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This entry was published on 2019-01-18
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Public Health (PBH) CHAPTER 45, ARTICLE 2-B
§ 290. Definitions. As used in this article, unless the context
clearly requires otherwise:

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 section sixty-eight hundred two 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 section
sixty-eight hundred eight 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 section sixty-eight hundred eight-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.