South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-79 - Hazardous Waste Management Regulations › Part 61-79.266 - STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS WASTES AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT FACILITIES › Subpart P - HAZARDOUS WASTE PHARMACEUTICALS › Section 61-79.266.P.500 - Definitions for this subpart

Current through Register Vol. 48, No. 6, June 28, 2024
The following definitions apply to this subpart:
"Evaluated hazardous waste pharmaceutical" means a
					 prescription hazardous waste pharmaceutical that has been evaluated by a
					 reverse distributor in accordance with section 266.510(a)(3) and will not be
					 sent to another reverse distributor for further evaluation or verification of
					 manufacture credit.
"Hazardous waste pharmaceutical" means a pharmaceutical
					 that is a solid waste, as defined in section 261.2, and exhibits one or more
					 characteristics identified in part 261 subpart C or is listed in part 261,
					 subpart D. A pharmaceutical is not a solid waste, as defined in section 261.2,
					 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 section 261.2, 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.
"Healthcare facility" means any person that is lawfully
					 authorized to -
(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;
				  or
(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.
"Household waste pharmaceutical" means a pharmaceutical
					 that is a solid waste, as defined in section 261.2, but is excluded from being
					 a hazardous waste under section 261.4(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, 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.
"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/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.
"Non-hazardous waste pharmaceutical" means a pharmaceutical
					 that is a solid waste, as defined in section 261.2, and is not listed in part
					 261, subpart D, and does not exhibit a characteristic identified in part 261,
					 subpart C.
"Non-pharmaceutical hazardous waste" means a solid waste,
					 as defined in section 261.2, that is listed in part 261, subpart D, or exhibits
					 one or more characteristics identified in part 261, subpart C, but 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, but is not limited
					 to, dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act;
					 prescription drugs, as defined by
					 21
					 CFR 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.
"Potentially creditable hazardous waste pharmaceutical"
					 means a prescription hazardous waste pharmaceutical that has a reasonable
					 expectation to receive manufacturer credit and is-
(1) in original manufacturer packaging
				  (except pharmaceuticals that were subject to a recall);
(2) undispensed; and
(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.
"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.