N.Y. Public Health Law 290 – Definitions
§ 290. Definitions. As used in this article, unless the context clearly requires otherwise:
Terms Used In N.Y. Public Health Law 290
- Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
- Covered drug: means any substance recognized as a drug under 21 USC § 321(g)(1), as amended, and any regulations promulgated thereunder that is sold, offered for sale or dispensed in the state, whether directly or through a wholesaler, in any form including prescription and nonprescription drugs, drugs in medical devices and combination products, brand and generic drugs and drugs for veterinary use; provided however, covered drug shall not include: (a) vitamins or supplements; (b) herbal-based remedies and homeopathic drugs, products or remedies; (c) cosmetics, soap (with or without germicidal agents), laundry detergent, bleach, household cleaning products, shampoos, sunscreens, toothpaste, lip balm, antiperspirants or other personal care products that are regulated as both cosmetics and nonprescription drugs under the Federal Food, Drug, and Cosmetic Act; (d) pet pesticide products contained in pet collars, powders, shampoos, topical applications, or other forms; (e) drugs that are biological products as defined in subdivision twenty-seven of § 6802 of the education law if the manufacturer already provides a take back program; (f) drugs for which a manufacturer provides a take back program as part of a Federal Food and Drug Administration managed risk evaluation and mitigation strategy; (g) emptied injector products or emptied medical devices and their component parts or accessories; and (h) drugs that are used solely in a clinical setting. See N.Y. Public Health Law 290
- Manufacturer: means a person, company, corporation or other entity engaged in the manufacture of covered drugs sold in the state. See N.Y. Public Health Law 290
- Pharmacies: means all pharmacies registered under § 6808 of the education law that are part of a group of ten or more establishments that conduct business under the same name, or operate under a common ownership or management, or pursuant to a franchise agreement with the same franchisor, and all nonresident pharmacies registered pursuant to § 6808-b of the education law that provide covered drugs to state residents by mail. See N.Y. Public Health Law 290
- Repackager: means an entity that owns or operates an establishment that repacks and relabels a product or package containing a covered drug for further sale or for distribution without further transaction. See N.Y. Public Health Law 290
- Wholesaler: means any person, company, corporation or other entity that sells or distributes drugs and covered drugs for resale to an entity in the state other than a consumer. See N.Y. Public Health Law 290
1. "Authorized collector" means: (a) a person, company, corporation or other entity that is registered with the United States Drug Enforcement Administration to collect controlled substances for the purposes of safe disposal and destruction; (b) a law enforcement agency; or (c) a person, company, corporation or other entity authorized by the department to provide alternative collection methods for covered drugs that are not controlled substances.
2. "Covered drug" means any substance recognized as a drug under 21 USC § 321(g)(1), as amended, and any regulations promulgated thereunder that is sold, offered for sale or dispensed in the state, whether directly or through a wholesaler, in any form including prescription and nonprescription drugs, drugs in medical devices and combination products, brand and generic drugs and drugs for veterinary use; provided however, covered drug shall not include: (a) vitamins or supplements; (b) herbal-based remedies and homeopathic drugs, products or remedies; (c) cosmetics, soap (with or without germicidal agents), laundry detergent, bleach, household cleaning products, shampoos, sunscreens, toothpaste, lip balm, antiperspirants or other personal care products that are regulated as both cosmetics and nonprescription drugs under the Federal Food, Drug, and Cosmetic Act; (d) pet pesticide products contained in pet collars, powders, shampoos, topical applications, or other forms; (e) drugs that are biological products as defined in subdivision twenty-seven of § 6802 of the education law if the manufacturer already provides a take back program; (f) drugs for which a manufacturer provides a take back program as part of a Federal Food and Drug Administration managed risk evaluation and mitigation strategy; (g) emptied injector products or emptied medical devices and their component parts or accessories; and (h) drugs that are used solely in a clinical setting.
3. "Manufacturer" means a person, company, corporation or other entity engaged in the manufacture of covered drugs sold in the state. Manufacturer does not include a repackager or wholesaler.
4. "Pharmacies" means all pharmacies registered under § 6808 of the education law that are part of a group of ten or more establishments that conduct business under the same name, or operate under a common ownership or management, or pursuant to a franchise agreement with the same franchisor, and all nonresident pharmacies registered pursuant to § 6808-b of the education law that provide covered drugs to state residents by mail.
5. "Drug take back organization" means an organization designated by a manufacturer or a group of manufacturers to act as an agent on behalf of the manufacturer or group of manufacturers to operate and implement a drug take back program as authorized by this article.
6. "Wholesaler" means any person, company, corporation or other entity that sells or distributes drugs and covered drugs for resale to an entity in the state other than a consumer.
7. "Repackager" means an entity that owns or operates an establishment that repacks and relabels a product or package containing a covered drug for further sale or for distribution without further transaction.