30 Tex. Admin. Code § 335.751

Current through Reg. 49, No. 44; November 1, 2024

Section 335.751 - Definitions

The following definitions apply to this subchapter:

(1) Evaluated hazardous waste pharmaceutical--A prescription hazardous waste pharmaceutical that has been evaluated by a reverse distributor in accordance with § 335.771(a)(3) of this title (relating to Standards for the Management of Potentially Creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals by Reverse Distributors) and will not be sent to another reverse distributor for further evaluation or verification of manufacture credit.

(2) Hazardous waste pharmaceutical--A pharmaceutical that is a solid waste, as defined in § 335.1 of this title (relating to Definitions), and exhibits one or more characteristics identified in 40 Code of Federal Regulations (CFR) Part 261, Subpart C, or is listed in 40 CFR Part 261, Subpart D as these subparts are adopted by reference under § 335.504 of this title (relating to Hazardous Waste Determination). A pharmaceutical is not a solid waste, as defined in § 335.1 of this title, 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 § 335.1 of this title, 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.

(3) Healthcare facility--Any person that is lawfully authorized to:

(A) provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure for 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 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.

(4) Household waste pharmaceutical--A pharmaceutical that is a solid waste, as defined in § 335.1 of this title (relating to Definitions), but is excluded from being a hazardous waste under 40 Code of Federal Regulations §261.4(b)(1) as adopted under § 335.504 of this title (relating to Hazardous Waste Determination).

(5) Long-term care facility--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.

(6) Non-creditable hazardous waste pharmaceutical--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.

(7) Nonhazardous waste pharmaceutical--A pharmaceutical that is a solid waste, as defined in § 335.1 of this title (relating to Definitions), and is not listed in 40 Code of Federal Regulations (CFR) Part 261, Subpart D, and does not exhibit a characteristic identified in 40 CFR Part 261, Subpart C.

(8) Non-pharmaceutical hazardous waste--A solid waste, as defined in § 335.1 of this title (relating to Definitions), that is listed in 40 Code of Federal Regulations (CFR) Part 261, Subpart D or exhibits one or more characteristics identified in 40 CFR Part 261 , Subpart C, but is not a pharmaceutical, as defined in this section.

(9) Pharmaceutical--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 Code of Federal Regulations §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.

(10) Potentially creditable hazardous waste pharmaceutical--A prescription hazardous waste pharmaceutical that has a reasonable expectation to receive manufacturer credit and:

(A) is in original manufacturer packaging (except pharmaceuticals that were subject to a recall);

(B) is undispensed;

(C) is unexpired or less than one year past expiration date; and

(D) is not an evaluated hazardous waste pharmaceutical.

(11) Reverse distributor--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.

30 Tex. Admin. Code § 335.751

Adopted by Texas Register, Volume 47, Number 04, January 28, 2022, TexReg 0346, eff. 2/3/2022