The following definitions apply to this subchapter:
(1) Evaluated hazardous waste pharmaceutical--A prescription
hazardous waste pharmaceutical that has been evaluated by a reverse
distributor in accordance with §335.771(a)(3) of this title (relating
to Standards for the Management of Potentially Creditable Hazardous
Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals
by Reverse Distributors) and will not be sent to another reverse distributor
for further evaluation or verification of manufacture credit.
(2) Hazardous waste pharmaceutical--A pharmaceutical
that is a solid waste, as defined in §335.1 of this title (relating
to Definitions), and exhibits one or more characteristics identified
in 40 Code of Federal Regulations (CFR) Part 261, Subpart C, or is
listed in 40 CFR Part 261, Subpart D as these subparts are adopted
by reference under §335.504 of this title (relating to Hazardous
Waste Determination). A pharmaceutical is not a solid waste, as defined
in §335.1 of this title, and therefore not a hazardous waste
pharmaceutical, if it is legitimately used/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 §335.1 of this title, and therefore not
a hazardous waste pharmaceutical, if it has a reasonable expectation
of being legitimately used/reused (e.g., lawfully redistributed for
its intended purpose) or reclaimed.
(3) Healthcare facility--Any person that is lawfully
authorized to:
(A) provide preventative, diagnostic, therapeutic,
rehabilitative, maintenance or palliative care, and counseling, service,
assessment or procedure for the physical or mental condition, or functional
status, of a human or animal or that affects the structure or function
of the human or animal body; or
(B) distribute, sell, or dispense pharmaceuticals,
including over-the-counter pharmaceuticals, dietary supplements, homeopathic
drugs, or prescription pharmaceuticals. This definition includes,
but is not limited to, 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.
(4) Household waste pharmaceutical--A pharmaceutical
that is a solid waste, as defined in §335.1 of this title (relating
to Definitions), but is excluded from being a hazardous waste under
40 Code of Federal Regulations §261.4(b)(1) as adopted under §335.504
of this title (relating to Hazardous Waste Determination).
(5) Long-term care facility--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, but is not limited to, 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.
(6) Non-creditable hazardous waste pharmaceutical--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/reused or reclaimed. This includes but is
not limited to, investigational drugs, free samples of pharmaceuticals
received by healthcare facilities, residues of pharmaceuticals remaining
in empty containers, contaminated personal protective equipment, floor
sweepings, and clean-up material from the spills of pharmaceuticals.
(7) Nonhazardous waste pharmaceutical--A pharmaceutical
that is a solid waste, as defined in §335.1 of this title (relating
to Definitions), and is not listed in 40 Code of Federal Regulations
(CFR) Part 261, Subpart D, and does not exhibit a characteristic identified
in 40 CFR Part 261, Subpart C.
(8) Non-pharmaceutical hazardous waste--A solid waste,
as defined in §335.1 of this title (relating to Definitions),
that is listed in 40 Code of Federal Regulations (CFR) Part 261, Subpart
D or exhibits one or more characteristics identified in 40 CFR Part
261, Subpart C, but is not a pharmaceutical, as defined in this section.
(9) Pharmaceutical--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, but is not limited to, dietary supplements, as defined by
the Federal Food, Drug and Cosmetic Act; prescription drugs, as defined
by 21 Code of Federal Regulations §203.3(y); over-the-counter
drugs; homeopathic drugs; compounded drugs; investigational new drugs;
pharmaceuticals remaining in non-empty containers; personal protective
equipment contaminated with pharmaceuticals; and clean-up material
from spills of pharmaceuticals. This definition does not include dental
amalgam or sharps.
(10) Potentially creditable hazardous waste pharmaceutical--A
prescription hazardous waste pharmaceutical that has a reasonable
expectation to receive manufacturer credit and:
(A) is in original manufacturer packaging (except pharmaceuticals
that were subject to a recall);
(B) is undispensed;
(C) is unexpired or less than one year past expiration
date; and
(D) is not an evaluated hazardous waste pharmaceutical.
(11) Reverse distributor--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.
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