§726.600. Definitions

The following definitions apply to this Subpart P:

 

"Evaluated hazardous waste pharmaceutical" means a prescription hazardous waste pharmaceutical that has been evaluated by a reverse distributor in accordance with Section 726.610(a)(3) and will not be sent to another reverse distributor for further evaluation or verification of manufacturer credit.

 

"Hazardous waste pharmaceutical" means a pharmaceutical that is a solid waste, as defined in 35 Ill. Adm. Code 721.102, and that exhibits one or more characteristics identified in Subpart C of 35 Ill. Adm. Code 721 or that is listed in Subpart D of 35 Ill. Adm. Code 721.  A pharmaceutical is not a solid waste, as defined in 35 Ill. Adm. Code 721.102, and therefore is not a hazardous waste pharmaceutical, if it is legitimately used or reused (e.g., lawfully donated for its intended purpose) or reclaimed.  An over-the-counter pharmaceutical, dietary supplement, or homeopathic drug is not a solid waste, as defined in 35 Ill. Adm. Code 721.102, and therefore is not a hazardous waste pharmaceutical, if there is a reasonable expectation of its being legitimately used or reused (e.g., lawfully redistributed for its intended purpose) or reclaimed.

 

"Healthcare facility" means any person that is lawfully authorized to do the following:

 

Provide preventative, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care and counseling, service, assessment, or procedure with respect to the physical or mental condition or functional status of a human or animal or affecting the structure or function of the human or animal body; or

 

Distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals.  This definition includes wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals.  This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers.

 

"Household waste pharmaceutical" means a pharmaceutical that is a solid waste, as defined in 35 Ill. Adm. Code 721.102, but that is excluded from being a hazardous waste under 35 Ill. Adm. Code 721.104(b)(1).

 

"Long-term care facility" means a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals, to one or more individuals at the facility.  This definition includes hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities.  Not included within the scope of this definition are group homes, independent living communities, assisted living facilities, and the independent and assisted living portions of continuing care retirement communities.

 

"Non-creditable hazardous waste pharmaceutical" means a prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit or a nonprescription hazardous waste pharmaceutical that does not have a reasonable expectation to be legitimately used or reused or reclaimed.  This includes investigational drugs, free samples of pharmaceuticals received by healthcare facilities, residues of pharmaceuticals remaining in empty containers, contaminated personal protective equipment, floor sweepings, and cleanup material from the spills of pharmaceuticals.

 

"Non-hazardous waste pharmaceutical" means a pharmaceutical that is a solid waste, as defined in 35 Ill. Adm. Code 721.102, and that is not listed in Subpart D of 35 Ill. Adm. Code 721, and that does not exhibit a characteristic identified in Subpart C of 35 Ill. Adm. Code 721.

 

"Non-pharmaceutical hazardous waste" means a solid waste, as defined in 35 Ill. Adm. Code 721, and that is listed in Subpart D of 35 Ill. Adm. Code 721, exhibits one or more characteristics identified in Subpart C of 35 Ill. Adm. Code 721, but that is not a pharmaceutical, as defined in this Section.

 

"Pharmaceutical" means any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system (e.g., electronic cigarette or vaping pen); or any liquid nicotine (e-liquid) packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials).  This definition includes dietary supplements, as defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 USC 321(ff)), incorporated by reference in 35 Ill. Adm. Code 720.111; prescription drugs, as defined in 21 CFR 203.3(y), incorporated by reference in 35 Ill. Adm. Code 720.111; over-the-counter drugs; homeopathic drugs; compounded drugs; investigational new drugs; pharmaceuticals remaining in nonempty containers; personal protective equipment contaminated with pharmaceuticals; and clean-up material from spills of pharmaceuticals.  This definition does not include dental amalgam or sharps.

 

"Potentially creditable hazardous waste pharmaceutical" means a prescription hazardous waste pharmaceutical that has a reasonable expectation to receive manufacturer credit and of which the following is true:

 

It is in original manufacturer packaging (except pharmaceuticals that were subject to a recall);

 

It is undispensed; and

 

It is unexpired or less than one year past its expiration date.  The term does not include evaluated hazardous waste pharmaceuticals or nonprescription pharmaceuticals, including over-the-counter drugs, homeopathic drugs, and dietary supplements.

 

"Reverse distributor" means any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit.  Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.

 

(Source:  Added at 44 Ill. Reg. 15427, effective September 3, 2020)