2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 1 - TENNESSEE FOOD, DRUG AND COSMETIC ACT (§§ 53-1-101 — 53-1-304) › Part 1 - GENERAL PROVISIONS (§§ 53-1-101 — 53-1-118) › Section 53-1-109 - Drugs or devices deemed misbranded - Exemptions

(a)
A drug or device shall be deemed to be misbranded:
(1)
If its labeling is false or misleading in any particular;
(2)
If in package form, unless it bears a label containing:
(A)
The name and place of business of the manufacturer, packer or distributor; and
(B)
An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that, under this subdivision (a)(2)(B), reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the commissioner;
(3)
If any word, statement or other information required by or under the authority of this chapter to appear on the label or labeling is not prominently placed on the label or labeling with such conspicuousness, as compared with other words, statements, designs or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(4)
If it is for use by humans and contains any quantity of the narcotic or hypnotic substance alpha eucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, or sulphonmethane, or any chemical derivative of those substances, which derivative has been found by the commissioner after investigation to be, and by regulations promulgated under this subdivision (a)(4) designated as habit forming; unless its label bears the name and quantity of proportion of the substance or derivative and in juxtaposition the statement "Warning - May be habit forming";
(5)
If it is a drug and is not designated solely by a name recognized in an official compendium, unless its label bears:
(A)
The common or usual name of the drug, if there is a common or usual name; and
(B)
In case it is fabricated from two (2) or more ingredients, the common or usual name of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, aminopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any of those substances contained in the drug; provided, that to the extent that compliance with the requirements of this subdivision (a)(5)(B) is impracticable, exemptions shall be established by regulations promulgated by the commissioner;
(6)
Unless its labeling bears:
(A)
Adequate directions for use; provided, that where any requirement of this subdivision (a)(6)(A), as applied to any drug or device, is not necessary for the protection of the public health, the commissioner shall promulgate regulations exempting the drug or device from the requirements; and
(B)
Adequate warning against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in a manner and form that are necessary for the protection of users;
(7)
If it purports to be a drug the name of which is recognized in an official compendium, unless it is packed and labeled as prescribed in the compendium; provided, that the method of packing may be modified with the consent of the commissioner. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling, unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia;
(8)
If it has been found by the commissioner to be a drug liable to deteriorate, unless it is packaged in a form and manner, and its label bears a statement of precautions that the commissioner requires by regulations as necessary for the protection of public health. Regulations shall not be established for any drug recognized in an official compendium until the commissioner has informed the appropriate body charged with the revision of the compendium of the need for the packaging or labeling requirements, and the body has failed within a reasonable time to prescribe the requirements;
(9)
If it is a drug and:
(A)
Its container is so made, formed or filled as to be misleading;
(B)
It is an imitation of another drug; or
(C)
It is offered for sale under the name of another drug;
(10)
If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended or suggested in the labeling of the drug; or
(11)
If it is a drug sold at retail for use by humans, and contains any quantity of aminopyrine, barbituric acid, cinchophon, dinitrophenol or sulfanilamide, or their derivatives, when used in the dosage, or with the frequency or duration prescribed, recommended or suggested in the labeling of the drug, unless it is sold on a written prescription authorized by a member of the medical, dental or veterinary profession who is licensed by law to administer the drugs, and its label bears the name and place of business of the seller, the serial number and date of the prescription, and the name of the member of the medical, dental or veterinary profession.
(b)
(1)
A drug sold on a written prescription signed or authorized by a member of the medical, dental or veterinary profession, except a drug sold in the course of the conduct of a business of selling drugs pursuant to diagnosis by mail, shall be exempt from the requirements of this section if:
(A)
The member of the medical, dental or veterinary profession is licensed by law to administer the drug; and
(B)
The drug bears a label containing the name and place of business of the seller, the serial number and date of the prescription, and the name of the member of the medical, dental or veterinary profession.
(2)
A drug or device that is, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at an establishment other than the establishment where it was originally processed or packed, is exempt from the affirmative labeling and packaging requirements of this section, while it is in transit in intrastate commerce from the one establishment to the other, if the transit is made in good faith for those completion purposes only; but it is otherwise subject to all applicable provisions of this chapter.
Acts 1941, ch. 120, § 16; C. Supp. 1950, § 6580.16; T.C.A. (orig. ed.), § 52-116.