Illinois Administrative Code › Title 35 - ENVIRONMENTAL PROTECTION › Part 726 - STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS WASTE AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT FACILITIES › Subpart P - HAZARDOUS WASTE PHARMACEUTICALS › Section 726.600 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
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.