Washington Administrative Code › Title 173 - Ecology, Department of (See also Titles 197, 317, 372, and 508) › Chapter 173-303 - Dangerous waste regulations › Section 173-303-555 - Special requirements for management of dangerous waste pharmaceuticals

Current through Register Vol. 24-14, July 15, 2024
(1)
Definitions.
The following definitions apply to this section:
"Dangerous waste pharmaceutical" means a pharmaceutical that is
				a solid waste, as defined in WAC
				173-303-016,
				and that exhibits a dangerous waste characteristic, criteria, or is listed as
				dangerous waste under WAC
				173-303-070.
				A pharmaceutical is not a solid waste, as defined in 173-303-016, 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 WAC
				173-303-016,
				if it has a reasonable expectation of being legitimately used/reused (e.g.,
				lawfully redistributed for its intended purpose) or reclaimed.
"Evaluated dangerous waste pharmaceutical" means a prescription
				dangerous waste pharmaceutical that has been evaluated by a reverse distributor
				in accordance with subsection (12)(c) of this section and will not be sent to
				another reverse distributor for further evaluation or verification of
				manufacture credit.
"Health care facility" means any person that is lawfully
				authorized to:
* 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; or
* 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 logistic centers.
"Household waste pharmaceutical" means a pharmaceutical that is
				a solid waste, as defined in WAC
				173-303-016,
				but is excluded from being a dangerous waste under WAC
				173-303-071(3)(c).
"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.
"Noncreditable dangerous waste pharmaceutical" means a
				prescription dangerous waste pharmaceutical that does not have a reasonable
				expectation to be eligible for manufacturer credit or a nonprescription
				dangerous 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 health care
				facilities, and residue of pharmaceuticals remaining in empty containers,
				pharmaceutical contaminated personal protection equipment, floor sweepings, and
				clean-up materials from the spills of pharmaceuticals.
"Nondangerous waste pharmaceutical" means a solid waste
				pharmaceutical that does not meet the definition of "dangerous waste
				pharmaceutical" in this section.
"Nonpharmaceutical dangerous waste" means a solid waste that is
				a dangerous waste as defined by this chapter, but is not a pharmaceutical as
				defined in this section.
"Pharmaceutical" means any drug or dietary supplement for use
				by humans or 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., prefilled
				cartridges or vials). This definition includes, but is not limited to, dietary
				supplements, as defined by the Federal Food, Drugs and Cosmetic Act;
				prescription drugs, as defined by
				21
				C.F.R. 203.3(y);
				over-the-counter drugs; homeopathic drugs; compounded drugs; investigational
				new drugs; pharmaceutical remaining in nonempty containers; personal protection
				equipment contaminated with pharmaceuticals; and clean-up material from spills
				of pharmaceuticals. This definition does not include dental amalgam or
				sharps.
"Potentially creditable dangerous waste pharmaceutical" means a
				prescription dangerous waste pharmaceutical that has a reasonable expectation
				to receive manufacturer credit and is:
(a) In original manufacturer packaging
			 (except pharmaceuticals that were subject to a recall); and
(b) Undispensed; and
(c) Unexpired or less than one year past
			 expiration date. This term does not include evaluated dangerous waste
			 pharmaceuticals or nonprescription pharmaceuticals including, but not limited
			 to, over-the-counter drugs, homeopathic drugs, and dietary supplements.
"Reverse distributor" means any person that receives and
				accumulates prescription pharmaceuticals that are potentially creditable
				dangerous 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.
"State-only dangerous waste pharmaceutical" means a dangerous
				waste pharmaceutical that only exhibits state criteria under WAC
				173-303-100.