North Dakota Administrative Code
Title 33.1 - Department of Environmental Quality
Article 33.1-24 - Hazardous Waste Management
Chapter 33.1-24-05 - Standards for Treatment, Storage, and Disposal Facilities and for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities
MISCELLANEOUS UNITS
Section 33.1-24-05-310 - Definitions of terms used in sections 33.1-24-05-310 through 33.1-24-05-320

Current through Supplement No. 395, January, 2025

1. "Evaluated hazardous waste pharmaceuticals" means a prescription hazardous waste pharmaceutical that has been evaluated by a reverse distributor in accordance with paragraph c of subsection 1 of section 33.1-24-05-320 and will not be sent to another reverse distributor for further evaluation or verification of manufacturer credit.

2. "Hazardous waste pharmaceutical" means a pharmaceutical that is a solid waste, as defined in section 33.1-24-02-02, and exhibits one or more characteristics identified in sections 33.1-24-02-10 through 33.1-24-02-14, or is listed in sections 33.1-24-02-15 through 33.1-24-02-19. A pharmaceutical is not a solid waste, as defined in section 33.1-24-02-02, and therefore is not a hazardous waste pharmaceutical, if it is legitimately used or 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 33.1-24-02-02, and therefore not a hazardous waste pharmaceutical, if it has a reasonable expectation of being legitimately used or reused, e.g., lawfully redistributed for its intended purpose, or reclaimed.

3. "Health care facility" means any person, by site, that is lawfully authorized to:

a. 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

b. Distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. This includes 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" means a pharmaceutical that is a solid waste, as defined in section 33.1-24-02-02, but is excluded from being a hazardous waste under paragraph a of subsection 2 of section 33.1-24-02-04.

5. "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 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. "Noncreditable 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 investigational drugs, free samples of pharmaceuticals received by health care facilities, residues of pharmaceuticals remaining in empty containers, contaminated personal protective equipment, floor sweepings, and cleanup material from the spills of pharmaceuticals.

7. "Nonhazardous waste pharmaceutical" means a pharmaceutical that is a solid waste, as defined in section 33.1-24-02-02, and is not listed in sections 33.1-24-02-15 through 33.1-24-02-19, and does not exhibit a characteristic identified in sections 33.1-24-02-10 through 33.1-24-02-14.

8. "Nonpharmaceutical hazardous waste" means a solid waste, as defined in section 33.1-24-02-02, that is listed in sections 33.1-24-02-15 through 33.1-24-02-19, or exhibits one or more characteristics identified in sections 33.1-24-02-10 through 33.1-24-02-14, but is not a pharmaceutical, as defined in this section.

9. "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., prefilled cartridges or vials. This definition includes dietary supplements, as defined by the Federal Food, Drug, and Cosmetic Act; prescription drugs, as defined by title 21, Code of Federal Regulations, section 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 cleanup material from spills of pharmaceuticals. This definition does not include dental amalgam or sharps.

10. "Potentially creditable hazardous waste pharmaceutical" means a prescription hazardous 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;

b. Undispensed; and

c. Unexpired or less than one year past expiration date. The term does not include evaluated hazardous waste pharmaceuticals or nonprescription pharmaceuticals, including over-the-counter drugs, homeopathic drugs, and dietary supplements.

11. "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 process prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.

General Authority: NDCC 23.1-04-03

Law Implemented: NDCC 23.1-04-03, 23.1-04-05; S.L. 2017, ch. 199, § 19

Disclaimer: These regulations may not be the most recent version. North Dakota may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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