35 Ill. Adm. Code 726.600
Definitions
Section
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. Â 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.Â
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.
"N
on-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.