A drug or device shall be deemed to be misbranded:

(a) if its labeling is false or misleading in any particular.

(b) if in package form unless it bears a label containing:

(1) the name and place of business of the manufacturer of any prescription drug or device and the packer or distributor; and the name and place of business of the manufacturer, packer or distributor of any nonprescription drug or device. Manufacturer, as used herein, shall mean the person or firm which has mixed, tableted, encapsulated or otherwise prepared the drug in the form in which it is offered for sale to pharmacies.

(2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count; provided that under this clause reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the State Board of Health.

(c) if any word, statement, or other information required by or under authority of this article to appear on the label or 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.

(d) if it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane; or any chemical derivative of such substance, which derivative has been by the State Commissioner of Health, after investigation, found to be, and by regulations under this article designated as, habit forming, unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement "Warning-May Be Habit Forming."

(e) if it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears:

(1) the common or usual name of the drug, if such there be; and

(2) in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the kind, quantity and proportion of any alcohol, and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, antipyrine, atropine, hyoscine, hyoscyamine, arsenic digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein; provided, that to the extent that compliance with the requirements of this clause is impracticable, exemptions shall be established by regulations promulgated by the Board.

(f) unless its labeling bears:

(1) adequate directions for use, and

(2) 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 clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Board shall promulgate regulations exempting such drug or device from such requirements.

(g) 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 the consent of the Board. Whenever a drug is recognized in both the United States Pharmacopoeia, and the Homeopathic Pharmacopoeia of the United States, it shall be subject to 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 provisions of the Homeopathic Pharmacopoeia of the United States, and not to those of the United States Pharmacopoeia.

(h) if it has been found by the Commissioner 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 Board shall by regulations require as necessary for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the Commissioner shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirement.

(i) if it is a drug and its container is so made, formed, or filled as to be misleading; if it is an imitation of another drug; or if it is offered for sale under the name of another drug.

(j) 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.

(k) if it is a drug intended for use by man which:

(1) is a habit-forming drug to which paragraph (d) of this section applies; or

(2) because of its toxicity or other potentiality for harmful effect, or the method of use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a physician, dentist or veterinarian; or

(3) is limited by an effective application under Section 505 of the Federal Act to use under professional supervision by a physician, dentist or veterinarian, unless it is dispensed only:

(i) upon a written prescription of a physician, dentist or veterinarian, or

(ii) upon the oral prescription of a physician, dentist or veterinarian which is reduced promptly to writing and filed by the pharmacist, or

(iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is promptly reduced to writing and filed by the pharmacist; provided, that any drug dispensed by filling or refilling a written or oral prescription of a physician, dentist, or veterinarian shall be exempt from the requirements of this section, except paragraphs (a) and (i), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs, pursuant to diagnosis by mail.

(1) if the packaging, name or appearance of a prescription drug product is deceptively similar to or would cause unnecessary confusion with competitive, chemically-similar drug products which have a previously established or substantial position in the marketplace.

Laws 1963, c. 325, art. 14, § 1409; Laws 1976, c. 181, § 1, eff. Jan. 1, 1977.