March 13, 2019

Management Standards for Hazardous Waste Pharmaceuticals

On February 22, 2019, the long-awaited “pharmaceutical rule” was published in the Federal Register. [84 FR 5816] First proposed in September 2015, this rule creates a new Part 266, Subpart P for healthcare facilities and reverse distributors managing RCRA hazardous waste pharmaceuticals. Subpart P is designed to improve and clarify the regulation of these materials. The rule defines and regulates two entities—healthcare facilities and reverse distributors—who must comply with the new subpart when it becomes effective in their state. Except for healthcare facilities that are very small quantity generators (VSQGs), these entities cannot opt to manage hazardous waste pharmaceuticals per the traditional Part 262 standards.

Healthcare Facilities

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 wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals and veterinary hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies and other retailers of pharmaceuticals, and veterinary clinics. Pharmaceutical manufacturers, reverse distributors, and reverse logistics centers are not healthcare facilities.

Healthcare facilities are subject to two different sets of standards when managing hazardous waste pharmaceuticals, based on whether such pharmaceuticals are “potentially creditable” or “non-creditable.” Nonhazardous waste pharmaceuticals are not subject to RCRA’s hazardous waste standards, but healthcare facilities may also manage their nonhazardous pharmaceuticals according to Part 266, Subpart P if they so choose.

Potentially creditable hazardous waste pharmaceutical means a prescription hazardous waste pharmaceutical that has a reasonable expectation of receiving manufacturer credit and is 1) in original manufacturer packaging, 2) undispensed, and 3) unexpired (or less than one year past its expiration date). The final rule allows healthcare facilities to send potentially creditable hazardous waste pharmaceuticals to reverse distributors, provided they meet the minimal requirements in new §§266.502(a), 266.503, and 266.509. These requirements primarily include notification, recordkeeping to ensure proper delivery, spill response, and DOT shipping provisions. Notably, a hazardous waste manifest is not required. EPA believes that creditable pharmaceuticals are less likely to be released to the environment and so has decided not to impose specific management standards during their accumulation (e.g., no accumulation time limits, no container labeling). Note that potentially creditable pharmaceuticals are solid and hazardous waste under the new Subpart P (although they are subject to minimal standards as noted above). This is a significant departure from previous EPA policy, which allowed pharmaceuticals to be sent from healthcare facilities to reverse distributors as products—not solid and hazardous waste.

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. These pharmaceuticals will typically be sent to a designated TSD facility and must be managed by healthcare facilities in accordance with the numerous requirements in new §§266.502 and 266.508. These requirements are comparable to the standards for traditional hazardous wastes managed at small quantity generators and include:

Notification as a healthcare facility using EPA’s Site Identification Form (Form 8700-12) is required as part of the facility’s next biennial report, or if not required to submit a biennial report, within 60 days of becoming subject to the new regulations.
Training is required so that applicable personnel are thoroughly familiar with proper waste handling and emergency procedures.
Hazardous waste determinations must be performed, unless the healthcare facility chooses to manage its hazardous and nonhazardous waste pharmaceuticals together as non-creditable hazardous waste pharmaceuticals. Hazardous waste codes need not be identified.
Containers used to manage non-creditable hazardous waste pharmaceuticals are subject to standards similar to those found in Part 262 for hazardous waste containers, including the requirements to be structurally sound, compatible with their contents, specially managed if holding ignitable or reactive wastes, closed and secured to prevent unauthorized access, and labeled “Hazardous Waste Pharmaceuticals.”
Waste accumulation time is up to one year.
Compliance with the land disposal restrictions (LDR) in Part 268, including completion of generator LDR paperwork per §268.7(a), is required although no hazardous waste codes need to be identified on these notifications.
Healthcare facilities must immediately contain and clean up spills. Spill clean-up materials must be managed as non-creditable hazardous waste pharmaceuticals in accordance with the requirements of Subpart P.
A uniform hazardous waste manifest must be used to ship non-creditable pharmaceuticals to a designated TSD facility, with the word “PHARMS” entered in Block 13. Rejected shipments from the designated facility may be managed for up to an additional 90 days at the healthcare facility.
DOT-required packaging, labeling, marking, and placarding are required for shipments of non-creditable pharmaceuticals that meet the definition of a DOT hazardous material. Additional RCRA marking is required when shipping containers with a capacity of 119 gal or less per §266.508(a)(1)(iii)(B).
Non-creditable hazardous waste pharmaceuticals do not have to be included in biennial reports (if required by the facility’s generator category). However, copies of hazardous waste determinations (if required), manifests, exception reports, and LDR paperwork must be maintained for at least three years.

Healthcare facilities that are VSQGs when factoring in both hazardous waste pharmaceuticals and nonpharmaceutical hazardous waste may choose to opt into Subpart P for the management of their hazardous pharmaceutical waste. [new §266.504] These facilities may also choose to manage all of their hazardous waste (pharmaceutical and nonpharmaceutical) in accordance with §262.14.

A healthcare facility does not have to count its hazardous waste pharmaceuticals (that are subject to or managed in accordance with Subpart P) when determining its generator category. [new §262.13(c)(9)] As a result, a healthcare facility may experience a change in RCRA generator category for its nonpharmaceutical hazardous waste.

Reverse Distributors

Reverse distributors are the entities that receive potentially creditable hazardous waste pharmaceuticals from healthcare facilities and evaluate them to determine if they are eligible for manufacturer credit. The new rule allows reverse distributors to accept these materials from offsite without a RCRA permit as long as they comply with the requirements in new §266.510. These requirements are comparable to the standards for traditional hazardous wastes managed at large quantity generators and include:

Notification as a reverse distributor using EPA’s Site Identification Form (Form 8700-12) is required within 60 days of becoming subject to the new regulations.
The reverse distributor must evaluate each potentially creditable hazardous waste pharmaceutical within 30 calendar days of receipt. Once the evaluation is complete, the material becomes known as an evaluated hazardous waste pharmaceutical.
A current inventory of both potentially creditable and evaluated hazardous waste pharmaceuticals must be maintained. This inventory must include the pharmaceutical identity (e.g., name) and quantity.
After evaluation, evaluated hazardous waste pharmaceuticals may be accumulated for up to 180 days.
Reverse distributors must prevent unknowing, and minimize unauthorized, entry to the hazardous waste pharmaceutical accumulation areas.
The contingency plan and emergency procedures of Part 262, Subpart M must be in place.
The notification and closure performance standards of §262.17(a)(8)(ii) and (iii) must be followed when closing an area where waste pharmaceuticals were accumulated.
Reporting and recordkeeping are required, including maintaining copies of notification paperwork (Site ID form), shipping papers, delivery confirmations, and any unauthorized waste reports. Unauthorized waste reports must be sent to EPA if the reverse distributor receives waste from offsite that it is not authorized to receive (e.g., nonpharmaceutical hazardous waste, regulated medical waste).

After evaluation of potentially creditable hazardous waste pharmaceuticals has been completed, the reverse distributor becomes subject to additional requirements for the management of evaluated hazardous waste pharmaceuticals, including:

An onsite accumulation area must be designated so that evaluated hazardous waste pharmaceuticals are segregated and clearly distinguished from potentially creditable hazardous waste pharmaceuticals. This designated area must be inspected at least once every seven days.
Training is required for applicable personnel according to §262.17(a)(7).
Containers used to manage evaluated hazardous waste pharmaceuticals are subject to standards similar to those found in Part 262 for hazardous waste containers, including the requirements to be structurally sound, compatible with their contents, kept closed (if holding liquids or gels), specially managed if holding ignitable or reactive wastes, and labeled “hazardous waste pharmaceuticals.”
Containers must be marked with applicable hazardous waste codes prior to shipping.
A uniform hazardous waste manifest must be used to ship evaluated pharmaceuticals to a designated TSD facility, with applicable waste codes entered in Block 13. Rejected shipments from the designated facility may be managed for up to an additional 90 days at the reverse distributor.
DOT-required packaging, labeling, marking, and placarding are required for shipments of evaluated pharmaceuticals that meet the definition of a DOT hazardous material. Additional RCRA marking is required when shipping containers with a capacity of 119 gal or less per §266.508(a)(1)(iii)(B).
Compliance with the LDR requirements in Part 268, including completion of generator LDR paperwork per §268.7(a), is required. Hazardous waste codes need to be identified on these notifications.
A biennial report must be submitted to EPA in accordance with §262.41 for evaluated hazardous waste pharmaceuticals that are transported to a TSD facility.
Records (i.e., logs) of accumulation area inspections and copies of manifests, biennial reports, exception reports, and LDR paperwork must be maintained for at least three years. Additionally, personnel training records must be maintained per §262.17(a)(7)(iv).

Additional Provisions

The following additional provisions are part of the final rule:

Revisions to P075 nicotine listing—EPA has amended the P075 listing, stating that “this listing does not include patches, gums and lozenges that are FDA-approved over-the-counter nicotine replacement therapies.” Because over-the-counter patches, gums, and lozenges are regulated by the FDA and have generally low and known nicotine concentrations, the agency has concluded that these products do not meet the acute toxicity criteria in §261.11(a)(2). Note that this exception from the P075 listing does not include e-cigarettes, nicotine-containing e-liquids (e.g., “vape-pen” cartridges), or prescription nicotine replacement therapies (NRTs). The agency found that the nicotine levels in these latter products are still potentially acutely toxic to both humans and animals and, therefore, these products must still be included in the P075 listing in §261.33(e). But, e-cigarettes, e-liquids, and prescription NRTs will still be eligible for management as hazardous waste pharmaceuticals under new Part 266, Subpart P when they are discarded.

Sewer ban—EPA is prohibiting the sewering of hazardous waste pharmaceuticals by all healthcare facilities and reverse distributors in new §266.505, including those that are VSQGs. This ban extends to pharmaceuticals that are DEA-controlled substances or mixed waste pharmaceuticals (i.e., those that are both RCRA hazardous and radioactive). Although EPA does not have the statutory authority to apply the prohibition to nonhazardous waste pharmaceuticals, the agency strongly recommends against sewering any pharmaceuticals.

Exemption for DEA-controlled substances—EPA has promulgated a conditional exemption from RCRA management for hazardous waste pharmaceuticals that are also controlled substances under the DEA regulations. [new §266.506] There are only a handful of drugs meeting this criterion that are in common usage: chloral/chloral hydrate, fentanyl sublingual spray, phenobarbital, testosterone gels, and valium injectable. To make use of the conditional exemption, the hazardous waste pharmaceutical must 1) not be sewered, 2) be managed in compliance with all DEA regulations for controlled substances, and 3) be destroyed by a method that meets DEA’s non-retrievable standard of destruction or combusted in one of five specific units. This exemption is also extended to household waste pharmaceuticals collected in take-back events and programs.

Empty pharmaceutical containers—In new §266.507, EPA made it easier to dispose of containers that still hold residues of hazardous waste pharmaceuticals but that don’t necessarily meet the definition of RCRA-empty in §261.7. Stock, dispensing, and unit-dose containers (not to exceed 1 liter or 10,000 pills) will be considered RCRA-empty if the pharmaceuticals have been removed using standard practices employed to remove materials from that type of container. Syringes will be regarded as empty if the contents have been removed by fully depressing the plunger of the syringe. Intravenous (IV) bags will be considered empty provided the pharmaceuticals in the IV bag have been fully administered to the patient.

Nonprescription pharmaceuticals and unsold retail items—Nonprescription pharmaceuticals sent through reverse logistics systems are not solid wastes if they have a reasonable expectation of being legitimately used/reused (e.g., lawfully redistributed for their intended purpose) or reclaimed. [new §266.501(g)(2)] Similarly, in the preamble to the final rule, EPA established a policy that other unsold retail items that are sent through reverse logistics are not solid wastes at the retail store, because they have a reasonable expectation of being legitimately used/reused or reclaimed.

Effective Date and State Authorization

The entire final rule will become effective in the non-RCRA-authorized states (i.e., Alaska and Iowa) on August 21, 2019. For the 48 authorized states:

The prohibition on sewering hazardous waste pharmaceuticals will become effective in all states on August 21, 2019, since this is the one rule provision that is promulgated under HSWA authority.
All other, non-HSWA rule provisions will not take effect until the state adopts equivalent state requirements. Taken as a whole, EPA considers new Subpart P to be more stringent than the current federal standards. Therefore, authorized states will be required to adopt most of the new provisions.
The P075 nicotine listing revision is the one new provision that is less stringent than the current RCRA requirements. Thus, authorized states are not required to adopt this change, although EPA encourages all states to do so to promote national consistency.

EPA has provided a summary of the final rule and answers to frequent questions.

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Disclaimer

Considerable care has been exercised in preparing this document; however, McCoy and Associates, Inc. makes no representation, warranty, or guarantee in connection with the publication of this information. McCoy and Associates, Inc. expressly disclaims any liability or responsibility for loss or damage resulting from its use or for the violation of any federal, state, or municipal law or regulation with which this information may conflict. McCoy and Associates, Inc. does not undertake any duty to ensure the continued accuracy of this information.

This document addresses issues of a general nature related to the federal RCRA regulations. Persons evaluating specific circumstances dealing with the RCRA regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.