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Rulemaking - Hazardous Waste Pharmaceuticals Rule

DEC issued an enforcement discretion letter allowing the use of the amended P075 nicotine and salts hazardous waste listing that exempts FDA-approved over-the-counter nicotine replacement therapies in New York State, effective August 21, 2019. Please see DEC's Management of Hazardous Waste Pharmaceuticals webpage for more information.

On February 22, 2019, the United States Environmental Protection Agency (EPA) adopted the Hazardous Waste Pharmaceuticals Rule (Pharms Rule) (link leaves DEC's website). Most of the provisions of this rule will not be in effect in New York until the State adopts them.

This rule adds regulations for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. Healthcare facilities and reverse distributors will manage their hazardous waste pharmaceuticals under this new set of sector-specific standards in lieu of the existing hazardous waste generator regulations. These new regulations exclude certain U.S. Food and Drug Administration (FDA) approved over-the-counter (OTC) nicotine replacement therapies (NRTs) (e.g., nicotine gums, patches, lozenges) from regulation as hazardous waste. These provisions also prohibit the disposal of hazardous waste pharmaceuticals down the drain (i.e., sewering). The ban on sewering hazardous waste pharmaceuticals went into effect nationwide on August 21, 2019.

About 5% of discarded pharmaceuticals are also hazardous wastes. This rule addresses these hazardous wastes and optionally allows health care facilities to co-manage pharmaceuticals that are not regulated hazardous waste under the rule.

Definitions

EPA definitions used in the rule include:

  • 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 pharmaceutical means a pharmaceutical that is a solid waste, as defined in § 261.2, and 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, as defined in § 261.2, 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 § 261.2, 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 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 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 clean-up material from the spills of pharmaceuticals.
  • Non-hazardous waste pharmaceutical means 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.
  • Non-pharmaceutical hazardous waste means a solid waste, as defined in § 261.2, that is listed in 40 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.
  • 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., 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 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.

Sewering Ban

  • 40 CFR 266.505 prohibits sewering of hazardous waste pharmaceuticals.
  • Ban applies to all healthcare facilities (as defined - includes pharmacies) including Conditionally Exempt Small Quantity Generators.
  • Went into effect nationally on August 21, 2019

Reverse Distribution - Pharmaceuticals

  • Not in effect in New York State until adopted by the State, however the State must adopt these provisions;
  • Once adopted, all hazardous waste pharmaceuticals must be managed by these provisions;
  • Prescription pharmaceuticals are solid waste at the healthcare facility;
  • Non-prescription pharmaceuticals are not solid waste (for the purposes of the hazardous waste regulations) at the retail store if there is a reasonable expectation of being legitimately used/reused (lawfully redistributed) or reclaimed.
  • Federal provisions:
    • 40 CFR 266.501 Applicability.
    • 40 CFR 266.502 Standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals.
    • 40 CFR 266.503 Standards for healthcare facilities managing potentially creditable hazardous waste pharmaceuticals.
    • 40 CFR 266.504 Healthcare facilities that are very small quantity generators for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste.
    • 40 CFR 266.508 Shipping non-creditable hazardous waste pharmaceuticals from a healthcare facility or evaluated hazardous waste pharmaceuticals from a reverse distributor.
    • 40 CFR 266.509 Shipping potentially creditable hazardous waste pharmaceuticals from a healthcare facility or a reverse distributor to a reverse distributor.
    • 40 CFR 266.510 Standards for the management of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals at reverse distributors.

Conditional exemption for hazardous waste pharmaceuticals that are DEA controlled substances and household hazardous waste pharmaceuticals collected in a take-back event or program

Under current State regulations, hazardous waste pharmaceuticals that are also controlled substances must be managed under both hazardous waste and Drug Enforcement Agency (DEA) requirements. DEA sets destruction methods and mandates who may handle controlled substances, which includes chain-of-custody requirements that are designed to prevent diversion. In 40 CFR 266.506, EPA established alternate standards for those pharmaceuticals that are both hazardous wastes and controlled substances. These include chloral, chloral hydrate, fentanyl sublingual spray, phenobarbital, testosterone gels, and less commonly paraldehyde, paregoric, and opium tincture. (Some other forms of these pharmaceuticals are still DEA-regulated controlled substances but might not meet the RCRA hazardous waste listings or characteristics.) The alternate standards:

  • Avoid dual regulation;
  • Require these pharmaceuticals to be destroyed by a method approved by DEA in writing to meet their non-retrievable standard; or in one of five (5) types of permitted combustion units;
  • Exclude these wastes from counting towards generator category.

Not in effect until adopted by the State.

Amendment of the P075 Nicotine Definition

Listing for nicotine and pyridine adds a parenthetical: "this listing does not include patches, gums and lozenges that are FDA-approved over-the-counter nicotine replacement therapies."

All other nicotine wastes that meet the listing (e.g., e-liquids) continue to be regulated as acute hazardous waste.

DEC issued an enforcement discretion letter allowing the use of the amended P075 nicotine and salts hazardous waste listing that exempts FDA-approved over-the-counter nicotine replacement therapies in New York State, effective August 21, 2019. See DEC's Management of Hazardous Waste Pharmaceuticals webpage for more information.

Amendment to "RCRA Empty" Definition

Amendment to this definition describes when containers or packaging commonly used for pharmaceuticals, such as unit-dose containers, syringes, intravenous bags, and other containers including delivery devices, are considered empty and no longer subject to hazardous waste regulation.

Not in effect until adopted by the State.

Reverse Logistics - Non-Pharmaceuticals

EPA set policy through the preamble of the pharmaceuticals rule that affects unsold retail items that are not pharmaceuticals, the policy:

  • Establishes that other retail items that are sent through reverse logistics are not solid waste (for the purposes of the hazardous waste regulations) at the retail store if they have a reasonable expectation of being legitimately used/reused (e.g. lawfully redistributed for their intended purpose) or reclaimed.
  • Is not effective in states until/unless they adopt through policy or regulation.

Request for Comment

DEC is interested in information, data, and comments about any issues or concerns with this rule. Please submit all information, data, or comments by:

Email: HWRegs@dec.ny.gov

or

Mail:
NYS Department of Environmental Conservation
RCRA Compliance and Technical Support Section
625 Broadway
Albany, NY 12233-7256