6802 - Definitions. - New York Statutes

§ 6802. Definitions. 1. "Pharmacy" means any place in which drugs, prescriptions or poisons are possessed for the purpose of compounding, preserving, dispensing or retailing, or in which drugs, prescriptions or poisons are compounded, preserved, dispensed or retailed, or in which such drugs, prescriptions or poisons are by advertising or otherwise offered for sale at retail. 3. "Formulary" means the latest edition of the official national formulary, and its supplement. 4. "Pharmacopeia", when not otherwise limited, means the latest edition of the official United States pharmacopeia, and its supplement. 5. "Homeopathic pharmacopeia" means the official homeopathic pharmacopeia of the United States, and its supplement. 6. "Official compendium" means the official United States pharmacopeia, official homeopathic pharmacopeia of the United States, official national formulary, or their supplements. 7. "Drugs" means: a. Articles recognized in the official United States pharmacopeia, official homeopathic pharmacopeia of the United States, or official national formulary. b. Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals. c. Articles (other than food) intended to affect the structure or any function of the body of man or animals. d. Articles intended for use as a component of any article specified in paragraphs a, b, or c; but does not include devices or their components, parts or accessories. 8. "Cosmetics" means: a. Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. b. Articles intended for use as a component of any such articles; except that the term shall not include soap. 9. "Poison", where not otherwise limited, means any drug, chemical or preparation likely to be destructive to adult human life in quantity of sixty grains or less. 10. "Label" means a display of written, printed or pictorial matter upon the immediate container of any drug, device or cosmetic. Any requirement made by or under authority of this article, that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement or other information also appears on the outside container or wrapper, if there be any, of the retail package of such drug, device or cosmetic or is easily legible through the outside container or wrapper. 11. "Immediate container" does not include package liners. 12. "Labeling" means all labels and other written, printed or pictorial matter: a. Upon any drug, device or cosmetic or any of its containers or wrappers, or b. Accompanying such drug, device or cosmetic. 13. "Misbranding". If a drug, device or cosmetic 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 any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the drug, device, orcosmetic to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual. No drug, device or cosmetic which is subject to, and complies with regulations promulgated under the provisions of the federal food, drug, and cosmetic act, relating to adulteration and misbranding shall be deemed to be adulterated or misbranded in violation of the provisions of this article because of its failure to comply with the board's regulations, or the rules of the state board of pharmacy, insofar as the regulations are in conflict with regulations relating to adulteration and misbranding under the federal food, drug and cosmetic act. 14. "Antiseptic". The representation of a drug, device or cosmetic in its labeling, 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 such other use as involves prolonged contact with the body. 15. "New drug" means: a. Any drug not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended or suggested by the drug's labeling, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to September first, nineteen hundred thirty-nine it was subject to the former federal food and drug act of June thirtieth, nineteen hundred six, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; b. Any drug, the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become recognized, but which has not otherwise than in such investigations been used to a material extent or for a material time under such conditions. 16. "Device" means instruments, apparatus, and contrivances, including their components, parts and accessories, intended: a. For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or b. To affect the structure or any function of the body of man or animals. 17. The term "Federal Food, Drug and Cosmetic Act" means the Federal Food, Drug, and Cosmetic Act of the United States of America, approved June twenty-fifth, nineteen hundred thirty-eight, officially cited as public document number seven hundred seventeen-seventy-fifth congress (chapter six hundred seventy-five--third session), and all its amendments now or hereafter enacted. 18. "Wholesaler" means a person who bottles, packs or purchases drugs, devices or cosmetics for the purpose of selling or reselling to pharmacies or to other channels as provided in this article. 19. "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 drugs, devices or cosmetics. 20. "Controlled substance" means any drug defined as a controlled substance by article thirty-three of the public health law. 21. "Manufacturer" means a person who compounds, mixes, prepares, produces, and bottles or packs drugs, cosmetics or devices for the purpose of distributing or selling to pharmacies or to other channels of distribution.* 22. "Administer", for the purpose of section sixty-eight hundred one of this article, means the direct application of an immunizing agent to adults, whether by injection, ingestion or any other means, pursuant to a patient specific order or non-patient specific regimen prescribed or ordered issued by a physician or certified nurse practitioner who has a practice site in the county in which the immunization is administered. However if the county where the immunization is to be administered has a population of seventy-five thousand or less, then the licensed physician or certified nurse practitioner may be in an adjoining county. Such administration shall be limited to immunizing agents to prevent influenza or pneumococcal disease and medications required for emergency treatment of anaphylaxis. * NB Repealed March 31, 2012