1. (a) Authorized collector means:

   1. (1) a person, company, corporation or other entity that is registered with the DEA to collect controlled substances for the purposes of safe disposal and destruction; or
   2. (2) a law enforcement agency; or
   3. (3) 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. (b) Covered drug shall have the same meaning as defined in section 290 of the Public Health Law; provided, however, that covered drug shall not include the following:

   1. (1) vitamins or supplements;
   2. (2) herbal-based remedies and homeopathic drugs, products or remedies;
   3. (3) 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 drugs by the FDA;
   4. (4) pet pesticide products contained in pet collars, powders, shampoos, topical applications, or other forms;
   5. (5) drugs that are biological products as defined in subdivision 27 of section 6802 of the Education Law if the manufacturer already provides a take back program;
   6. (6) veterinary biological products regulated by the United States Department of Agriculture;
   7. (7) drugs for which a manufacturer provides a take back program as part of a FDA managed risk evaluation and mitigation strategy;
   8. (8) emptied injector products, emptied medical devices, including dialysis bags and solutions, and their component parts or accessories;
   9. (9) medical marihuana as defined in section 3360 of the Public Health Law; and
   10. (10) drugs that are used solely in a clinical setting.
3. (c) DEA means the Drug Enforcement Administration of the United States Department of Justice, or its successor agency.
4. (d) 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.
5. (e) FDA means the Food and Drug Administration of the United States Department of Health and Human Services, or its successor agency.
6. (f) Manufacturer means a person, company, corporation or other entity engaged in the manufacture of covered drugs, or, a person, company, corporation, or other entity using a contract manufacturing organization for the manufacture of covered drugs, sold in the state. Manufacturer includes a virtual manufacturer but does not include a repackager or wholesaler.
7. (g) Operator means any manufacturer, individually or jointly, or a drug take back organization, that implements or operates an authorized drug take back program.

8. (h) Pharmacies means all pharmacies registered under section 6808 of the Education Law that are:

   1. (1) part of a group of 10 or more pharmacies under common ownership or management; or
   2. (2) part of a group of 10 or more pharmacies linked to the same company via franchise agreements; or
   3. (3) non-resident pharmacies registered pursuant to section 6808-b of the Education Law that provide covered drugs to state residents by mail; or
9. (i) Population means the total population of a given city, or a given county in the City of New York, according to the most recent decennial United States Census.
10. (j) 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.
11. (k) Reverse distributor means a person, company, corporation or other entity that is licensed by the New York State Department of Education and Department of Health as a distributor, and registered with the DEA to acquire controlled substances from another DEA registrant or law enforcement agency for the purpose of destruction.
12. (l) 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.

For purposes of this Subpart, the following terms shall have the following meanings: