N.Y. Public Health Law § 290: Definitions

§ 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.