A drug or device is misbranded

(1) if its labeling is false or misleading in any particular;
lawyer at desk

Ask a legal question, get an answer ASAP!
Click here to chat with a lawyer about your rights.

(2) if it is 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; however, under (B) of this paragraph reasonable variations shall be permitted and exemptions for small packages shall be established by regulations adopted by the department;
(3) if a word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed with conspicuousness as compared with other words, statements, designs, or devices, in the labeling and in terms which render it likely to be read and understood by the ordinary individual under customary conditions of the purchase and use;
(4) if it is for use by man and contains a quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, or sulphonmethane, or a chemical derivative of any of them, which has been by the commissioner after investigation found to be and by regulations 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 with it 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; 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 alcohol, and including, whether active or not, the name and quantity or proportion of bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis glucosines, mercury, quabain, strophanthin, strychnine, thyroid, or derivative or preparation of any of these substances contained in them; however, to the extent that compliance with the requirements of (B) of this paragraph is impracticable, exemptions shall be established by regulations adopted by the department;
(6) unless its labeling bears (A) adequate directions for use; and (B) 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 the manner and form necessary for the protection of users; however, where a requirement of (A) of this paragraph as applied to a drug or device is not necessary for the protection of the public health, the department shall adopt regulations exempting the drug or device from these 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 in the compendium; however, the method of packing may be modified with the consent of the commissioner, and when a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it is 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 provisions of 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 deterioration, unless it is packaged in the form and manner and its label bears a statement of the precautions the department by regulation requires as necessary for the protection of public health; and no regulation shall be established for a 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 packaging or labeling requirements and that body has failed within a reasonable time to prescribe the requirements;
(9) if it is a drug and its container is made, formed, or filled so as to be misleading or if it is an imitation of another drug; or 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 its labeling;
(11) if (A) it is a drug sold at retail and contains any quantity of aminopyrine, barbituric acid, cinchophen, pituitary, thyroid, or their derivatives, or (B) it is a drug or device sold at retail and its label as originally packed bears a statement that it is to be dispensed or sold only by or on the prescription of a physician, dentist, or veterinarian, unless it is sold on a written prescription signed by a member of the medical, dental, or veterinary profession licensed by law to administer the drug or device, and its label as dispensed 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, and the prescription shall not be refilled except on the written authorization of the prescribing physician, dentist, or veterinarian.
  Previous section
Next section  
 Article 3 Contents