Environmental Protection Agency Issues New Rule for Handling of Hazardous Waste Pharmaceuticals

The Environmental Protection Agency (“EPA) issued a Final Rule imposing new streamlined standards for the management of hazardous waste pharmaceuticals by health care facilities and reverse distributors. All health care providers and distributors handling pharmaceuticals should be aware of these new standards and be prepared to implement compliant policies and procedures by the applicable effective date.
 
Background
 
Effective August 21, 2019, the EPA is significantly changing how hazardous waste pharmaceuticals are regulated within the healthcare sector. Earlier this year, the EPA published a Final Rule under the Resource Conservation and Recovery Act (“RCRA”) imposing new streamlined standards for the handling and management of hazardous waste pharmaceuticals by “health care facilities” and “reverse distributors.”¹  Previously, industrial-centered management standards governed pharmaceutical hazardous waste procedures of health care facilities. Health care facilities, however, are unique and unlike industrial hazardous waste generators. Health care facilities typically generate numerous different types of pharmaceutical wastes in small quantities across multiple locations within a single facility.
 
The standards in the Final Rule bring needed clarity for health care facilities. This is done in large part by specifically tailoring standards for the management of hazardous waste pharmaceuticals by certain healthcare facilities and professionals.
 
Who must comply with the Final Rule?
 
The Final Rule applies to: (1) healthcare facilities that generate, accumulate, or otherwise handle hazardous waste pharmaceuticals, and (2) reverse distributors that engage in the management of prescription hazardous waste pharmaceuticals. It does not apply to hazardous waste pharmaceuticals at any other type of facility or distributor (i.e., does not apply to pharmaceutical manufacturers, unless they act as reverse distributors, or production facilities).
 
40 C.F.R. § 266.500 outlines several new definitions to help determine who must comply to the Final Rule.
 
Definition of a Healthcare Facility
 
A healthcare facility²  under the Final Rule is defined broadly and includes 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, and veterinary clinics and hospitals, wholesale distributors, third-party logistics providers that serve as forward distributors, and military medical logistics facilities.
 
The Final Rule defines a long-term care facility as “a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility.” Long-term care facilities subject to the new standards include hospice facilities, nursing facilities, and skilled nursing facilities.  However, facilities such as independent living communities, assisted living facilities, and group homes are not considered long-term care facilities, and continue to be excluded from RCRA regulations as household hazardous wastes. 
 
Definition of a Reverse Distributor
 
Healthcare facilities frequently enter into contracts with reverse distributors that receive the facilities’ unused or expired waste pharmaceuticals. The reverse distributors then review and send the received waste pharmaceuticals out for disposal. They also work with the pharmaceutical manufacturers to provide credits back to the healthcare facilities for the unused pharmaceuticals they no longer need.
 
Reverse distributors that must comply with the Final Rule are defined as:
 
[A]ny 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.
 
Definition of Hazardous Waste Pharmaceuticals
 
The standards outlined in the Final Rule only apply to hazardous waste pharmaceuticals. They do not apply to non-hazardous waste pharmaceuticals or non-pharmaceutical hazardous wastes. 
 
Under the Final Rule, pharmaceutical³  includes, but is not limited to, dietary supplements, prescription drugs, 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. Pharmaceuticals do not include medical wastes, dental amalgam or sharps, which are all governed by other regulatory standards.
 
More specifically, a hazardous waste pharmaceutical is a pharmaceutical that: (1) is a solid waste per RCRA § 261.2 and (2) exhibits one or more characteristics of a hazardous waste (as per 40 CFR Part 261(C) (i.e., ignitability, corrosivity, reactivity and toxicity) or is listed in the 40 CFR Part 261(D) regulations as a hazardous waste. 
 
A pharmaceutical is not a solid waste and therefore is not a hazardous waste pharmaceutical if it is legitimately used, reused, or reclaimed. Likewise, over-the-counter pharmaceuticals, dietary supplements, and homeopathic drugs are not solid wastes or hazardous waste pharmaceuticals if they have a reasonable expectation of being legitimately used, reused, or reclaimed.
 
New Categories of Hazardous Waste Pharmaceuticals
 
The Final Rule also identifies three subsets of hazardous waste pharmaceuticals: (1) non-creditable hazardous waste pharmaceuticals; (2) potentially creditable hazardous waste pharmaceuticals; and (3) evaluated hazardous waste pharmaceuticals:⁴

• Non-creditable hazardous waste pharmaceuticals are either (i) prescription hazardous waste pharmaceuticals that do not have reasonable expectations of eligibility for manufacturer credit, or (ii) non-prescription hazardous waste pharmaceuticals that do not have reasonable expectations to be legitimately used or reclaimed.
• Potentially creditable hazardous waste pharmaceuticals are prescription hazardous waste pharmaceuticals that have a reasonable expectation to be eligible for manufacturer credit and are: (i) in their original manufacturer packaging, (ii) undispensed, and (iii) unexpired or less than one year past their expiration date.
• Evaluated hazardous waste pharmaceuticals are prescription hazardous waste pharmaceuticals that have been evaluated by a reverse distributor under § 266.510(a)(3) and will not be sent to another reverse distributor for further evaluation or verification of manufacturer credit. 
   

These categories are important for health care facilities because hazardous waste pharmaceuticals at a healthcare facility are either non-creditable or potentially creditable and hazardous waste pharmaceuticals at a reverse distributor are either potentially creditable or evaluated for credit.
 
New Management Requirements under Part 266, Subpart P

The Final Rule outlines the requirements that healthcare facilities and reverse distributors must follow in managing hazardous waste pharmaceuticals under Part 266, Subpart P. The particular credit status and classification of hazardous waste pharmaceuticals noted above are important because they determine which of the new management standards apply.
 
Healthcare Facility Standards
 
Regardless of the hazardous waste pharmaceutical’s credit status, all affected healthcare facilities (aside from VSQG)⁵  must follow certain general management standards⁶, including:

• Submit a one-time notification to the appropriate EPA Regional Administrator that they are operating under Subpart P;⁷
• Make a hazardous waste determination (unless a healthcare facility manages all of its waste pharmaceuticals as hazardous);
• May accumulate both hazardous and non-hazardous waste pharmaceuticals in the same container;
• Recordkeeping (specific requirements vary depending on whether dealing with a potentially creditable or non-creditable hazardous waste pharmaceutical);
• Respond to spills (specific requirements vary depending on whether dealing with a potentially creditable or non-creditable hazardous waste pharmaceutical); and
• Department of Transportation shipping provisions (specific requirements vary depending on whether dealing with a potentially creditable or non-creditable hazardous waste pharmaceutical).
   

Healthcare facilities managing a non-creditable hazardous waste pharmaceuticals must adhere to additional requirements, which are comparable to the standards for traditional wastes managed at small quantity generators:⁸

• Training so that personnel are thoroughly familiar with proper waste handling and emergency procedures;
• Accumulation containers must be labeled with the words “Hazardous Waste Pharmaceuticals” (no hazardous waste codes or other labeling requirements);
• Containers must be structurally sound and compatible with contents;
•  A one-year accumulation time limit from date accumulation began; and
•  Land disposal restrictions.
   

Healthcare facilities dealing with potentially creditable hazardous waste pharmaceuticals are not subject to these additional standards because creditable pharmaceuticals are less likely to be released into the environment.

Reverse Distributor Standards
 
Under the Final Rule, reverse distributors may accept potentially creditable hazardous waste pharmaceuticals from offsite without a RCRA storage permit if they comply with the following requirements similar to those governing traditional wastes managed at large quantity generators:⁹

• Submit a one-time notification that they are operating under Subpart P;
• Maintain a current inventory of potentially creditable and evaluated hazardous waste pharmaceuticals;
• Evaluate each potentially creditable hazardous waste pharmaceutical within 30 days of receipt;
• Evaluated hazardous wastes may be accumulated for up to 180 days;
• Deploy security measures;
• Implement a contingency plan and emergency procedures;
• Have closure performance measures; and
• Proper reporting and recordkeeping.
   

Additional standards for reverse distributors that send potentially creditable hazardous waste pharmaceuticals to another reverse distributor include:

• The hazardous waste pharmaceutical must be sent to the other reverse distributor or manufacturer within 180 days;
• Deploy certain shipping requirements; and
• Maintain proper recordkeeping for 3 years from shipment.
   

Upon evaluation of a potentially creditable hazardous waste pharmaceutical, reverse distributors are subject to additional standards for the management of evaluated hazardous waste pharmaceuticals, including:

• Designate an on-site accumulation area and conduct weekly inspections;
• Large quantity generator training for personnel handling evaluated hazardous waste pharmaceuticals;
• Labeling and management for containers;
• Containers marked with hazardous waste codes prior to shipping off-site;
• Use uniform hazardous waste manifest to ship evaluated pharmaceuticals to a designated transfer and storage disposal facility;
• Comply with land disposal restrictions; and
• Proper reporting and recordkeeping.
   

Notwithstanding these requirements, there are no generator categories for either healthcare facilities or reverse distributors under Subpart P. Meaning, all healthcare facilities and reverse distributors are regulated the same amongst their respective sector classes for their hazardous waste pharmaceuticals. Moreover, healthcare facilities and reverse distributors operating under Subpart P no longer have to track how much hazardous waste pharmaceuticals they generate per month, or have to segregate acute and non-acute hazardous waste pharmaceuticals. These changes incentivize facilities to over-manage non-hazardous pharmaceuticals as though they are hazardous without concern about the applicable generator category and the possibility of incurring additional regulations.      
 
Sewering Ban
 
In addition to the new management standards, all healthcare facilities (including very small quantity generators) and reverse distributors “are prohibited from discharging hazardous waste pharmaceuticals and controlled substances to a sewer system.”¹⁰ The EPA further strongly discourages the sewering of any pharmaceuticals (i.e., nonhazardous pharmaceuticals). 
 
Exemption for DEA Controlled Substances
 
Under § 266.506 of the Final Rule, the EPA has promulgated new conditional exemptions for healthcare facilities and reverse distributors from RCRA management of hazardous waste pharmaceuticals for: (1) hazardous waste pharmaceuticals that are also controlled substances; and (2) household waste pharmaceuticals that are collected in DEA authorized reception reciprocals. For a healthcare facility or reverse distributor to fall under these conditional exemptions, the hazardous waste pharmaceutical must:

• Not be sewered;
• Be managed in compliance with DEA regulations for controlled substances;
• Be destroyed by a method that the DEA has deemed to meet their non-retrievable standard for destruction; and
• Be combusted at one of five types of permitted facilities.
   

Effective Dates
 
The Final Rule in its entirety will become effective at the federal level on August 21, 2019.

For Part 266, Subpart P management standards, the effective date depends on whether a state is “non-authorized” or “authorized.” For non-authorized states (Iowa and Alaska), which do not have an EPA-approved hazardous waste program, Part 266, Subpart P is effective on August 21, 2019. In contrast, before Part 266, Subpart P becomes effective for the 48 authorized states (including Arizona, Nevada, and Colorado), these states must adopt the Final Rule and modify their applicable state RCRA programs to retain their authorized status. Authorized states have until July 1, 2021 to adopt Part 266, Subpart P. However, if an authorized state requires a statutory amendment to adopt Part 266, Subpart P, they have until July 1, 2022.
 
Because the sewering ban is being promulgated under the authority of the Hazardous and Solid Waste Amendments, it becomes effective in all states on August 21, 2019.

 

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[1] EPA, Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine, 84 Fed. Reg. 5816 (Feb. 22, 2019), available here.
[2] The broad definition of “health care facility” in the Final Rule is 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.
[3] The term “pharmaceutical” is broadly defined as “[A]ny 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 for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials).”
[4] 40 C.F.R. § 266.500
[5] Healthcare facilities that are very small quantity generators (VSQG) may choose to opt-in to Subpart P for the management of their hazardous waste pharmaceuticals.
[6] 40 C.F.R. §§ 266.502(a), 266.503, and 266.509 for potentially creditable; §§ 266.502 and 266.508 for non-creditable.
[7] The notice can be  submitted in the next normal biennial reporting cycle, if applicable, or within 60 days of the Final Rule going into effect.
[8] 40 C.F.R. § 266.502
[9] Id. § 266.510
[10] 40 C.F.R. § 266.505