Pharmaceutical waste

Scope

EPA published the final rule, Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine, on February 22, 2019. The rule is intended to streamline standards for managing hazardous waste pharmaceuticals in the healthcare and retail sectors.

Regulatory citations

• 40 CFR 261.2 — Definition of solid waste.
• 40 CFR 262 — Standards applicable to generators of hazardous waste
• 40 CFR 266 Subpart P — Hazardous Waste Pharmaceuticals 

Key definitions

• Evaluated hazardous waste pharmaceutical: A prescription hazardous waste pharmaceutical that has been evaluated by a reverse distributor and will not be sent to another reverse distributor for further evaluation or verification of manufacture credit.
• Hazardous waste pharmaceutical: A pharmaceutical that is a solid waste, as defined in 261.2, that 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, 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, 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: Any person who 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.
• 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.
• Non-hazardous waste pharmaceutical: A pharmaceutical that is a solid waste, as defined in 261.2, and is not listed in 40 CFR Part 261 Subpart D, and does not exhibit a characteristic identified in 40 CFR Part 261 Subpart C.
• 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 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: 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: Any person who receives and accumulatesprescription 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, who processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.

Summary of requirements

Healthcare facilities

• Count up monthly generation of all hazardous waste (pharmaceutical and non-pharmaceutical).
• If the total amount of waste is more than 1 kg of acute hazardous waste or 100 kg of nonacute hazardous waste, the facility may manage its pharmaceutical wastes under 40 CFR 266 Subpart P. Non-pharmaceutical hazardous waste must be managed under the hazardous waste generator regulations at 40 CFR 262, 264, and 265.
• Do not count hazardous waste pharmaceuticals toward the facility’s generator category.

Reverse distributors

• Manage hazardous waste pharmaceuticals under 40 CFR 266 Subpart P, even if the facility is a very small quantity generator.
• Reverse distributors do not count hazardous waste pharmaceuticals toward the facility’s generator category.

Training

• Inform all employees that handle or have responsibility for generating and/or managing hazardous waste pharmaceuticals of the proper handing and emergency procedures for hazardous waste pharmaceuticals. Training may be verbal or written.
• Large quantity generators may choose to train pharaceutical waste handlers personnel according to the requirements in 40 CFR 262.17.

Accumulation

• Facilities have up to one year to accumulate non-creditable hazardous waste pharmaceuticals.

Labeling

• Containers of hazardous waste pharmaceuticals being managed under Subpart P must be labeled “Hazardous Waste Pharmaceuticals.”