Tenn. Code Ann. § 53-1-203 — TN Code / Title 53 / Chapter 1 / Section 53-1-203
Access to factories, warehouses, or establishments, or vehicles, for purpose of inspection and securing samples - Access to, and copying of, records
Status: in_force

(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. Added by 2021 Tenn. Acts, ch. 202, s 1, eff. 4/22/2021. Acts 1941, ch. 120, § 7; C. Supp. 1950, § 6580.7; T.C.A. (orig. ed.), § 52-107.
(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.
Added by 2021 Tenn. Acts, ch. 202, s 1, eff. 4/22/2021.
Acts 1941, ch. 120, § 7; C. Supp. 1950, § 6580.7; T.C.A. (orig. ed.), § 52-107.
Tenn. Code Ann. § 53-2-116 — TN Code / Title 53 / Chapter 2 / Section 53-2-116
[Repealed]
Status: repealed

Repealed by 2020 Tenn. Acts, ch. 727, s 2, eff. 6/22/2020. Acts 2011 , ch. 388, § 1.
Repealed by 2020 Tenn. Acts, ch. 727, s 2, eff. 6/22/2020.
Acts 2011 , ch. 388, § 1.
Tenn. Code Ann. § 53-10-209 — TN Code / Title 53 / Chapter 10 / Section 53-10-209
Construction
Status: in_force

(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. Acts 2005, ch. 434, §§ 11, 13.
(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.
Acts 2005, ch. 434, §§ 11, 13.
Tenn. Code Ann. § 53-1-102 — TN Code / Title 53 / Chapter 1 / Section 53-1-102
Chapter definitions
Status: in_force

As used in this chapter, unless the context otherwise requires: (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) "Alcohol" means: (A) Rubbing alcohol compound; (B) Isopropyl alcohol; or (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) "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) "Catfish" means any species within the family Ictaluridae or the family Anarchichadidae ; (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) "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: (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 (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) (A) (i) "Color additive" means a material that: (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 (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; (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; (B) "Color" includes black, white and intermediate grays; (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) "Commissioner" means the commissioner of agriculture; (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) "Cosmetic" means: (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 (B) Articles intended for use as a component of the articles listed in subdivision (10)(A), except that "cosmetic" does not include soap; (11) "Delivered" means transferred to the consumer, either immediately upon sale or at a time thereafter; (12) "Department" means the department of agriculture; (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: (A) For use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; or (B) To affect the structure or any function of the body of humans or other animals; (14) (A) "Drug" means articles, not including devices or their components, parts or accessories, that are: (i) Recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any supplement to any of them; (ii) Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; (iii) Intended, other than food, to affect the structure or any function of the body of humans or other animals; and (iv) Intended for use as a component of any article specified in subdivisions (14)(i)-(iii); and (B) "Drug" also means food that contains a vaccine or vaccine material; (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) "Federal act" means the federal Food, Drug and Cosmetic Act ( 21 U.S.C. § 301 et seq.), as amended; (17) "Food" means: (A) Articles used for food or drink for humans or other animals; (B) Chewing gum; and (C) Articles used for components of any article listed in subdivisions (17)(A) and (B); (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: (A) A pesticide chemical in or on an agricultural commodity; (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; (C) A color additive; (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 (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) "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) "Immediate container" does not include package liners; (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) "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) "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) "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) "Labeling" means all labels and other written, printed or graphic matter: (A) Upon any article or any of its containers or wrappers; or (B) Accompanying the article; (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) "New drug" means: (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 (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) "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) "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) "Person" includes an individual, partnership, corporation and association; (31) "Pesticide chemical" means: (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 (B) Any substance or mixture of substances intended for use as a plant regulator, defoliant or desiccant; (32) "Produce" means to prepare a food item by cooking, baking, drying, mixing, cutting, fermenting, preserving, dehydrating, growing, raising, or other process; (33) "Producer" means a person who produces a homemade food item; (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) "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) "Seller" means a person who sells a homemade food item to a consumer; (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; (38) "State" means the state of Tennessee and its political subdivisions; and (39) "Vaccine or vaccine material" means a substance intended for use in humans to stimulate the production of antibodies and provide immunity against disease, prepared from the causative agent of a disease, its products, or a synthetic substitute, treated to act as an antigen without inducing the disease, that is authorized or approved by the United States food and drug administration. Amended by 2024 Tenn. Acts, ch. 742,s 2, eff. 4/22/2024. Amended by 2024 Tenn. Acts, ch. 742,s 1, eff. 4/22/2024. Amended by 2022 Tenn. Acts, ch. 862, s 2, eff. 7/1/2022. Amended by 2017 Tenn. Acts, ch. 272, s 1, eff. 5/4/2017. Acts 1941, ch. 120, § 2; C. Supp. 1950, § 6580.2; Acts 1961, ch. 55, § 1; 1967, ch. 42, § 1; 1971, ch. 163, § 44; 1976, ch. 658, § 1; T.C.A. (orig. ed.), § 52-102; Acts 2002, ch. 634, § 1; 2002, ch. 640, § 30; 2003 , ch. 29, § 1; 2006, ch. 573, § 1.
As used in this chapter, unless the context otherwise requires:
(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) "Alcohol" means: (A) Rubbing alcohol compound; (B) Isopropyl alcohol; or (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;
(A) Rubbing alcohol compound;
(B) Isopropyl alcohol; or
(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) "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) "Catfish" means any species within the family Ictaluridae or the family Anarchichadidae ;
(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) "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: (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 (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;
(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
(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) (A) (i) "Color additive" means a material that: (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 (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; (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; (B) "Color" includes black, white and intermediate grays; (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;
(A) (i) "Color additive" means a material that: (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 (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; (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;
(i) "Color additive" means a material that: (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 (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;
(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
(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;
(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;
(B) "Color" includes black, white and intermediate grays;
(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) "Commissioner" means the commissioner of agriculture;
(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) "Cosmetic" means: (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 (B) Articles intended for use as a component of the articles listed in subdivision (10)(A), except that "cosmetic" does not include soap;
(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
(B) Articles intended for use as a component of the articles listed in subdivision (10)(A), except that "cosmetic" does not include soap;
(11) "Delivered" means transferred to the consumer, either immediately upon sale or at a time thereafter;
(12) "Department" means the department of agriculture;
(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: (A) For use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; or (B) To affect the structure or any function of the body of humans or other animals;
(A) For use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; or
(B) To affect the structure or any function of the body of humans or other animals;
(14) (A) "Drug" means articles, not including devices or their components, parts or accessories, that are: (i) Recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any supplement to any of them; (ii) Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; (iii) Intended, other than food, to affect the structure or any function of the body of humans or other animals; and (iv) Intended for use as a component of any article specified in subdivisions (14)(i)-(iii); and (B) "Drug" also means food that contains a vaccine or vaccine material;
(A) "Drug" means articles, not including devices or their components, parts or accessories, that are: (i) Recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any supplement to any of them; (ii) Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; (iii) Intended, other than food, to affect the structure or any function of the body of humans or other animals; and (iv) Intended for use as a component of any article specified in subdivisions (14)(i)-(iii); and
(i) Recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any supplement to any of them;
(ii) Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals;
(iii) Intended, other than food, to affect the structure or any function of the body of humans or other animals; and
(iv) Intended for use as a component of any article specified in subdivisions (14)(i)-(iii); and
(B) "Drug" also means food that contains a vaccine or vaccine material;
(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) "Federal act" means the federal Food, Drug and Cosmetic Act ( 21 U.S.C. § 301 et seq.), as amended;
(17) "Food" means: (A) Articles used for food or drink for humans or other animals; (B) Chewing gum; and (C) Articles used for components of any article listed in subdivisions (17)(A) and (B);
(A) Articles used for food or drink for humans or other animals;
(B) Chewing gum; and
(C) Articles used for components of any article listed in subdivisions (17)(A) and (B);
(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: (A) A pesticide chemical in or on an agricultural commodity; (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; (C) A color additive; (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 (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;
(A) A pesticide chemical in or on an agricultural commodity;
(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;
(C) A color additive;
(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
(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) "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) "Immediate container" does not include package liners;
(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) "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) "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) "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) "Labeling" means all labels and other written, printed or graphic matter: (A) Upon any article or any of its containers or wrappers; or (B) Accompanying the article;
(A) Upon any article or any of its containers or wrappers; or
(B) Accompanying the article;
(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) "New drug" means: (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 (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;
(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
(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) "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) "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) "Person" includes an individual, partnership, corporation and association;
(31) "Pesticide chemical" means: (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 (B) Any substance or mixture of substances intended for use as a plant regulator, defoliant or desiccant;
(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
(B) Any substance or mixture of substances intended for use as a plant regulator, defoliant or desiccant;
(32) "Produce" means to prepare a food item by cooking, baking, drying, mixing, cutting, fermenting, preserving, dehydrating, growing, raising, or other process;
(33) "Producer" means a person who produces a homemade food item;
(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) "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) "Seller" means a person who sells a homemade food item to a consumer;
(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;
(38) "State" means the state of Tennessee and its political subdivisions; and
(39) "Vaccine or vaccine material" means a substance intended for use in humans to stimulate the production of antibodies and provide immunity against disease, prepared from the causative agent of a disease, its products, or a synthetic substitute, treated to act as an antigen without inducing the disease, that is authorized or approved by the United States food and drug administration.
Amended by 2024 Tenn. Acts, ch. 742,s 2, eff. 4/22/2024.
Amended by 2024 Tenn. Acts, ch. 742,s 1, eff. 4/22/2024.
Amended by 2022 Tenn. Acts, ch. 862, s 2, eff. 7/1/2022.
Amended by 2017 Tenn. Acts, ch. 272, s 1, eff. 5/4/2017.
Acts 1941, ch. 120, § 2; C. Supp. 1950, § 6580.2; Acts 1961, ch. 55, § 1; 1967, ch. 42, § 1; 1971, ch. 163, § 44; 1976, ch. 658, § 1; T.C.A. (orig. ed.), § 52-102; Acts 2002, ch. 634, § 1; 2002, ch. 640, § 30; 2003 , ch. 29, § 1; 2006, ch. 573, § 1.
Tenn. Code Ann. § 53-1-202 — TN Code / Title 53 / Chapter 1 / Section 53-1-202
Promulgation of rules
Status: in_force

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. Added by 2021 Tenn. Acts, ch. 202, s 1, eff. 4/22/2021. Acts 1941, ch. 120, § 6; mod. C. Supp. 1950, § 6580.6; Acts 1967, ch. 42, § 3; T.C.A. (orig. ed.), § 52-106.
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.
Added by 2021 Tenn. Acts, ch. 202, s 1, eff. 4/22/2021.
Acts 1941, ch. 120, § 6; mod. C. Supp. 1950, § 6580.6; Acts 1967, ch. 42, § 3; T.C.A. (orig. ed.), § 52-106.
Tenn. Code Ann. § 53-10-104 — TN Code / Title 53 / Chapter 10 / Section 53-10-104
Selling, bartering, giving away or obtaining legend drugs
Status: in_force

(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) The writing or signing a prescription for any drug or medication; (2) The dispensing or administration of any prescribed or legend drug or medication; or (3) The performing of any procedure that involves the use of a legend drug or medication. Acts 1939, ch. 164, § 1; C. Supp. 1950, § 6632.24 (Williams, § 6632.6); Acts 1953, ch. 52, § 1; 1955, ch. 89, § 1; 1961, ch. 6, § 1; 1963, ch. 369, §§ 1, 4; 1971, ch. 163, § 43; 1980, ch. 851, § 8; 1980, ch. 858, § 1; T.C.A. (orig. ed.), § 52-1204; Acts 1987, ch. 217, § 3; 1994, ch. 569, § 4; 1994, ch. 722, § 3; 1994, ch. 853, §§ 1-3; 1996, ch. 754, § 1; 1997, ch. 507, § 1; 2000, ch. 541, § 1.
(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) The writing or signing a prescription for any drug or medication; (2) The dispensing or administration of any prescribed or legend drug or medication; or (3) The performing of any procedure that involves the use of a legend drug or medication.
(1) The writing or signing a prescription for any drug or medication;
(2) The dispensing or administration of any prescribed or legend drug or medication; or
(3) The performing of any procedure that involves the use of a legend drug or medication.
Acts 1939, ch. 164, § 1; C. Supp. 1950, § 6632.24 (Williams, § 6632.6); Acts 1953, ch. 52, § 1; 1955, ch. 89, § 1; 1961, ch. 6, § 1; 1963, ch. 369, §§ 1, 4; 1971, ch. 163, § 43; 1980, ch. 851, § 8; 1980, ch. 858, § 1; T.C.A. (orig. ed.), § 52-1204; Acts 1987, ch. 217, § 3; 1994, ch. 569, § 4; 1994, ch. 722, § 3; 1994, ch. 853, §§ 1-3; 1996, ch. 754, § 1; 1997, ch. 507, § 1; 2000, ch. 541, § 1.
Tenn. Code Ann. § 53-10-305 — TN Code / Title 53 / Chapter 10 / Section 53-10-305
Submission of information - Data format
Status: in_force

(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) Each healthcare practitioner or healthcare practitioner's agent shall, regarding each controlled substance dispensed, submit to the database all of the following information: (A) Prescriber identifier; (B) Dispensing date of controlled substance; (C) Patient identifier; (D) Controlled substance dispensed identifier; (E) Quantity of controlled substance dispensed; (F) Strength of controlled substance dispensed; (G) Estimated days' supply; (H) Dispenser identifier; (I) Date the prescription was issued by the prescriber; (J) Whether the prescription was new or a refill; (K) Source of payment; (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; (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 (N) Other relevant information as required by rule. (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) Prescribing and dispensing practices and patterns of prescribing and dispensing controlled substances; and (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. (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) (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. (B) The committee may authorize a designee to initially approve a waiver subject to ratification by the committee. (2) The commissioner shall ensure the database system records and maintains for reference, for a period of at least one (1) year: (A) The identification of each person who requests or receives information from the database; (B) The information provided to each person; and (C) The date and time the information is requested or provided. (h) The commissioner, in consultation with the committee, shall make rules to: (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) Establish standards and procedures to ensure accurate identification of individuals requesting information or receiving information from the database without a request. Amended by 2022 Tenn. Acts, ch. 825, Secs.s6, s7 eff. 4/14/2022. Amended by 2018 Tenn. Acts, ch. 1039, s 2, eff. 7/1/2018. Acts 2002, ch. 840, § 1; 2004, ch. 673, § 26; 2012 , ch. 880, § 5; 2014, ch. 1011, §§ 1, 3.
(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) Each healthcare practitioner or healthcare practitioner's agent shall, regarding each controlled substance dispensed, submit to the database all of the following information: (A) Prescriber identifier; (B) Dispensing date of controlled substance; (C) Patient identifier; (D) Controlled substance dispensed identifier; (E) Quantity of controlled substance dispensed; (F) Strength of controlled substance dispensed; (G) Estimated days' supply; (H) Dispenser identifier; (I) Date the prescription was issued by the prescriber; (J) Whether the prescription was new or a refill; (K) Source of payment; (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; (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 (N) Other relevant information as required by rule. (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.
(1) Each healthcare practitioner or healthcare practitioner's agent shall, regarding each controlled substance dispensed, submit to the database all of the following information: (A) Prescriber identifier; (B) Dispensing date of controlled substance; (C) Patient identifier; (D) Controlled substance dispensed identifier; (E) Quantity of controlled substance dispensed; (F) Strength of controlled substance dispensed; (G) Estimated days' supply; (H) Dispenser identifier; (I) Date the prescription was issued by the prescriber; (J) Whether the prescription was new or a refill; (K) Source of payment; (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; (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 (N) Other relevant information as required by rule.
(A) Prescriber identifier;
(B) Dispensing date of controlled substance;
(C) Patient identifier;
(D) Controlled substance dispensed identifier;
(E) Quantity of controlled substance dispensed;
(F) Strength of controlled substance dispensed;
(G) Estimated days' supply;
(H) Dispenser identifier;
(I) Date the prescription was issued by the prescriber;
(J) Whether the prescription was new or a refill;
(K) Source of payment;
(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;
(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
(N) Other relevant information as required by rule.
(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) Prescribing and dispensing practices and patterns of prescribing and dispensing controlled substances; and (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.
(1) Prescribing and dispensing practices and patterns of prescribing and dispensing controlled substances; and
(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.
(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) (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. (B) The committee may authorize a designee to initially approve a waiver subject to ratification by the committee. (2) The commissioner shall ensure the database system records and maintains for reference, for a period of at least one (1) year: (A) The identification of each person who requests or receives information from the database; (B) The information provided to each person; and (C) The date and time the information is requested or provided.
(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. (B) The committee may authorize a designee to initially approve a waiver subject to ratification by the committee.
(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.
(B) The committee may authorize a designee to initially approve a waiver subject to ratification by the committee.
(2) The commissioner shall ensure the database system records and maintains for reference, for a period of at least one (1) year: (A) The identification of each person who requests or receives information from the database; (B) The information provided to each person; and (C) The date and time the information is requested or provided.
(A) The identification of each person who requests or receives information from the database;
(B) The information provided to each person; and
(C) The date and time the information is requested or provided.
(h) The commissioner, in consultation with the committee, shall make rules to: (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) Establish standards and procedures to ensure accurate identification of individuals requesting information or receiving information from the database without a request.
(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) Establish standards and procedures to ensure accurate identification of individuals requesting information or receiving information from the database without a request.
Amended by 2022 Tenn. Acts, ch. 825, Secs.s6, s7 eff. 4/14/2022.
Amended by 2018 Tenn. Acts, ch. 1039, s 2, eff. 7/1/2018.
Acts 2002, ch. 840, § 1; 2004, ch. 673, § 26; 2012 , ch. 880, § 5; 2014, ch. 1011, §§ 1, 3.
Tenn. Code Ann. § 53-10-311 — TN Code / Title 53 / Chapter 10 / Section 53-10-311
Establishment of operations committee - Agreements with federal government and other jurisdictions for sharing and dissemination of data and information
Status: in_force

(a) There is created an operations committee. The operations committee shall be composed of: (1) The board of medical examiners' medical director for special projects; (2) An epidemiologist employed by the department of health; (3) The executive director of the board of pharmacy; (4) The director of the controlled substance database; (5) A member of the controlled substance database committee; (6) The executive director of the board of nursing as an ex officio non-voting member; and (7) The executive director of the board of medical examiners as an ex officio non-voting member. (b) (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) The operations committee's approval shall be necessary for all rules, agreements, and policies concerning: (A) Access to the database and how that access is obtained; (B) Dissemination of data and information in the database and control over that data; and (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) 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) 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) 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) Any information disseminated pursuant to this subsection (e) shall be for: (A) Analysis of controlled substance prescriptions for public health research or patient care coordination; or (B) Data sharing consistent with the requirements of § 53-10-306 . (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) 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) 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. Amended by 2022 Tenn. Acts, ch. 825, Secs.s13, s14, s15, s16, s17, s18 eff. 4/14/2022. Amended by 2021 Tenn. Acts, ch. 136, s 10, eff. 4/13/2021.
(a) There is created an operations committee. The operations committee shall be composed of: (1) The board of medical examiners' medical director for special projects; (2) An epidemiologist employed by the department of health; (3) The executive director of the board of pharmacy; (4) The director of the controlled substance database; (5) A member of the controlled substance database committee; (6) The executive director of the board of nursing as an ex officio non-voting member; and (7) The executive director of the board of medical examiners as an ex officio non-voting member.
(1) The board of medical examiners' medical director for special projects;
(2) An epidemiologist employed by the department of health;
(3) The executive director of the board of pharmacy;
(4) The director of the controlled substance database;
(5) A member of the controlled substance database committee;
(6) The executive director of the board of nursing as an ex officio non-voting member; and
(7) The executive director of the board of medical examiners as an ex officio non-voting member.
(b) (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) The operations committee's approval shall be necessary for all rules, agreements, and policies concerning: (A) Access to the database and how that access is obtained; (B) Dissemination of data and information in the database and control over that data; and (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) 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) 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.
(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) The operations committee's approval shall be necessary for all rules, agreements, and policies concerning: (A) Access to the database and how that access is obtained; (B) Dissemination of data and information in the database and control over that data; and (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.
(A) Access to the database and how that access is obtained;
(B) Dissemination of data and information in the database and control over that data; and
(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) 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) 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) 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) Any information disseminated pursuant to this subsection (e) shall be for: (A) Analysis of controlled substance prescriptions for public health research or patient care coordination; or (B) Data sharing consistent with the requirements of § 53-10-306 . (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) 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) 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.
(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) Any information disseminated pursuant to this subsection (e) shall be for: (A) Analysis of controlled substance prescriptions for public health research or patient care coordination; or (B) Data sharing consistent with the requirements of § 53-10-306 .
(A) Analysis of controlled substance prescriptions for public health research or patient care coordination; or
(B) Data sharing consistent with the requirements of § 53-10-306 .
(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) 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) 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.
Amended by 2022 Tenn. Acts, ch. 825, Secs.s13, s14, s15, s16, s17, s18 eff. 4/14/2022.
Amended by 2021 Tenn. Acts, ch. 136, s 10, eff. 4/13/2021.
Tenn. Code Ann. § 53-10-108 — TN Code / Title 53 / Chapter 10 / Section 53-10-108
Violation - Penalty
Status: in_force

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. Acts 1972, ch. 597, § 8; T.C.A., § 52-1208; Acts 1989, ch. 591, § 113.
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.
Acts 1972, ch. 597, § 8; T.C.A., § 52-1208; Acts 1989, ch. 591, § 113.
Tenn. Code Ann. § 53-14-114 — TN Code / Title 53 / Chapter 14 / Section 53-14-114
Restricted access to information
Status: in_force

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) The board; (2) The director; (3) The commissioner; (4) The attorney general and reporter or the attorney general and reporter's designee; (5) Any person directly connected with the research who has a legitimate need for the information; and (6) Any federal agency having responsibility for the research project. Acts 1984, ch. 717, §14; 2012 , ch. 848, § 57.
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) The board;
(2) The director;
(3) The commissioner;
(4) The attorney general and reporter or the attorney general and reporter's designee;
(5) Any person directly connected with the research who has a legitimate need for the information; and
(6) Any federal agency having responsibility for the research project.
Acts 1984, ch. 717, §14; 2012 , ch. 848, § 57.
Tenn. Code Ann. § 53-11-308 — TN Code / Title 53 / Chapter 11 / Section 53-11-308
Prescription requirements
Status: in_force

(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) 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: (A) Advise the patient of the risk associated with opioid use during pregnancy; (B) Counsel the patient on appropriate and effective forms of birth control; and (C) Offer information about the availability of free or reduced cost birth control to the patient. (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) This subsection (h) does not apply if: (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 (B) The prescriber reasonably believes that the patient is not capable of becoming pregnant. (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) The department of health shall develop and publish guidance to assist prescribers of opioids in complying with this subsection (h). (i) (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: (A) The healthcare provider prescribes more than a three-day supply of an opioid medication; and (B) (i) The healthcare provider prescribes an opioid medication concurrently with a prescription by the same provider for benzodiazepine; or (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) Subdivision (i)(1) does not apply to: (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 (B) An opioid prescription that is written by a licensed veterinarian, as defined in § 63-12-103 . Amended by 2022 Tenn. Acts, ch. 1061, s 1, eff. 7/1/2022. Amended by 2018 Tenn. Acts, ch. 883, s 2, eff. 1/1/2019. Amended by 2013 Tenn. Acts, ch. 430, s 4, eff. 5/16/2013. Acts 1971, ch. 163, § 24; T.C.A., § 52-1431.
(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) 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: (A) Advise the patient of the risk associated with opioid use during pregnancy; (B) Counsel the patient on appropriate and effective forms of birth control; and (C) Offer information about the availability of free or reduced cost birth control to the patient. (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) This subsection (h) does not apply if: (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 (B) The prescriber reasonably believes that the patient is not capable of becoming pregnant. (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) The department of health shall develop and publish guidance to assist prescribers of opioids in complying with this subsection (h).
(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: (A) Advise the patient of the risk associated with opioid use during pregnancy; (B) Counsel the patient on appropriate and effective forms of birth control; and (C) Offer information about the availability of free or reduced cost birth control to the patient.
(A) Advise the patient of the risk associated with opioid use during pregnancy;
(B) Counsel the patient on appropriate and effective forms of birth control; and
(C) Offer information about the availability of free or reduced cost birth control to the patient.
(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) This subsection (h) does not apply if: (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 (B) The prescriber reasonably believes that the patient is not capable of becoming pregnant.
(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
(B) The prescriber reasonably believes that the patient is not capable of becoming pregnant.
(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) The department of health shall develop and publish guidance to assist prescribers of opioids in complying with this subsection (h).
(i) (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: (A) The healthcare provider prescribes more than a three-day supply of an opioid medication; and (B) (i) The healthcare provider prescribes an opioid medication concurrently with a prescription by the same provider for benzodiazepine; or (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) Subdivision (i)(1) does not apply to: (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 (B) An opioid prescription that is written by a licensed veterinarian, as defined in § 63-12-103 .
(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: (A) The healthcare provider prescribes more than a three-day supply of an opioid medication; and (B) (i) The healthcare provider prescribes an opioid medication concurrently with a prescription by the same provider for benzodiazepine; or (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.
(A) The healthcare provider prescribes more than a three-day supply of an opioid medication; and
(B) (i) The healthcare provider prescribes an opioid medication concurrently with a prescription by the same provider for benzodiazepine; or (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.
(i) The healthcare provider prescribes an opioid medication concurrently with a prescription by the same provider for benzodiazepine; or
(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) Subdivision (i)(1) does not apply to: (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 (B) An opioid prescription that is written by a licensed veterinarian, as defined in § 63-12-103 .
(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
(B) An opioid prescription that is written by a licensed veterinarian, as defined in § 63-12-103 .
Amended by 2022 Tenn. Acts, ch. 1061, s 1, eff. 7/1/2022.
Amended by 2018 Tenn. Acts, ch. 883, s 2, eff. 1/1/2019.
Amended by 2013 Tenn. Acts, ch. 430, s 4, eff. 5/16/2013.
Acts 1971, ch. 163, § 24; T.C.A., § 52-1431.
Tenn. Code Ann. § 53-2-107 — TN Code / Title 53 / Chapter 2 / Section 53-2-107
[Repealed]
Status: repealed

Repealed by 2020 Tenn. Acts, ch. 727, s 2, eff. 6/22/2020. Amended by 2017 Tenn. Acts, ch. 150, s 4, eff. 4/17/2017. Acts 1951, ch. 124, § 7 (Williams, § 6579.35); 1955, ch. 9, §1; 1981, ch. 322, §§ 6, 7; T.C.A. (orig. ed.), § 52-207.
Repealed by 2020 Tenn. Acts, ch. 727, s 2, eff. 6/22/2020.
Amended by 2017 Tenn. Acts, ch. 150, s 4, eff. 4/17/2017.
Acts 1951, ch. 124, § 7 (Williams, § 6579.35); 1955, ch. 9, §1; 1981, ch. 322, §§ 6, 7; T.C.A. (orig. ed.), § 52-207.
Tenn. Code Ann. § 53-3-104 — TN Code / Title 53 / Chapter 3 / Section 53-3-104
Authority and powers of the commissioner - Special provisions for trade products - Rules and regulations
Status: in_force

(a) (1) (A) The commissioner has the authority to define all varieties and types of dairy products and trade products. (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) 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) 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) 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) 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) 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) 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) Any revision, amendment or termination of existing rules and regulations shall follow the same procedure as set forth in this section. (e) (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: (A) In a facility separate from production of pasteurized products; (B) Solely for intrastate commerce; and (C) By a person licensed by the department as a dairy plant. (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: 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. Amended by 2019 Tenn. Acts, ch. 258,s 1, eff. 4/30/2019. Acts 1970, ch. 577, § 2; 1981, ch. 29, § 2; 1981, ch. 326, § 1; T.C.A., § 52-304.
(a) (1) (A) The commissioner has the authority to define all varieties and types of dairy products and trade products. (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) 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.
(1) (A) The commissioner has the authority to define all varieties and types of dairy products and trade products. (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.
(A) The commissioner has the authority to define all varieties and types of dairy products and trade products.
(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) 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) 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) 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) 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) 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) 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) Any revision, amendment or termination of existing rules and regulations shall follow the same procedure as set forth in this section.
(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) 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) 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) 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) 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) Any revision, amendment or termination of existing rules and regulations shall follow the same procedure as set forth in this section.
(e) (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: (A) In a facility separate from production of pasteurized products; (B) Solely for intrastate commerce; and (C) By a person licensed by the department as a dairy plant. (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: 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.
(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: (A) In a facility separate from production of pasteurized products; (B) Solely for intrastate commerce; and (C) By a person licensed by the department as a dairy plant.
(A) In a facility separate from production of pasteurized products;
(B) Solely for intrastate commerce; and
(C) By a person licensed by the department as a dairy plant.
(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: 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.
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.
Amended by 2019 Tenn. Acts, ch. 258,s 1, eff. 4/30/2019.
Acts 1970, ch. 577, § 2; 1981, ch. 29, § 2; 1981, ch. 326, § 1; T.C.A., § 52-304.
Tenn. Code Ann. § 53-8-107 — TN Code / Title 53 / Chapter 8 / Section 53-8-107
Application for permits - Inspection - Renewals - Exception
Status: in_force

(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. Repealed by 2017 Tenn. Acts, ch. 150, s 5, eff. 4/17/2017. Acts 1909, ch. 473, § 5; Shan., § 3473a47; Code 1932, § 6604; T.C.A. (orig. ed.), § 52-1008.
(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.
Repealed by 2017 Tenn. Acts, ch. 150, s 5, eff. 4/17/2017.
Acts 1909, ch. 473, § 5; Shan., § 3473a47; Code 1932, § 6604; T.C.A. (orig. ed.), § 52-1008.
Tenn. Code Ann. § 53-11-303 — TN Code / Title 53 / Chapter 11 / Section 53-11-303
Criteria for registration issuance
Status: in_force

(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) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific or industrial channels; (2) Compliance with applicable state and local law; (3) Any convictions of the applicant under any federal and state laws relating to any controlled substance; (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) 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) Suspension or revocation of the applicant's federal registration to manufacture, distribute or dispense controlled substances as authorized by federal law; and (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. Acts 1971, ch. 163, § 19; T.C.A., § 52-1426; Acts 1996, ch. 675, §§ 53, 54.
(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) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific or industrial channels; (2) Compliance with applicable state and local law; (3) Any convictions of the applicant under any federal and state laws relating to any controlled substance; (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) 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) Suspension or revocation of the applicant's federal registration to manufacture, distribute or dispense controlled substances as authorized by federal law; and (7) Any other factors relevant to and consistent with the public health and safety.
(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific or industrial channels;
(2) Compliance with applicable state and local law;
(3) Any convictions of the applicant under any federal and state laws relating to any controlled substance;
(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) 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) Suspension or revocation of the applicant's federal registration to manufacture, distribute or dispense controlled substances as authorized by federal law; and
(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.
Acts 1971, ch. 163, § 19; T.C.A., § 52-1426; Acts 1996, ch. 675, §§ 53, 54.
Tenn. Code Ann. § 53-11-406 — TN Code / Title 53 / Chapter 11 / Section 53-11-406
Inspection
Status: in_force

(a) (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) 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. Acts 1971, ch. 163, § 33; T.C.A., § 52-1440; Acts 1996, ch. 675, § 59.
(a) (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) 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.
(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) 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.
Acts 1971, ch. 163, § 33; T.C.A., § 52-1440; Acts 1996, ch. 675, § 59.
Tenn. Code Ann. § 53-3-203 — TN Code / Title 53 / Chapter 3 / Section 53-3-203
Penalty for violations - Enforcement procedures - Regulations - Delegation of duties and powers by commissioner
Status: in_force

(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) Revoke or suspend any license or permit issued by the department to the person found in violation of this part; (2) Seek injunctive relief in any court of competent jurisdiction to enjoin any violation of this part; (3) Impose civil penalties of up to one thousand dollars ($1,000) each day that a violation occurs; or (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) 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) 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. Acts 1955, ch. 74, § 3; 1957, ch. 109, § 1; 1959, ch. 79, § 2; 1961, ch. 203, § 3; modified; T.C.A., § 52-333; modified; Acts 1989, ch. 591, § 113; 2005, ch. 300, § 3.
(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) Revoke or suspend any license or permit issued by the department to the person found in violation of this part; (2) Seek injunctive relief in any court of competent jurisdiction to enjoin any violation of this part; (3) Impose civil penalties of up to one thousand dollars ($1,000) each day that a violation occurs; or (4) Recover any and all expenses for investigation and prosecution of violations of this part from any person found in violation.
(1) Revoke or suspend any license or permit issued by the department to the person found in violation of this part;
(2) Seek injunctive relief in any court of competent jurisdiction to enjoin any violation of this part;
(3) Impose civil penalties of up to one thousand dollars ($1,000) each day that a violation occurs; or
(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) 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) 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.
(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) 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.
Acts 1955, ch. 74, § 3; 1957, ch. 109, § 1; 1959, ch. 79, § 2; 1961, ch. 203, § 3; modified; T.C.A., § 52-333; modified; Acts 1989, ch. 591, § 113; 2005, ch. 300, § 3.
Tenn. Code Ann. § 53-3-301 — TN Code / Title 53 / Chapter 3 / Section 53-3-301
Short title
Status: in_force

This part shall be known and may be cited as the "Dairy Farmers Prosperity Act." Acts 2010, ch. 627, § 2.
This part shall be known and may be cited as the "Dairy Farmers Prosperity Act."
Acts 2010, ch. 627, § 2.
Tenn. Code Ann. § 53-1-106 — TN Code / Title 53 / Chapter 1 / Section 53-1-106
Certain food exempted from affirmative labeling requirements
Status: in_force

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. Acts 1941, ch. 120, § 13; C. Supp. 1950, § 6580.13; T.C.A. (orig. ed.), § 52-113.
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.
Acts 1941, ch. 120, § 13; C. Supp. 1950, § 6580.13; T.C.A. (orig. ed.), § 52-113.
Tenn. Code Ann. § 53-11-305 — TN Code / Title 53 / Chapter 11 / Section 53-11-305
Revocation, suspension or denial of registration
Status: in_force

(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) 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) 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. Acts 1971, ch. 163, § 21; 1973, ch. 110, § 15; T.C.A., § 52-1428.
(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) 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) 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.
(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) 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.
Acts 1971, ch. 163, § 21; 1973, ch. 110, § 15; T.C.A., § 52-1428.
Tenn. Code Ann. § 53-3-204 — TN Code / Title 53 / Chapter 3 / Section 53-3-204
Exemptions
Status: in_force

Section 53-3-202 shall not apply to advertisements or offers to sell, or sales, where: (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) The merchandise is damaged; (3) The items are sold upon the final liquidation of any business; (4) The items are sold or given away for any charitable purposes; (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) The items are sold by an officer acting under the direction of any court; (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) The items are sold for consumption on the premises where sold; or (9) The items are sold within twenty-four (24) hours of the expiration or sell-by date imprinted on the item. Acts 1955, ch. 74, § 4; 1957, ch. 109, § 1; 1961, ch. 203, § 4; T.C.A., § 52-334; Acts 2005, ch. 300, § 4.
Section 53-3-202 shall not apply to advertisements or offers to sell, or sales, where:
(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) The merchandise is damaged;
(3) The items are sold upon the final liquidation of any business;
(4) The items are sold or given away for any charitable purposes;
(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) The items are sold by an officer acting under the direction of any court;
(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) The items are sold for consumption on the premises where sold; or
(9) The items are sold within twenty-four (24) hours of the expiration or sell-by date imprinted on the item.
Acts 1955, ch. 74, § 4; 1957, ch. 109, § 1; 1961, ch. 203, § 4; T.C.A., § 52-334; Acts 2005, ch. 300, § 4.
Tenn. Code Ann. § 53-8-116 — TN Code / Title 53 / Chapter 8 / Section 53-8-116
Examination of food - Hold orders
Status: in_force

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. Repealed by 2017 Tenn. Acts, ch. 150, s 5, eff. 4/17/2017. Acts 1986, ch. 756, § 1.
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.
Repealed by 2017 Tenn. Acts, ch. 150, s 5, eff. 4/17/2017.
Acts 1986, ch. 756, § 1.
Tenn. Code Ann. § 53-2-108 — TN Code / Title 53 / Chapter 2 / Section 53-2-108
[Repealed]
Status: repealed

Repealed by 2020 Tenn. Acts, ch. 727, s 2, eff. 6/22/2020. Acts 1951, ch. 124, § 7; 1953, ch. 98, § 3 (Williams, § 6579.35); 1981, ch. 322, § 8; T.C.A. (orig. ed.), § 52-208.
Repealed by 2020 Tenn. Acts, ch. 727, s 2, eff. 6/22/2020.
Acts 1951, ch. 124, § 7; 1953, ch. 98, § 3 (Williams, § 6579.35); 1981, ch. 322, § 8; T.C.A. (orig. ed.), § 52-208.
Tenn. Code Ann. § 53-2-113 — TN Code / Title 53 / Chapter 2 / Section 53-2-113
[Repealed]
Status: repealed

Repealed by 2020 Tenn. Acts, ch. 727, s 2, eff. 6/22/2020. Acts 1951, ch. 124, § 9 (Williams, § 6579.37); T.C.A. (orig. ed.), § 52-213.
Repealed by 2020 Tenn. Acts, ch. 727, s 2, eff. 6/22/2020.
Acts 1951, ch. 124, § 9 (Williams, § 6579.37); T.C.A. (orig. ed.), § 52-213.
Tenn. Code Ann. § 53-11-310 — TN Code / Title 53 / Chapter 11 / Section 53-11-310
Identification requirements for dispensing of certain Schedule II to IV prescription medications for greater than a seven-day supply
Status: in_force

(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) 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) Apply to any controlled substance dispensed by a licensed veterinarian; (3) Apply to drug samples dispensed by a healthcare professional; or (4) Apply to prescriptions written for: (A) Inpatients in a hospital; (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; (C) Residents of a nursing home or an assisted living facility; (D) Inpatients or residents of a mental health hospital or residential facility licensed under title 33; (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 ; (F) Individuals incarcerated in a local, state or federal correctional facility; (G) Patients receiving prescriptions from mail order pharmacies; or (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. Added by 2014 Tenn. Acts, ch. 872,s 1, eff. 7/1/2014.
(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) 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) Apply to any controlled substance dispensed by a licensed veterinarian; (3) Apply to drug samples dispensed by a healthcare professional; or (4) Apply to prescriptions written for: (A) Inpatients in a hospital; (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; (C) Residents of a nursing home or an assisted living facility; (D) Inpatients or residents of a mental health hospital or residential facility licensed under title 33; (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 ; (F) Individuals incarcerated in a local, state or federal correctional facility; (G) Patients receiving prescriptions from mail order pharmacies; or (H) Patients receiving home deliveries from pharmacies.
(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) Apply to any controlled substance dispensed by a licensed veterinarian;
(3) Apply to drug samples dispensed by a healthcare professional; or
(4) Apply to prescriptions written for: (A) Inpatients in a hospital; (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; (C) Residents of a nursing home or an assisted living facility; (D) Inpatients or residents of a mental health hospital or residential facility licensed under title 33; (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 ; (F) Individuals incarcerated in a local, state or federal correctional facility; (G) Patients receiving prescriptions from mail order pharmacies; or (H) Patients receiving home deliveries from pharmacies.
(A) Inpatients in a hospital;
(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;
(C) Residents of a nursing home or an assisted living facility;
(D) Inpatients or residents of a mental health hospital or residential facility licensed under title 33;
(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 ;
(F) Individuals incarcerated in a local, state or federal correctional facility;
(G) Patients receiving prescriptions from mail order pharmacies; or
(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.
Added by 2014 Tenn. Acts, ch. 872,s 1, eff. 7/1/2014.