For purposes of this chapter, the following terms have the following meanings: (a) âAuthorized collection siteâ means a location where an authorized collector operates a secure collection receptacle for collecting covered products. (b) âAuthorized collectorâ means a person or entity that has entered into an agreement with a program operator to collect covered drugs, including, but not limited to, any of the following: (1) A person or entity that is registered with the United States Drug Enforcement Administration and that qualifies under federal law to modify that registration to collect controlled substances for the purpose of destruction. (2) A law enforcement agency. (3) A retail pharmacy that offers drug take-back services in compliance with Article 9.1 (commencing with Section 1776) of Title 16 of the California Code of Regulations. (c) âControlled substanceâ means a substance listed under Sections 11053 to 11058, inclusive, of the Health and Safety Code or Section 812 or 813 of Title 21 of the United States Code, or any successor section. (d) âCosmeticâ means an article, or a component of an article, intended to be rubbed, poured, sprinkled, sprayed, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. âCosmeticâ includes articles with or without expiration dates. (e) (1) âCovered drugâ means a drug, including a brand name or generic drug, sold, offered for sale, or dispensed in the State of California in any form, including, but not limited to, any of the following: (A) Prescription and nonprescription drugs approved by the United States Food and Drug Administration pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355) or Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262). (B) A drug marketed pursuant to an over-the-counter drug monograph. (C) A drug in a medical device, or a combination product containing a drug and a medical device. (2) âCovered drugâ does not include any of the following: (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 any other personal care product that is regulated as both a cosmetic and a nonprescription drug under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.). (D) A drug for which a pharmaceutical product stewardship program or drug takeback program is provided in the state as part of a United States Food and Drug Administration managed risk evaluation and mitigation strategy under 21 U.S.C. Sec. 355-1. (E) Biological drug products, as defined by 42 U.S.C. Sec. 262(i)(1), including those products currently approved in the state under a new drug application that will be deemed to be licensed under Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262) pursuant to Section 7002(e) of the federal Biologics Price Competition and Innovation Act of 2009 (Public Law 111-148). (F) A medical device, or a component part or accessory of a medical device, if it does not contain a covered drug. (G) Drugs that are used for animal medicines, including, but not limited to, parasiticide products for animals. (H) Dialysate drugs or other saline solutions required to perform kidney dialysis. (f) (1) (A) âCovered entityâ means the manufacturer of covered products that are sold in or into the state. (B) If no entity that meets the definition in subparagraph (A) is in the state, âcovered entityâ means the distributor of covered products that are sold in or into the state that is licensed as a wholesaler, as defined in Section 4043 of the Business and Professions Code, but does not include a warehouse of a retail pharmacy chain that is licensed as a wholesaler if it engages only in in
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