Title 53, Food, Drugs And Cosmetics

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

(a) Inspection results for food establishments shall be recorded on standard departmental forms that summarize the requirements of the law and rules and regulations. (b) A copy of the completed inspection report shall be furnished to the person in charge of the facility at the co…

(a) The completed inspection report shall specify a reasonable period of time for correction of violations found. (b) Corrections of violations shall be accomplished within the period specified in accordance with the following:(1) If an imminent health hazard exists, the facility…

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 ope…

Whenever a food establishment is constructed or extensively remodeled, and whenever an existing structure is converted to use as a food establishment, plans and specifications shall be submitted to the commissioner for review and approval before construction, remodeling, or conve…

(a) When the commissioner has reasonable cause to suspect possible disease transmission by an employee of the facility, the commissioner may secure information about any recent illness of the employee or make other investigations as may be indicated. The commissioner may require …

Any person operating a food establishment who fails or refuses to comply with any provision of this chapter or of rules and regulations, or obstructs or hinders the regulatory authority in the discharge of the regulatory authority's duties, or otherwise operates a food establishm…

When the commissioner has reason to believe that a person is causing, is about to cause, or has caused a violation of this chapter or of the rules and regulations promulgated under this chapter, the commissioner may initiate proceedings in either the chancery court of Davidson Co…

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

When the commissioner has reason to believe that a person has caused, is causing, or is about to cause a violation of this chapter or the rules and regulations promulgated under this chapter, the commissioner may initiate proceedings in either the chancery court of Davidson Count…

(a) Notwithstanding any law to the contrary, and except for subdivision (c)(1), the local government's authority under title 13, chapters 7, 16, and 28, and the local government's authority to regulate roadways, traffic, and the provision of utility services, this state is the ex…

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

(a) There are exempted from this part:(1) The sale of legend drugs by legitimate wholesale druggists to registered pharmacists and the sale by registered pharmacists to duly licensed physicians, dentists and veterinarians; and(2) The sale of legend drugs by registered pharmacists…

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

(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 …

(a) It is unlawful for any person to have in the person's possession, any drug defined or enumerated in this part, without the drug having been prescribed by a duly licensed physician, certified physician assistant, dentist, optometrist authorized pursuant to § 63-8-102(12), phar…

(a) (1) Any drug or device that is misbranded, out of date, old, deteriorated, not kept under proper refrigeration as required, or that has been exposed to fire, heat, smoke, water, flood or windstorm damage is deemed to be adulterated, and the possession, sale or distribution of…

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

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.

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

(a) Any person dispensing a legend drug for a patient shall include on the label of the container in which the legend drug is dispensed the indication or indications for which the drug is being prescribed if requested by the prescriber, patient, or patient's caregiver and the pre…

(a) Notwithstanding any other provision of law to the contrary, when a pharmacist becomes aware that a healthcare practitioner authorized to prescribe by the law of this state has died, a prescription issued by the practitioner may continue to be dispensed based on the pharmacist…

(a) For purposes of this section:(1) “Pharmacist” has the same meaning as defined in § 63-10-204; and(2) “Pharmacy” has the same meaning as defined in § 63-10-204. (1) “Pharmacist” has the same meaning as defined in § 63-10-204; and (2) “Pharmacy” has the same meaning as defined …

(a) As used in this section, and unless the context otherwise requires:(1) “Misbranding” means either the federal definition under 21 U.S.C. § 352 or drugs or devices that are misbranded under § 53-10-106; and(2) “Off-label” means the use of a United States food and drug administ…

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

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

(1) As used in this part, unless the context otherwise requires:(1) “Biological product” has the same meaning as defined in 42 U.S.C. § 262(i);(2) “Brand name” means the registered trademark name of a drug or drug product given by its manufacturer, labeler or distributor;(3) “Fin…

(a) The prescriber shall allow for substitution with a generic equivalent of a brand name drug or drug product under all circumstances, unless:(1) The prescriber determines the medical necessity of a brand name drug or drug product due to:(A) An adverse reaction previously experi…

(a) When a pharmacist receives a written, verbal, electronic or facsimile prescription order, and the prescriber has not noted medical necessity of the brand name prescribed, as required in § 53-10-204, the pharmacist shall dispense the least expensive generic equivalent in stock…

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

(a) The manufacturer, packager, or distributor of any human use legend drug sold, delivered or offered for sale in the state must have printed on the label of the immediate container of the drug the name and address of the manufacturer, packager, or distributor of the finished do…

(a) In making substitutions as allowed by this part, the pharmacist may use drugs and drug products manufactured within the territorial limits of any one (1) of the states of the United States, or of any other country, if the products have been approved by the federal food and dr…

(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 oth…

(a) As used in this section, unless the context otherwise requires:(1) “Anti-epileptic drug” means:(A) Any drug prescribed for the treatment of epilepsy; or(B) A drug used to treat or prevent seizures;(2) “Epilepsy” means a neurological condition characterized by recurrent seizur…

(a) A prescriber shall allow for substitution with an interchangeable biological product of a prescribed biological product under all circumstances unless:(1) The prescriber determines the medical necessity of a prescribed biological product due to:(A) An adverse reaction previou…

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

(1) As used in this part, unless the context requires otherwise:(1) “Board” means the board of pharmacy created by title 63, chapter 10, part 3;(2) “Commissioner” means the commissioner of health;(3) “Committee” means the controlled substance database committee created by § 53-10…

(a) There is created the controlled substance database committee. The committee members shall be:(1) One (1) of the governor-appointed licensed members of each of the following healthcare professional licensure boards or committees to be chosen by the licensing board or committee…

(a) There is created within the department a controlled substance database. The director of the controlled substance database shall be responsible for determining staffing in consultation with the executive director of the board of pharmacy. (b) The director shall administer, mai…

(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 ad…

(a) Information sent to, contained in, and reported from the database in any format is confidential and not subject to title 10, chapter 7, regarding public records, and not subject to subpoena from any court and shall be made available only as provided for in § 53-10-308 and to …

(a) The failure of a healthcare practitioner to submit information to the database required under this part after the committee or the commissioner has submitted a specific written request for the information, or when the committee or the commissioner determines the individual ha…

(a) Notwithstanding this part to the contrary, the committee or the commissioner:(1) May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to department personnel engaged in an investigation, adju…

In addition to the annual report submitted to the general assembly by the commissioner, authorized committee, board, or department personnel engaged in analysis of controlled substance prescription information as a part of the assigned duties and responsibilities of their employm…

(a) Each person or entity operating a practice site where a controlled substance is prescribed or dispensed to a human patient shall provide for electronic access to the database at all times when a healthcare practitioner provides healthcare services to a human patient potential…

(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)…