20-56-202. Definitions.

20-56-202. Definitions. As used in this subchapter, unless the context otherwise requires: (1) “Abandoned drug” means a drug which: (A) Is in the possession or control of a person who is without authority under law to possess, purchase, or sell; (B) In its present circumstances presents a danger to the public health or safety; (C) Is not properly controlled by the person who by law has authority to possess, purchase, or sell the drug; (D) Is the subject of a recall order by the United States Food and Drug Administration but has not been returned within a reasonable time after the publication of that order; (E) Is adulterated, misbranded, or a new drug as defined in this subchapter or a drug intended solely for investigational use and approved by the United States Food and Drug Administration as such for which there is no approval in effect; or (F) Is otherwise rendered unsafe for use as a result of fire, flood, or other natural disaster; (2) “Advertisement” means all representations disseminated in any manner, or by any means other than by labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics; (3) The representation of a drug, in its labeling or advertisement, as an antiseptic shall be considered to be a representation that it is a germicide except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or other use which involves prolonged contact with the body; (4) “Board” means the State Board of Health; (5) “Contaminated with filth” applies to any food, drug, device, or cosmetic not securely protected from dust, dirt, and, as far as may be necessary and by all reasonable means, from all foreign or injurious contaminations; (6) “Cosmetic” means: (A) Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; and (B) Articles intended for use as a component of any such articles, except that the term shall not include soap; (7) “Counterfeit substance” means a drug which, or the container or labeling of which, without authorization bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who, in fact, manufactured, processed, packed, or distributed the drug and which thereby falsely purports or is represented to be the product of or to have been packed or distributed by another drug manufacturer, processor, packer, or distributor; (8) “Device”, except when used in subdivision (16)(B) of this section, and in § 20-56-209(6), § 20-56-211(3), § 20-56-213(3), and § 20-56-215, means instruments, apparatus, and contrivances, including their components, parts, and accessories which are intended: (A) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; or (B) To affect the structure or any function of the bodies of humans or other animals; (9) “Drug” means: (A) Articles recognized in the official United States Pharmacopoeia , the official Homeopathic Pharmacopoeia of the United States , the official National Formulary , or in any supplement to any of them; (B) Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; (C) Articles other than food intended to affect the structure or any function of the bodies of humans or other animals; and (D) Articles intended for use as a component of any article specified in subdivisions (9)(A)-(C) of this section, but does not include devices or their components, parts, or accessories; (10) “Federal act” means the Federal Food, Drug, and Cosmetic Act; (11) “Food” means: (A) Articles used for food or drink for humans or other animals; (B) Chewing gum; and (C) Articles used for components of any such article; (12) “Human growth hormone” means somatrem, somatropin, or an analogue of either of them; (13) “Human growth hormone” includes both cadaver source and biosynthetic human growth hormones; (14) “Immediate container” does not include package liners; (15) “Label” means a display of written, printed, or graphic matter upon the immediate container of any article. A requirement made by or under authority of this subchapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless the word, statement, or other information also appears on the outside container or wrapper, if there is any, of the retail package of the article, or is easily legible through the outside container or wrapper; (16)(A) “Labeling” means all labels and other written, printed, or graphic matter upon an article or any of its containers or wrappers, or accompanying the article. (B) If any article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, then, in determining whether the labeling or advertisement is misleading, there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device, sound, or in any combination thereof, but also the extent to which the labeling or advertisement fails to reveal facts material in the light of the representations or material with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual; (17) “New drug” means: (A) Any drug the composition of which is such that the drug is not generally recognized among experts who are qualified by scientific training and experience to evaluate the safety of drugs as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof; or (B) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions; (18) “Official compendium” means the official United States Pharmacopoeia , the official Homeopathic Pharmacopoeia of the United States , the official National Formulary , or any supplement to any of them; and (19) “Person” includes an individual, partnership, corporation, or association.