Ohio Admin. Code 3745-266-500 - Definitions - hazardous waste pharmaceuticals
(A)
"Evaluated
hazardous waste pharmaceutical" means a prescription hazardous waste
pharmaceutical that has been evaluated by a reverse distributor in accordance
with paragraph (A)(3) of rule 3745-266-510 of the Administrative Code and will
not be sent to another reverse distributor for further evaluation or
verification of manufacture credit.
(B)
"Hazardous waste
pharmaceutical" means a pharmaceutical that is a waste, as defined in rule
3745-51-02 of
the Administrative Code, and exhibits one or more characteristics identified in
rules
3745-51-20
to
3745-51-24
of the Administrative Code or is listed in rules
3745-51-30
to
3745-51-35
of the Administrative Code. A pharmaceutical is not a waste, as defined in rule
3745-51-02 of
the Administrative Code, and therefore not a hazardous waste pharmaceutical, if
the pharmaceutical is legitimately used or reused (e.g., lawfully donated for
the waste's intended purpose) or reclaimed. An over-the-counter pharmaceutical,
dietary supplement, or homeopathic drug is not a waste, as defined in rule
3745-51-02 of
the Administrative Code, and therefore not a hazardous waste pharmaceutical, if
such item has a reasonable expectation of being legitimately used or reused
(e.g., lawfully redistributed for the item's intended purpose) or
reclaimed.
(C)
"Healthcare facility" means any person that is lawfully
authorized to do either of the following:
(1)
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 that affects the structure or function of the human or animal
body.
(2)
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.
(D)
"Household waste pharmaceutical" means a pharmaceutical
that is a waste, as defined in rule
3745-51-02 of
the Administrative Code, but is excluded from being a hazardous waste under
paragraph (B)(1) of rule
3745-51-04 of the
Administrative Code.
(E)
"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, 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.
(F)
"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 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 cleanup material from the spills of
pharmaceuticals.
(G)
"Non-hazardous waste pharmaceutical" means a
pharmaceutical that is a "waste," as defined in rule
3745-51-02 of
the Administrative Code, and is not listed in rules
3745-51-30
to
3745-51-35
of the Administrative Code, and does not exhibit a characteristic identified in
rules
3745-51-20
to
3745-51-24
of the Administrative Code.
(H)
"Non-pharmaceutical hazardous waste" means a waste, as
defined in rule
3745-51-02 of
the Administrative Code, that is listed in rules
3745-51-30
to
3745-51-35
of the Administrative Code, or exhibits one or more characteristics identified
in rules
3745-51-20
to
3745-51-24
of the Administrative Code, but is not a pharmaceutical, as defined in this
rule.
(I)
"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, but is not limited
to, "dietary supplements," as defined by the Federal Food, Drug, and Cosmetic
Act; "prescription drugs," as defined in
21
C.F.R. 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.
(J)
"Potentially creditable hazardous waste pharmaceutical"
means a prescription hazardous waste pharmaceutical that has a reasonable
expectation to receive manufacturer credit and is all of the following:
(1)
In original
manufacturer packaging (except pharmaceuticals that were subject to a
recall).
(2)
Undispensed.
(3)
Unexpired or less
than one year past expiration date. The term does not include evaluated
hazardous waste pharmaceuticals or nonprescription pharmaceuticals including,
but not limited to, over-the-counter drugs, homeopathic drugs, and dietary
supplements.
(K)
"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.
Notes
Five Year Review (FYR) Dates: Exempt
Promulgated Under: 119.03
Statutory Authority: 3734.12
Rule Amplifies: 3734.12
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