NDAC 33.1-24-05-309
[Reserved]
Cite as N.D. Admin. Code § 33.1-24-05-309
33.1-24-05-310. Definitions of terms used in sections 33.1-24-05-310 through 33.1-24-05-320.
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.