties of this part, other than the penalties for violation of § 53-7-208, by reason of the receipt, carriage, holding, or delivery, in the usual course of business, as a carrier or warehouseman, of livestock or poultry carcasses, parts of livestock or poultry carcasses, meat food products, or poultry products, owned by another person, unless the carrier or warehouseman has knowledge, or is in possession of facts that would cause a reasonable person to believe that the articles were not inspected or marked in accordance with this part or were not otherwise in compliance with this part.
(b) In addition to the remedies provided in this part, the commissioner, or the commissioner's designated representative, may file for an injunction in the county in which an offense occurred, or in which the offender has the offender's principal place of business or is doing business, or resides, and if the chancellor concludes that the offender has been guilty of violating this part, then the chancellor may enjoin the offender, or owner, or manager, or other person in charge, from slaughtering, processing, handling, transporting or any other activity done in conjunction with meat or poultry for a period of not less than ten (10) days and until such time as the offender comes into compliance with this part. The injunction commences on the day following the date when the judgment becomes final.

§ 53-7-211. Violators entitled to notice and hearing preceding reports of violations to district attorney general — Alternatives to criminal prosecution.

(a) Before any violation of this part is reported by the commissioner to the district attorney general for institution of a criminal proceeding, the person against whom the proceeding is contemplated shall be given reasonable notice of the alleged violation and opportunity to present the person's views orally or in writing with regard to the contemplated proceeding.
(b) Nothing in this part shall be construed as requiring the commissioner to report for criminal prosecution violations of this part if the commissioner believes that the public interest will be adequately served and compliance with this part obtained by a suitable written notice or warning.

§ 53-7-212. Cease and desist orders.

(a) Whenever it is brought to the attention of the commissioner that any person operating an establishment continues to willfully operate in violation of this part and after written notice of the violations has been given, the commissioner may issue a cease and desist order against the establishment.
(b) The cease and desist order issued under subsection (a) shall set forth the reasons for its issuance, and shall be personally delivered to the person or the person's agents or sent by registered mail to the address of the establishment.
(c) If the person continues to ignore the cease and desist order, the commissioner is authorized to withdraw or deny inspection for such length of time as is necessary to effectuate compliance with this part.
(d) Any court review that might be desired of action taken by the commissioner shall be reviewed exclusively as provided for in § 53-7-217.

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53-7-217(c)

§ 53-7-213. Commissioner to promulgate rules and regulations. [Effective until contingency met. See the Compiler's Notes.]

(a) The commissioner is authorized to promulgate rules and regulations that in the commissioner's judgment will implement and help effectuate the purposes of this part.
(b)
1. (1) By rules and regulations, the commissioner is authorized to establish standards for meat and poultry and for meat food products and poultry products, and to prescribe labeling and advertising standards and requirements.
2. (2) Subdivision (b)(1) is not intended in any way to limit the commissioner's authority to prescribe other rules and regulations pursuant to this part.
(c) The rules and regulations shall be promulgated pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
(d) In promulgating rules and regulations pursuant to this part, the commissioner may consider rules and regulations that have been promulgated pursuant to the federal Meat Inspection Act (21 U.S.C. § 601 et seq.), or the federal Poultry Products Inspection Act (21 U.S.C. § 451 et seq.).

§ 53-7-213. Commissioner to promulgate rules and regulations. [For contingent amendment, see the Compiler's Notes.]

(a) The commissioner is authorized to promulgate rules and regulations that in the commissioner's judgment will implement and help effectuate the purposes of this part.
(b)
1. (1) The commissioner is authorized to promulgate rules to establish standards for poultry and poultry products, and to prescribe labeling and advertising standards and requirements for poultry and poultry products.
2. (2) The commissioner shall promulgate rules and appoint qualified personnel as are necessary to establish a state meat inspection program within the department of agriculture to perform inspections required by this part. The rules must establish standards for meat and meat food products, and prescribe labeling and advertising standards and requirements for meat and meat food products. The commissioner shall consult with the department of health and representatives of the meat industry in this state when promulgating rules required by this subdivision (b)(2).
3. (3) Subdivisions (b)(1) and (2) do not limit the commissioner's authority to prescribe other rules pursuant to this part.
(c) The rules and regulations shall be promulgated pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
(d)
1. (1) Except as required by subdivision (d)(2), in promulgating rules pursuant to this part, the commissioner may consider rules and regulations that have been promulgated pursuant to the federal Meat Inspection Act (21 U.S.C. § 601 et seq.) or the federal Poultry Products Inspection Act (21 U.S.C. § 451 et seq.).
2. (2) The rules promulgated pursuant to subdivision (b)(2) must conform with the federal Meat Inspection Act (21 U.S.C. § 601 et seq.) and incorporate the regulations compiled at 9 CFR, Chapter III, Subchapters A and E.
(e) The commissioner shall hire:
1. (1) One (1) state meat inspection program administrator who shall be responsible for:
  1. (A) Compiling documents to demonstrate adoption of, and statutory authority and food safety regulations to run, a meat inspection program; policies to implement inspection activities, sampling programs, humane handling, and compliance programs; civil rights accountability; and a proposed budget;
  2. (B) Submitting the documents listed in subdivision (e)(1)(A), along with any other required documents, to the federal food safety and inspection service (FSIS) of the United States department of agriculture, for the purpose of entering into a cooperative agreement with FSIS for a state meat inspection program; and
  3. (C) Performing other duties concerning the administration of a state meat inspection program, as determined by the commissioner;
2. (2) One (1) administrative assistant to assist the program administrator in carrying out the program administrator's duties; and
3. (3) Sufficient staff to inspect:
  1. (A) Livestock that are subject to inspection under this part;
  2. (B) Livestock carcasses, parts of livestock carcasses, and meat food products; and
  3. (C) Sanitary conditions of official establishments in which meat and meat food products are prepared.

§ 53-7-214. Relation of part to other laws. [Effective until contingency met. See the Compiler's Notes.]

(a) This part shall not apply to any act or transaction subject to regulation under the federal Meat Inspection Act (21 U.S.C. § 601 et seq.), or the federal Poultry Products Inspection Act (21 U.S.C. § 451 et seq.); provided, that inspectors are not excluded from making routine inspections and from taking samples at federally inspected plants for determining compliance with related federal acts and for compliance with state acts; and provided, further, that graduated license fees shall be required of those plants slaughtering livestock and poultry and processing meat food products and poultry products.
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(b) The commissioner may cooperate with the federal government in carrying out this part or the federal Meat Inspection Act or the federal Poultry Products Inspection Act.
(c) Compliance with this part does not relieve any person from compliance with the Tennessee Food, Drug and Cosmetic Act, compiled in chapter 1 of this title, and associated regulations and with the Testing and Sealing — Use of Weights and Measures Act, compiled in title 47, chapter 26, part 9, and associated regulations.

§ 53-7-214. Relation of part to other laws. [For contingent amendment, see the Compiler's Notes.]

(a) This part does not apply to any act or transaction subject to regulation under the federal Poultry Products Inspection Act (21 U.S.C. § 451 et seq.); provided, that inspectors are not excluded from making routine inspections and from taking samples at federally inspected plants for determining compliance with related federal acts and for compliance with state law.
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(b) Notwithstanding a law to the contrary, the commissioner may cooperate with the federal government in carrying out this part or the federal Meat Inspection Act for a state inspection program for interstate commerce.
(c) Compliance with this part does not relieve any person from compliance with the Tennessee Food, Drug and Cosmetic Act, compiled in chapter 1 of this title, and associated regulations and with the Testing and Sealing — Use of Weights and Measures Act, compiled in title 47, chapter 26, part 9, and associated regulations.

§ 53-7-215. Cost of inspections borne by department of agriculture — Exception.

The cost of inspections made to effectuate this part shall be borne by the department of agriculture; provided, that any extra cost of inspection resulting from overtime operation shall be borne by the establishment operating overtime pursuant to reasonable rules and regulations with respect to inspections that may be promulgated by the commissioner.

§ 53-7-216. License required for the operation of an establishment — Application.

(a) No person shall maintain an establishment for the slaughtering of livestock or poultry or the processing of livestock, deer, or poultry without first having secured a license from the department of agriculture and having paid all inspection and license fees.
(b) Each separate business location shall be licensed, and the license shall not be transferable.
(c) Any person desiring a license shall make written application to the commissioner, stating the information required by the commissioner.
(d) Upon receipt of the application, the department shall make an examination and inspection of the establishment, and if it is found to be in a sanitary condition and to conform to the requirements of this part and of the regulations promulgated pursuant to this part, the commissioner, upon receipt of the license and inspection fees provided in § 53-7-219, shall issue a license authorizing the applicant to carry on the establishment for the slaughtering of livestock or poultry or the processing of livestock, deer, or poultry.
(e) The license shall be valid for the remainder of the calendar year for which it is issued.

§ 53-7-217. Revocation or suspension of license — General provisions for hearings and appeals.

(a)
1. (1) If any establishment licensed under this part is deemed by the commissioner to be operated or maintained in any unsanitary manner, or in violation of any of this part or of any regulation duly promulgated pursuant to this part, the commissioner may give written notice of at least ten (10) days to the person operating the establishment to appear before the commissioner or the commissioner's designated hearing officer at a time and place to be set out in the written notice, to show cause why the license of the establishment should not be suspended or revoked. Upon the hearing, the person or establishment cited may be heard in person or with counsel, or both, may present evidence, and may cross-examine witnesses. A full and complete record of the hearing shall be recorded and any party to the proceedings, upon request, shall be supplied with a transcript of the proceedings at the usual cost.
2. (2) The commissioner is authorized, in the commissioner's discretion, to appoint and designate a hearing officer who shall preside at the hearing in the place of and in the absence of the commissioner. The hearing officer shall have the power and authority to conduct the hearing, to administer oaths, and make findings of fact, conclusions of law, and the proposed order based on the findings of fact and conclusions of law. If the commissioner concurs, the commissioner shall issue the order; or the commissioner may, upon review of the record, make findings, conclusions and issue orders that, in the commissioner's discretion, the record justifies.
3. (3) Any person whose license has been suspended or revoked by the commissioner pursuant to a hearing under this section shall be assessed and shall pay all costs in connection with the hearing. The commissioner shall take all steps necessary to collect the costs as may be authorized under the statutes of the state in the same manner as now authorized for the collection of taxes by the state.
4. (4) No later than sixty (60) days following the hearing, the commissioner shall issue any order that may be appropriate under the circumstances, and the commissioner may, if the facts adduced at the hearing warrant, suspend for any period or revoke any license issued under this part.
(b)
1. (1) The action of the commissioner and the order issued by the commissioner may be reviewed by petition for common law writ of certiorari, addressed to the circuit court of Davidson County, which petition shall be filed within ten (10) days from the date the order of the commissioner is made.
2. (2) Immediately upon the grant of the writ of certiorari, the commissioner shall cause to be made, certified and forwarded to the court a complete transcript of the proceedings in the cause, which shall contain all the proof submitted before the commissioner. All defendants named in the petition desiring to make defense shall answer or otherwise plead to the petition within ten (10) days from the date of the filing of the transcript, unless the time is extended by the court.
3. (3) The decision of the commissioner shall be reviewed by the circuit court solely upon the pleadings and the transcript of the proceedings before the commissioner or the hearing examiner, and neither party shall be entitled to introduce any additional evidence in the circuit court.
4. (4) Either party dissatisfied with the judgment or decree of the circuit court may, upon giving bond as required in other suits, appeal, and have a reexamination, in that court, of the whole matter of law and fact appearing in the record. When the appeal is made, the clerk of the circuit court in which the suit was pending shall include as a part of the record the original certified transcript of the proceedings had before the commissioner.
(c) This section with regard to hearing and appeal shall also apply to actions of the commissioner pursuant to §§ 53-7-205, 53-7-212, 53-7-218 and 53-7-220, and shall be available to any party aggrieved by any act of the commissioner pursuant thereto.

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§ 53-7-218. Exclusive method of reviewing orders of commissioner — Disposition of confiscated property.

(a) The remedy and procedure provided in § 53-7-217 shall be the exclusive method of reviewing all orders of the commissioner issued pursuant to the hearing authorized by this part and shall be the sole remedy of any petitioner or claimant. No judge or any court shall have the authority or jurisdiction to interfere by replevin, injunction, supersedeas or in any other manner, with any order of the commissioner issued pursuant to this part, but the order shall remain in full force and effect until the final decision of the supreme court, except where the judgment of the circuit court is not appealed from and has become a final judgment.
(b)
1. (1) When the order of the commissioner or the judgment of any court becomes final, authorizing a seizure or confiscation, the device, material, article, commodity, product or any other thing being used, possessed or handled in contravention of this part shall be destroyed by the commissioner.
2. (2) If no petition or claim is interposed, the property seized or confiscated shall be forfeited without further proceedings and the property shall be disposed of as provided for in subdivision (b)(1).

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53-7-217(c)

§ 53-7-219. Fees for licenses and inspections.

The fee for licenses and inspection issued pursuant to this part shall be set by rule pursuant to § 43-1-703.

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53-7-216(d)

§ 53-7-220. Licensing of custom slaughterers — Fee.

(a) Upon application, custom slaughterers shall also be licensed by the department of agriculture for the same periods of time as other licensees; provided, that the custom slaughterers first satisfy the commissioner that they are qualified and competent to conduct their operations in conformity with the applicable provisions of this part and regulations duly promulgated pursuant to this part.
(b) No person shall engage in custom slaughtering or deer processing without first being licensed.
(c) The department shall collect from each custom slaughterer or deer processor an annual license fee set by rule pursuant to § 43-1-703.

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53-7-217(c)

§ 53-7-221. State cooperation with federal and local entities — Expenditure funding. [For contingent enactment, see Compiler's Notes.]

(a) The commissioner is designated as the state official responsible for cooperating with the United States secretary of agriculture under the federal Meat Inspection Act (21 U.S.C. § 601 et seq.). The commissioner shall cooperate with the United States secretary of agriculture in developing and administering the meat inspection program of this state under this part to assure that its requirements will be at least equal to those imposed by the federal Meat Inspection Act (21 U.S.C. § 601 et seq.), and in developing and administering the program of this state under this part in a manner that will effectuate the purposes of this part and federal law.
(b) The commissioner may accept from the United States secretary of agriculture advisory assistance in planning and developing the state program, technical and laboratory assistance and training, and financial and other aid for administration of the program.
(c) The commissioner may spend public funds of this state, subject to appropriation in the general appropriations act, for administration of this part to pay this state's cost of the cooperative programs developed under this section.
(d) The commissioner may recommend to the United States secretary of agriculture such officials or employees of this state as the commissioner designates for appointment to the advisory committee provided for in 21 U.S.C. § 661(a)(4), and the commissioner shall serve as the representative of the governor of this state for consultation with the United States secretary of agriculture under 21 U.S.C. § 661(c), unless the governor designates another representative.
(e) For the purpose of preventing and eliminating burdens on intrastate commerce with respect to meat and meat products, the jurisdiction of the commissioner within the scope of this part is exclusive, and a county or municipal board of health or other county or municipal agency does not have any power or jurisdiction to regulate the slaughtering of any livestock or the processing or transportation of the carcasses or parts thereof or the meat and meat food products of such animals, nor does any county or municipal board of health or other county or municipal agency have any power or jurisdiction with regard to the inspections provided for in this part, nor with respect to any other activity committed to the authority of the commissioner by this part.
(f)
1. (1) In carrying out this part, the commissioner may cooperate with all other branches of government, county and municipal, and with county and municipal health departments or other agencies and may conduct such examinations, investigations, and inspections as provided for in this part and as the commissioner determines practical through any officer or employee of this state or any municipality or county in this state qualified for such purpose.
2. (2) The commissioner may contract with any municipal or county health departments to carry out the duties and requirements of this part. Any municipal or county health department may contract with the commissioner for the purpose of meeting the requirements of this part.
(g) This section does not preclude or restrict any municipality or county from the exercise of its police powers with regard to the establishment and maintenance of the facilities at which the activities regulated by this part are conducted.

Part 3 Tennessee Biological Residue Act of 1972

§ 53-7-301. Short title.

This part shall be known and may be cited as the “Tennessee Biological Residue Act of 1972.”

§ 53-7-302. Part definitions.

As used in this part, unless the context otherwise requires:
1. (1) “Animal” means any member of the animal kingdom whether domesticated or wild, but not including humans;
2. (2) “Animal product” means any product derived from any animal or animals that is or could be suitable for human consumption;
3. (3) “Biological residue” means any substance, including metabolites, remaining in or on any animal prior to or at the time of slaughter, in or on any of its tissues after slaughter, or in or on any animal product as the result of treatment with or exposure of the animal or animal product to any pesticide, organic or inorganic compound, hormone-like substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or other therapeutic or prophylactic agent;
4. (4) “Commissioner” means the commissioner of agriculture or the commissioner's designated representative; and
5. (5) “Person” means any individual, partnership, corporation, association or other business unit.

§ 53-7-303. Administration — Detention, quarantine and destruction of affected animals and animal products.

(a) This part shall be administered by the commissioner.
(b) Whenever any animal or animal product is found within the state to bear or contain any biological residue that has been found to be hazardous to human health, as well as any other animal or animal product that the commissioner has reason to believe contains a biological residue, it may be detained or quarantined by order of the commissioner. The animal or animal product shall remain under detention or quarantine until such time as:
1. (1) The commissioner determines that the animal or animal product is within established tolerances; or
2. (2) The animal or animal product is destroyed or otherwise disposed of in accordance with regulations that the commissioner shall prescribe.

§ 53-7-304. Right of entry for examination purposes.

The commissioner may enter at normal business hours every place where animals or animal products are kept within the state, to examine the facilities, inventory and records pertaining to the animals or animal products, to copy all records, and to take reasonable samples of any animals or animal products, and to make additional investigations as to the source and use of substances contributing to biological residues.

§ 53-7-305. Authority of commissioner to promulgate tolerance regulations.

(a) The commissioner shall promulgate regulations setting forth tolerances for biological residues in or on animals or animal products that are consistent with tolerances adopted under authority of the Tennessee Food, Drug and Cosmetic Act, compiled in chapter 1 of this title and the Tennessee Meat and Poultry Inspection Act, compiled in part 2 of this chapter.
(b) No tolerances may be adopted that are in excess of or that are more restrictive than those adopted by the United States department of agriculture or the federal food and drug administration for biological residues.

§ 53-7-306. Violation of provisions — Penalties.

A violation of this part is a Class C misdemeanor.

§ 53-7-307. Injunctive relief.

In addition to the remedies provided in this part, the commissioner may apply to any chancery court, and the chancery court shall have jurisdiction, for a temporary or permanent injunction restraining any person from violating this part, regardless of whether or not there exists an adequate remedy at law.

Chapter 8 Establishments Selling Food

§ 53-8-101. Short title.

This chapter shall be known as the “Tennessee Retail Food Safety Act.”

§ 53-8-102. Purpose.

It is the purpose of this chapter to ensure that foods offered for public consumption in this state are safe as prepared, processed, served, packaged, and delivered. Food service establishments that are located within retail food stores are subject to this chapter and exempt from regulation in accordance with the Tennessee Food Safety Act, compiled in title 68, chapter 14, part 7.

§ 53-8-103. Chapter definitions.

As used in this chapter:
1. (1) “Alteration” shall be defined by rule, but shall not mean function replacement that equals or makes better the existing operation of the facility;
2. (2) “Commissioner” means the commissioner of agriculture, the commissioner's duly authorized representative, and in the event of the commissioner's absence or vacancy in the office of commissioner, the deputy commissioner;
3. (3)
  1. (A) “Demonstration of knowledge” means the ability to demonstrate knowledge of food safety principles as applicable to establishments regulated in accordance with this chapter;
  2. (B) For the purposes of this chapter, “demonstration of knowledge” may be accomplished by one (1) or more of the following means:
    1. (i) Completing an inspection that reflects no priority item violation;
    2. (ii) Employing at least one (1) person certified as a food protection manager who has shown proficiency of food protection information through passing a test that is part of a certification program that is evaluated and listed by an accrediting agency recognized by the Conference for Food Protection as conforming to the Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Programs; or
    3. (iii) Responding correctly to food protection questions related to the specific food operation. A person responding to the questions may be aided by the utilization of food safety procedures posted prominently for employees who may use the procedures as reference guides. The commissioner shall assist establishments that request information relative to risks associated with the establishments' specific food operation, which may be posed as questions during the inspection;
4. (4) “Department” means the department of agriculture;
5. (5) “Employee” means a person:
  1. (A) In charge of a food establishment;
  2. (B) Engaged in the preparation of food or drink;
  3. (C) Engaged in service of food to the establishment's clientele; or
  4. (D) Engaged in ware washing;
6. (6) “Extensive remodeling” means the repair, construction, alteration or installation of new equipment, modification of existing equipment or fixtures, changes in floor plan layout, addition of new processes, expansion to new space, or significant changes to use of space or equipment;
7. (7) “Farm to consumer distribution point” means a temporary or permanent location, that is not open to the general public, where a farmer or the farmer's agent delivers food, produced by the farmer and previously sold under an agreement entered into between the farmer and the consumer, directly to the consumer or the consumer's agent;
8. (8) “Food Code” means the 2009 Food Code as published by the United States department of health and human services, public health service, food and drug administration;
9. (9)
  1. (A) “Food establishments” means retail food stores, and food service establishments located within retail food stores;
  2. (B) The term “food establishments” is to be used throughout this chapter when a provision is applicable to both retail food stores and food service establishments located within retail food stores;
10. (10)
  1. (A) “Food service establishment” means any establishment, place or location, whether permanent, temporary, seasonal, or itinerant, where food is prepared and the public is offered to be served or is served food, including, but not limited to, foods, vegetables, or beverages not in an original package or container, food and beverages dispensed at soda fountains and delicatessens, sliced watermelon, ice balls, or water mixtures;
  2. (B) “Food service establishment” includes places identified in subdivision (10)(A), regardless of whether there is a charge for the food;
  3. (C) “Food service establishment” does not include private homes where food is prepared or served and not offered for sale, retail food store operations other than delicatessens, the location of vending machines or supply vehicles;
  4. (D) “Food service establishment” does not include churches, temples, synagogues or other religious institutions, civic, fraternal, or veteran's organizations where food is prepared, served, transported, or stored by volunteer personnel only on non-consecutive days; provided, however, that the storage of unopened, commercially canned food, packaged bulk food that is not potentially hazardous as defined by department rules and regulations, and dry goods shall not apply for these purposes;
  5. (E) “Food service establishment” does not include grocery stores that may, incidentally, make infrequent casual sales of uncooked foods for consumption on the premises, or any establishment whose primary business is other than food service, that may, incidentally, make infrequent casual sales of coffee or prepackaged foods, or both, for consumption on the premises. For the purposes of this subdivision (10)(E), “infrequent casual sales” means sales not in excess of one hundred fifty dollars ($150) per day on any particular day;
  6. (F) “Food service establishment” does not include a location from which casual, occasional food sales are conducted solely in connection with youth-related amateur athletic or recreational activities or primary or secondary school-related clubs by volunteer personnel and that are in operation for twenty-four (24) consecutive hours or less;
  7. (G) “Food service establishment” does not include a catering business that employs no regular, full-time employees, the food preparation for such business is solely performed within the confines of the principal residence of the proprietor, and the catering business makes only “occasional sales” during any thirty-day period; and
  8. (H) “Food service establishment” does not include a house or other residential structure where seriously ill or injured children and their families are provided temporary accommodations in proximity to their treatment hospitals and where food is prepared, served, transported or stored by volunteer personnel; provided, that the house or structure is supported by a § 501(c)(3) organization, as defined in 26 U.S.C. § 501(c)(3), that has as a component of its mission the support of programs that directly improve the health and well-being of children;
11. (11) “Imminent health hazard” means any condition, deficiency, or practice that, if not corrected, is very likely to result in illness, injury, or loss of life to any person;
12. (12) “Person” means any individual, partnership, firm, corporation, agency, municipality, state or political subdivision, or the federal government and its agencies and departments;
13. (13) “Person in charge” means an individual present at a food establishment who is responsible for the operation at the time of inspection. A “person in charge” shall be present at the establishment during food preparation and handling, and may put instructions in place for cleaning and preparing the establishment prior to the preparation of any food or beverage; and
14. (14)
  1. (A) “Retail food store” means any establishment or a section of an establishment where food and food products are offered to the consumer and intended for off-premise consumption;
  2. (B) “Retail food store” does not include:
    1. (i) Establishments that handle only prepackaged, non-potentially hazardous foods, as defined by department rules and regulations;
    2. (ii) Roadside markets that offer only fresh fruits and fresh vegetables;
    3. (iii) Food and beverage vending machines;
    4. (iv) Food service establishments not located within a retail food store; or
    5. (v) A person who makes infrequent casual sales of honey or who packs or sells less than one hundred fifty gallons (150 gals.) of honey per year.

§ 53-8-104. Authority of commissioner.

(a) The commissioner is authorized to:
1. (1) Carry out or cause to be carried out all provisions of this chapter;
2. (2) Collect all fees established pursuant to this chapter and apply the fees in accordance with the procedures of the department of finance and administration to the necessary and incidental costs of the administration of this chapter. Nothing in this subdivision (a)(2) shall be construed to prohibit the department from receiving, by way of general appropriation, such sums as may be required to fund adequately the implementation of this chapter, as recommended in the annual budget by the governor to the general assembly;
3. (3) Prescribe rules and regulations, including emergency rules, governing the alteration, construction, sanitation, safety of food, and operation of food establishments as may be necessary to protect the health and safety of the public, and require food establishments to comply with these rules and regulations. A non-elected body of any municipality, county, or metropolitan government shall not enact any ordinance or issue any rule or regulation pertaining to food safety or the provision of nutritional information related to food or drink, or otherwise regulate menus at food establishments. If, on July 1, 2015, the federal government takes action regarding the provision of food nutritional information at food establishments, and the federal action specifically authorizes state agencies to enforce such action, then the department of agriculture shall be the department that is primarily responsible for the implementation and supervision of any new requirements and shall have the authority to promulgate rules and regulations in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, as necessary to effectuate the purposes of such requirements. The commissioner shall not prescribe any such rules and regulations that are in conflict with the minimum statewide building construction standards established by the state fire marshal pursuant to § 68-120-101. The rules with respect to food temperature shall be specific with respect to the types of food prepared and the risks presented by those foods. Except as specifically provided herein, the commissioner may, by the promulgation of rules and regulations, adopt all or part of the Food Code;
4. (4) Inspect or cause to be inspected as often as the commissioner, in the commissioner's discretion may deem necessary, every food establishment in the state as authorized by this chapter, to determine compliance with this chapter and with rules and regulations;
5. (5) Issue or cause to be issued, suspend, and revoke permits to operate food establishments as provided in this chapter;
6. (6) Notify the owner, proprietor, or agent of any food establishment of such changes or alterations as may be necessary, to effect complete compliance with this chapter and with rules and regulations governing the construction, alteration, and operation of the facilities, and close the facilities for failure to comply within specified times as provided in this chapter and in rules and regulations;
7. (7) Enter into agreements or contracts with the Shelby, Davidson, and Knox county health departments for the health departments to implement this chapter in their areas of jurisdiction, if the commissioner deems it appropriate; provided, that the following conditions shall apply:
  1. (A) State reporting requirements shall be met by the county health department or departments;
  2. (B) The county health department program standards shall be identical to those of the state law, and to rules and regulations;
  3. (C) The commissioner shall retain the right to exercise oversight and evaluation of performance of the county health department or departments and terminate the agreement or contract for cause immediately, or otherwise upon reasonable notice;
  4. (D) The commissioner may set such other fiscal, administrative, or program requirements as the commissioner deems necessary to maintain consistency and integrity of the statewide program;
  5. (E) Staffing and resources shall be adequate to implement and enforce the program in the local jurisdiction;
  6. (F) Contract county health departments that collect the applicable permit fees from food establishments located within the county shall retain one hundred percent (100%) of the permit fees and penalty fees. Contract counties that utilize the services of the department for the collection of permit fees shall receive ninety-five percent (95%) of permit fees collected within a contract county pursuant to §§ 53-8-104 — 53-8-106. This amount shall be calculated based upon fees collected in the contract county during the state's fiscal year multiplied by ninety-five percent (95%).
(b)
1. (1) Upon the application of a food establishment for a variance based on a showing of good cause and an affirmative demonstration that the risks to the public attendant to the limited activities have been mitigated, the commissioner shall grant the establishment a variance from the limitations in the Food Code regarding restrictions pertaining to bare hand contact. A request for a variance shall be granted or denied within sixty (60) days of the commissioner's receipt of the application for variance. A request for a variance shall include the following:
  1. (A) A listing of the specific ready-to-eat foods that are touched by bare hands;
  2. (B) Diagrams and other information showing that hand washing facilities are located and equipped as prescribed by the applicable provisions of the Food Code;
  3. (C) An employee health policy documenting that the food service establishment complies with:
    1. (i) The person in charge requirements; and
    2. (ii) Requirements for monitoring the health of food service employees;
  4. (D) Documentation that food service employees have received training on the:
    1. (i) Risks of contacting ready-to-eat foods with bare hands;
    2. (ii) Practice of proper hand washing;
    3. (iii) Proper fingernail maintenance;
    4. (iv) Prohibition on jewelry; and
    5. (v) Good hygienic practices;
  5. (E) Documentation that food employees contacting ready-to-eat foods with bare hands used two (2) or more of the following control measures:
    1. (i) Double hand washing;
    2. (ii) Nail brushes;
    3. (iii) A hand antiseptic after hand washing;
    4. (iv) Incentive programs that assist or encourage food service employees not to work when they are ill; or
    5. (v) Other control measures approved by the commissioner.
2. (2) Notwithstanding any provisions of the Food Code to the contrary, the commissioner shall not require any further documentation for the granting of a variance other than those contained in this section.

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53-8-104(a)(7)(F)

§ 53-8-105. Appropriation of moneys.

All moneys coming into the state treasury pursuant to this chapter from fees, fines, and penalties shall be appropriated to the department for the payment of necessary expenses incident to the administration of this chapter, as determined by the commissioner. Any unexpended balance of the fund in any fiscal year shall be retained by the department to be used to provide or expand training for food service operators and the department's food safety staff.

§ 53-8-106. Permits — Expiration — Transfer not allowed — Display.

(a) No person shall operate a food establishment who does not hold a valid permit issued to the person by the commissioner on or before July 1 of each year, or as the commissioner may otherwise provide by rule and regulation.
(b) Every person now engaged in the business of operating a food establishment, and every person who, on July 1, 2015, engages in such a business, shall procure a permit from the commissioner for each food establishment so operated or proposed to be operated.
(c) Each permit for food establishments shall expire on June 30 following its issuance or as the commissioner may otherwise provide by rule and regulation.
(d) No permit shall be transferred from one (1) location or person to another.
(e) The permit shall be kept and displayed in a conspicuous manner, and visible to the public in the food establishment for which it is issued.

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53-8-104(a)(7)(F)

§ 53-8-107. Application for permits — Inspection — Renewals — Exception.

(a) Any person planning to operate a food establishment shall first submit an application for a permit on forms provided by the commissioner. The application shall be completed and submitted to the commissioner with the proper permit fee.
(b) Prior to the approval of the application for a permit, the commissioner shall inspect the proposed facility to determine if the person applying for the permit is in compliance with the requirements of this chapter and with applicable rules and regulations. The commissioner shall issue a permit to the applicant if the inspection reveals that the facility is in compliance with such requirements.
(c) Applications for renewal of permits for existing food establishments will be issued to the operators prior to the expiration date of the permit. When completed applications and the proper permit fees are returned to the commissioner, the commissioner shall issue new permits to applicants.
(d) A permit shall not be required for the operation of a farm to consumer distribution point.

§ 53-8-108. Suspension of permits.

(a) The commissioner has the authority to suspend any permit to operate a food establishment issued pursuant to this chapter if the commissioner has reasonable cause to believe that the permittee is not in compliance with this chapter; provided, that the permittee shall be given the opportunity to correct violations as provided in § 53-8-115.
(b) Suspension of permits, other than those for temporary food service establishments, shall be of the following two (2) types:
1. (1) A Class 1 suspension, which provides an opportunity for a hearing prior to the effective date of the suspension; and
2. (2) A Class 2 suspension, which provides an opportunity for a hearing after the effective date of the suspension and is effective immediately.
(c) Notice of either type of suspension may be given by the inspector on the inspector's regular inspection form or by written notification from the commissioner. When a permit suspension is effective, all food establishment operations shall cease. Class 2 suspensions shall only be issued if an imminent health hazard exists.
(d) A written request for a hearing on either type of suspension shall be filed by the permittee within ten (10) days of the receipt of notice. This ten-day period may run concurrently with the ten-day period set forth in § 53-8-115. If a hearing is requested, it shall be commenced within a reasonable time of the request. If no request for a hearing is made within ten (10) days of receipt of notice, the suspension becomes final and is not subject to review.
(e) The commissioner may end the suspension at any time if the reasons for the suspension no longer exist.

§ 53-8-109. Revocation of permits.

(a) The commissioner may, after providing opportunity for a hearing, revoke a permit for serious or repeated violations of the requirements of this chapter or for interference with the commissioner in the performance of the commissioner's duty.
(b) Prior to revocation, the commissioner shall notify the permittee, in writing, of the specific reason or reasons for which the permit is being revoked at the end of ten (10) days following service of the notice, unless a written request for a hearing is filed with the commissioner within the ten-day period. If no request for a hearing is filed within the ten-day period, the revocation of the permit becomes final.

§ 53-8-110. Service of notice.

A notice provided for in this chapter is properly served when it is delivered to the permittee or person in charge, or when it is sent by certified mail, return receipt requested, to the last known address of the permittee. A copy of the notice shall be filed in the records of the commissioner.

§ 53-8-111. Hearings — Appeals.

(a) The hearings provided for in this chapter shall be conducted by the commissioner in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
(b) Appeals from any final decision after a hearing shall be pursued in accordance with the Uniform Administrative Procedures Act.
(c) Subsections (a) and (b) shall not apply in a county where the health department is operating a program pursuant to § 53-8-104(7) that meets the minimum requirements of due process; provided, that appeals from final decisions made under such programs may be made to the commissioner, for the limited purpose of determining whether a material error of law was made at the county level. The appeal to the commissioner shall not be de novo, but shall be limited to a review of the record of the hearing at the county level.

§ 53-8-112. Application for permit after revocation.

Whenever revocation of a permit becomes final, upon demonstration that the conditions which led to the revocation have been cured, the holder of the revoked permit may make written application for a new permit.

§ 53-8-113. Permit fees.

The permit fee to operate a food establishment shall be set by rule pursuant to § 43-1-703.

§ 53-8-114. Inspection reports.

(a) Inspection results for food establishments shall be recorded on standard departmental forms that summarize the requirements of the law and rules and regulations.
(b) A copy of the completed inspection report shall be furnished to the person in charge of the facility at the conclusion of the inspection.
(c) The most current inspection report furnished to the operator or person in charge of the establishment shall be made available at the facility for public disclosure to any person who requests to review it.

§ 53-8-115. Correction of violations.

(a) The completed inspection report shall specify a reasonable period of time for correction of violations found.
(b) Corrections of violations shall be accomplished within the period specified in accordance with the following:
1. (1) If an imminent health hazard exists, the facility shall immediately cease operations until authorized to reopen by the commissioner;
2. (2) All violations of priority items shall be corrected as soon as possible and in any event within ten (10) days following inspection. Within fifteen (15) days after inspection, the permittee shall notify the commissioner stating that priority item violations have been corrected. A follow-up inspection may be made for confirmation;
3. (3) All other items shall be corrected as soon as possible, but no later than the time of the next routine inspection.
(c) The inspection report shall state that failure to comply with any time limits specified by the commissioner for correction may result in cessation of operations. An opportunity for a hearing on the ordered corrective action shall be provided, if a written request is filed with the commissioner within ten (10) days following cessation of operations. If a request for a hearing is received, a hearing shall be held within a reasonable time after receipt of the request.
(d) Whenever a facility is required under this section to cease operations, it shall not resume operations until it has shown on reinspection that the conditions that led to the order to cease operations no longer exist. Opportunity for reinspection shall be offered within a reasonable time.

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§ 53-8-116. Examination of food — Hold orders.

Food may be examined or sampled by the commissioner as deemed necessary for the enforcement of this chapter. The commissioner may place a hold order on any food that the commissioner believes is in violation of this chapter or rules and regulations, upon written notice to the operator specifying particular reasons for the hold order. The commissioner shall tag, label, or otherwise identify any food subject to a hold order. No food subject to a hold order shall be used, served, sold, or moved from the establishment. The hold order may state that the food be held while confirmation is obtained that the condition violates this chapter or rules and regulations. The hold order may also order the operator to destroy food that violates this chapter or rules and regulations. The commissioner shall permit storage of the food under the conditions specified in the hold order, unless storage is not possible without risk to the health of the public, in which case immediate destruction shall be ordered and accomplished. The hold order shall state that a request for a hearing may be filed within ten (10) days. If a request for a hearing is received, the hearing shall be held within a reasonable time after receipt of the request. On the basis of evidence produced at the hearing, the hold order may be rescinded, or the owner or person in charge may be directed by written order to denature or destroy such food or to bring it into compliance with this chapter.

§ 53-8-117. Review and approval of plans and specifications.

Whenever a food establishment is constructed or extensively remodeled, and whenever an existing structure is converted to use as a food establishment, plans and specifications shall be submitted to the commissioner for review and approval before construction, remodeling, or conversion begins. The plans and specifications shall indicate the proposed layout, arrangement, mechanical plans, construction materials and work areas, and the type and model of proposed fixed equipment and facilities. The commissioner shall approve the plans and specifications, if they meet the requirements of this chapter and rules and regulations. No food establishment shall be constructed, extensively remodeled or converted, except in accordance with plans and specifications approved by the commissioner. Any deviation from the submitted plans and specifications previously approved by the commissioner discovered during an inspection that would not compromise the safety of food products shall not delay the issuance of a permit to operate a food establishment.

§ 53-8-118. Employee health.

(a) When the commissioner has reasonable cause to suspect possible disease transmission by an employee of the facility, the commissioner may secure information about any recent illness of the employee or make other investigations as may be indicated. The commissioner may require any of the following:
1. (1) The immediate exclusion of the employee from employment in the food establishment;
2. (2) The immediate closing of the facility until, in the commissioner's opinion, no further danger of disease outbreak exists;
3. (3) Restricting the employee's service to some area of the facility where there would be little likelihood of transmitting disease; or
4. (4) Adequate medical and laboratory examinations of the employee and of other employees.
(b) A person in charge, having been provided by the employee with written documentation from a person who practices in a medical profession in accordance with title 63 that the employee has been diagnosed with a condition set forth in Chapter 2, § 2-201.11(B)(2) of the Food Code shall have an affirmative duty to notify the commissioner or the commissioner's designee. A person in charge shall not be required to obtain medical records from a prospective employee prior to hiring such individual as an employee.

§ 53-8-119. Violations.

Any person operating a food establishment who fails or refuses to comply with any provision of this chapter or of rules and regulations, or obstructs or hinders the regulatory authority in the discharge of the regulatory authority's duties, or otherwise operates a food establishment in violation of this chapter or of rules and regulations commits a Class C misdemeanor. Each day of operation after notice of non-compliance of violation has been given and such violation has not been corrected constitutes a separate offense.

§ 53-8-120. Injunctive relief.

When the commissioner has reason to believe that a person is causing, is about to cause, or has caused a violation of this chapter or of the rules and regulations promulgated under this chapter, the commissioner may initiate proceedings in either the chancery court of Davidson County or the chancery court of the county where the violation is occurring, for injunctive relief to prevent the continuance of the violation or to correct the conditions resulting in, or about to result in, the violation.

§ 53-8-121. Sale of food by children at public events.

Notwithstanding this chapter to the contrary, children eighteen (18) years of age or younger do not need a license or permit to sell bakery goods, homemade or otherwise, soft drinks, or other similar food commodities at public events.

§ 53-8-122. Injunctions.

When the commissioner has reason to believe that a person has caused, is causing, or is about to cause a violation of this chapter or the rules and regulations promulgated under this chapter, the commissioner may initiate proceedings in either the chancery court of Davidson County or the chancery court of the county where the violation is occurring for injunctive relief to prevent the continuance of the violation or to correct the conditions resulting in, or about to result in, the violation.

§ 53-8-123. Limited authority of local government to regulate food or drink.

(a) Notwithstanding any law to the contrary, and except for subdivision (c)(1), the local government's authority under title 13, chapters 7, 16, and 28, and the local government's authority to regulate roadways, traffic, and the provision of utility services, this state is the exclusive regulator of food and drink sellers, vendors, vending machine operators, food establishments, and food service establishments in this state.
(b) A local government, as that term is defined in § 7-51-2001, shall not impose a tax, fee, or otherwise regulate the wholesale or retail sale, manufacture, or distribution of any food or drink, food or drink content, amount of food or drink content, or food or drink ingredients, except as authorized under title 67, chapter 6, or § 67-4-504, or pursuant to a contract with the department of agriculture.
(c) This section:
1. (1) Does not prohibit a local government from regulating zoning, building codes, locations, hours of operation, or the issuance of permits, or from performing any other local governmental functions as authorized by existing state law, with respect to food and drink sellers and vendors, vending machine operators, food establishments, and food service establishments; and
2. (2) Applies to both the sale and distribution of food or drink by food and drink sellers, food establishments, food service establishments, manufacturers of food and drink products regulated under chapter 1 of this title, and vending machines.

Chapter 10 Legend Drugs

Part 1 General Provisions

§ 53-10-101. “Legend Drugs” defined.

(a) For the purpose of this part, “legend drugs” means any item that federal law prohibits dispensing without a prescription from a licensed doctor, dentist, optometrist or veterinarian.
(b) This definition of legend drugs shall not be construed to include blood and blood fractions.

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§ 53-10-102. Application of part.

(a) There are exempted from this part:
1. (1) The sale of legend drugs by legitimate wholesale druggists to registered pharmacists and the sale by registered pharmacists to duly licensed physicians, dentists and veterinarians; and
2. (2) The sale of legend drugs by registered pharmacists to duly licensed optometrists and the possession and use of legend drugs by duly licensed optometrists as authorized by § 63-8-102.
(b) This part shall apply to this state, its departments, agencies and employees and to the political subdivisions of the state and their departments, agencies and employees, except the department of health and local health departments, which shall be subject to § 63-10-405.

§ 53-10-103. Enforcement — Rules and regulations — Fines.

(a) The board of pharmacy has the power to enforce this part and shall make rules and regulations for its enforcement.
(b) All fines collected under the enforcement of this part shall be paid to the board and deposited to the state treasury as other funds received by the board.

§ 53-10-104. Selling, bartering, giving away or obtaining legend drugs.

(a) It is unlawful for any person, firm or corporation to possess, sell, barter or give away any drug known as a legend drug, as defined in § 53-10-101, except upon the written prescription of a duly licensed physician; certified physician assistant; nurse authorized pursuant to § 63-6-204 or § 63-9-113, who is rendering service under the supervision, control and responsibility of a licensed physician, and who meets the requirements pursuant to § 63-7-123; a dentist; an optometrist authorized pursuant to § 63-8-102(12); or a veterinarian, and compounded or dispensed by a duly registered pharmacist.
(b) It is unlawful for any person, firm or corporation to obtain or to attempt to obtain a legend drug, or to procure or to attempt to procure the administration of a legend drug, by fraud, deceit, misrepresentation, subterfuge, forgery, alteration of a prescription, by the concealment of a material fact, or by the use of a false name or address.
(c) Under no circumstances shall a nurse practitioner who has met the additional requirements of § 63-7-207(14) to write and sign prescriptions or issue drugs, nor a physician assistant working under a physician's supervision, be delegated the authority to prescribe drugs, whose sole purpose is to cause or perform an abortion, that involve the following:
1. (1) The writing or signing a prescription for any drug or medication;
2. (2) The dispensing or administration of any prescribed or legend drug or medication; or
3. (3) The performing of any procedure that involves the use of a legend drug or medication.

§ 53-10-105. Possession without prescription unlawful.

(a) It is unlawful for any person to have in the person's possession, any drug defined or enumerated in this part, without the drug having been prescribed by a duly licensed physician, certified physician assistant, dentist, optometrist authorized pursuant to § 63-8-102(12), or veterinarian, and having been dispensed by a pharmacy duly licensed and registered in this state, unless the person was a resident of another state and had the prescription filled by a duly licensed and registered pharmacist of the other state.
(b)
1. (1) This section does not apply to authorized agents and representatives of pharmaceutical manufacturers, firms or wholesalers.
2. (2) Nothing in this section applies to a licensed physician, certified physician assistant, dentist, optometrist authorized pursuant to § 63-8-102(12), or veterinarian, nor to the drugs under the control of the physician, certified physician assistant, dentist, optometrist authorized pursuant to § 63-8-102(12), or veterinarian in the practice of that person's profession, and the exemption includes a nurse authorized pursuant to § 63-6-204 or § 63-9-113, who is rendering service under the supervision, control and responsibility of a licensed physician, and who meets the requirements pursuant to § 63-7-207(13).

§ 53-10-106. Adulterated drugs or devices.

(a)
1. (1) Any drug or device that is misbranded, out of date, old, deteriorated, not kept under proper refrigeration as required, or that has been exposed to fire, heat, smoke, water, flood or windstorm damage is deemed to be adulterated, and the possession, sale or distribution of those drugs or devices is prohibited.
2. (2) Any drug or device that is deemed misbranded or adulterated by federal law is deemed misbranded or adulterated within the purview of this section.
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  - 53-10-113(c)(1)
(b) The drugs or devices listed in subsection (a) are subject to seizure and subsequent destruction unless specifically exempted by the board of pharmacy.
(c) Prior to the destruction of any drugs or devices deemed to be adulterated, the owner or person in legal possession of the drugs or devices shall be given written notice of the intent to destroy the drug or device and the reason for the destruction.
(d) The owner or person in legal possession shall have ten (10) days from the receipt of the written notice to request in writing a hearing to show cause to the board why the drugs or devices are not within the purview of this section.

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53-10-113(a)(1)

§ 53-10-107. Fines and fees to be paid to board of pharmacy.

All fines and fees received in the regulation and enforcement of this part shall be paid to the secretary-treasurer of the board of pharmacy.

§ 53-10-108. Violation — Penalty.

Any person, firm or corporation possessing, selling, bartering or giving away any drug in violation of this part or violating any other provision of this part commits a Class C misdemeanor.

§ 53-10-109. Prescription of certain stimulants for weight control prohibited.

(a) No amphetamine classified as a Schedule II stimulant under § 39-17-408(d) shall be prescribed for the purpose of assisting a patient to gain or lose weight.
(b) A violation of this section is a ground for license denial, suspension or revocation.

§ 53-10-110. Contents of label — Damages in civil action.

(a) Any person dispensing a legend drug for a patient shall include on the label of the container in which the legend drug is dispensed the indication or indications for which the drug is being prescribed if requested by the prescriber, patient, or patient's caregiver and the prescriber, patient, or patient's caregiver provides the indication or indications to the person dispensing the legend drug.
(b) Any person dispensing a legend drug shall not be liable in any civil action for any alleged injury resulting solely from:
1. (1) Failing to include the indication or indications on the label when not requested to do so by the prescriber, patient or patient's caregiver; or
2. (2) Reasonably relying upon the prescriber, patient or patient's caregiver in obtaining the indication or indications included on the label.
(c) No prescriber shall be liable for damages in any civil action solely:
1. (1) For refusing a patient or patient's caregiver's request to the prescriber that the prescriber request that the dispenser provide the indication or indications on the label of the legend drug container;
2. (2) Alleging any cause of action for violation of the patient's privacy for complying with a patient or the patient's caregiver's request that the prescriber request that the dispenser provide the indication or indications on the label of the legend drug container; or
3. (3) For any incorrect information placed on the label of any legend drug by the dispenser pursuant to the terms of this section unless the dispenser only relied on information provided by the prescriber.
(d) This section shall not apply to prescriptions dispensed for inpatients of a hospital, a nursing home or an assisted care living facility as defined in § 68-11-201 or inpatients or residents of a mental health hospital or residential facility licensed under title 33 or individuals incarcerated in a local, state or federal correctional facility.
(e) Nothing in this section shall limit in any manner the civil liability of any person guilty of willful or wanton misconduct, gross negligence, reckless conduct or criminal conduct.

§ 53-10-111. Requirements for filling prescriptions of prescribers who have died.

(a) Notwithstanding any other provision of law to the contrary, when a pharmacist becomes aware that a healthcare practitioner authorized to prescribe by the law of this state has died, a prescription issued by the practitioner may continue to be dispensed based on the pharmacist's professional judgment and in accordance with the following requirements:
1. (1) If the prescription is a new prescription that has not been previously dispensed, it may be dispensed within ninety (90) days of the date on which the practitioner has died;
2. (2) If the prescription has been previously dispensed and has valid authorization to be refilled, the refills may be dispensed but not for a period of more than ninety (90) days from the date on which the practitioner died for Schedule III, IV and V drugs and one hundred eighty (180) days from the date on which the practitioner died for non-scheduled drugs; and
3. (3) Nothing in this section shall authorize the dispensing of a prescription that was issued for a controlled substance unless permitted by the federal Controlled Substances Act and regulations of the federal drug enforcement administration.
(b) These provisions shall not apply to a schedule II controlled substance.

§ 53-10-112. Prevention of abuse of drugs dispensed by pharmacist.

(a) For purposes of this section:
1. (1) “Pharmacist” has the same meaning as defined in § 63-10-204; and
2. (2) “Pharmacy” has the same meaning as defined in § 63-10-204.
(b) A pharmacy owner, manager or operator shall respect the professional judgment of the pharmacist in holding the health and safety of a patient to be their first consideration.
(c) A pharmacist shall, by utilizing education, skill, experience and professional judgment, make every reasonable effort to prevent the abuse of drugs which the pharmacist dispenses. In doing so, a pharmacist may decline to dispense to a patient a legend drug which in that pharmacist's professional judgment, lacks a therapeutic value for the patient or which is not for a legitimate medical purpose.
(d) A pharmacist shall not be subject to any penalty or fine when fulfilling the pharmacist's obligation to uphold the health and safety of a patient which results in the pharmacist declining to dispense any legend drug.
(e) It shall be a Class A misdemeanor, punishable by fine only, for the owner, manager or operator of a pharmacy to knowingly restrict or interfere with, or knowingly require a protocol or procedure that restricts or interferes with, a pharmacist's professional duty to counsel with patients and to evaluate the patients' appropriate pharmaceutical needs and the exercise of the pharmacist's professional judgment as to whether it is appropriate to dispense a legend drug to a patient.

§ 53-10-113. Off-label drug use.

(a) As used in this section, and unless the context otherwise requires:
1. (1) “Misbranding” means either the federal definition under 21 U.S.C. § 352 or drugs or devices that are misbranded under § 53-10-106; and
2. (2) “Off-label” means the use of a United States food and drug administration (FDA) approved drug, biological product, or device other than the use or uses approved by the FDA.
(b)
1. (1) A pharmaceutical manufacturer or its representatives may engage in truthful promotion of off-label uses.
2. (2) This section does not require a health insurance entity, as defined in § 56-7-109, other third-party payer, or other health plan sponsor to provide coverage for the cost of any off-label treatment. A health insurance entity, other third-party payer, or other health plan sponsor may provide coverage for an off-label treatment.
(c)
1. (1) Notwithstanding any other law, no official, employee, or agent of this state shall enforce or apply § 53-10-106(a)(2) against or otherwise prosecute a pharmaceutical manufacturer or its representatives for engaging in truthful promotion of off-label uses.
2. (2) Notwithstanding any other law, no state regulatory board may revoke, fail to renew or take any other action against a pharmaceutical manufacturer's or representative's, healthcare institution's, or physician's license solely for engaging in truthful promotion of off-label uses.

Part 2 Tennessee Affordable Drug Act of 2005

§ 53-10-201. Short title.

This part shall be known and may be cited as the “Tennessee Affordable Drug Act of 2005.”

§ 53-10-202. Legislative intent.

The general assembly declares it to be the public policy that, in order to lower the cost of prescription drugs to its citizens, pharmacists may substitute less costly generic drugs or drug products for higher priced brand name or trade name drugs or drug products.

§ 53-10-203. Part definitions.

As used in this part, unless the context otherwise requires:
1. (1) “Biological product” has the same meaning as defined in 42 U.S.C. § 262(i);
2. (2) “Brand name” means the registered trademark name of a drug or drug product given by its manufacturer, labeler or distributor;
3. (3) “Finished dosage form” means that form of a drug that is, or is intended to be, dispensed or administered to a patient and requires no further manufacturing or processing other than packaging, reconstitution or labeling;
4. (4) “Generic equivalent” means a drug product that has the same established name, active ingredients, strength or concentration, dosage form, and route of administration and that is formulated to contain the same amount of active ingredients, in the same dosage form, and to meet the same compendial or other applicable standards, i.e. strength, quality, purity, and identity, but that may differ in characteristics, such as shape, scoring, configuration, packaging, excipients, including colors, flavors, preservatives, and expiration time;
5. (5) “Interchangeable biological product” means:
  1. (A) A biological product licensed by the federal food and drug administration and determined to meet the safety standards for determining interchangeability pursuant to 42 U.S.C. § 262(k)(4); or
  2. (B) A biological product determined by the federal food and drug administration to be therapeutically equivalent as set forth in the latest edition or supplement of the federal food and drug administration's “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the “Orange Book”; and
6. (6) “Prescriber” means an individual authorized by law to prescribe drugs.

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56-7-3702(10)

§ 53-10-204. Substitution authorized — Instructions of prescriber.

(a) The prescriber shall allow for substitution with a generic equivalent of a brand name drug or drug product under all circumstances, unless:
1. (1) The prescriber determines the medical necessity of a brand name drug or drug product due to:
  1. (A) An adverse reaction previously experienced by the patient to a generic equivalent;
  2. (B) A generic equivalent has previously been demonstrated as ineffective for the patient; or
  3. (C) Any other clinically based prescriber determined need;
2. (2) A generic equivalent is not available; or
3. (3) Section 53-10-210 concerning notification to the patient and the prescriber have not been complied with in instances involving an anti-epileptic drug.
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(b) If the prescriber determines a brand name drug or drug product is medically necessary for a patient, the prescriber shall, in the prescriber's own handwriting, place the instruction showing intent upon the prescription at the time it is prepared and issued. For the purposes of this subsection (b), instructions showing intent may include, but not be limited to, the following language:
1. (1) “Brand name medically necessary”, “dispense as written”, “medically necessary”, “brand name”, “no generic”;
2. (2) Any abbreviation of the language in subdivision (b)(1); or
3. (3) Any other prescriber handwritten notation, such as circling a preprinted instruction to dispense as written on the prescription order, that clearly conveys the intent that a brand name is necessary for this patient.
(c) If the prescriber determines a brand name drug or drug product is medically necessary for a patient and that prescription order is issued verbally, the prescriber shall alert the pharmacist that use of the brand name drug or drug product is medically necessary for the patient.
(d) If the prescriber determines a brand name drug or drug product is medically necessary for a patient and that prescription order is issued by the prescriber in the form of an electronic prescription order or facsimile prescription order, the prescriber shall place, or cause to be placed, the proper instruction on the electronic prescription order or facsimile prescription order prior to it being transmitted to the pharmacist.
(e) Nothing in this section shall be construed to prevent a prescriber from informing a patient of the prescriber's professional opinion as to the capabilities, effectiveness and acceptability of any drug.

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§ 53-10-205. Least expensive generic equivalent if authorized by prescriber.

(a) When a pharmacist receives a written, verbal, electronic or facsimile prescription order, and the prescriber has not noted medical necessity of the brand name prescribed, as required in § 53-10-204, the pharmacist shall dispense the least expensive generic equivalent in stock, or a generic equivalent covered under the patient's drug plan, except as provided in subsections (c) and (d).
(b) A pharmacist shall make a reasonable attempt to notify a prescriber if a generic equivalent has become available since the last dispensing of a prescription, and, if authorized by the prescriber, the pharmacist shall dispense the least expensive generic equivalent in stock, or a generic equivalent covered under the patient's drug plan.
(c) If a pharmacist has reason to believe that the brand name drug or drug product is less expensive to the patient or patient's drug plan than the generic equivalent, the pharmacist shall fill the prescription with the brand name drug or drug product.
(d) Nothing in this section shall be construed as prohibiting a pharmacist from complying with the request of a patient with a valid prescription order to obtain a brand name drug or drug product, if:
1. (1) The patient has prescription drug coverage under a prescription benefit plan and agrees to pay the additional cost, if any, of purchasing the brand name drug or drug product, as that cost is determined according to the benefits provided by the patient's prescription benefit plan and when cost sharing that would be required to cover the additional cost is permissible under the patient's prescription benefit plan guidelines and all applicable laws and regulations; or
2. (2) The patient does not have a prescription benefit plan or the patient's prescription benefit plan does not provide coverage for the brand name drug or drug product, and the patient agrees to pay the entire cost at the pharmacy of the brand name drug or drug product.

§ 53-10-206. Responsibility of pharmacist.

A pharmacist who selects a generic equivalent for substitution, pursuant to § 53-10-204, has the same responsibility for the selected drug as the pharmacist would in dispensing a prescription for the drug prescribed by the drug's trade or brand name.

§ 53-10-207. Contents of label.

(a) The manufacturer, packager, or distributor of any human use legend drug sold, delivered or offered for sale in the state must have printed on the label of the immediate container of the drug the name and address of the manufacturer, packager, or distributor of the finished dosage form of the drug.
(b) The pharmacist shall notify the patient of the substitution with a generic equivalent by noting the substitution on the prescription label.
(c) This section shall not apply to prescriptions dispensed for inpatients of a hospital, a nursing home or an assisted care living facility, as defined in § 68-11-201.

§ 53-10-208. Source of products substituted — FDA approval required.

(a) In making substitutions as allowed by this part, the pharmacist may use drugs and drug products manufactured within the territorial limits of any one (1) of the states of the United States, or of any other country, if the products have been approved by the federal food and drug administration (FDA), and have been given an “A” therapeutic equivalent rating by the FDA in the agency's publication, “Approved Drug Products with Therapeutic Equivalence Evaluations”, also known as the “Orange Book”. “A” rated drug products are those that the FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, including, but not limited to, drug products for which:
1. (1) There are no known or suspected bioequivalence problems and are designated “AA”, “AN”, “AO”, “AP” or “AT”, depending on the dosage form; or
2. (2) Actual or potential bioequivalence problems have been resolved with adequate in vivo or in vitro evidence supporting bioequivalence and are designated “AB”.
(b) This section shall not apply to generic drugs and drug products that have not been rated.
(c) For those drugs that have not been evaluated and rated for bioequivalency by the FDA, pharmacists are permitted to use their professional judgment in selecting a generic product for substitution.

§ 53-10-209. Construction.

(a) Nothing in this part shall be construed as authorizing any person or entity to interfere with a prescriber's obligation to exercise independent medical judgment in rendering health care services to patients.
(b) Nothing in this part shall be construed to interfere with or otherwise limit, constrain or alter the ability of any health plan or payor, including the bureau of TennCare, to utilize prior authorization in the implementation of a formulary or preferred drug list.

§ 53-10-210. Prescription drugs for epilepsy patients.

(a) As used in this section, unless the context otherwise requires:
1. (1) “Anti-epileptic drug” means:
  1. (A) Any drug prescribed for the treatment of epilepsy; or
  2. (B) A drug used to treat or prevent seizures;
2. (2) “Epilepsy” means a neurological condition characterized by recurrent seizures;
3. (3) “Interchange” means the dispensing of one (1) manufacturer of an anti-epileptic drug for a different manufacturer of an anti-epileptic drug for which the patient is currently receiving therapy. This includes the substitution of a generic version for a brand version, a brand version for a generic version, or a generic version for a generic version by a different manufacturer; and
4. (4) “Seizure” means a brief disturbance in electrical activity of the brain.
(b) A pharmacist, pharmacy intern or pharmacy technician shall provide notification to the patient, a family member, other relative, or a close personal friend of the individual or any other person identified by the patient before interchanging one manufacturer of an anti-epileptic drug for another manufacturer of an anti-epileptic drug in instances where the patient's epilepsy or seizures are currently being controlled on a specific drug, strength, dosage form, and dosing regimen from a specific manufacturer. The prescriber of the medication shall also be notified prior to the interchange.
(c) This section shall not apply to prescriptions dispensed for inpatients of a hospital, nursing home or assisted care living facility as defined in § 68-11-201, or inpatients or residents of a mental health hospital or residential facility licensed under title 33.

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53-10-204(a)(3)

§ 53-10-211. Interchangeable biological products.

(a) A prescriber shall allow for substitution with an interchangeable biological product of a prescribed biological product under all circumstances unless:
1. (1) The prescriber determines the medical necessity of a prescribed biological product due to:
  1. (A) An adverse reaction previously experienced by the patient to an interchangeable biological product;
  2. (B) An interchangeable biological product having previously been demonstrated as ineffective for the patient; or
  3. (C) Any other clinically based, prescriber-determined need; or
2. (2) An interchangeable biological product is not available.
(b)
1. (1) If the prescriber determines a prescribed biological product is medically necessary for a patient, the prescriber shall, in the prescriber's own handwriting, place the instructions showing intent upon the prescription at the time it is prepared and issued.
2. (2) For the purposes of this subsection (b), “instructions showing intent” includes, but is not limited to, the following language:
  1. (A) “Brand name medically necessary,” “dispense as written,” “medically necessary,” “brand name,” or “no generic”;
  2. (B) Any abbreviation of the language in subdivision (b)(1)(A); or
  3. (C) Any other prescriber handwritten notation, such as circling a preprinted instruction to dispense as written on the prescription order, that clearly conveys the intent that a brand name is necessary for this patient.
(c) If the prescriber determines that a prescribed biological product is medically necessary for a patient and the prescription order is issued orally, the prescriber shall alert the pharmacist that use of the prescribed biological product is medically necessary for the patient.
(d) If the prescriber determines that a prescribed biological product is medically necessary for a patient and the prescription order is issued by the prescriber in the form of an electronic prescription order or facsimile prescription order, the prescriber shall place, or cause to be placed, the proper instruction on the electronic prescription order or facsimile prescription order prior to it being transmitted to the pharmacist.
(e) Nothing in this section shall prevent a prescriber or dispenser from informing a patient of the prescriber or dispenser's professional opinion as to the capabilities, effectiveness, and acceptability of any biological product.
(f) A pharmacist who selects an interchangeable biological product for substitution, pursuant to this section, has the same responsibility for the selected product as the pharmacist would in dispensing a prescription for the product prescribed.
(g) The manufacturer, packager, or distributor of any human use legend drug or biological product sold, delivered, or offered for sale in this state shall have printed on the label of the immediate container of the biological product the name and address of the manufacturer, packager, or distributor of the finished dosage form of the biological product.
(h) The pharmacist shall notify the patient of the substitution with an interchangeable biological product by noting the substitution on the prescription label.
(i) Within five (5) business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer. The communication shall be conveyed by making an entry in an interoperable electronic medical records system, through an electronic prescribing technology or a pharmacy record that can be accessed electronically by the prescriber, or as set forth in a collaborative pharmacy practice agreement as defined in § 63-10-217; otherwise, the pharmacist or the pharmacist's designee shall communicate to the prescriber the biological product dispensed to the patient, using facsimile, telephone, electronic transmission, or other prevailing means; provided, that communication shall not be required where:
1. (1) There is no FDA-approved interchangeable biological product for the product prescribed; or
2. (2) A prescription is not changed from the product dispensed on the prior filling of the prescription.
(j) This section shall not apply to prescriptions administered to patients in a hospital, a nursing home, or an assisted-care living facility, as defined in § 68-11-201.
(k) The notification and communication requirements in this section shall not apply to vaccines.
(l) The board of pharmacy shall maintain a link on its website to the current list of all biological products determined by the federal food and drug administration to be interchangeable biological products.
(m) The pharmacist shall maintain a record of the biological product dispensed as required pursuant to § 53-14-110.
(n) If this state mandates electronic medical records between a pharmacist and a prescriber as described in subsection (i), then the pharmacist shall only be required to communicate the biological product dispensed through an electronic medical records system when such a system is in place and the information is accessible to prescribers.

Part 3 Tennessee Prescription Safety Act of 2016

§ 53-10-301. Short title.

This part shall be known and may be cited as the “Tennessee Prescription Safety Act of 2016”.

§ 53-10-302. Part definitions.

As used in this part, unless the context requires otherwise:
1. (1) “Board” means the board of pharmacy created by title 63, chapter 10, part 3;
2. (2) “Commissioner” means the commissioner of health;
3. (3) “Committee” means the controlled substance database committee created by § 53-10-303;
4. (4) “Controlled substances” means a drug, substance, or immediate precursor in Schedules I through VI defined or listed in the Tennessee Drug Control Act of 1989, compiled in title 39, chapter 17, part 4;
5. (5) “Database” means the controlled substance database created by § 53-10-304;
6. (6) “Department” means the department of health;
7. (7) “Director” means the director of the controlled substance database, who shall be a Tennessee licensed pharmacist designated by the commissioner, in consultation with the executive director of the board of pharmacy and with the committee, to administer, maintain, and direct the operation and function of the controlled substance database;
8. (8) “Dispense” means to physically deliver a controlled substance covered by this part to any person, institution, or entity with the intent that it be consumed away from the premises on which it is dispensed. “Dispense” does not include the act of writing a prescription by a practitioner to be filled at a pharmacy licensed by the board. For purposes of this part, physical delivery includes mailing controlled substances into this state;
9. (9) “Healthcare practitioner,” for the purposes of this part only, means:
  1. (A) A person licensed, registered, or otherwise permitted to prescribe, distribute, or dispense a controlled substance in the course of professional practice;
  2. (B) A pharmacy, hospital, or other institution licensed, registered, or otherwise permitted to distribute, or dispense, or administer a controlled substance in the course of professional practice;
  3. (C) A certified registered nurse anesthetist (CRNA) as described in § 63-7-103; or
  4. (D) The state chief medical examiner, a county medical examiner, a deputy or assistant state medical examiner or forensic pathologist under the control or direction of the chief medical examiner, or a deputy or assistant county medical examiner or forensic pathologist under the control or direction of a county medical examiner;
10. (10) “Healthcare practitioner delegate” means any person designated by a healthcare practitioner to act as an agent of the healthcare practitioner, upon registering the person as a delegate and providing any information required by the department. A healthcare practitioner shall have the ability to authorize a healthcare practitioner delegate to check the controlled substance database as stipulated in this part. The healthcare practitioner shall be responsible for actions taken by their healthcare practitioner delegates pursuant to this part;
11. (11) “Law enforcement personnel” means agents of the Tennessee bureau of investigation, agents of a judicial district drug task force, drug enforcement administration agents, and certified law enforcement officers certified pursuant to § 38-8-107, and certified law enforcement officers by other states;
12. (12) “Manufacturer” means any person, except a pharmacist compounding in the normal course of professional practice, engaged in the commercial production, preparation, propagation, conversion, or processing of a drug, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis, or both, and includes any packaging or repackaging of a drug or the labeling or relabeling of its container and the promotion and marketing of such drugs or devices;
13. (13) “Operations committee” means the operations committee created by this part to consult with and confirm or deny decisions made by the commissioner within the authority granted to the commissioner by this part;
14. (14) “Part 2 Program” has the same meaning as defined by 42 CFR § 2.11; and
15. (15) “Wholesaler” or “wholesale distributor” means a person primarily engaged in the wholesale distribution of drugs or devices; provided, that “wholesaler” or “wholesale distributor” does not include licensed third-party logistics providers. For the purposes of this part, transfers and sales of drugs or devices from one (1) licensed pharmacy to another shall not constitute wholesale distribution of drugs or devices.

§ 53-10-303. Controlled substance database committee.

(a) There is created the controlled substance database committee. The committee members shall be:
1. (1) One (1) of the governor-appointed licensed members of each of the following healthcare professional licensure boards or committees to be chosen by the licensing board or committee:
  1. (A) The board of medical examiners;
  2. (B) The board of osteopathic examination;
  3. (C) The board of dentistry;
  4. (D) The board of podiatric medical examiners;
  5. (E) The board of optometry;
  6. (F) The board of veterinary medical examiners;
  7. (G) The board of nursing;
  8. (H) The board of physician assistants; and
  9. (I) The board of pharmacy; and
2. (2) One (1) of the members of the board of pharmacy and one (1) of the members of the board of medical examiners who were appointed to those boards to represent the general public. The boards shall choose those representatives.
(b) The committee shall have a chair and vice chair, who shall be elected annually from its members.
(c) The committee shall meet at least annually and as often as deemed necessary either at the call of the chair or upon request of at least three (3) members of the committee. A quorum for purposes of official actions by the committee shall be six (6) members.
(d) The members of the committee chosen to serve by the respective licensure boards and committees, while serving on this committee, shall be deemed to be performing official duties as members of their respective board or committee and shall be entitled to the same per diem and travel reimbursements as they would receive for performing their duties for their respective board or committee. The respective board or committee of each member shall pay such per diem and travel reimbursement.
(e) At all times, except when considering, reviewing, discussing, advising, or taking action in reference to specifically named individuals or healthcare practitioners identified from information contained in, or reported to the database, the committee shall be subject to title 8, chapter 44, part 1, regarding public meetings.
(f) Pursuant to § 53-10-311 and the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, the commissioner shall have the authority to promulgate rules as necessary for implementation of this part regarding:
1. (1) Establishing, maintaining, and operating the database;
2. (2) Access to the database and how access is obtained;
3. (3) Control and dissemination of data and information in the database;
4. (4) The control, sharing, and dissemination of data and information in the database with other states, other governmental entities, and other entities acting on behalf of any such state or governmental entity; and
5. (5) Establishing the morphine milligram equivalent calculation for an opioid drug contained in Schedules II-V for purposes of § 63-1-164; provided, that if no such rule is promulgated for an opioid drug, the morphine milligram equivalent calculation established by the federal centers for disease control and prevention for that drug shall be used.
(g) The committee shall advise the commissioner with respect to any contemplated rulemaking under this part. The committee may make formal recommendations to the commissioner.
(h)
1. (1) The committee and the commissioner shall have the right to examine database information to identify unusual patterns of prescribing, distributing, or dispensing controlled substances that appear to be higher than normal, taking into account the particular specialty, circumstances, patient type, or location of the healthcare practitioner.
2. (2) If the committee or the commissioner determines that a healthcare practitioner has an unusually high pattern of prescribing, distributing, or dispensing controlled substances that is not explained by other factors, the committee or the commissioner shall refer the healthcare practitioner to the appropriate licensing board.
3. (3) If an investigator in service of a health-related board as licensed under title 63 or title 68 has reason to believe during any part of an investigation that a healthcare practitioner is in violation of a criminal law, the investigator is authorized to report the conduct to the appropriate law enforcement personnel.

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§ 53-10-304. Controlled substance database — Director — Administration — Requirements.

(a) There is created within the department a controlled substance database. The director of the controlled substance database shall be responsible for determining staffing in consultation with the executive director of the board of pharmacy.
(b) The director shall administer, maintain, and direct the functioning of the database in accordance with this part. The department in consultation with the committee and board may, under state procurement laws, contract with another state agency or private entity to establish, operate, or maintain the database. Additionally, the department, in consultation with the committee and board, shall determine whether to operate the database within the department or contract with another entity to operate the database, based on an analysis of costs and benefits.
(c) The purpose of the database is to increase the quality of patient care by equipping healthcare practitioners with accurate, timely information that the practitioners can use to determine when patients acquiring controlled substances may require counseling or intervention for substance abuse, by collecting and maintaining data as described in this part regarding all controlled substances in Schedules II, III, and IV dispensed in this state, and Schedule V controlled substances identified by the controlled substance database committee as demonstrating a potential for abuse. Further, the database is to be used to assist in research, statistical analysis, criminal investigations, enforcement of standards of health professional practice, and state or federal laws involving controlled substances.
(d) The data required by this part shall be submitted in compliance with this part to the database by any healthcare practitioner who dispenses a controlled substance contained in Schedules II, III, and IV, and Schedule V controlled substances identified by the committee as demonstrating a potential for abuse, or by any healthcare practitioner delegate who is designated to submit data on a healthcare practitioner's behalf. The reporting requirement shall not apply for the following:
1. (1) [Deleted by 2022 amendment.]
2. (2) Complimentary packages of medicinal drugs that are labeled as a drug sample or complimentary drug dispersed to the practitioner's own patients adequate to treat the patient for a maximum of forty-eight (48) hours in the regular course of practice without the payment of a fee or remuneration of any kind;
3. (3) A sample of a schedule IV or schedule V controlled substance in a quantity limited to an amount that is adequate to treat a patient for a maximum of seventy-two (72) hours or a sample of a non-narcotic schedule V controlled substance in a quantity limited to an amount that is adequate to treat a patient for a maximum of fourteen (14) days, provided without charge by a medical doctor, osteopathic physician, advanced practice nurse with certificates of fitness to prescribe, or physician assistant working at a pain management clinic from providing to that practitioner's patient;
4. (4) Any drug dispensed by a licensed veterinarian; provided, that the quantity dispensed is limited to an amount adequate to treat the nonhuman patient for a maximum of five (5) days; or
5. (5) [Deleted by 2022 amendment.]
6. (6) [Deleted by 2022 amendment.]
7. (7) Any drug prescribed for administration directly to a patient during the course of inpatient or residential treatment in a hospital or nursing home licensed under title 68 or during the course of inpatient treatment in a hospital licensed under title 33.
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- 53-10-310(b)
(e) Notwithstanding subsection (c) or (d), a healthcare practitioner whose practice is a Part 2 Program shall submit the dispensing and administration of all controlled substances in accordance with this part. However, reporting of dispensing or administration by a Part 2 Program is not required by this subsection (e) until the commissioner promulgates rules regulating the reporting of such dispensing and administration, and access to that reported information in a manner consistent with the confidentiality provisions of 42 CFR Part 2.
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§ 53-10-305. Submission of information — Data format.

(a) All healthcare practitioners who prescribe or dispense controlled substances in practice providing direct care to patients in this state by prescribing or dispensing on more than fifteen (15) days in a calendar year total and are required to have a federal drug enforcement administration (DEA) registration pursuant to federal law shall be registered in the controlled substance database. Healthcare practitioners or their agents shall have up to thirty (30) calendar days after receiving a DEA number to register in the database; such privilege shall apply equally to both prescribers and dispensers. Licensed veterinarians who never prescribe or dispense controlled substances in an amount intended to treat a nonhuman patient for more than five (5) days shall not be required to register in the database.
(b)
1. (1) Each healthcare practitioner or healthcare practitioner's agent shall, regarding each controlled substance dispensed, submit to the database all of the following information:
  1. (A) Prescriber identifier;
  2. (B) Dispensing date of controlled substance;
  3. (C) Patient identifier;
  4. (D) Controlled substance dispensed identifier;
  5. (E) Quantity of controlled substance dispensed;
  6. (F) Strength of controlled substance dispensed;
  7. (G) Estimated days' supply;
  8. (H) Dispenser identifier;
  9. (I) Date the prescription was issued by the prescriber;
  10. (J) Whether the prescription was new or a refill;
  11. (K) Source of payment;
  12. (L) The ICD-10 code for any prescription that contains an ICD-10 code; provided, that this shall not be mandatory prior to January 1, 2019, for a dispenser who has not updated the dispenser's software system to enable submission of ICD-10 codes;
  13. (M) A value signifying opioid treatment is occurring pursuant to a medical necessity under § 63-1-164 for any prescription containing the words “medical necessity.” The value will be determined by the committee and published through the committee's website; and
  14. (N) Other relevant information as required by rule.
2. (2) The information in the database, as required by subdivision (b)(1), shall be submitted by a procedure and in a format established by the committee, for each business day but no later than the close of business on the following business day; provided, that a veterinarian shall submit information at least once every fourteen (14) days and shall not be required to use a computerized system in order to submit required information pursuant to this section.
(c) The commissioner, pursuant to § 53-10-311, shall have the authority to change the length of time in which healthcare practitioners are required to submit information to the database through the promulgation of rules pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5. When the committee shortens the length of time in which healthcare practitioners are required to submit information to the database, the department shall provide notice to all healthcare practitioners who are registered in the database at least sixty (60) days prior to the date in which the rule goes into effect. If the committee, pursuant to § 53-10-311, shortens the length of time in which healthcare practitioners must submit information to the database, a healthcare practitioner may provide to the committee a written statement indicating why it creates a hardship for that healthcare practitioner to submit information within that time period, and the committee may grant an extension of up to seven (7) days within which that healthcare practitioner shall submit the information to the database. Such a hardship extension shall be valid for two (2) years and may be renewed by the committee upon request of the healthcare practitioner.
(d) Any healthcare practitioner, except veterinarian healthcare practitioners, that uses a computerized system to record information concerning the dispensing of controlled substances, shall submit the required information to the database utilizing nationally recognized pharmacy telecommunications format standards.
(e) The commissioner, pursuant to § 53-10-311, shall maintain the database in an electronic file or by other means established by the commissioner in such a manner so as not to infringe on the legal use of controlled substances, and in such a manner as to facilitate use of the database for identification of:
1. (1) Prescribing and dispensing practices and patterns of prescribing and dispensing controlled substances; and
2. (2) Individuals, facilities, or entities that receive prescriptions for controlled substances from healthcare practitioners, and who subsequently obtain dispensed controlled substances from a healthcare practitioner in quantities or with a frequency inconsistent with generally recognized standards of dosage for that controlled substance, or by means of forged or otherwise false or altered prescriptions.
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- 53-10-306(a)(11)(D)
(f) The committee or the commissioner or a designee appointed by the committee or commissioner may review information in the database, subject to the privacy protections of 42 CFR Part 2 for information reported to the database by a Part 2 Program. If the committee or commissioner or their designee determines from review that a healthcare practitioner has committed a violation of the law, the committee or commissioner shall notify the entity responsible for licensure, regulation, or discipline of that healthcare practitioner and shall supply information required by the entity for an investigation of the violation of the law that may have occurred.
(g)
1. (1)
  1. (A) The commissioner, pursuant to § 53-10-311, shall by rule establish the electronic format in which the information required under this section shall be submitted to the database, and the committee shall allow for waiver of electronic reporting for individual healthcare practitioners for whom it would cause undue hardship as determined by the committee. The waiver may be valid for two (2) years from ratification by the committee.
  2. (B) The committee may authorize a designee to initially approve a waiver subject to ratification by the committee.
2. (2) The commissioner shall ensure the database system records and maintains for reference, for a period of at least one (1) year:
  1. (A) The identification of each person who requests or receives information from the database;
  2. (B) The information provided to each person; and
  3. (C) The date and time the information is requested or provided.
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- 53-10-310(b)
(h) The commissioner, in consultation with the committee, shall make rules to:
1. (1) Effectively enforce the limitations on access to the database as described in this part, including rules that ensure compliance with 42 CFR Part 2 for information reported to the database by a Part 2 Program; and
2. (2) Establish standards and procedures to ensure accurate identification of individuals requesting information or receiving information from the database without a request.

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63-10-218(b)

§ 53-10-306. Confidentiality — Disclosure of information — Penalties.

(a) Information sent to, contained in, and reported from the database in any format is confidential and not subject to title 10, chapter 7, regarding public records, and not subject to subpoena from any court and shall be made available only as provided for in § 53-10-308 and to the following persons in accordance with the limitations stated and rules promulgated pursuant to this part, or as otherwise provided for in §§ 53-10-304 and 53-10-311:
1. (1) Personnel of the committee specifically assigned to conduct analysis or research;
2. (2) Authorized committee, board, or department personnel engaged in analysis of controlled substances prescription information as a part of their assigned duties and responsibilities;
3. (3) A healthcare practitioner conducting medication history reviews who is involved in the care of a patient or making decisions regarding patient care or patient enrollment; a healthcare practitioner or supervising physician of a healthcare practitioner conducting a review of all medications dispensed by prescription attributed to that healthcare practitioner or a healthcare practitioner having authority to prescribe or dispense controlled substances, to the extent the information relates specifically to a current or bona fide prospective patient of the healthcare practitioner, to whom the healthcare practitioner has prescribed or dispensed, is prescribing, dispensing, approving of the prescribing or dispensing, or considering prescribing or dispensing any controlled substance. Each authorized individual referenced under this subdivision (a)(3) shall have a separate identifiable authentication for access;
4. (4) A healthcare practitioner under review by a quality improvement committee, as defined in § 63-1-150, who submits information contained in, and reported from the database to a quality improvement committee;
5. (5) A licensed pharmacist conducting drug utilization or medication history reviews who is actively involved in the care of the patient or making decisions regarding care of the patient or patient enrollment. Each authorized individual referenced under this subdivision (a)(5) shall have a separate identifiable authentication for access;
6. (6) The state chief medical examiner, a deputy or assistant state medical examiner appointed pursuant to § 38-7-103, a county medical examiner or deputy county medical examiner appointed pursuant to § 38-7-104, or a forensic pathologist under the control or direction of the chief medical examiner or a county medical examiner when acting in an official capacity as established in § 38-7-109; provided, that any access to information from the database is subject to the confidentiality provisions of this part, except where information obtained from the database is appropriately included in any official report under § 38-7-110(c);
7. (7) Personnel of the following entities actively engaged in analysis of controlled substances prescription information as a part of their assigned duties and responsibilities related directly to the TennCare program:
  1. (A) The office of inspector general;
  2. (B) The medicaid fraud control unit; and
  3. (C) The bureau of TennCare's chief medical officer, associate chief medical directors, director of quality oversight, and directors of pharmacy;
8. (8) Personnel of the bureau of TennCare who request deidentified controlled substances prescribing information from the database which does not contain personally identifiable data but only on request by the following personnel of the bureau:
  1. (A) The chief medical officer;
  2. (B) Associate chief medical directors;
  3. (C) Director of quality oversight; and
  4. (D) Directors of pharmacy;
9. (9) A quality improvement committee, as defined in § 63-1-150, of a group practice that is engaged in the provision of healthcare services, as part of the committee's confidential and privileged activities under § 63-1-150(c)(3) with respect to the evaluation of the safety, quality, appropriateness, or necessity of healthcare services performed by a healthcare practitioner, if the information is furnished to a quality improvement committee by the healthcare practitioner that is the subject of review by the quality improvement committee;
10. (10) A quality improvement committee, as defined in § 68-11-272, of a hospital licensed under title 68 or title 33, as part of the committee's confidential and privileged activities under § 68-11-272(b)(4) with respect to the evaluation, supervision, or discipline of a healthcare provider employed by the hospital or any of its affiliates or subsidiaries, who is known or suspected by the hospital's administrator to be prescribing controlled substances for the healthcare practitioner's personal use;
11. (11)
  1. (A) Law enforcement personnel; provided, that such personnel are engaged in the official investigation and enforcement of state or federal laws involving controlled substances or violations under this part; and that any law enforcement personnel receiving information from the database pursuant to this section shall comply with this subsection (a);
  2. (B) Any law enforcement personnel; provided, that for an officer or agent to have the authorization to request information from the database, the officer or agent shall first be preapproved. Preapproval shall require:
    1. (i) Agents of a judicial drug task force employed by the United States department of justice, law enforcement officers certified pursuant to § 38-8-107, and law enforcement officers certified by other states to require:
      1. (a) The list of preapproved agents to be sent to the district attorney general in the judicial district in the district in which the task force has jurisdiction; and
      2. (b) By December 1 of each year, each district attorney general shall send to the director a list of applicants authorized to request information from the database from that general's judicial district; or
    2. (ii) Tennessee bureau of investigation (TBI) agents or drug enforcement administration agents to require:
      1. (a) Preapproval by the assistant special agent in charge or the agent's immediate supervisor and division head. Approved applicants shall be sent to the board by the director; and
      2. (b) By December 1 of each year, the TBI director or the assistant special agent in charge shall send to the director of the controlled substance database, committee, or commissioner a list of applicants authorized to request information from the database;
  3. (C) An application submitted by law enforcement personnel shall include, but not be limited to, the:
    1. (i) Applicant's name; title; agency; agency address; agency contact number; agency supervisor; and badge number, identification number, or commission number; and the business e-mail address of each applicant officer or agent, the appropriate district attorney general, DEA agent, and, if a TBI agent, the TBI director and their business e-mail addresses; and
    2. (ii) Signatures of the applicant, the applicant's approving supervisor, and the district attorney general of the judicial district, assistant special agent in charge in which the applicant has jurisdiction, or the approving division head and the TBI director; and
  4. (D) It shall be a duty of the committee or commissioner, through the director, as part of the duties to maintain the database pursuant to § 53-10-305(e), to receive and verify the lists of authorized applications sent to it by the district attorneys general, assistant special agent in charge, and the director of the TBI pursuant to this subsection (a);
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  - 53-10-308(a)(2)
12. (12) The judge of a drug court treatment program, created under the Drug Court Treatment Act of 2003, compiled in title 16, chapter 22, and pursuant to this part to the extent the information relates specifically to a current participant in the drug court treatment program. Any judge or personnel of a drug court treatment program receiving information from the database pursuant to this subdivision (a)(12) shall comply with this subsection (a) and the following:
  1. (A) Any judge of a participating drug court requesting information from the database shall submit an application to the director pursuant to subdivision (a)(12)(B) that must include acknowledgment by the district attorney general of the judge's judicial district that the judge is seeking information from the database on a current participant in the drug court treatment program;
  2. (B) An application submitted by the judge of a drug court treatment program shall include:
    1. (i) The applicant's name, title, agency, agency address, and business e-mail address;
    2. (ii) The signatures of the judge and the district attorney general of the judicial district in which the judge has jurisdiction; and
    3. (iii) The names of any current participants in the drug court treatment program that the judge has a reasonable belief may not be in compliance with the guidelines or rules of participation in the drug court treatment program as they pertain solely to the participant's unauthorized use or misuse of controlled substances. Such information shall not be considered a public record as defined by § 10-7-503; and
  3. (C) The commissioner, through the director, shall, as part of the duty to maintain the database pursuant to this part, receive the authorized application sent by the judge of the participating drug court treatment program pursuant to this subsection (a); and
13. (13) A healthcare practitioner delegate, who is acting under the direction and supervision of a healthcare practitioner as an agent of a healthcare practitioner. Each authorized individual shall have a separate identifiable authentication for access.
(b) When requesting information from the database, law enforcement personnel shall provide a case number as part of the process for requesting information from the database. The case number entered shall correspond with an official investigation involving controlled substances and information requested should directly relate to the investigation.
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- 53-11-309(c)
(c) The commissioner, in consultation with the committee, may, by rule, establish a fee for providing information to a law enforcement agency, judicial district drug task force, TBI, or a judge of a drug court treatment program pursuant to this section. In determining the fee and type of fee to be charged, the commissioner may consider options such as an annual fee or a per use, incremental cost basis fee, or other methods as the commissioner deems appropriate.
(d) Law enforcement personnel, who are authorized to request information from the database, shall resubmit their identifying application information that was submitted pursuant to this section to the appropriate district attorney, United States attorney, TBI director, or assistant special agent in charge by November 20 of each year. Such resubmitted applications shall be sent by the appropriate district attorney general, TBI director, or assistant special agent in charge to the board by December 1 of each year. If during the calendar year a name is added to the list, removed from the list, or information about a person on the list changes, the appropriate district attorney, or special agent in charge, shall immediately notify the director of the controlled substance database, committee, or commissioner of any changes to the list submitted or in the information submitted for each attorney, officer, or agent on the list application.
(e)
1. (1) Information obtained by law enforcement personnel from the database may be shared with other law enforcement personnel or prosecutorial officials only upon the direction of the officer or agent who originally requested the information and may only be shared with law enforcement personnel from other law enforcement agencies who are directly participating in an official joint investigation.
2. (2) Any information obtained from the database that is sent to law enforcement personnel shall also be sent to the district attorney general of the judicial district to the district in which such officer or agent has jurisdiction. Likewise, any database information sent to a TBI agent or DEA agent shall also be sent to the TBI director or the assistant special agent in charge.
3. (3)
  1. (A) Information obtained from the database by the judge of a drug court treatment program may be shared with personnel of a drug court treatment program.
  2. (B) For the purposes of this subdivision (e)(3), “personnel of a drug court treatment program” includes a judge of a drug court and any person employed by the drug court and designated by the judge to require access to the information in order to efficiently administer the drug court treatment program.
4. (4) Any information obtained from the database that is sent to a judge of a drug court treatment program shall also be sent to the district attorney general of the judicial district in which the judge has jurisdiction.
(f)
1. (1) To ensure the privacy and confidentiality of patient records, information obtained from the database by law enforcement personnel shall be retained by the law enforcement personnel's respective department or agency. The information obtained from the database shall not be made a public record. Any information used in a criminal or administrative action from the controlled substance monitoring database shall be placed under seal or have patient names and all other personally identifying information of patients redacted. Information obtained from the database shall be maintained as evidence in accordance with each law enforcement agency's respective procedures relating to the maintenance of evidence.
2. (2) To ensure the privacy and confidentiality of patient records, information obtained from the database by a drug court treatment program shall be retained by the program director of the drug court treatment program. The information obtained from the database shall not be made a public record, notwithstanding the use of the information in court for prosecution purposes.
(g) Any information disseminated pursuant to subdivisions (a)(1)-(3) and (a)(5)-(8) shall be released to the individual or entity requesting the information by the database manager or by password-protected internet access.
(h)
1. (1) Any healthcare practitioner or healthcare practitioner delegate receiving patient-specific information pursuant to subdivision (a)(1), (a)(2), (a)(3), or (a)(5) shall not disclose the information to any person other than:
  1. (A) The patient to whom the information relates;
  2. (B) Other healthcare practitioners who are involved or have a bona fide prospective involvement in the treatment of the patient, or healthcare practitioners identified by the information for the purpose of verifying the accuracy of the information; or
  3. (C) Any law enforcement personnel to whom reporting of controlled substances being obtained in a manner prohibited by § 53-11-401, or § 53-11-402(a)(3) or (a)(6), is required by § 53-11-309, or any agent of the healthcare practitioner who is directed by the healthcare practitioner to cause a report to law enforcement to be made in accordance with § 53-11-309(a) and (d).
2. (2) A healthcare practitioner or healthcare practitioner delegate may place a copy of a patient's report obtained from the database pursuant to this section in that patient's medical records, with the exception of information reported to the database by a Part 2 Program. Once a copy of a patient's report obtained from the database pursuant to this section is placed in the patient's medical records, the copy is subject to disclosure on the same terms and conditions as medical records under §§ 63-1-117 and 63-2-101. A patient's information reported to the database by a Part 2 Program shall not be placed in the patient's medical records unless doing so complies with the privacy requirements of 42 CFR Part 2 and the rules promulgated by the commissioner pursuant to § 53-10-304(e).
(i) If law enforcement personnel or a judge of a drug court treatment program has probable cause to believe, based upon information received from a database request, that a healthcare practitioner may be acting or may have acted in violation of the law, the officer, agent, or judge shall consult with the appropriate licensing board as established under title 63 or title 68.
(j)
1. (1)
  1. (A) At least every six (6) months, the committee or commissioner or their designee shall send a list to each district attorney general containing all requests made for database information during the previous six (6) months.
  2. (B) The list shall include:
    1. (i) The name of the requesting attorney, officer, or agent;
    2. (ii) The attorney, officer, or agent's agency;
    3. (iii) The date of the request; and
    4. (iv) The nature of the request, including the case number for each attorney, officer, or agent making a request in such district attorney's judicial district.
  3. (C) Likewise, a list shall be sent to the director of the TBI for all TBI agents or the assistant special agent in charge for all DEA agents making requests during the previous six (6) months.
2. (2) Each district attorney general, or assistant special agent in charge and the TBI director shall use the list to perform an audit to determine if the database information requests made during the preceding six-month period correspond to specific cases under investigation in the applicable judicial district or by the bureau and if the information requested is relevant and pertinent to an investigation.
3. (3) Each district attorney general, assistant special agent in charge, and the TBI director shall verify all database information requests contained on the list received and send it back to the board within sixty (60) days of receipt. If a database information request does not correspond to an investigation in the applicable jurisdiction or if the information requested was not relevant or pertinent to the information requested, the district attorney general, assistant special agent in charge, or TBI director shall so note on the verified list and shall investigate the discrepancy and make a report back to the director of the controlled substance database within a reasonable period of time.
4. (4) The results of the audit conducted pursuant to subdivision (j)(2) shall be discoverable by a healthcare practitioner or healthcare practitioner delegate charged with violating any state or federal law involving controlled substances or under a notice of charges proffered by an appropriate licensing board for a violation of any law involving controlled substances, but only the results pertaining to that healthcare practitioner or healthcare practitioner delegate are discoverable. If, however, there is an active criminal investigation involving a healthcare practitioner or healthcare practitioner delegate or the healthcare practitioner or healthcare practitioner delegate is under investigation by any investigations or prosecution unit of the appropriate licensure board, the results of the audit conducted pursuant to subdivision (j)(2) shall not be discoverable by the healthcare practitioner or the healthcare practitioner delegate during either such period.
(k)
1. (1) Any person who obtains or attempts to obtain information from the database by misrepresentation or fraud is guilty of a Class A misdemeanor.
2. (2) Any person who knowingly uses, releases, publishes, or otherwise makes available to any other person or entity any information submitted to, contained in, or obtained from the database for any purpose other than those specified in this part is guilty of a Class A misdemeanor.
3. (3) Intentional unauthorized use or disclosure of database information by law enforcement personnel is a Class A misdemeanor.
4. (4) Any law enforcement personnel whom the department has reason to suspect of violation of this section or who has been charged with a violation of this section shall have such person's authorization to request information from the database suspended. Any law enforcement personnel, found guilty of a violation of this subsection (k) shall have such person's authorization to request information from the database permanently revoked.
5. (5) Where an individual authorized under subsection (a) acts in good faith in accessing or using information from the database in accordance with the limitations under this part, that person shall not incur any civil or criminal liability as a result of that use or access.
(l)
1. (1) The following personnel of the department of mental health and substance abuse services actively engaged in analysis of controlled substances prescription information as a part of their assigned duties and responsibilities shall have access to the database for controlled substances prescription information for specific patients or healthcare practitioners:
  1. (A) The chief pharmacist;
  2. (B) The state opioid treatment authority (SOTA) or SOTA designee; and
  3. (C) The medical director.
2. (2) Deidentified controlled substances prescribing information from the database may be provided upon request by the following personnel of the department of mental health and substance abuse services, who are actively engaged in analysis of controlled substances prescription information as provided in this subsection (l), and may be provided upon request to other personnel of the department of mental health and substance abuse services and other state government agencies as needed to fulfill assigned duties and responsibilities:
  1. (A) The chief pharmacist;
  2. (B) The SOTA; or
  3. (C) The medical director.
(m) Where an investigation is conducted under § 38-7-109, and information within the database is obtained pursuant to the requirements of this part, there exists a rebuttable presumption that the county medical examiner is acting in good faith.
(n) Authorized committee, board, or department personnel and any designee appointed by the committee engaged in analysis of controlled substances prescription information as a part of the assigned duties and responsibilities of their employment may publish, or otherwise make available to healthcare practitioners and to the general public, deidentified personal data contained in or derived from the database for the purpose of educational outreach.
(o) Prohibited access to, an inappropriate request for, or illegal disclosure of information from the database by a judge of a drug court treatment program shall be considered a violation of the canons of the Code of Judicial Conduct, including Rules 1.2, 1.3, and 3.5.
(p) Deidentified information from the database must not include the identifying information of any patient, healthcare practitioner, healthcare practitioner delegate, or healthcare facility.
(q) Notwithstanding subsections (a)-(p), information reported to the database by a Part 2 Program, as well as a subsequent disclosure of such information, may only be made available in accordance with 42 CFR Part 2 and the rules promulgated by the commissioner pursuant to § 53-10-304(e).

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§ 53-10-307. Failure to submit information — Liability.

(a) The failure of a healthcare practitioner to submit information to the database required under this part after the committee or the commissioner has submitted a specific written request for the information, or when the committee or the commissioner determines the individual has a demonstrable pattern of failing to submit the information as required, is grounds for the denial of licensure, renewal of licensure, or other disciplinary action against the healthcare practitioner before the licensing board with jurisdiction over the healthcare practitioner and for the committee to take the following actions:
1. (1) Recommend to the appropriate licensure board that it should refuse to issue a license to the individual;
2. (2) Recommend to the appropriate licensure board that it should refuse to renew the individual's license; and
3. (3) Recommend to the appropriate licensure board that it should commence disciplinary action against the licensee seeking revocation, suspension, or other appropriate discipline, including civil penalties.
(b) An individual or entity that has submitted information to the database in accordance with this part and in good faith shall not be subject to a suit for civil damages nor held civilly liable for having submitted the information.
(c) An individual or entity that in good faith disseminates information contained in, or derived from, the database to the individuals authorized by this part to receive it in the manner authorized by this part or rules promulgated pursuant to this part, shall not be subject to a suit for civil damages nor held individually liable for having done so.
(d) Submitting information as required by this part shall not subject the person submitting the information to licensure disciplinary action or any action for breach of confidentiality, ethical duty to a patient, or the sharing of any professional secret.
(e)
1. (1) Failure to submit the required information by any healthcare practitioner shall not be considered a violation if a good faith effort was made and the failure of the report to be transmitted was due to technical difficulties or the inability to have the report received by the database.
2. (2) Technical difficulties shall include the failure of the database to receive the transmission of any report, the failure of any healthcare practitioner's system or switch used in the transmission of a report, electrical problems, natural disasters, fires, flooding, or other unforeseen circumstances as defined in rules by the commissioner pursuant to § 53-10-311.

§ 53-10-308. Release of confidential information.

(a) Notwithstanding this part to the contrary, the committee or the commissioner:
1. (1) May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to department personnel engaged in an investigation, adjudication, or prosecution of a violation under any state or federal law that involves a controlled substance;
2. (2) May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to law enforcement personnel engaged in an investigation, adjudication, or prosecution of a violation under any state or federal law that involves a controlled substance, pursuant to the procedure established in § 53-10-306(a)(11);
3. (3) Shall release information from the database when ordered by a court to do so upon the court's finding that disclosure is necessary for the conduct of proceedings before the court regarding the investigation, adjudication, or prosecution of a violation under any state or federal law that involves controlled substances and after an appropriate protective order is issued regarding the information to be released to the court; and
4. (4)
  1. (A) Shall release confidential information from the database to the attorney general and reporter upon request for the purpose of reviewing, querying, or otherwise using the data in conjunction with investigating or litigating a civil action involving controlled substances. The data may be disclosed at the attorney general and reporter's discretion to:
    1. (i) Designees within the office of the attorney general and reporter who are participating in, assisting with, or supervising any such investigation or litigation;
    2. (ii) Other parties to litigation to which the attorney general and reporter is a party in which the data is relevant so long as disclosure of the data is in furtherance of litigation or resolution of litigation, and the data is provided only after an appropriate protective order is issued prohibiting the other parties from using the confidential information for any purpose other than defending or resolving the litigation and prohibiting the sharing of confidential information with litigants in other cases or other parties;
    3. (iii) Targets of an investigation conducted by the attorney general and reporter for the purpose of negotiating a settlement regarding conduct to which the data is relevant only after an appropriate protective order is issued or a confidentiality agreement is executed regarding the data;
    4. (iv) Designated consultants or experts who agree to maintain the confidentiality of the data and who are retained, in conjunction with an investigation or litigation, by:
      1. (a) The attorney general and reporter;
      2. (b) Other parties to litigation to which the attorney general and reporter is a party as described in subdivision (a)(4)(A)(ii); or
      3. (c) Targets of an investigation conducted by the attorney general and reporter as described in subdivision (a)(4)(A)(iii); and
    5. (v) A court for evidentiary or other purposes after an appropriate protective order is issued regarding the confidential information;
  2. (B) The attorney general and reporter shall comply with the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.) to the extent that it applies to any such disclosure.
(b) Any data authorized to be released under this section or § 53-10-306, other than deidentified data or data released to personnel of the department, the attorney general and reporter, or a health-related board is limited to reports of drugs prescribed to specific patients or prescribed by specific providers, and nothing in this part creates a right to other data such as provider query audits or registration information, nor does anything in this part require the committee or department to provide analytics or analysis of any data available in the database.
(c) Data reported to the database by a Part 2 Program shall not be released under this section or § 53-10-306 unless such release complies with 42 CFR Part 2 and the rules promulgated by the commissioner pursuant to § 53-10-304(e).

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53-10-306(a)

§ 53-10-309. Reports.

The commissioner or commissioner's designee shall report annually on the outcome of the program with respect to its effect on distribution and abuse of controlled substances, including recommendations for improving control and prevention of diversion of controlled substances in this state. The committee, its designee, or the commissioner shall also file an annual report with the health and welfare committee of the senate and the health committee of the house of representatives by March 1, 2017, and each March 1 thereafter, to include analysis about tracking the individuals or entities that access the database and the security measures taken to ensure that only authorized persons or entities access the database. In addition to the annual report submitted to the general assembly by the commissioner, authorized committee, board, or department personnel engaged in analysis of controlled substance prescription information as a part of the assigned duties and responsibilities of their employment shall release information from the database requested by a member of the general assembly that is related to research, statistical analysis, or education of healthcare practitioners relative to controlled substances. However, no report released pursuant to this section shall contain the name or other identifying information of a specific healthcare practitioner or specific healthcare practitioner delegate contained in the report. All information released from the database for such a report shall be in the aggregate.

§ 53-10-310. Practice sites where a controlled substance dispensed required to provide for electronic access to the controlled substance database — Exceptions — Violations and penalties.

(a) Each person or entity operating a practice site where a controlled substance is prescribed or dispensed to a human patient shall provide for electronic access to the database at all times when a healthcare practitioner provides healthcare services to a human patient potentially receiving a controlled substance.
(b) This section shall not apply to any person or entity that is not required to report pursuant to § 53-10-304(d) or § 53-10-305(g).
(c) A violation of subsection (a) is punishable by a civil penalty not to exceed one hundred dollars ($100) per day assessed against the person or entity operating the practice site; provided, however, that the penalty shall only be imposed when there is a continued pattern or practice of not providing electronic access to the database.
(d) Any healthcare practitioner, individual, or entity who is authorized to access the database by this part shall not be subject to a suit for civil damages or held civilly liable for the failure to register in, report to, or check the database, or for actions taken after reasonable reliance on information in the database, or for accessing the database to determine whether or not the healthcare practitioner's professional credentials are being inappropriately used, or for reporting the same to the appropriate authorities, except as otherwise provided in this part.
(e)
1. (1) When prescribing a controlled substance, all healthcare practitioners, unless otherwise exempted under this part, shall check the controlled substance database prior to prescribing one (1) of the controlled substances identified in subdivision (e)(4) to a human patient at the beginning of a new episode of treatment, prior to the issuance of each new prescription for the controlled substance for the first ninety (90) days of a new episode of treatment, and shall check the controlled substance database for that human patient at least every six (6) months when that prescribed controlled substance remains part of the treatment. An authorized healthcare practitioner's delegate may check the controlled substance database on behalf of the healthcare practitioner. A “new episode of treatment” means a prescription for a controlled substance that has not been prescribed by that healthcare practitioner within the previous six (6) months.
2. (2) When dispensing a controlled substance, all healthcare practitioners, unless otherwise exempted under this part, shall check the controlled substance database prior to dispensing one (1) of the controlled substances identified in subdivision (e)(4) to a human patient the first time that patient is dispensed a controlled substance at that practice site. The dispenser shall check the controlled substance database again at least once every six (6) months for that human patient after the initial dispensing for the duration of time the controlled substance is dispensed to that patient. The initial dispensing check fulfills the check requirement for the first six-month period. An authorized healthcare practitioner's delegate may check the controlled substance database on behalf of the healthcare practitioner.
3. (3) Before prescribing or dispensing, a healthcare practitioner shall have the professional responsibility to check the database or have a healthcare practitioner delegate check the database if the healthcare practitioner is aware or reasonably certain that a person is attempting to obtain a Schedule II-V controlled substance, identified by the committee or commissioner as demonstrating a potential for abuse for fraudulent, illegal, or medically inappropriate purposes, in violation of § 53-11-402.
4. (4) The controlled substances that trigger a check of the controlled substance database pursuant to subdivisions (e)(1) and (2) include, but are not limited to, all opioids and benzodiazepines. By rule, the commissioner, pursuant to § 53-10-311, may require a check of the database for additional Schedule II-V controlled substances that are identified by the committee or commissioner as demonstrating a potential for abuse.
5. (5) The commissioner, pursuant to § 53-10-311, shall adopt rules in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, that establish standards and procedures to be followed by a healthcare practitioner regarding the review of patient information available through the database.
6. (6) Healthcare practitioners are not required to check the controlled substance database before prescribing or dispensing one (1) of the controlled substances identified in subdivision (e)(4) or added to that list by the committee or commissioner if one (1) or more of the following conditions are met:
  1. (A) The controlled substance is prescribed or dispensed for a patient who is currently receiving hospice care;
  2. (B) The quantity of the controlled substance which is prescribed or dispensed does not exceed an amount which is adequate for a single, three-day treatment period and does not allow a refill; or
  3. (C) The controlled substance is prescribed for administration directly to a patient during the course of inpatient or residential treatment in a hospital or nursing home licensed under title 68.
(f) Each appropriate licensure board may promulgate rules pursuant to the Uniform Administrative Procedures Act, to establish procedures, notice requirements, and penalties for healthcare practitioners who fail to register in, report to, or check the controlled substance database as required.
(g) Notwithstanding this part to the contrary, a healthcare practitioner or healthcare practitioner delegate shall not be in violation of this part during any time period in which the controlled substance database is suspended or not operational or the internet is not operational or available as defined by rules promulgated by the commissioner.

§ 53-10-311. Establishment of operations committee — Agreements with federal government and other jurisdictions for sharing and dissemination of data and information.

(a) There is created an operations committee. The operations committee shall be composed of:
1. (1) The board of medical examiners' medical director for special projects;
2. (2) An epidemiologist employed by the department of health;
3. (3) The executive director of the board of pharmacy;
4. (4) The director of the controlled substance database;
5. (5) A member of the controlled substance database committee;
6. (6) The executive director of the board of nursing as an ex officio non-voting member; and
7. (7) The executive director of the board of medical examiners as an ex officio non-voting member.
(b)
1. (1) The commissioner shall have the duty to convene the operations committee at least annually and request approval by the operations committee of actions taken under the authority granted by this part prior to those actions becoming final. The operations committee shall meet at such other times as needed and as convened by the commissioner to confirm or deny decisions made by the commissioner pursuant to the authority granted to the commissioner by this part.
2. (2) The operations committee's approval shall be necessary for all rules, agreements, and policies concerning:
  1. (A) Access to the database and how that access is obtained;
  2. (B) Dissemination of data and information in the database and control over that data; and
  3. (C) The control, sharing, and dissemination of data and information in the database with other states or other entities acting on behalf of a state.
3. (3) The operations committee's approval shall not be necessary for any rules, agreements, or policies that concern the daily operations decisions, which may be delegated to the director of the database, concerning establishing, maintaining, or operating the database. The operations committee shall not set fees.
4. (4) The operations committee may make formal recommendations to the commissioner with respect to any contemplated rulemaking under this part, which does not require its approval.
(c) Three (3) voting members of the operations committee shall constitute a quorum for official actions. A majority of those voting members present shall be necessary to approve an action proposed by the commissioner.
(d) The operations committee shall not be subject to title 8, chapter 44, part 1, regarding public meetings.
(e)
1. (1) Notwithstanding this part to the contrary, the commissioner is authorized to enter into agreements with the federal centers for disease control and prevention (CDC), other states, other governmental entities, or entities acting on behalf of the CDC or such state or governmental entity for the purposes of sharing and disseminating data and information in the database.
2. (2) Any information disseminated pursuant to this subsection (e) shall be for:
  1. (A) Analysis of controlled substance prescriptions for public health research or patient care coordination; or
  2. (B) Data sharing consistent with the requirements of § 53-10-306.
3. (3) Before the commissioner executes an agreement with the CDC, another state, another governmental entity, or an entity acting on behalf of the CDC or such state or governmental entity, the agreement must be approved by the operations committee.
4. (4) All agreements entered into by the commissioner subject to this subsection (e) shall be governed by a contract entered into between the two (2) parties.
5. (5) An agreement executed by the commissioner pursuant to this subsection (e) must comply with 42 CFR Part 2 to the extent that the agreement includes information reported to the database by a Part 2 Program.

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§ 53-10-312. Minimum reporting requirements for wholesalers and manufacturers — Establishment of rules as to reporting requirements.

(a) Wholesalers and manufacturers, as defined in § 63-10-204, that sell controlled substances at wholesale must at least report the following information to the committee in Automation of Reports and Consolidated Orders System (ARCOS) format or other mutually acceptable format:
1. (1) Wholesaler or manufacturer with a drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier;
2. (2) Purchaser's drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier;
3. (3) National drug code number of the actual drug sold;
4. (4) Quantity of the drug sold;
5. (5) Date of sale; and
6. (6) Transaction identifier or invoice number.
(b) The board may establish such rules as are necessary to specify which medications shall be reported, the time frames for such reporting, and other reporting requirements as required.
(c) A wholesaler shall design and operate a system to disclose to the wholesaler suspicious orders of controlled substances. A wholesaler shall inform the board of pharmacy and the boards whose licensees have prescribing authority of suspicious orders when discovered. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
(d) In the event of the discovery of the theft or significant loss of controlled substances, a wholesaler shall report such theft or significant loss to the committee and local law enforcement within one (1) business day of discovery of the theft or loss.

Part 4 Tamper-Proof Prescriptions

§ 53-10-401. Tamper-proof prescriptions.

(a) All prescriptions written or printed by practitioners authorized to write prescriptions in this state shall be written on either tamper-resistant prescription paper or printed utilizing a technology that results in a tamper-resistant prescription that meets the current centers for medicare and medicaid services guidance to state medicaid directors regarding § 7002(b) of the United States Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007, P.L. 110-28, and meets or exceeds specific TennCare requirements for tamper-resistant prescriptions.
(b) A pharmacist shall not fill a written prescription from a Tennessee practitioner unless issued in compliance with tamper-resistant prescription requirements as described in subsection (a), except that a pharmacist may provide emergency supplies in accordance with TennCare or other insurance contract requirements. Nothing in this section shall be construed to impact regulations regarding verbal, facsimile, electronic, or out-of-state prescription practices.
(c) All existing statutory requirements regarding prescriber-specific information to be included on prescriptions shall also apply to tamper-resistant prescriptions.
(d) Unique serial numbers may be included on tamper-resistant prescriptions for purposes of enhancing efforts to track and enforce any potential fraud. Inclusion of such numbers on the prescription shall not be construed as obligating prescribers or pharmacists to any additional tracking, monitoring or reporting requirements and prescribers and pharmacists shall bear no responsibility or liability with respect to the potential use of these unique serial numbers for enforcement purposes.
(e) Practitioners shall utilize reasonable safeguards to assure against theft or unauthorized use of any prescriptions.
(f) Manufacturers of tamper-resistant prescription paper shall have an annual industry-approved SAS 70 audit that shall be made available by the manufacturer upon request by the board of pharmacy. The board of pharmacy shall maintain a list of any manufacturers who fail to show proof of such audit. The list shall be made available to prescribers and pharmacists in this state in a manner deemed appropriate by the board of pharmacy.
(g) This section shall not apply to prescriptions written by veterinarians.
(h) This section shall not apply to prescriptions written for inpatients of a hospital, outpatients of a hospital where the doctor, or other person authorized to write prescriptions, writes the order into the hospital medical record and then the order is given directly to the hospital pharmacy and the patient never has the opportunity to handle the written order, a nursing home or an assisted care living facility as defined in § 68-11-201 or inpatients or residents of a mental health hospital or residential facility licensed under title 33 or individuals incarcerated in a local, state or federal correctional facility.

Chapter 11 Narcotic Drugs and Drug Control

Part 2 Confiscation

§ 53-11-201. Procedure in confiscation.

(a)
1. (1)
  1. (A) In all cases of seizure of any narcotic drugs or marijuana or any vehicle, aircraft or boat or other property subject to forfeiture under this chapter, the officer or other person making the seizure shall deliver a receipt to the person, if any, found in possession of the property or conveyance.
  2. (B) The receipt shall state a general description of the seized property or conveyance, the reasons for the seizure, the procedure by which recovery of the property or conveyance may be sought, including the time period in which a claim for recovery must be presented, and the consequences of failing to file within the time period.
  3. (C) If the person found in possession of the conveyance is not the sole unencumbered owner of the conveyance, the department of safety shall make a reasonable effort to notify the owner or lienholder of the seizure by furnishing all parties known to have an interest in the conveyance with a copy of the receipt.
  4. (D) A copy of the receipt shall be filed in the office of the department of safety and shall be open to the public for inspection.
2. (2) In all cases of seizure under subdivision (a)(1) involving a commercial vehicle or common carrier, any cargo or products transported by the commercial vehicle or common carrier shall not be subject to forfeiture, unless the cargo or products are otherwise subject to forfeiture under this chapter, or any other law of this state or the federal government. The cargo or products shall, upon request, immediately be made available for release to the owner or transporting agent.
(b)
1. (1) All property seized and forfeited under this chapter shall be sold at public sale by the commissioner of general services when seized by an agency of the state or a campus police officer as defined in § 49-7-118, or, if seized by a county or municipality, by the seizing agency of the county or municipality when the seized and forfeited property has been released by the commissioner of safety as now authorized by law.
2. (2)
  1. (A) However, any vehicle seized by an agency of the state and forfeited under this chapter may, with the permission of the commissioner of safety and under terms and conditions approved by the commissioner of safety, be used, for a period of time not to exceed one (1) year, in the drug enforcement program of the state.
  2. (B) No vehicle seized by an agency of the state and forfeited under this chapter shall be used in the county or municipality in which it was seized.
  3. (C) Notwithstanding subdivision (b)(2)(B) to the contrary, any vehicle seized by a county or municipal agency and forfeited under title 40, chapter 33, part 2, may be used in the local drug enforcement program for a period not to exceed five (5) years.
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- 40-33-211(e)
(c)
1. (1) Any person claiming any property seized as contraband goods may, within thirty (30) days after receipt of notification of seizure, file with the commissioner at Nashville a claim in writing, requesting a hearing and stating the person's interest in the articles seized.
2. (2) The claimant shall also file with the claimant's claim a cost bond with one (1) or more good and solvent sureties in the sum of two hundred fifty dollars ($250), the bond being made payable to the state.
3. (3) An indigent person may file the claim in forma pauperis by filing with the claim an affidavit stating that the indigent person is unable to bear the cost of the proceeding.
(d)
1. (1)
  1. (A) Within thirty (30) days from the day the claim is filed, the commissioner shall establish a hearing date and set the case on the docket.
  2. (B) Nothing in subdivision (d)(1)(A) shall be construed as requiring the hearing to be conducted within the thirty-day period.
2. (2) At each hearing, the state shall have the burden of proving by a preponderance of the evidence that the seized property was of a nature making its possession illegal or was used in a manner making it subject to forfeiture under this chapter, and failure to carry the burden of proof shall operate as a bar to any forfeiture under this chapter.
(e)
1. (1) If the ruling of the commissioner is favorable to the claimant, the commissioner shall deliver to the claimant the vehicle and any other property seized that is not contraband, and the claimant shall not be required to pay any of the expenses incurred in the storage, transportation, and impoundment of the seized property.
2. (2) If the ruling of the commissioner is adverse to the claimant, the commissioner shall proceed to sell or dispose of the contraband goods in accordance with this section and the expenses incurred in the storage, transportation, and impoundment, of the property shall be adjudged as part of the cost of the proceeding in any manner the commissioner determines.
(f)
1. (1) Whenever, in any proceeding under this section, a claim is filed for any property seized, as provided in this section, by an owner or other person asserting the interest of the owner, the commissioner shall not allow the claim unless and until the claimant proves that the claimant:
  1. (A) Has an interest in the property, which the claimant acquired in good faith; and
  2. (B) Had at no time any knowledge or reason to believe that it was being or would be used in violation of the laws of the United States or of the state relating to narcotic drugs or marijuana.
2. (2) Whenever, in any proceeding under this section, a claim is filed for any property seized, as provided in this section, by a person who is the holder of a security interest or other claim arising out of a contract or agreement, the commissioner shall not allow the claim unless and until the claimant proves that the claimant has an interest in the property, which the claimant acquired in good faith. An interest that is acquired in the ordinary course of business shall be presumed to be in good faith unless the commissioner receives evidence that the holder of the security interest had knowledge, at the time the interest attached, of the intended illegal use of the vehicle or was a co-conspirator in furtherance of the illegal activity. A holder of a security interest that is other than a natural person shall be considered a co-conspirator for purposes of this section, if evidence shows that an officer, employee or agent of the holder acting within the scope of employment is a co-conspirator, and the holder either:
  1. (A) Has actual knowledge of the illegal activities of the officer, employee or agent from an individual other than the officer, employee or agent and fails to take appropriate action; or
  2. (B) Has failed to reasonably supervise or monitor the activities of the holder's officer, employee or agent.
3. (3) In the event the interest of the owner is forfeited, as provided in subdivision (f)(1), and the interest of the holder of a security interest is not forfeited as provided in subdivision (f)(2), the commissioner may, at the request of the holder of the security interest, return the property to the holder for disposition in accordance with the applicable security agreement or other contract. If the commissioner does not return the property to the holder, the forfeiture shall be subject to the holder's interest.
(g) Pending any proceeding to recover a vehicle, aircraft or boat seized under this chapter, the commissioner may order delivery of the vehicle, aircraft or boat to any claimant who shall establish the claimant's right to immediate possession of the vehicle, aircraft or boat, and who shall execute, with one (1) or more sureties approved by the commissioner, and deliver to the commissioner, a bond in favor of the state and for the payment of the NADA retail value of the vehicle, aircraft or boat as of the time of the hearing, and conditioned further that, if the vehicle, aircraft or boat is not returned at the time of hearing, the bond shall stand in lieu of and be forfeited in the same manner as the vehicle, aircraft or boat.
(h)
1. (1) The commissioner, in the commissioner's discretion, is authorized to appoint or designate a hearing officer to sit, and set the case on the docket, as the hearing officer at the request and in the absence of the commissioner for the purpose of conducting the hearing as the commissioner may deem necessary.
2. (2) The hearing officer designated by the commissioner shall make findings of fact, conclusions of law, and recommendations for the issuance of the proposed order based on the findings, conclusions and recommendations.
3. (3) If the commissioner concurs, the commissioner shall issue the order, or the commissioner may, upon review of the record, make findings, conclusions, and issue an order that, in the commissioner's discretion, the record justifies.
4. (4) The commissioner, personally, may hold hearings that the commissioner deems proper.
5. (5) The hearing officer is likewise empowered to subpoena witnesses and compel their attendance and the production of records, memoranda, papers and other documents at any hearing authorized under this section.
(i)
1. (1) At all hearings provided for in this section, the commissioner or the hearing officer shall provide a stenographer or court reporter to take a stenographic record of the evidence adduced at the hearing.
2. (2) The claimant shall be entitled to a copy of the stenographic record, upon application for a copy and upon paying the reasonable costs of the copy to be fixed by the commissioner.
(j) The commissioner may make or publish other and further procedural rules and regulations, not inconsistent with this section, that the commissioner deems proper, governing any hearing provided for in this section.
(k) If a law enforcement agency seizes a motor vehicle as the result of a violation of the drug control law, the agency may elect whether to go forward with the forfeiture proceeding through either an administrative agency or through a court having civil jurisdiction in the county where the seizure occurred.

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§ 53-11-202. [Reserved.]

§ 53-11-203. Procedure final when no claim interposed.

If no claim is interposed, narcotic drugs, marijuana or other property shall be forfeited without further proceedings and the drugs, marijuana or other property shall be sold or disposed of as provided in this chapter.

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12-2-201(a)

§ 53-11-204. Disposition of proceeds.

The proceeds of all seizures, confiscations and sales made by a state agency pursuant to this chapter shall be transmitted to the state treasurer and deposited in the state treasury; provided, that upon application of the commissioner, the proceeds or any part of the proceeds may be allocated by the commissioner of finance and administration to the department of safety as expendable receipts for use in the enforcement of this chapter and the other laws of this state regulating narcotic drugs and marijuana.

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12-2-201(a)

Part 3 Regulations and Registration

§ 53-11-301. Rules and fees for controlled drugs.

The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances may promulgate rules and charge reasonable fees relating to the registration and control of the manufacture, distribution, dispensing, warehousing of, and the provision of logistics services for controlled substances within this state.

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53-11-302(a)

§ 53-11-302. Handlers of controlled substances — Registration and inspection.

(a) Every person who manufactures, distributes, dispenses, or is a third-party logistics provider for any controlled substance pursuant to § 53-11-301 within this state or who proposes to engage in the manufacture, distribution, dispensing, warehousing, or providing logistics services for any controlled substance within this state, shall annually obtain a registration issued by the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances in accordance with the licensing board's rules.
(b) Persons registered by the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances under this part, part 4 of this chapter, and title 39, chapter 17, part 4, to manufacture, distribute, dispense, warehouse, or provide logistics services for controlled substances may possess, manufacture, warehouse, distribute, or dispense those substances to the extent authorized by their registration and in conformity with this section.
(c) The following persons need not register and may lawfully possess controlled substances under this part, part 4 of this chapter and title 39, chapter 17, part 4:
1. (1) A common or contract carrier or warehouseman, or an employee of a common or contract carrier or warehouseman, whose possession of any controlled substance is in the usual course of business or employment; or
2. (2) An ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner or in lawful possession of a Schedule V substance.
(d) The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances may waive by rule the requirement for registration of certain manufacturers, distributors, dispensers, or entities providing warehousing or logistics services if they find it consistent with the public health and safety.
(e) A separate registration is required at each principal place of business or professional practice where the applicant manufactures, distributes or dispenses controlled substances.
(f) The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances may inspect the establishment of a registrant or applicant for registration in accordance with the board's rules and regulations.

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53-11-304(a)

§ 53-11-303. Criteria for registration issuance.

(a) The state board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances shall register an applicant to manufacture or distribute controlled substances included in title 39, chapter 17, part 4, unless it determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances shall consider the following factors:
1. (1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific or industrial channels;
2. (2) Compliance with applicable state and local law;
3. (3) Any convictions of the applicant under any federal and state laws relating to any controlled substance;
4. (4) Past experience in the manufacture or distribution of controlled substances, and the existence in the applicant's establishment of effective controls against diversion;
5. (5) Furnishing by the applicant of false or fraudulent material in any application filed under this part and part 4 of this chapter, or title 39, chapter 17, part 4;
6. (6) Suspension or revocation of the applicant's federal registration to manufacture, distribute or dispense controlled substances as authorized by federal law; and
7. (7) Any other factors relevant to and consistent with the public health and safety.
(b) Registration under subsection (a) does not entitle a registrant to manufacture and distribute controlled substances in Schedule I, II or VI other than those specified in the registration.
(c) Practitioners must be registered to dispense any controlled substances in Schedules II through V if they are authorized to dispense under the law of this state.
(d) Compliance by manufacturers and distributors with the federal law respecting registration, excluding fees, entitles them to be registered under this part, part 4 of this chapter and title 39, chapter 17, part 4.

§ 53-11-304. Suspension and revocation of registration.

(a) A registration under § 53-11-302 to manufacture, warehouse, distribute, dispense, or provide logistics services for a controlled substance may be suspended or revoked by the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances upon a finding that the registrant has:
1. (1) Furnished false or fraudulent material information in any application filed under this part and part 4 of this chapter, or title 39, chapter 17, part 4;
2. (2) Been convicted of a felony under any state or federal law relating to any controlled substance; or
3. (3) Had the registrant's federal registration suspended or revoked to manufacture, distribute or dispense controlled substances.
(b) The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances may limit revocation or suspension of a registration to the particular controlled substance with respect to which grounds for revocation or suspension exist.
(c)
1. (1) If the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances suspend or revoke a registration, all controlled substances owned or possessed by the registrant at the time of suspension or the effective date of the revocation order may be placed under seal.
2. (2) No disposition may be made of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded, unless a court, upon application for disposition, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court.
3. (3) Upon a revocation order becoming final, all controlled substances may be forfeited to the state.
(d) The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances shall promptly notify the bureau, as defined in § 39-17-402, of all orders suspending or revoking registration and all forfeitures of controlled substances.

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53-11-305(d)(1)

§ 53-11-305. Revocation, suspension or denial of registration.

(a) Before denying, suspending or revoking a registration, or refusing a renewal of registration, the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked or suspended, or why the renewal should not be refused.
(b) The order to show cause shall contain a statement of the basis for denying, suspending or revoking a registration, or refusing a renewal of registration and shall call upon the applicant or registrant to appear before the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances at a time and place not less than thirty (30) days after the date of service of the order, but in the case of a denial of renewal of registration, the show cause order shall be served not later than thirty (30) days before the expiration of the registration.
(c) Proceedings to refuse renewal of registration shall not abate the existing registration, which shall remain in effect pending the outcome of the administrative hearing.
(d)
1. (1) The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances may suspend, without an order to show cause, any registration simultaneously with the institution of proceedings under § 53-11-304, or where renewal of registration is refused, if they find that there is an imminent danger to the public health or safety that warrants this action.
2. (2) The suspension shall continue in effect until the conclusion of the proceedings, including judicial review of the suspension, unless sooner withdrawn by the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances or dissolved by a court of competent jurisdiction.

§ 53-11-306. Records and inventories required.

Persons registered to manufacture, distribute or dispense controlled substances under this part and part 4 of this chapter and title 39, chapter 17, part 4, shall keep records and maintain inventories in conformance with the record keeping and inventory requirements of federal law, and with any additional rules the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances.

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53-11-308(b)

§ 53-11-307. Inter-registrant distribution.

(a) Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to an order form.
(b) Compliance with federal law respecting order forms shall be deemed compliance with this section.

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53-11-402(a)(1)

§ 53-11-308. Prescription requirements.

(a) Except when dispensed directly by a health care prescriber other than a pharmacy to an ultimate user, no controlled substance in Schedule II may be dispensed without the electronic prescription of a health care prescriber, unless authorized by § 63-1-160. To the extent federal law does not permit an electronic prescription, a written prescription from a health care prescriber is required.
(b) In emergency situations, Schedule II drugs may be dispensed upon oral prescription of a health care prescriber, reduced promptly to writing or to electronic form, as appropriate, and filed by the pharmacy. Prescriptions shall be retained in conformity with the requirements of § 53-11-306. No prescription for a Schedule II substance may be refilled.
(c) Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, a controlled substance included in Schedule III or IV that is a prescription drug shall not be dispensed without a written or oral prescription of a practitioner. The prescription shall not be filled or refilled more than six (6) months after the date of the written or oral prescription or be refilled more than five (5) times, unless renewed by the practitioner.
(d) A controlled substance included in Schedule V shall not be distributed or dispensed other than for a medical purpose.
(e) No prescription for any opioids or benzodiazepines may be dispensed in quantities greater than a thirty-day supply.
(f) If a prescriber dispenses any opioids, benzodiazepines, barbiturates, or carisoprodol, then the prescriber shall submit the transaction to the controlled substances monitoring database operated under chapter 10, part 3 of this title.
(g) Any prescribers of opioids, benzodiazepines, barbiturates or carisoprodol, either alone, concurrently, or sequentially with any other opioids, benzodiazepines, barbiturates, or carisoprodol to patients who are in chronic, long-term drug therapy for ninety (90) days or longer shall consider mandatory urine drug testing. This subsection (g) shall not supercede any rules promulgated by the commissioner for urine drug testing by registered pain management clinics.
(h)
1. (1) Prior to prescribing more than a three-day supply of an opioid or an opioid dosage that exceeds a total of a one hundred eighty (180) morphine milligram equivalent dose to a woman of childbearing age, a prescriber shall:
  1. (A) Advise the patient of the risk associated with opioid use during pregnancy;
  2. (B) Counsel the patient on appropriate and effective forms of birth control; and
  3. (C) Offer information about the availability of free or reduced cost birth control to the patient.
2. (2) As used in this subsection (h), “a woman of childbearing age” means any woman between the ages of fifteen (15) and forty-four (44).
3. (3) This subsection (h) does not apply if:
  1. (A) The prescriber has previously taken all actions required by subdivision (h)(1) with respect to the patient within the past three (3) months; or
  2. (B) The prescriber reasonably believes that the patient is not capable of becoming pregnant.
4. (4) If the patient is under eighteen (18) years of age, the physician may satisfy this subsection (h) by advising, counseling, and providing information to the parent or guardian instead of the patient. This subdivision (h)(4) does not prohibit a physician from advising, counseling, and providing information directly to the patient if not otherwise prohibited by law.
5. (5) The department of health shall develop and publish guidance to assist prescribers of opioids in complying with this subsection (h).
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- 53-11-401(b)(1)
(i)
1. (1) Notwithstanding another law, and except as otherwise provided in subdivision (i)(2), when prescribing an opioid to a patient, a healthcare prescriber shall offer a prescription for an opioid antagonist, or another drug approved by the United States food and drug administration for the complete or partial reversal of an opioid overdose event, to the patient when one (1) or more of the following conditions are present in accordance with the federal centers for disease control and prevention opioid-prescribing guidelines setting forth treatment of a known or suspected opioid overdose:
  1. (A) The healthcare provider prescribes more than a three-day supply of an opioid medication; and
  2. (B)
    1. (i) The healthcare provider prescribes an opioid medication concurrently with a prescription by the same provider for benzodiazepine; or
    2. (ii) The patient presents with an increased risk for overdose, including a history of overdose, a history of substance use disorder, or being at risk for returning to a high dose of opioid medication to which the patient is no longer tolerant.
2. (2) Subdivision (i)(1) does not apply to:
  1. (A) An opioid prescription that is written as part of a patient's palliative care treatment. As used in this subdivision (i)(2)(A), “palliative care” has the same meaning as defined in § 63-1-164; or
  2. (B) An opioid prescription that is written by a licensed veterinarian, as defined in § 63-12-103.
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- 53-11-401(b)(1)

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§ 53-11-309. Reporting persons obtaining or attempting to obtain controlled substances — Immunity — Exception.

(a) Any physician, dentist, optometrist, podiatrist, veterinarian, pharmacist, advanced practice registered nurse with a certificate of fitness issued under title 63, chapter 7, or physician assistant, hereinafter referred to collectively as “health care providers”, who has actual knowledge that a person has knowingly, willfully and with intent to deceive, obtained or attempted to obtain controlled substances in the manner prohibited by § 53-11-402(a)(6) shall cause a report to be submitted regarding such activity within five (5) business days of obtaining such knowledge. The report should be submitted to the local law enforcement agency where the health care provider is located or, where one exists, to a judicial district or multi-judicial district drug task force. The controlled substance database advisory committee established by § 53-10-303 shall develop a form by no later than August 1, 2010, that health care providers may choose to use to make reports. The department of health shall make the form available on its website.
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- 53-10-306(h)(1)(C)
- 53-11-401(a)(3)
(b) Any physician or advanced practice registered nurse with a certificate of fitness issued under title 63, chapter 7, or physician assistant who has actual knowledge that a person has knowingly, willfully and with the intent to deceive, obtained or attempted to obtain controlled substances in the manner prohibited by § 53-11-402(a)(6) and who is providing treatment to a person with a mental illness as defined in § 33-1-101 may, but is not required to, report as provided for under subsection (a).
(c) If the health care provider's actual knowledge of conduct prohibited by § 53-11-402(a)(6) is a result of the health care provider accessing the information available in the controlled substance database established in § 53-10-304, then notwithstanding the confidentiality provisions in § 53-10-306, the local law enforcement agency or, where one exists, a judicial district or multi-judicial district drug task force may receive from the health care provider only the pertinent information from the database for the thirty (30) days prior to the date of treatment leading to the alleged offense which ostensibly demonstrates non-compliance with § 53-11-402(a)(6). A report with information from the database not exceeding thirty (30) days prior to the date of treatment made under this provision to local law enforcement or, where one exists, to a judicial district or multi-judicial district drug task force is sufficient grounds for the production of complete or more detailed controlled substance database information for purposes of a criminal investigation or pending prosecution pursuant to the procedures established by § 53-10-306(b).
(d) A health care provider, or any person under the direction of the health care provider or any entity that assumes the responsibility of reporting for the provider who furnishes any information in good faith is immune from liability if a complaint, report, information, or record is furnished to a law enforcement agency.
(e) This section shall not apply in the case of a person who, on the date of treatment by the health care provider, is enrolled in or covered by TennCare.

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§ 53-11-310. Identification requirements for dispensing of certain Schedule II to IV prescription medications for greater than a seven-day supply.

(a) Prior to an authorized dispenser dispensing a prescription for any Schedule II-IV opioid, benzodiazepine, zolpidem, barbiturate, or carisoprodol medication for greater than a seven-day supply, a pharmacist, pharmacy technician, pharmacy intern, or any other person authorized to dispense controlled substances shall require the person taking possession of the dispensed prescription to present a valid government issued identification or public or private insurance card, unless the person is personally known to the pharmacist, pharmacy technician, pharmacy intern or any other person authorized to dispense controlled substances. The identification requirements described in subsection (a) shall apply to all authorized dispensers who dispense Schedule II-IV opioid, benzodiazepine, zolpidem, barbiturate, and carisoprodol medications for greater than a seven-day supply.
(b) Should any person who is a minor or who is homeless seek to take possession of a dispensed prescription for a Schedule II-IV opioid, benzodiazepine, zolpidem, barbiturate, or carisoprodol medication not have a valid identification, the pharmacist, pharmacy technician, pharmacy intern or any other person authorized to dispense controlled substances shall use professional judgment in determining whether to dispense the prescription to the person.
(c) Nothing in this section shall be construed to:
1. (1) Require that the person taking possession of a Schedule II-IV opioid, benzodiazepine, zolpidem, barbiturate, or carisoprodol medication and the person for whom the prescription is written be the same person;
2. (2) Apply to any controlled substance dispensed by a licensed veterinarian;
3. (3) Apply to drug samples dispensed by a healthcare professional; or
4. (4) Apply to prescriptions written for:
  1. (A) Inpatients in a hospital;
  2. (B) Outpatients of a hospital where the prescriber writes the order in the medical chart and the order is given directly to the hospital pharmacy and the patient does not have the opportunity to handle the written order;
  3. (C) Residents of a nursing home or an assisted living facility;
  4. (D) Inpatients or residents of a mental health hospital or residential facility licensed under title 33;
  5. (E) Inpatients or residents of any facility that is registered by the United States drug enforcement administration as a narcotic treatment program and is subject to the record keeping provisions of 21 CFR § 1304.24;
  6. (F) Individuals incarcerated in a local, state or federal correctional facility;
  7. (G) Patients receiving prescriptions from mail order pharmacies; or
  8. (H) Patients receiving home deliveries from pharmacies.
(d) A healthcare provider in violation of this section shall only be subject to a civil penalty assessed by the provider's licensing board. Section 53-11-401 shall not apply to penalties imposed under this section.
(e) The board of pharmacy is authorized to promulgate rules to implement this section in accord with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.

§ 53-11-311. Use of buprenorphine products.

(a) Any product containing buprenorphine, whether with or without naloxone, may only be prescribed for a use recognized by the federal food and drug administration. This subsection (a) shall not apply to a person:
1. (1) Who has a documented diagnosis of opiate addiction as shown in their medical record;
2. (2) Who receives treatment from a provider practicing under 21 U.S.C. § 823(g)(2); and
3. (3) Who is counted against the total number of patients allowed to the provider as set forth in 21 U.S.C. § 823(g)(2).
(b)
1. (1) Any prescription for buprenorphine mono or for buprenorphine without use of naloxone for the treatment of substance use disorder shall only be permitted to a patient who is:
  1. (A) Pregnant;
  2. (B) A nursing mother;
  3. (C) Has a documented history of an adverse reaction or hypersensitivity to naloxone; or
  4. (D) Directly administered the buprenorphine mono or buprenorphine without use of naloxone by a healthcare provider, acting within the healthcare provider's scope of practice, for the treatment of substance use disorder pursuant to a medical order or prescription order from a physician licensed under title 63, chapter 6 or 9; provided, however, that this subdivision (b)(1)(D) does not permit buprenorphine mono or buprenorphine without use of naloxone to be dispensed to a patient in a manner that would permit it to be administered away from the premises on which it is dispensed.
2. (2) If the prescriber of buprenorphine mono or buprenorphine without use of naloxone for a patient under subdivision (b)(1)(A) or (b)(1)(B) is not the patient's obstetrical or gynecological provider, the prescriber shall consult with the patient's obstetrical or gynecological provider to the extent possible to determine whether the prescription is appropriate for the patient.
(c)
1. (1) Notwithstanding any other provision of this title, and except as otherwise provided in subdivision (c)(2), a physician licensed under title 63, chapter 6 or 9, is the only healthcare provider authorized to prescribe any buprenorphine product for any federal food and drug administration approved use in recovery or medication-assisted treatment.
2. (2) Healthcare providers not licensed pursuant to title 63, chapter 6 or 9, and who are otherwise permitted to prescribe Schedule II or III drugs under this title, are prohibited from prescribing any buprenorphine product for the treatment of opioid use disorder unless the provider:
  1. (A) Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state;
  2. (B) Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years;
  3. (C) Is employed by a community mental health center, as defined in § 33-1-101, or a federally qualified health center, as defined in § 63-10-601(a), that employs one (1) or more physicians and has adopted clinical protocols for medication-assisted treatment;
  4. (D) Is employed at a facility at which healthcare providers are contracted and credentialed with TennCare and TennCare's managed care organizations to treat opioid use disorder with buprenorphine products for use in recovery or medication-assisted treatment;
  5. (E) Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction;
  6. (F) Is employed by a facility that requires patients to verify identification;
  7. (G) Does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent;
  8. (H) Does not prescribe or dispense a mono product or buprenorphine without naloxone;
  9. (I) Works under the supervision of a physician who holds an active federal Drug Addiction Treatment Act of 2000 (DATA 2000) waiver registration from the federal drug enforcement agency that authorizes the physician to prescribe buprenorphine products and is actively treating patients with buprenorphine products for recovery or medication-assisted treatment;
  10. (J) Obtains a waiver registration pursuant to the federal Drug Addiction Treatment Act of 2000 (DATA 2000) from the federal drug enforcement agency that authorizes the provider to prescribe buprenorphine products under federal law;
  11. (K) Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider;
  12. (L) Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration for, a maximum of four (4) licensed nurse practitioners or physician assistants;
  13. (M) Is supervised by or collaborates with a physician who reviews one hundred percent (100%) of the charts of the patients being prescribed a buprenorphine product;
  14. (N) Weighs the risk of relapse with the benefit of tapering down or off of buprenorphine when, similar to other disease states, tapering from the treatment medication is clinically appropriate and in agreement with the patient and tapering schedules and durations are patient specific. Providers shall initiate and lead a discussion regarding patient readiness to taper down or taper off treatment medications employed in the patient's treatment with each patient at any time upon the patient's request but no later than one (1) year after initiating treatment and then every six (6) months thereafter;
  15. (O) Writes prescriptions that can only be dispensed by a licensed pharmacy to ensure entry into the controlled substance database; and
  16. (P) Writes prescriptions of buprenorphine products to fifty (50) or fewer patients at any given time.
(d)
1. (1) A prescriber who treats a patient with more than sixteen milligrams (16 mg) per day of buprenorphine or its therapeutic equivalent for more than thirty (30) consecutive days for treatment of opioid dependence shall clearly document in the patient's medical record why the patient needs the higher dosage amounts of buprenorphine. A prescriber who does not meet the requirements established in the manner described in subdivision (d)(2) and treats a patient with more than twenty milligrams (20 mg) per day of buprenorphine or its therapeutic equivalent for more than thirty (30) consecutive days for treatment of opioid dependence shall, to the extent possible, either consult with an addiction specialist meeting the requirements established in the manner described in subdivision (d)(2) or refer the patient to the addiction specialist for management of the patient's treatment plan. If a prescribing physician cannot make the required consultation or referral as outlined in this subsection (d), the reasons shall be set out in the medical record.
2. (2) The board of medical examiners and the board of osteopathic examination shall promulgate rules establishing the requirements for licensees to qualify as addiction specialists.
(e) This section shall not apply to perioperative surgery or ventilator sedation that is performed in a licensed healthcare facility set forth in § 68-11-201(3) or (26).
(f) When patients are admitted as inpatients of a hospital, or registered as outpatients of a hospital, prescribers may continue orders for these drug products as part of a medication reconciliation process to continue home medications as previously prescribed and without restrictions pertaining to the use of the product until the patient is discharged from the facility. However, prescriptions written upon discharge from the facility and intended to be filled by the patient at a retail pharmacy and consumed post-discharge shall follow the requirements of this section.
(g)
1. (1)
  1. (A) Notwithstanding any other law, the dispensing of buprenorphine products is prohibited by any person or entity unless the dispensing is done by a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, with approval from the department of mental health and substance abuse services, a nonresidential substitution-based treatment center for opiate addiction as defined in § 33-2-402, a pharmacy licensed under title 63, chapter 10, or a hospital licensed under title 33, or title 68, chapter 11. This subsection (g) does not apply to the administering of buprenorphine products as otherwise permitted by law.
  2. (B) A pharmacy and a distributor, as defined in § 63-10-204, shall report to the department of health the quantities of buprenorphine that the pharmacy or distributor delivers to nonresidential office-based opiate treatment facilities in this state.
2. (2) The department of mental health and substance abuse services shall promulgate rules to establish requirements for approval of dispensing of buprenorphine products at a nonresidential office-based opiate treatment facility as defined in § 33-2-402. These rules shall include a requirement that a provider who dispenses buprenorphine products at a nonresidential office-based opiate treatment facility must report the fact that the provider dispenses buprenorphine products to the provider's licensing board, check the controlled substance database prior to dispensing, and enter the amounts dispensed into the controlled substance database, to the extent permitted by 42 CFR part 2.
(h)
1. (1) Notwithstanding subsection (c), this subsection (h) controls the prescription of buprenorphine products by any healthcare provider licensed under title 63, chapter 7 or 19, who is employed by or contracted with a nonresidential office-based opiate treatment facility, as defined in § 33-2-402.
2. (2) A healthcare provider licensed under title 63, chapter 7 or 19, may prescribe a buprenorphine product, as approved by the federal food and drug administration for use in recovery or medication-assisted treatment if:
  1. (A) The provider works in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, that is licensed by the department of mental health and substance abuse services and that does not have authority to dispense buprenorphine products;
  2. (B) The provider practices under the direct supervision of a physician who is licensed under title 63, chapter 6 or chapter 9; holds an active Drug Addiction Treatment Act of 2000 (DATA 2000) waiver from the United States drug enforcement administration; and is actively treating patients with buprenorphine products for recovery or medication-assisted treatment at the same nonresidential office-based opiate treatment facility, as defined in § 33-2-402, as the provider;
  3. (C) The facility and its healthcare providers are contracted and credentialed with TennCare and TennCare's managed care organizations to treat opioid use disorder with buprenorphine products for use in recovery or medication-assisted treatment;
  4. (D) The facility or its healthcare providers are directly billing TennCare and TennCare's managed care organizations for the services provided within the facility;
  5. (E) The facility or its healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction;
  6. (F) The provider does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent;
  7. (G) Except as provided in subdivision (h)(2)(H), the provider does not prescribe or dispense a mono product or buprenorphine without naloxone;
  8. (H) The provider uses injectable or implantable buprenorphine formulations in accordance with subdivision (b)(1)(D);
  9. (I) The provider has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state;
  10. (J) The provider obtains a waiver registration from the United States drug enforcement administration that authorizes the provider to prescribe buprenorphine products under federal law and regulations;
  11. (K) The provider prescribes buprenorphine products only to patients who are treated through a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, that employs or contracts with the provider;
  12. (L) The provider writes prescriptions of buprenorphine products that can only be dispensed by a licensed pharmacy to ensure entry into the controlled substance monitoring database;
  13. (M) The provider writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time;
  14. (N) When providing direct supervision, the physician does not oversee more than two (2) providers licensed under title 63, chapter 7 or 19, at one (1) time during clinical operations; and
  15. (O) The supervising physician ensures all rules of operation for a nonresidential office-based opiate treatment facility, as defined in § 33-2-402; the Tennessee Nonresidential Buprenorphine Treatment Guidelines as established by the department of mental health and substance abuse services and the department of health; and all other state laws, rules, and guidelines regarding use of buprenorphine products for medication assisted treatment are followed.

§ 53-11-312. Educational materials for providers and facilities where medication assisted treatment is prescribed or provided.

(a) No later than January 1, 2021, the departments of health and mental health and substance abuse services, and the bureau of TennCare shall collaborate to develop educational materials for providers and facilities where medication assisted treatment including treatment involving controlled substances is prescribed or provided. The educational materials shall include the following:
1. (1) Access to and availability of family planning services and contraception;
2. (2) Risks and effects of neonatal abstinence syndrome; and
3. (3) Approaches to client-centered counseling.
(b) The departments of health and mental health and substance abuse services and the bureau of TennCare shall make the educational materials available to prescribers of medication assisted treatment and facilities that use medication assisted treatment for the treatment of substance use disorder.

§ 53-11-313. Payment for buprenorphine products.

(a) Except as provided in subsection (b), a healthcare prescriber of a buprenorphine product for use in recovery or medication-assisted treatment, or a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, shall only accept a check, money order, or debit card or credit card that is linked to a bank or credit card account from a financial institution, in payment for services provided by the healthcare prescriber or facility. Use of prepaid debit cards, prepaid credit cards, gift cards, or any other card not linked with a bank or credit card account from a financial institution is prohibited. As used in this subsection (a), “financial institution” means a state or national bank, a state or federally chartered credit union, or a savings bank.
(b) A healthcare prescriber or facility described in subsection (a) may accept payment for services provided to a patient by the prescriber or facility in cash for a co-pay, coinsurance, or deductible if the prescriber or facility submits the remainder of the bill for the services provided to the patient's insurance plan for reimbursement. If the patient does not have an insurance plan, then the healthcare prescriber or facility shall not accept cash as payment for services provided.
(c) No healthcare provider, licensed by title 63, chapter 6, 7, 9, or 19, shall be compensated or receive payment for services related to buprenorphine treatment:
1. (1) By which the provider receives an amount per patient that is treated within the office or other setting; or
2. (2) By any means by which the provider receives a percentage of a payment that is directly received by a patient to the office, nonresidential office-based opiate treatment facility, as defined in § 33-2-402, or other provider.
(d) A healthcare provider licensed under title 63, or a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, shall not knowingly treat any TennCare enrollee with buprenorphine products for use in recovery or medication-assisted treatment unless that provider directly bills or seeks reimbursement from TennCare or TennCare's managed care organizations for services provided to the TennCare enrollee. A person is required to disclose to the healthcare provider or nonresidential office-based opiate treatment facility, as defined in § 33-2-402, that the person is a TennCare enrollee seeking treatment with buprenorphine products for use in recovery or medication-assisted treatment.

§ 53-11-314. No private right of action.

This chapter does not create a private right of action.

Part 4 Criminal Penalties and Enforcement

§ 53-11-401. Miscellaneous offenses — Penalties.

(a) It is unlawful for any person:
1. (1) Who is subject to part 3 of this chapter, to distribute or dispense a controlled substance in violation of § 53-11-308 or to distribute or dispense any controlled substance for any purposes other than those authorized by and consistent with the person's professional or occupational licensure or registration law, or to distribute or dispense any controlled substance in a manner prohibited by the person's professional or occupational licensure or registration law;
2. (2) Who is a registrant to manufacture a controlled substance not authorized by the registrant's registration, or to distribute or dispense a controlled substance not authorized by the registrant's registration to another registrant or other authorized person;
3. (3) To refuse or fail to make, keep or furnish any record, notification, order form, statement, invoice or information required under part 3 of this chapter and this part, or title 39, chapter 17, part 4, except sanctions against a health care provider for the provider's failure to make a report required by § 53-11-309(a) shall be limited only to cases involving a pattern of willful failure to make such reports and, in those instances, the health care provider shall only be subject to a civil penalty assessed by the provider's licensing board;
4. (4) To refuse an entry into any premises for any inspection authorized by part 3 of this chapter and this part, or title 39, chapter 17, part 4; or
5. (5) Knowingly to keep or maintain any store, shop, warehouse, dwelling, building, vehicle, boat, aircraft or other structure or place that is resorted to by persons using controlled substances in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, for the purpose of using these substances, or that is used for keeping or selling them in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4.
(b)
1. (1) A violation of this section is a Class D felony; provided, however, a healthcare provider who fails to make a report required by § 53-11-309 shall not be guilty of a felony and shall be punishable only by the sanctions set forth in subdivision (a)(3); and provided, further, that a person who fails to comply with § 53-11-308(h) or § 53-11-308(i) is not guilty of a felony and shall be punishable only by a civil penalty assessed by the provider's licensing board and only in cases involving a pattern of willful failure to comply.
2. (2) Notwithstanding § 40-35-111, regarding the authorized fine for a Class D felony, the authorized fine for a violation of this section shall be as follows:
  1. For a violation involving a Schedule I or II controlled substance$ 100,000
  2. For a violation involving a Schedule III or IV controlled substance50,000
  3. For a violation involving a Schedule V or VI controlled substance5,000
  4. For a violation involving a Schedule VII controlled substance1,000
  5. For any other violation of this section not involving a scheduled controlled substance20,000
3. (3) Nothing contained in this section shall preclude a prosecution under the general drug laws.

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§ 53-11-402. Fraud — Penalties.

(a) It is unlawful for any person knowingly or intentionally to:
1. (1) Distribute as a registrant a controlled substance classified in Schedule I or II, except pursuant to an order form as required by § 53-11-307;
2. (2) Use in the course of the manufacture or distribution of a controlled substance a registration number that is fictitious, revoked, suspended or issued to another person;
3. (3) Acquire or obtain, or attempt to acquire or attempt to obtain, possession of a controlled substance by misrepresentation, fraud, forgery, deception or subterfuge. Any person who violates this subdivision (a)(3) may, upon first conviction, have the sentence suspended and may as a condition of the suspension be required to participate in a program of rehabilitation at a drug treatment facility operated by the state or a comprehensive community mental health center;
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  - 40-32-101(g)(1)(D)(xxxiii)
  - 53-10-306(h)(1)(C)
4. (4) Furnish false or fraudulent material information in, or omit any material information from, any application, report or other document required to be kept or filed under part 3 of this chapter and this part, or title 39, chapter 17, part 4, or any record required to be kept by part 3 of this chapter and this part, or title 39, chapter 17, part 4;
5. (5) Make, distribute or possess any punch, die, plate, stone or other thing designed to print, imprint or reproduce the trademark, trade name, or other identifying mark, imprint or device of another or any likeness of the trademark, trade name, or other identifying mark, imprint or device of another upon any drug or container or labeling of any drug or container so as to render the drug a counterfeit substance; or
6. (6) Notwithstanding § 71-5-2601, deceive or fail to disclose to a physician, nurse practitioner, ancillary staff or other health care provider from whom the person obtains a controlled substance or a prescription for a controlled substance that the person has received either the same controlled substance or a prescription for the same controlled substance or a controlled substance of similar therapeutic use or a prescription for a controlled substance of similar therapeutic use from another practitioner within the previous thirty (30) days.
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(b)
1. (1) A violation of this section is a Class D felony, except that a violation of subdivision (a)(6) is a Class A misdemeanor and any violation of subdivision (a)(6) involving more than two hundred fifty (250) units of a controlled substance is a Class E felony. For purposes of this subdivision (b)(1), a “unit” means an amount of a controlled substance in any form that would equate to the initial single individual dosage recommended by the manufacturer of the controlled substance.
2. (2) Notwithstanding § 40-35-111, regarding the authorized fine for a Class D felony, the authorized fine for a violation of this section shall be as follows:
  1. For a violation involving a Schedule I or II controlled substance $ 100,000
  2. For a violation involving a Schedule III or IV controlled substance 50,000
  3. For a violation involving a Schedule V or VI controlled substance 5,000
  4. For a violation involving a Schedule VII controlled substance 1,000
  5. For any other violation of this section not involving a scheduled controlled substance 20,000
3. (3) Nothing contained in this section shall preclude a prosecution under the general drug laws.
(c) Any person who violates subdivision (a)(3) may, upon first conviction, have the sentence suspended and may as a condition of the suspension be required to participate in a program of rehabilitation at a drug treatment facility operated by the state or a comprehensive community mental health center.

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§ 53-11-403. Criminal penalty not exclusive.

Any penalty imposed for a violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, is in addition to, and not in lieu of, any civil or administrative penalty or sanction otherwise authorized by law.

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53-11-413(a)

§ 53-11-404. [Reserved.]

§ 53-11-405. Enforcement officers.

(a) Any officer or authorized representative of the Tennessee bureau of investigation designated by the director of that bureau may:
1. (1) Carry firearms in the performance of the individual's official duties;
2. (2) Execute and serve search warrants, arrest warrants, subpoenas and summonses issued under the authority of this state;
3. (3) Make arrests without warrant for any offense under part 3 of this chapter and this part, or title 39, chapter 17, part 4, committed in the individual's presence, or if the individual has probable cause to believe that the person to be arrested has committed or is committing a violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4 that may constitute a felony;
4. (4) Make seizures of property pursuant to part 3 of this chapter and this part, or title 39, chapter 17, part 4; or
5. (5) Perform other law enforcement duties as the director of the bureau designates.
(b) It is the duty of the principal, or of the comparable chief administrative officer designated by any other equivalent title, of any school, public, private, denominational or parochial, who has probable cause to believe that any person has committed, or is committing, any violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, upon the school grounds or within any buildings or structures embraced by such individual's administrative responsibility, to report the probable cause intelligence immediately to the sheriff of the county if the school is in an unincorporated area, or to the police chief or other equivalent law enforcement official if the school is located within an incorporated municipality.

§ 53-11-406. Inspection.

(a)
1. (1) Prescriptions, orders and records, required by part 3 of this chapter and this part, or title 39, chapter 17, part 4, and stocks of controlled substances, shall be open for inspection only to federal, state, county and municipal officers whose duty it is to enforce the laws or regulations of this state or of the United States relating to controlled substances or narcotic drugs.
2. (2) No officer having knowledge by virtue of the officer's office of the prescription, order or record shall divulge the knowledge, except in connection with a prosecution or proceeding in court or before a licensing or registration board or officer if the person to whom the prescriptions, orders or records relate is a party to the prosecution or proceeding.
(b) An inspection authorized by this section shall not extend to financial data, sales data, other than shipment data, or pricing data, unless the owner, operator or agent in charge of the controlled premises consents in writing.

§ 53-11-407. Injunctions — Jury trial.

(a) The criminal and circuit courts of this state may exercise jurisdiction to restrain or enjoin violations of part 3 of this chapter and this part, or title 39, chapter 17, part 4.
(b) The defendant may demand trial by jury for an alleged violation of an injunction or restraining order under this section.

§ 53-11-408. Bureau of investigation — Powers and duties.

(a) The Tennessee bureau of investigation shall cooperate with federal and other state agencies in discharging its responsibilities concerning traffic in controlled substances and controlled substance analogues and in suppressing the abuse of controlled substances and controlled substance analogues. To this end, it may:
1. (1) Arrange for the exchange of information among governmental officials concerning the use and abuse of controlled substances and controlled substance analogues;
2. (2) Coordinate and cooperate in training programs concerning controlled substance and controlled substance analogue law enforcement at local and state levels;
3. (3) Cooperate with the United States drug enforcement administration by establishing a centralized unit to accept, catalogue, file and collect statistics, including records of drug dependent persons and other controlled substance and controlled substance analogue law offenders within the state, and make the information available for federal, state and local law enforcement purposes. It shall not furnish the name or identity of a patient or research subject whose identity could not be obtained under subsection (c); and
4. (4) Conduct programs of eradication aimed at destroying wild or illicit growth of plant species from which controlled substances and controlled substance analogues may be extracted.
(b) Results, information and evidence received from the United States drug enforcement administration relating to the regulatory functions of part 3 of this chapter and this part, or title 39, chapter 17, part 4, including results of inspections conducted by it, may be relied and acted upon by the Tennessee bureau of investigation in the exercise of its regulatory functions under part 3 of this chapter and this part, or title 39, chapter 17, part 4.
(c) A practitioner engaged in medical practice or research is not required or compelled to furnish the name or identity of a patient or research subject to the Tennessee bureau of investigation, nor may the practitioner be compelled in any state or local civil, criminal, administrative, legislative or other proceedings to furnish the name or identity of an individual that the practitioner is obligated to keep confidential, except the commissioner of mental health and substance abuse services may require the disclosure of information to the department of mental health and substance abuse services concerning individuals being treated with controlled substances that is necessary to ensure compliance by a practitioner and the practitioner's patient or research subject with state or federal laws and regulations governing the use of controlled substances.

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57-5-205(1)

§ 53-11-409. [Reserved.]

§ 53-11-410. Evidence — Immunity from liability.

(a) It is not necessary for the state to negate any exemption or exception in part 3 of this chapter and this part, or title 39, chapter 17, part 4, in any complaint, information, indictment or other pleading or in any trial, hearing or other proceeding under part 3 of this chapter and this part, or title 39, chapter 17, part 4. The burden of proof of any exemption or exception is upon the person claiming it.
(b) In the absence of proof that a person is the duly authorized holder of an appropriate registration or order form issued under part 3 of this chapter and this part, or title 39, chapter 17, part 4, the person is presumed not to be the holder of the registration or form. The burden of proof is upon the person to rebut the presumption.
(c) No liability is imposed by part 3 of this chapter and this part, or title 39, chapter 17, part 4, upon any authorized state, county or municipal officer, engaged in the lawful performance of the officer's duties.

§ 53-11-411. Administrative decisions — Judicial review.

(a) All final determinations, findings and conclusions of the department of safety, department of mental health and substance abuse services, department of health, or the board of pharmacy under part 3 of this chapter and this part, or title 39, chapter 17, part 4, are final and conclusive decisions of the matters involved.
(b) Any person aggrieved by the decision may obtain review of the decision in the circuit court of Davidson County upon petition for writ of certiorari.
(c) Findings of fact by the department of safety, department of mental health and substance abuse services, or department of health, or the board of pharmacy, if supported by substantial evidence, are conclusive.

§ 53-11-412. Research, instruction or chemical analysis.

No person shall manufacture, obtain, possess, administer or dispense any controlled substance or controlled substance analogue for the purpose of scientific research, instruction or chemical analysis except as provided in the Tennessee Legend Drug and Controlled Substance Research Act of 1984, compiled in chapter 14 of this title.

§ 53-11-413. Prior actions and pending litigation.

(a) Prosecution for any violation of law occurring prior to July 1, 1971, is not affected or abated by part 3 of this chapter and this part, or former title 39, chapter 6, part 4 [repealed]. If the offense being prosecuted is similar to one set out in [former] §§ 39-6-417 — 39-6-419 [repealed], or in §§ 53-11-401 — 53-11-403, then the penalties under former §§ 39-6-417 — 39-6-419 [repealed], and under §§ 53-11-401 and 53-11-402 apply if they are less than those under prior law.
(b) Civil seizures or forfeitures and injunctive proceedings commenced prior to July 1, 1971, are not affected by part 3 of this chapter and this part, or former title 39, chapter 6, part 4 [repealed].
(c) All administrative proceedings pending under prior laws that are superseded by part 3 of this chapter and this part, or former title 39, chapter 6, part 4 [repealed], shall be continued and brought to a final determination in accordance with the laws and rules in effect prior to July 1, 1971. Any substance controlled under prior law that is not listed within Schedules I through VI is automatically controlled without further proceedings and shall be listed in the appropriate schedule.
(d) The board of pharmacy shall initially permit persons to register who own or operate any establishment engaged in the manufacture, distribution or dispensing of any controlled substance prior to July 1, 1971, and who are registered or licensed by the state.
(e)
1. (1) Part 3 of this chapter and this part, and former title 39, chapter 6, part 4 [repealed], apply to violations of law, seizures and forfeitures, injunctive proceedings, administrative proceedings and investigations that occur after July 1, 1971, and before November 1, 1989.
2. (2) Part 3 of this chapter, this part and title 39, chapter 17, part 4 apply to violations of law, seizures and forfeitures, injunctive proceedings, administrative proceedings and investigations that occur on or after November 1, 1989.

§ 53-11-414. [Reserved.]

§ 53-11-415. Special revenue fund.

(a) Except as provided in subsection (b), the county or municipality shall account for those funds received under title 39, chapter 17, part 4 in a special revenue fund. Upon demand of the chief executive of the arresting law enforcement agency, the county or municipality shall pay to that agency the funds demanded for use in cash transactions related to undercover investigative drug enforcement operations. The amount of the funds demanded and the requirement to pay the funds are subject to the availability of funds and budgetary appropriations for that purpose.
(b) In any county having a metropolitan form of government and a population in excess of five hundred thousand (500,000), according to the 1990 federal census or any subsequent federal census, the county trustee or city recorder shall set up a special account for those funds received under title 39, chapter 17, part 4. Upon demand of the chief executive of the arresting law enforcement agency, the county trustee or city recorder shall pay to that agency the demanded funds for use in the drug enforcement program. An accounting of all expenditures from the funds shall be made by the agency to the county trustee or city recorder.

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39-17-420(f)

§ 53-11-416. Offense of prescription drug fraud.

(a) It is unlawful for any person knowingly or intentionally to acquire or obtain, or attempt to acquire or obtain, possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge or in violation of § 39-14-150. A violation of this section shall be deemed the offense of prescription drug fraud.
(b) Prescription drug fraud is a continuing offense because the offense may involve an unlawful taking and use of personal identifying information that remains in the lawful possession of a victim wherever the victim currently resides or is found. As provided in this section, such unlawful taking and use may be elements of an offense of prescription drug fraud and continues to occur wherever the victim resides or is found.
(c) For purposes of a violation of this section, “victim” includes, but is not limited to, the person whose personal identifying information, as defined in § 39-14-150(e), was acquired, obtained, possessed, bought, or used in violation of this section or sold, transferred, given, traded, loaned, delivered, or possessed in violation of this section. “Victim” also includes, but is not limited to, a physician, nurse practitioner, or other health care provider whose personal identifying information was unlawfully used.
(d) Pursuant to §§ 39-11-103 and 39-14-150(j)(2), if a victim of prescription drug fraud resides or is found in this state, an essential element of the offense is committed in this state, and a defendant is subject to prosecution in this state, regardless of whether the defendant was ever actually in this state.
(e) Venue for the offense of prescription drug fraud shall be in any county where an essential element of the offense was committed, including, but not limited to, in any county where the victim resides or is found, regardless of whether the defendant was ever actually in such county.
(f) The offense of prescription drug fraud shall be punished in the same manner as a violation of § 53-11-402.

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39-14-150(b)(1)(B)(iii)

§ 53-11-417 — 53-11-450. [Reserved.]

§ 53-11-451. Goods subject to forfeiture — Seizure — Disposition. [Effective on July 1, 2024. See the version effective until July 1, 2024.]

(a) The following are subject to forfeiture:
1. (1) All controlled substances or controlled substance analogues that have been manufactured, distributed, dispensed or acquired in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4;
2. (2) All raw materials, products and equipment of any kind that are used, or intended for use, in manufacturing, compounding, processing, delivering, importing or exporting any controlled substance or controlled substance analogue in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4;
3. (3) All property that is used, or intended for use, as a container for property described in subdivision (a)(1) or (a)(2);
4. (4) All conveyances, including aircraft, vehicles or vessels that are used, or are intended for use, to transport, or in any manner to facilitate the transportation, sale or receipt of property described in subdivision (a)(1) or (a)(2), but:
  1. (A) No conveyance used by any person as a common carrier in the transaction of business as a common carrier is subject to forfeiture under this section, unless it appears that the owner or other person in charge of the conveyance is a consenting party or privy to a violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4;
  2. (B) No conveyance is subject to forfeiture under this section by reason of any act or omission established by the owner of the conveyance to have been committed or omitted without the owner's knowledge or consent;
  3. (C) A conveyance is not subject to forfeiture for a violation of § 39-17-418(a) or (b) or § 39-17-425; and
  4. (D) A forfeiture of a conveyance encumbered by a bona fide security interest is subject to the interest of the secured party if the secured party neither had knowledge of nor consented to the act or omission;
5. (5) All books, records, and research products and materials, including formulas, microfilm, tapes and data that are used, or intended for use, in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4;
6. (6)
  1. (A) Everything of value furnished, or intended to be furnished, in exchange for a controlled substance or controlled substance analogue in violation of the Tennessee Drug Control Act of 1989, compiled in part 3 of this chapter, this part and title 39, chapter 17, part 4, all proceeds traceable to the exchange, and all moneys, negotiable instruments, and securities used, or intended to be used, to facilitate any violation of the Tennessee Drug Control Act;
  2. (B) No property shall be forfeited under subdivision (a)(6)(A), to the extent of the interest of an owner, by reason of any act or omission established by the owner to have been committed or omitted without the owner's knowledge or consent;
7. (7) All drug paraphernalia as defined by § 39-17-402; and
8. (8) All products containing a hemp-derived cannabinoid that are manufactured, transported, packaged, labeled, displayed, distributed as samples, offered for sale, or sold in violation of title 43, chapter 27, part 2.
(b) Property subject to forfeiture under part 3 of this chapter and this part, or title 39, chapter 17, part 4, may be seized by the director of the Tennessee bureau of investigation or the director's authorized representative, agent or employee, the commissioner of safety or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable upon process issued by any circuit or criminal court having jurisdiction over the property. Property subject to forfeiture under title 43, chapter 27, part 2, may be seized by the director of the Tennessee bureau of investigation or the director's authorized representative, agent, or employee; the commissioner of safety or the commissioner's authorized representative, agent, or employee; the commissioner of agriculture or the commissioner's authorized representative, agent, or employee; the commissioner of revenue or the commissioner's authorized representative, agent, or employee; or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable upon process issued by any circuit or criminal court having jurisdiction over the property. Seizure without process may be made if:
1. (1) The seizure is incident to an arrest or a search under a search warrant or an inspection under an administrative inspection warrant;
2. (2) The property subject to seizure has been the subject of a prior judgment in favor of the state in a criminal injunction or forfeiture proceeding based upon part 3 of this chapter and this part, or title 39, chapter 17, part 4;
3. (3) The director or the director's authorized representative, agent or employee, the commissioner or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable has probable cause to believe that the property is directly or indirectly dangerous to health or safety; or
4. (4) The director or the director's authorized representative, agent or employee, the commissioner or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable has probable cause to believe that the property was used or is intended to be used in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4.
(c) In the event of seizure pursuant to subsection (b), proceedings under subsection (d) shall be instituted promptly.
(d) Property taken or detained under this section shall not be subject to replevin, but is deemed to be in the custody of the director or the director's authorized representative, agent or employee, the commissioner or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable, subject only to the orders and decrees of the circuit or criminal court. When property is seized under part 3 of this chapter and this part, or title 39, chapter 17, part 4, the seizing authority may:
1. (1) Place the property under seal;
2. (2) Remove the property to a place designated by the seizing authority;
3. (3) Require the director or the director's authorized representative, agent or employee, the commissioner or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable to take custody of the property and remove it to an appropriate location for disposition in accordance with law; or
4. (4)
  1. (A) Regardless of any other method of disposition of property contained in this chapter, use of the property taken or detained, with permission of the court and under such terms and conditions as are approved by the court, for use in the drug enforcement program of the county in which the goods are seized, or, with approval of the court having jurisdiction over the property, sell the property and utilize the proceeds for the drug enforcement program of the county in which the property was seized, or both;
  2. (B) In the case of property seized by the Tennessee bureau of investigation, the director of the bureau is authorized to designate, in writing, any part of the property for use by the bureau for any period of time, subject to inventory, management and disposition as provided by law;
  3. (C) In the case of an aircraft seized by the bureau, the director is also authorized to designate, in writing, any such property for transfer to and use by the department of general services subject to inventory, management and disposition as provided by law. If an aircraft is not sold, but is to be transferred to another state governmental entity, such transfer shall be approved by the commissioner of finance and administration;
  4. (D) The proceeds from any sale conducted under this chapter of forfeited property seized by the bureau and not designated for its use, or not transferred to the department of general services as provided in subdivision (d)(4)(C), shall be paid to the state treasurer to be used only as appropriated by the general assembly.
(e) When property is forfeited under part 3 of this chapter and this part, or title 39, chapter 17, part 4, the director or the director's authorized representative, agent or employee, the commissioner of safety or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable shall remove it for disposition in accordance with law.
(f) Controlled substances listed in Schedule I that are possessed, transferred, sold, or offered for sale in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, are contraband and shall be seized and summarily forfeited to the state. Controlled substances listed in Schedule I that are seized or come into the possession of the state, the owners of which are unknown, are contraband and shall be summarily forfeited to the state.
(g) Species of plants from which controlled substances in Schedules I, II and VI may be derived that have been planted or cultivated in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, or of which the owners or cultivators are unknown, or that are wild growths, may be seized and summarily forfeited to the state.
(h) Controlled substance analogues that are possessed, transferred, sold, or offered for sale in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, are contraband and shall be seized and summarily forfeited to the state. Controlled substance analogues that are seized or come into the possession of the state, the owners of which are unknown, are contraband and shall be summarily forfeited to the state.
(i) The failure, upon demand by the commissioner of safety, the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable, of the person in occupancy or in control of land or premises upon which the species of plants are growing or being stored, to produce an appropriate registration, or proof that such person is the holder thereof, constitutes authority for the seizure and forfeiture of the plants.
(j) Confiscation proceedings under part 3 of this chapter and this part, or title 39, chapter 17, part 4, shall be conducted in accordance with part 2 of this chapter.
(k) Any property of the type set forth in subdivisions (a)(1), (7), and (8) that is in the custody and possession of a clerk of any court of this state by virtue of the property having been held as evidence or exhibits in any criminal prosecution where all appeals or potential appeals of a judgment have ended, or when the case has been dismissed or otherwise brought to a conclusion, shall be disposed of as follows:
1. (1) The clerk of the court having custody of the property to be disposed of shall, no less than once annually, inventory the property and prepare a list of the property proposed to be destroyed with references to the cases involved and the name of the case, the case number and date when the property was used;
2. (2) The clerk shall submit the inventory list with a filed petition to the court and shall serve a copy of the petition upon the district attorney general. After determining that the listed property is not needed as evidence in any pending or potential judicial proceeding, the court shall order the property to be destroyed; and
3. (3) The clerk, or a deputy clerk that the clerk may designate, shall completely destroy each item by cutting, crushing, burning or melting and shall file, together with the petition and order relating to the destroyed property, an affidavit concerning the destruction, showing a description of each item, the method of destruction, the date and place of destruction, and the names and addresses of all witnesses to the destruction.

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§ 53-11-451. Goods subject to forfeiture — Seizure — Disposition. [Effective until July 1, 2024. See the version effective on July 1, 2024.]

(a) The following are subject to forfeiture:
1. (1) All controlled substances or controlled substance analogues that have been manufactured, distributed, dispensed or acquired in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4;
2. (2) All raw materials, products and equipment of any kind that are used, or intended for use, in manufacturing, compounding, processing, delivering, importing or exporting any controlled substance or controlled substance analogue in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4;
3. (3) All property that is used, or intended for use, as a container for property described in subdivision (a)(1) or (a)(2);
4. (4) All conveyances, including aircraft, vehicles or vessels that are used, or are intended for use, to transport, or in any manner to facilitate the transportation, sale or receipt of property described in subdivision (a)(1) or (a)(2), but:
  1. (A) No conveyance used by any person as a common carrier in the transaction of business as a common carrier is subject to forfeiture under this section, unless it appears that the owner or other person in charge of the conveyance is a consenting party or privy to a violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4;
  2. (B) No conveyance is subject to forfeiture under this section by reason of any act or omission established by the owner of the conveyance to have been committed or omitted without the owner's knowledge or consent;
  3. (C) A conveyance is not subject to forfeiture for a violation of § 39-17-418(a) or (b) or § 39-17-425; and
  4. (D) A forfeiture of a conveyance encumbered by a bona fide security interest is subject to the interest of the secured party if the secured party neither had knowledge of nor consented to the act or omission;
5. (5) All books, records, and research products and materials, including formulas, microfilm, tapes and data that are used, or intended for use, in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4;
6. (6)
  1. (A) Everything of value furnished, or intended to be furnished, in exchange for a controlled substance or controlled substance analogue in violation of the Tennessee Drug Control Act of 1989, compiled in part 3 of this chapter, this part and title 39, chapter 17, part 4, all proceeds traceable to the exchange, and all moneys, negotiable instruments, and securities used, or intended to be used, to facilitate any violation of the Tennessee Drug Control Act;
  2. (B) No property shall be forfeited under subdivision (a)(6)(A), to the extent of the interest of an owner, by reason of any act or omission established by the owner to have been committed or omitted without the owner's knowledge or consent; and
7. (7) All drug paraphernalia as defined by § 39-17-402.
(b) Property subject to forfeiture under part 3 of this chapter and this part, or title 39, chapter 17, part 4, may be seized by the director of the Tennessee bureau of investigation or the director's authorized representative, agent or employee, the commissioner of safety or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable upon process issued by any circuit or criminal court having jurisdiction over the property. Seizure without process may be made if:
1. (1) The seizure is incident to an arrest or a search under a search warrant or an inspection under an administrative inspection warrant;
2. (2) The property subject to seizure has been the subject of a prior judgment in favor of the state in a criminal injunction or forfeiture proceeding based upon part 3 of this chapter and this part, or title 39, chapter 17, part 4;
3. (3) The director or the director's authorized representative, agent or employee, the commissioner or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable has probable cause to believe that the property is directly or indirectly dangerous to health or safety; or
4. (4) The director or the director's authorized representative, agent or employee, the commissioner or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable has probable cause to believe that the property was used or is intended to be used in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4.
(c) In the event of seizure pursuant to subsection (b), proceedings under subsection (d) shall be instituted promptly.
(d) Property taken or detained under this section shall not be subject to replevin, but is deemed to be in the custody of the director or the director's authorized representative, agent or employee, the commissioner or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable, subject only to the orders and decrees of the circuit or criminal court. When property is seized under part 3 of this chapter and this part, or title 39, chapter 17, part 4, the seizing authority may:
1. (1) Place the property under seal;
2. (2) Remove the property to a place designated by the seizing authority;
3. (3) Require the director or the director's authorized representative, agent or employee, the commissioner or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable to take custody of the property and remove it to an appropriate location for disposition in accordance with law; or
4. (4)
  1. (A) Regardless of any other method of disposition of property contained in this chapter, use of the property taken or detained, with permission of the court and under such terms and conditions as are approved by the court, for use in the drug enforcement program of the county in which the goods are seized, or, with approval of the court having jurisdiction over the property, sell the property and utilize the proceeds for the drug enforcement program of the county in which the property was seized, or both;
  2. (B) In the case of property seized by the Tennessee bureau of investigation, the director of the bureau is authorized to designate, in writing, any part of the property for use by the bureau for any period of time, subject to inventory, management and disposition as provided by law;
  3. (C) In the case of an aircraft seized by the bureau, the director is also authorized to designate, in writing, any such property for transfer to and use by the department of general services subject to inventory, management and disposition as provided by law. If an aircraft is not sold, but is to be transferred to another state governmental entity, such transfer shall be approved by the commissioner of finance and administration;
  4. (D) The proceeds from any sale conducted under this chapter of forfeited property seized by the bureau and not designated for its use, or not transferred to the department of general services as provided in subdivision (d)(4)(C), shall be paid to the state treasurer to be used only as appropriated by the general assembly.
(e) When property is forfeited under part 3 of this chapter and this part, or title 39, chapter 17, part 4, the director or the director's authorized representative, agent or employee, the commissioner of safety or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable shall remove it for disposition in accordance with law.
(f) Controlled substances listed in Schedule I that are possessed, transferred, sold, or offered for sale in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, are contraband and shall be seized and summarily forfeited to the state. Controlled substances listed in Schedule I that are seized or come into the possession of the state, the owners of which are unknown, are contraband and shall be summarily forfeited to the state.
(g) Species of plants from which controlled substances in Schedules I, II and VI may be derived that have been planted or cultivated in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, or of which the owners or cultivators are unknown, or that are wild growths, may be seized and summarily forfeited to the state.
(h) Controlled substance analogues that are possessed, transferred, sold, or offered for sale in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, are contraband and shall be seized and summarily forfeited to the state. Controlled substance analogues that are seized or come into the possession of the state, the owners of which are unknown, are contraband and shall be summarily forfeited to the state.
(i) The failure, upon demand by the commissioner of safety, the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, or constable, of the person in occupancy or in control of land or premises upon which the species of plants are growing or being stored, to produce an appropriate registration, or proof that such person is the holder thereof, constitutes authority for the seizure and forfeiture of the plants.
(j) Confiscation proceedings under part 3 of this chapter and this part, or title 39, chapter 17, part 4, shall be conducted in accordance with part 2 of this chapter.
(k) Any property of the type set forth in subdivisions (a)(1) and (7) that is in the custody and possession of a clerk of any court of this state by virtue of the property having been held as evidence or exhibits in any criminal prosecution where all appeals or potential appeals of a judgment have ended, or when the case has been dismissed or otherwise brought to a conclusion, shall be disposed of as follows:
1. (1) The clerk of the court having custody of the property to be disposed of shall, no less than once annually, inventory the property and prepare a list of the property proposed to be destroyed with references to the cases involved and the name of the case, the case number and date when the property was used;
2. (2) The clerk shall submit the inventory list with a filed petition to the court and shall serve a copy of the petition upon the district attorney general. After determining that the listed property is not needed as evidence in any pending or potential judicial proceeding, the court shall order the property to be destroyed; and
3. (3) The clerk, or a deputy clerk that the clerk may designate, shall completely destroy each item by cutting, crushing, burning or melting and shall file, together with the petition and order relating to the destroyed property, an affidavit concerning the destruction, showing a description of each item, the method of destruction, the date and place of destruction, and the names and addresses of all witnesses to the destruction.

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§ 53-11-452. Real property subject to forfeiture due to illegal drug-related activities — Procedure.

(a)
1. (1) The following real property shall be subject to forfeiture to the state and no property right shall exist in the property:
  1. (A) All real property, including any right, title and interest in the whole of or any part of any lot or tract of land and any appurtenances or improvements that is used in any manner or part either to commit a violation of § 39-17-417(i) or (j), or in the commission of three (3) or more acts occurring on three (3) or more separate days within a sixty-day period, and each act results in a felony conviction under title 39, chapter 17, part 4; and
  2. (B) Any real property, including any right, title and interest in the whole of or any part of any lot or tract of land and any appurtenances or improvements that is acquired with the proceeds of a violation of title 39, chapter 17, part 4, constituting a felony, shall be subject to forfeiture and no property right shall exist in the property.
2. (2) No interest in real property shall be forfeited under this section, unless the holder is convicted of a crime or crimes described in subdivision (a)(1)(A) or (a)(1)(B), subject to subsection (d).
(b) Upon the entry of an order of forfeiture in favor of the state, the title of the state to the forfeited property shall relate back to the date of filing of the notice of lis pendens in the office of the register of deeds of the county in which the property or the beneficial interest is located.
(c)
1. (1) When a lis pendens is filed concerning property pursuant to this section, a forfeiture proceeding shall be instituted within sixty (60) days in the circuit or chancery court of the county where the property is located.
2. (2) The complaint shall state a deed description of the property to be forfeited and the reasons for forfeiture under this section.
3. (3) The complaint shall also name as defendants all persons having an interest in the property as reflected in public records.
4. (4) The rules of civil procedure shall apply to proceedings under this section, and any named defendant may demand a jury trial in the appropriate circuit or chancery court.
(d)
1. (1)
  1. (A) The district attorney general for the judicial district in which the real property lies or the attorney general and reporter shall institute all civil proceedings under this section.
  2. (B) The district attorney general or the attorney general and reporter shall, prior to the filing or concurrent to the filing of a civil forfeiture suit, file a lis pendens in the county where the real property is located to assert an interest of record on behalf of the state in the real property subject to this section.
  3. (C) The failure of the district attorney general or attorney general and reporter to file a lien lis pendens shall not raise any defense on the part of any party named in the civil suit.
  4. (D) In any action brought under this section, the circuit or chancery court shall proceed as soon as practicable to the hearing and determination.
  5. (E) The state shall have the burden of proving beyond a reasonable doubt that the property was used in a manner making it subject to forfeiture or was acquired with proceeds that make it subject to forfeiture under this section. Failure to carry the burden of proof shall operate as a bar to any forfeiture under this section.
2. (2)
  1. (A) In order to obtain a forfeiture of a holder's interest in real property, the state must establish:
    1. (i) The prior conviction or convictions of the holder; or
    2. (ii) If an entity other than a natural person, the conviction or convictions of the holder's officer, employee or agent.
  2. (B) If the holder's officer, employee or agent, but not the holder, has been convicted, then the state shall also have the burden to establish beyond a reasonable doubt the additional requirements in subdivision (d)(3), for forfeiture of the holder's interest.
3. (3) The interest of a holder, if an entity other than a natural person, shall be subject to forfeiture if any of the following have been convicted:
  1. (A) The holder of the interest; or
  2. (B) The holder's officer, employee or agent, if:
    1. (i) The conviction is based on acts by the person in the course of and within the scope of the person's employment; and
    2. (ii) The holder knew, or had reason to know from information in the holder's possession, other than through its convicted officer, employee or agent, of the criminal nature of the acts.
(e)
1. (1)
  1. (A) The filing of an indictment, presentment or information alleging a violation of title 39, chapter 17, part 4 that is also related to a civil forfeiture proceeding under this section, shall stay the civil forfeiture proceeding.
  2. (B) The stay shall cease upon the termination of the trial of any criminal proceedings related to the forfeiture sought under this section.
  3. (C) Upon motion of the state and for good cause shown, the district attorney general or the attorney general and reporter may obtain an order that removes the stay from the court in which the forfeiture proceeding is pending.
2. (2) Subject to the limitations of subsection (g), nothing in this section shall limit or restrict the right of a secured party possessing an interest in the property that was of record, prior to the filing of the notice of lien lis pendens, to enforce its deed of trust or to take any other action permitted under its deed of trust.
3. (3)
  1. (A) If a notice of lien lis pendens has been filed prior to the filing of a civil action, the secured party shall give the district attorney general or attorney general and reporter who filed the lis pendens notice of any action taken under the mortgage or deed of trust. The secured party may not exercise its right to foreclose its deed of trust on the property, unless it gives the district attorney general or attorney general and reporter written notice at least twenty (20) days prior to the date of a foreclosure sale and indicates the time, date and place of sale and the balance owing on the debt. Upon receipt of the notice of foreclosure, the district attorney general or attorney general and reporter may apply to the circuit or chancery court to enjoin the foreclosure sale.
  2. (B) Upon completion of a foreclosure sale, the secured party or the secured party's trustee shall notify the district attorney general or attorney general and reporter in writing of the distribution of the proceeds of the sale. The secured party shall hold any proceeds in excess of the debt and fees and expenses secured by its deed of trust of the sale for a period of twenty (20) days. The district attorney general or attorney general and reporter may apply to the circuit or chancery court for an order directing the secured party to pay the overage proceeds into the court, subject to a civil action based on the notice of lien lis pendens.
4. (4) Notwithstanding a stay in the civil proceeding, or during pendency of the case, a secured party or the secured party's trustee may apply to the court to foreclose its mortgage or deed of trust on the property.
(f) In the event that a district attorney general or the attorney general and reporter has probable cause to believe that any individual having a right to enter the property is engaged in any act that will result in diminution of the value of the property to the state, then the district attorney general or the attorney general and reporter may obtain an injunction from the court in which the forfeiture proceeding is pending, enjoining any action diminishing the value of the property.
(g)
1. (1) Whenever property is forfeited under this section, the court may require the director of the Tennessee bureau of investigation or the director's authorized representative, agent or employee, the commissioner of safety or the commissioner's authorized representative, agent or employee, or a sheriff, deputy sheriff, municipal law enforcement officer, campus police officer as defined in § 49-7-118, internal affairs director or internal affairs special agent of the department of correction, constable, or clerk of the court or special master to sell the property at a public auction, subject to an order of the court. Whenever property is forfeited under this section, the court may also, if appropriate, require that the department of general services take custody of the property and dispose of it at a public auction, subject to an order of the court.
2. (2) The court, in lieu of a sale as provided in subdivision (g)(1), may order that the property be sold by any person having an interest in the real property whose interest has not been forfeited. The proceeds of the sale shall be subject to an order of the court.
3. (3)
  1. (A) If the court orders a property interest in property owned as tenants in common forfeited under this section to be sold, whether by a public official as provided in subdivision (g)(1) or by a person having an interest in the property as in subdivision (g)(2), the innocent spouse of a person whose property interest has been forfeited shall have the same right to the property interest as granted an innocent spouse in subdivision (g)(4) or (g)(5). If there is no spouse or if the spouse does not elect to pursue the rights provided in subdivision (g)(4) or (g)(5), then any other person or persons whose interest in the property has not been forfeited shall have the first right to purchase the forfeited interest for its fair market value prior to the court ordered sale. In order to exercise the first right to purchase, the person or persons must petition the appropriate circuit or chancery court at least fifteen (15) days prior to the date the court ordered sale is to be conducted. If the person or persons do not purchase the forfeited property, the sale shall be conducted as provided by law.
  2. (B) For the purposes of subdivision (g)(3)(A), “fair market value” is determined by taking an average of three (3) appraisals conducted by separate and qualified real estate appraisers selected by the court. Before the purchase, the court shall approve the average of the appraisals for fair market value as reasonable.
4. (4)
  1. (A) Notwithstanding subdivision (g)(3) to the contrary, if a court orders property forfeited under this section pursuant to subdivision (g)(1) or (g)(2) and the property is held through tenancy by the entirety and one (1) spouse's interest is not forfeited, then the spouse shall have the first right to purchase the forfeited expectancy interest in the property.
  2. (B) A spouse purchasing the forfeited property interest in the manner described in subdivision (g)(4)(A) shall take the property subject to all bona fide liens on the property. In order to exercise the right of purchase, the spouse shall petition the court in which the forfeiture proceeding is pending for the purchase at least fifteen (15) days prior to the court ordered sale.
  3. (C) If the spouse does not purchase the forfeited expectancy interest, the spouse shall retain the spouse's interest subject to all bona fide liens, and the forfeited expectancy interest shall be sold and the proceeds applied in the following manner:
    1. (i) Reasonable expenses of the proceedings for forfeiture and sale, including, but not limited to, expenses, seizure, maintenance of custody, advertising and court costs; and
    2. (ii) The remaining proceeds shall be distributed as provided in subdivision (h)(2).
  4. (D) If a party possessing a security interest in property being held by an innocent spouse institutes proceedings pursuant to its deed of trust, or otherwise, that results in the foreclosure and sale of the property, the innocent spouse shall be entitled to receive from the first proceeds of the sale an amount equal to an elective share as provided in § 31-4-101, subject to bona fide outstanding liens not satisfied by the remainder of the proceeds.
  5. (E) If the innocent spouse predeceases the other spouse, if there are children of the innocent and guilty spouse, at least one (1) of whom is eighteen (18) years of age or younger on the date of the sale, and if the entity holding the right of expectancy is the state, then upon the sale of the property, one-third (⅓) of the proceeds from the sale shall be allocated and divided equally among all the children, subject to all outstanding bona fide liens not satisfied by the remainder of the proceeds.
5. (5)
  1. (A) Notwithstanding subdivision (g)(3) to the contrary, if the property subject to forfeiture under this section is property titled solely in the name of a guilty spouse or titled in the name of the guilty spouse as tenants in common with any other person or persons, the innocent spouse may petition the court, at least thirty (30) days prior to the court ordered forfeiture sale, to have the court vest the ownership of the property in the couple as tenants by the entirety, and the innocent spouse shall have the same rights as provided in subdivision (g)(4). If the petition is timely filed, it shall be granted.
  2. (B) The filing of the petition shall act as a stay of any court ordered sale of the property and the stay shall remain in effect until disposition is made of the petition.
  3. (C) If the innocent spouse does not petition the court to vest the property ownership in the couple as tenants by the entirety, then the property shall be forfeited and disposed of as provided by this section.
6. (6) Notwithstanding any other provision of this section to the contrary, the proceeds derived from the sale of property forfeited because it was acquired with the proceeds of a violation of title 39, chapter 17, part 4 shall be distributed solely as provided in subsection (h).
(h)
1. (1) The proceeds from any sale under subsection (g) shall be applied first to all reasonable expenses of the proceedings for forfeiture and sale, including, but not limited to, expenses, seizure, maintenance of custody, advertising, and court costs, and second to the satisfaction of all bona fide liens on the property. These liens and expenses shall be paid out of the proceeds before any allocation of proceeds required by subdivision (h)(2).
2. (2)
  1. (A) Any proceeds received by any state agency pursuant to this section shall be allocated as follows:
    1. (i) Fifty percent (50%) of all proceeds resulting from actions of any state agency or awarded the agency in a division of funds shall be paid to the state treasurer to be used only for agency purposes as appropriated by the general assembly;
    2. (ii) Forty percent (40%) of all proceeds resulting from actions of any state agency or awarded the agency in a division of funds shall be paid to the state treasurer to be used only for the purpose of providing additional funds for the operation, maintenance and construction of prisons under the control of the department of correction as appropriated by the general assembly; and
    3. (iii) Ten percent (10%) of the proceeds shall be paid to the special drug case investigation fund created in subsection (j).
  2. (B)
    1. (i) Any proceeds received or produced as a result of the activities of a law enforcement agency of a local government shall be paid into the treasury of the respective local government. These proceeds may be appropriated by the local governmental body for any public purpose allowed by law. For purposes of this section, “local government” means a city, county or county with a metropolitan form of government. Any purchase made with these proceeds shall be made in accordance with all purchasing laws applicable to the particular local government.
    2. (ii) Subdivision (h)(2)(B)(i) regarding any purchase made with the proceeds being in accordance with purchasing laws does not apply in any county having a metropolitan form of government and a population in excess of five hundred thousand (500,000), according to the 1990 federal census or any subsequent federal census.
(i) If more than one (1) law enforcement agency or department is involved in a seizure, then the court may divide the proceeds of property seized under this section among the agencies or departments involved in the seizure.
(j)
1. (1) There is created a special fund in the state treasury to be known as the special drug case investigation fund. Ten percent (10%) of all proceeds from any sale under this section shall be ordered paid into this fund by the court.
2. (2) This fund shall finance investigations of complex drug offense cases by the Tennessee bureau of investigation and the attorney general and reporter involving civil forfeitures pursuant to title 39, chapter 12, part 2, or this section.
3. (3) This fund shall not revert to the general fund on any June 30, but shall remain available for expenditure for its intended purposes.
(k)
1. (1) The attorney general and reporter is authorized to call on the assistance of the Tennessee bureau of investigation in the civil investigation of complex drug cases involving civil forfeiture proceedings brought by the bureau and the attorney general and reporter pursuant to title 39, chapter 12, part 2, or this section.
2. (2) The Tennessee bureau of investigation is authorized to provide assistance to the attorney general and reporter as required for the civil investigation of complex drug cases involving civil forfeiture proceedings brought by the bureau and the attorney general and reporter pursuant to title 39, chapter 12, part 2, or this section.

Chapter 13 Liability of Free Food Distributors

§ 53-13-101. Chapter definitions.

As used in this chapter, unless the context otherwise requires:
1. (1) “Apparently wholesome deer meat” means deer meat that complies with applicable standards, requirements, and procedures established by the department of agriculture;
2. (2) “Apparently wholesome food” means food that meets all standards of quality established by local, county, state and federal agricultural and health laws and regulations, even though the food is not readily marketable due to appearance; age; freshness, including bearing a past-due expiration date, sell-by date, use-by date, or other date; grade; size; surplus; or other condition. “Apparently wholesome food” does not include canned goods that are leaking, swollen, dented on a seam, or no longer airtight; and
3. (3) “Gleaner” means a person who harvests for free distribution an agricultural crop that has been donated by the owner.

§ 53-13-102. Immunity of good-faith donor or gleaner from liability.

(a)
1. (1) The good-faith donor of any apparently wholesome food fit for human consumption shall not be subject to criminal penalty for violation of unfair trade practice laws or civil damages arising from the condition of the food, unless an injury is caused by the gross negligence, recklessness, or intentional conduct of the donor. This subdivision (a)(1) applies if the donor donates the food:
  1. (A) Directly to an individual for personal use; or
  2. (B) To a bona fide charitable or nonprofit organization for free distribution.
2. (2) Any local education agency may donate any apparently wholesome food fit for human consumption to a county jail, directly to an individual for personal use, or to a bona fide charitable or nonprofit organization for free distribution, and shall not be subject to criminal penalty for violation of unfair trade practice laws or civil damages arising from the condition of the food, unless an injury is caused by the gross negligence, recklessness, or intentional conduct of the agency.
3. (3) A gleaner of any apparently wholesome food fit for human consumption shall not be subject to criminal penalty for violation of unfair trade practice laws or civil damages arising from the condition of the food, unless an injury is caused by the gross negligence, recklessness, or intentional conduct of the gleaner.
(b)
1. (1) The good-faith donor of any apparently wholesome deer meat, fit for human consumption, directly to an individual for personal use, to a bona fide charitable or nonprofit organization for free distribution, or to an on-site feeding program, shall not be subject to civil damages arising from the condition of the food, unless an injury is caused by the gross negligence, recklessness, or intentional conduct of the donor.
2. (2) As used in subdivision (b)(1), “good-faith donor” means deer hunters, deer meat inspectors, and processing facilities acting in compliance with applicable standards, requirements, and procedures established by the department of agriculture.
(c) A restaurant, convention center, or other food service establishment that serves food and is regulated pursuant to title 68, chapter 14, when acting as a good faith donor of any apparently wholesome food fit for human consumption, directly to an individual for personal use or to a bona fide charitable or nonprofit organization that operates a food bank or on-site feeding program, or both, for free distribution of food to combat poverty and hunger, shall not be subject to criminal penalty for violation of unfair trade practice laws or civil damages arising from the condition of the donated food, unless an injury is caused by the gross negligence, recklessness, or intentional conduct of the donor.

§ 53-13-103. Immunity of distributing organization from liability.

(a) A bona fide charitable or nonprofit organization that in good faith receives apparently wholesome food, fit for human consumption, and distributes it, shall not be subject to criminal penalty for violation of unfair trade practice laws or civil damages resulting from the condition of the food, unless an injury results from the gross negligence, recklessness or intentional conduct of the organization.
(b)
1. (1) A bona fide charitable or nonprofit organization that in good faith receives apparently wholesome deer meat, fit for human consumption, and distributes or serves it, shall not be subject to civil damages resulting from the condition of the food, unless an injury results from the gross negligence, recklessness, or intentional conduct of the organization.
2. (2) As used in subdivision (b)(1), “bona fide charitable or nonprofit organization” means an organization that operates a food bank or on-site feeding program to combat poverty and hunger and that acts in compliance with applicable standards, requirements, and procedures established by the department of agriculture.

§ 53-13-104. Regulation or prohibition of certain foods.

Nothing in this chapter shall restrict the authority of any appropriate agency to regulate or ban the use of any apparently wholesome food for human consumption.

§ 53-13-105. Compliance with Food, Drug and Cosmetic Act.

The qualification of civil liability provided under this chapter shall apply only to food that meets the standards of the Tennessee Food, Drug and Cosmetic Act, compiled in chapter 1 of this title, or the regulations under that chapter, and shall not apply to food that was unfit for human consumption at the time of distribution.

Chapter 14 Legend Drug and Controlled Substance Research Act of 1984

§ 53-14-101. Short title.

This chapter shall be known and may be cited as the “Tennessee Legend Drug and Controlled Substance Research Act of 1984.”

§ 53-14-102. Exemption from chapter.

This chapter shall not apply to:
1. (1) A licensed physician, dentist or veterinarian lawfully administering, dispensing or prescribing a legend drug or controlled substance in the course of the individual's professional practice to an ultimate user for a recognized medical purpose; or
2. (2) A manufacturer or distributor whose research protocol has been approved by the federal food and drug administration under that agency's auspices, or otherwise subject to jurisdiction of the federal food and drug administration and if lawful under that jurisdiction.

§ 53-14-103. Chapter definitions.

As used in this chapter, unless the context otherwise requires:
1. (1) “Board” means the board of pharmacy created by § 63-10-301;
2. (2) “Commissioner” means the commissioner of health;
3. (3) “Controlled substance analogues” is defined as in § 39-17-454;
4. (4) “Controlled substances” is defined as in § 39-17-402;
5. (5) “Director” means the director of the board of pharmacy elected pursuant to § 63-10-303;
6. (6) “Legend drugs” is defined as in § 53-10-101; and
7. (7) “Person” means an individual, corporation, government or governmental subdivision or agency, business trust, estate, trust, partnership or association, or any other legal entity.

§ 53-14-104. License — Required — Application — Fees.

(a) No person shall manufacture, obtain, possess, administer or dispense a legend drug, controlled substance or controlled substance analogue for the purpose of scientific research, chemical analysis, instruction or training of detection animals without having first secured a license to do so from the director.
(b) An application for the license shall be submitted on the prescribed form, and shall be accompanied by:
1. (1) A nonrefundable fee of thirty dollars ($30.00), or in an amount set by the board;
2. (2) Copies of all papers and materials filed with any state or federal governmental agency in connection with the applicant's proposed project; and
3. (3) A detailed protocol, in triplicate, setting forth:
  1. (A) The nature of the proposed project;
  2. (B) The qualifications of the applicant to engage in the project;
  3. (C) The proposed quantity of each drug involved;
  4. (D) The measures proposed to provide for security and proper record-keeping of the drugs;
  5. (E) Specific provisions for the safe administration or dispensing of drugs to humans, if contemplated, and the proposed method for selecting the humans; and
  6. (F) Other information the commissioner may require.

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53-14-109(a)

§ 53-14-105. License — Issuance.

(a) Upon approval by the commissioner, the director shall issue a license authorizing the holder to manufacture, obtain, possess, dispense, or administer legend drugs, controlled substances or controlled substance analogues, or any combination thereof, for the purpose of scientific research, instruction or chemical analysis.
(b) The commissioner shall not grant approval unless the commissioner determines that the applicant:
1. (1) Has submitted a satisfactory protocol for the proposed project, except as provided in § 53-14-109;
2. (2) Is of good character;
3. (3) Possesses, or is capable of acquiring, sufficient staff, facilities and equipment to conduct properly the proposed project;
4. (4) Is able to maintain effective control against diversion of the drugs for which the license is sought; and
5. (5) Is able to comply with all applicable state and federal laws and regulations relating to the drugs for which the license is sought.

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53-14-106(a)

§ 53-14-106. License — Contents — Expiration — Nontransferable.

(a) All licenses issued pursuant to § 53-14-105 shall specify:
1. (1) The name and address of the licensees;
2. (2) The nature of the authorized project or projects;
3. (3) The nature of legend drugs, controlled substances or controlled substance analogues to be used in the project; and
4. (4) Whether dispensing to human subjects is permitted.
(b) A license shall expire one (1) year from the date of issuance, or upon termination of the authorized project or projects, whichever comes first, and shall be renewable annually at a fee of thirty dollars ($30.00).
(c) No license shall be transferable.

§ 53-14-107. Modification of license.

(a) If any licensee under this chapter wishes to amend the terms or conditions of the licensee's license, the licensee shall make application to the director.
(b) The application shall be accompanied by a nonrefundable fee of five dollars ($5.00), or other amount set by the board.
(c) The director shall grant the requested amendment upon approval by the commissioner.

§ 53-14-108. Denial of application for license.

(a) If an application for a license or amendment under this chapter is denied, the director shall notify the applicant in writing of the reason or reasons for the denial.
(b) The applicant may, within thirty (30) days of the date of the notification, submit responsive materials for consideration by the commissioner.

§ 53-14-109. Institutional applicants for licenses.

(a) Any institution that regularly engages in research, instruction or chemical analysis may apply for a license authorizing internal approval of specific projects conducted under the institution's immediate auspices. The application shall be accompanied by the fee and materials specified in § 53-14-104; provided, that in lieu of a detailed protocol, the institutional applicant may submit a written statement containing:
1. (1) The qualifications of each member of the committee within the institution that will approve specific projects;
2. (2) A description of the system within the institution for approving, supervising and evaluating the projects; and
3. (3) Other information the commissioner may require.
(b) Any institution licensed pursuant to subsection (a) shall maintain for review by the board:
1. (1) A description of the project, including the names and qualifications of the individuals assigned to work on and supervise the project;
2. (2) A description of the provisions for safe administration or dispensing of drugs to human subjects, if contemplated; and
3. (3) Upon request of the commissioner, progress reports, evaluations and revisions, if any, of the project, in a form the commissioner prescribes.

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53-14-105(b)(1)

§ 53-14-110. Records and documents.

All licensees under this chapter shall maintain in a readily retrievable manner for a period of two (2) years:
1. (1) Records showing the receipt, administration, dispensing or destruction of all legend drugs, controlled substances and controlled substance analogues; and
2. (2) Copies of any protocols, including revisions of the protocols, progress reports, evaluations and other project documents.

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53-10-211(m)

§ 53-14-111. Inspections.

(a) The board, or its officers, agents or employees, shall periodically inspect the premises of licensees under this chapter for compliance with the submitted protocol, record-keeping and security requirements, and other state and federal laws or regulations relating to legend drugs, controlled substances and controlled substance analogues.
(b) Any applicant for a license under this chapter shall be deemed to have consented to the inspections.

§ 53-14-112. Suspension or revocation of license — Probation.

The board may, in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, suspend or revoke any license issued pursuant to this chapter or place on probation any licensee, if the licensee is found to have:
1. (1) Falsified any application, record, report or information required by this chapter;
2. (2) Failed to comply with the protocol of a project;
3. (3) Failed to maintain effective control against diversion of legend drugs, controlled substances or controlled substance analogues;
4. (4) Willfully and unreasonably refused to permit an inspection authorized by this chapter;
5. (5) Been convicted of an offense in any jurisdiction relating to legend drugs, controlled substances or controlled substance analogues; or
6. (6) Willfully or negligently violated this chapter or any state or federal drug laws or regulations.

§ 53-14-113. Restraining or enjoining violations — Jurisdiction.

The board may seek relief at law or equity to restrain or enjoin any act or practice in violation of this chapter. Jurisdiction is conferred upon the chancery and circuit courts of this state to hear and determine a suit to restrain or enjoin. No bond shall be required for the prosecution of the suit or for the issuance of an injunction.

§ 53-14-114. Restricted access to information.

Only the following persons shall have a right of access to the names and other identifying characteristics of individuals who are the subjects of research on the use and effects of legend drugs, controlled substances or controlled substance analogues:
1. (1) The board;
2. (2) The director;
3. (3) The commissioner;
4. (4) The attorney general and reporter or the attorney general and reporter's designee;
5. (5) Any person directly connected with the research who has a legitimate need for the information; and
6. (6) Any federal agency having responsibility for the research project.

Chapter 15 Sorghum Molasses

§ 53-15-101. Labeling.

All sorghum molasses that is sold or offered for sale in this state shall be prominently labeled as being either one hundred percent (100%) pure sorghum molasses or not pure sorghum molasses. Only sorghum molasses that contains no additives shall be labeled as one hundred percent (100%) pure sorghum molasses.

§ 53-15-102. Construction regarding testing.

Nothing in this chapter shall be construed to require the department of agriculture to test, or cause to be tested, any sorghum molasses.

§ 53-15-103. Cause of action for loss.

(a)
1. (1) Any person who suffers an injury or death, or an ascertainable loss of money or property, as a result of a violation of this chapter, may bring an action individually to recover actual damages.
2. (2) The action may be brought in a court of competent jurisdiction in the county where the alleged violation took place or is taking place, or in the county in which such person resides, has such person's principal place of business, conducts, transacts, or has transacted business, or, if the person cannot be found in any of the foregoing locations, in the county in which such person can be found.
(b)
1. (1) The trial court may award reasonable expenses, including court costs, discretionary costs and reasonable attorneys' fees to a plaintiff who prevails in a proceeding that is brought pursuant to this chapter.
2. (2) On termination of the proceeding, the trial court may require the plaintiff to pay any defendant's reasonable expenses, including court costs, discretionary costs and reasonable attorneys' fees, incurred in defending the proceeding if the court finds that the proceeding was commenced without reasonable cause.