Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 266.1 - HAZARDOUS WASTE MANAGEMENT: STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS WASTES AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT FACILITIES › Part 266 - STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS WASTES AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT FACILITIES › Subpart P - Hazardous Waste Pharmaceuticals and Hazardous Waste Electronic Nicotine Delivery Systems › Section 11-266.500 - Definitions for this subpart

Current through June, 2024
The following definitions apply to this subpart:
Electronic nicotine delivery system
means any electronic device that can be used to aerosolize and deliver nicotine
						to the person inhaling from the device (e.g., electronic cigarette, electronic
						pipe, vaping pen) and any liquid nicotine (e-liquid) packaged for retail sale
						for use in such a device (e.g., pre-filled cartridge, tank, pod, or
						vial).
Electronic nicotine delivery system
retailer means any person who distributes or sells electronic nicotine delivery
						systems. This definition includes, but is not limited to, retailers who sell
						products directly to consumers, wholesale distributors, and third-party
						logistics providers that serve as forward distributors. This definition does
						not include manufacturers or reverse logistics centers.
Evaluated hazardous waste pharmaceutical
means a prescription hazardous waste pharmaceutical that has been evaluated by
						a reverse distributor in accordance with § 266.510(a)(3) and will not be
						sent to another reverse distributor for further evaluation or verification of
						manufacture credit.
Hazardous waste electronic nicotine delivery
						system
means an electronic nicotine delivery system that is a solid
						waste, as defined in
						40 C.F.R. section
						261.2, as incorporated and amended in section
						11-261.1-1, and a hazardous waste, as defined in
						40 C.F.R. section
						261.3, as incorporated and amended in section
						11-261.1-1.
Hazardous waste pharmaceutical
means a
						pharmaceutical that is a solid waste, as defined in
						40 C.F.R. section
						261.2, as incorporated and amended in section
						11261.1-1, and a hazardous waste, as defined in
						40 C.F.R. section
						261.3, as incorporated and amended in section
						11-261.1-1.
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 electronic nicotine delivery
						system
means an electronic nicotine delivery system that is a solid
						waste, as defined in
						40 C.F.R. section
						261.2, as incorporated and amended in section
						11-261.1-1, but is excluded from being a hazardous waste under
						40
						C.F.R. section 261.4(b)(1),
						as incorporated and amended in section 11-261.1-1.
Household waste pharmaceutical
means a
						pharmaceutical that is a solid waste, as defined in § 261.2, but is
						excluded from being a hazardous waste under§ 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 cleanup material from the spills of
						pharmaceuticals.
Non-creditable subpart P hazardous waste
means a non-creditable hazardous waste pharmaceutical or a hazardous waste
						electronic nicotine delivery system.
Non-subpart P hazardous waste
means a
						solid waste, as defined in
						40 C.F.R. section
						261.2, as incorporated and amended in section
						11-261.1-1, that is a hazardous waste, as defined in
						40 C.F.R. section
						261.3, as incorporated and amended in section
						11-261.1-1, and is not a pharmaceutical or electronic nicotine delivery system,
						as defined in this section.
Pharmaceutical
means any drug or dietary
						supplement for use by humans or other animals. 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 nonempty containers; personal
						protective equipment contaminated with pharmaceuticals; and clean-up material
						from spills of pharmaceuticals. Pharmaceutical includes an electronic nicotine
						delivery system that is subject to regulation as a drug, device, or combination
						product by the U.S. Food and Drug Administration. 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.
Subpart P hazardous waste
means a
						hazardous waste pharmaceutical or a hazardous waste electronic nicotine
						delivery system.