A drug or device is 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 (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established by rules adopted by the Department.
(3)If any word, statement, or other information required by or under authority of this chapter to appear on the labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms
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A drug or device is 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 (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established by rules adopted by the Department.
(3) If any word, statement, or other information required by or under authority of this chapter to appear on the labeling is not prominently placed thereon 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, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, morphine, opium, paraldehyde, peyote, sulphonmethane, or other recognized narcotic or hypnotic substances or any chemical derivative of those substances, which derivative has been by the Department, after investigation, found to be, and by rules under this chapter, designated as habit forming, unless its label bears the name and quantity or proportion of the substance or derivative and in juxtaposition therewith 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 such there be; and
(B) in case it is fabricated from two 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, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or other synthetic compounds, or any derivative or preparation of any of those substances, contained therein, provided that to the extent that compliance with the requirements of this subdivision (B) is impracticable, exemptions shall be established by rules adopted by the Department.
(6) Unless its labeling bears:
(A) adequate directions for use; and
(B) such adequate warnings 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 such manner and form, as are necessary for the protection of users, provided that where any requirement of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the Department shall adopt rules exempting the drug or device from the requirements.
(7) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein, provided that the method of packing may be modified with consent of the Commissioner. Whenever a drug is recognized in both the U.S. Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the U.S. 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 provisions of the Homeopathic Pharmacopoeia of the United States, and not to those of the U.S. Pharmacopoeia.
(8) If it has been found by the Department to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the Department shall by rule require as necessary for the protection of public health. No such rule shall be established for any drug recognized in an official compendium until the Board informs the appropriate body charged with the revision of the compendium of the need for the packaging or labeling requirements and that body fails within a reasonable time to prescribe the requirements.
(9)(A) If it is a drug and its container is so made, formed, or filled as to be misleading;
(B) if it is an imitation of another drug; or
(C) if 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 thereof.
(11) If it is a drug sold at retail and contains any quantity of aminopyrine, barbituric acid, cinchophen, pituitary, thyroid, or their derivatives; or it is a drug or device sold at retail and its label, as originally packed, directs that it is to be dispensed or sold only on prescription, unless it is dispensed or sold on a written prescription signed by a practitioner who is licensed by law to administer the drug or device and its label, as dispensed, bears the name and place of business of the dispenser or seller, the serial number and date of the prescription, and the name of the licensed practitioner. Those prescriptions shall not be refilled except on the specific authorization of the prescribing practitioner, provided that where any requirement of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the Department shall adopt rules exempting the drug or device from the requirement.
(12) A drug sold on a written prescription signed 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 requirement of this section if:
(A) the member of the medical, dental, or veterinary profession is licensed by law to administer the drug or recognized synthetic compounds; 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. (Added 1959, No. 172, § 15, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 112; 2023, No. 6, § 143, eff. July 1, 2023; 2023, No. 53, § 93, eff. June 8, 2023.)