January 17, 2019

New Rule Clarifies Management of Hazardous Waste Pharmaceuticals

On December 11, 2018, the EPA administrator signed a pre-publication copy of the long-awaited “pharmaceutical rule.” 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 ensure these materials are appropriately managed to protect human health and the environment. Many of the commenters on the proposed rule agreed that clarified and improved management is necessary and that the regulations are not overly burdensome.

The final rule also contains additional provisions not directly tied to healthcare facilities or reverse distributors: a change to the P075 nicotine listing, a sewering prohibition for hazardous waste pharmaceuticals, a conditional exemption for hazardous waste pharmaceuticals that are also DEA-controlled substances, and a new definition for empty containers that once held hazardous waste pharmaceuticals.

The final rule will take effect at the federal level six months after publication in the Federal Register. Below is a brief overview of the new provisions in this rule. Once the final rule is published in the Federal Register, we will release a more comprehensive article detailing additional requirements.

Healthcare Facilities

Healthcare facilities aren’t limited to just dispensing pharmaceuticals. They include facilities that provide preventative, rehabilitative, and counseling services. Hospitals, health clinics, physician’s offices, pharmacies, optical and dental providers, and military medical logistics facilities are just some of the entities that are included in the definition of healthcare facility and are affected by this rule. These facilities will now have to determine if the prescription pharmaceuticals they cannot use are hazardous according to Part 261, Subparts C and D. (Optionally, healthcare facilities may choose to commingle all of their waste pharmaceuticals and manage them all under new Subpart P.)

A healthcare facility will also need to determine if the pharmaceutical is potentially eligible for manufacturer credit. If so, then it becomes a potentially creditable hazardous waste pharmaceutical. The final rule allows healthcare facilities to send potentially creditable hazardous waste pharmaceuticals to reverse distributors, provided they meet the minimal requirements in new §§266.503 and 266.509. These requirements primarily include recordkeeping, spill response, and DOT shipping provisions to ensure their proper delivery. A hazardous waste manifest is not required. The agency 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, etc.).

Non-creditable hazardous waste 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.

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 (LQGs). One new requirement that is less stringent than traditional LQG standards is that reverse distributors will have up to 30 days to evaluate potentially creditable hazardous waste pharmaceuticals and then an additional 180 days for accumulation.

Additional Provisions

• Nicotine wastes—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 very small quantity generators (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.
• 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 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.

Effective Date and State Authorization

The entire final rule will become effective in the non-RCRA-authorized states (i.e., Alaska and Iowa) six months after its publication in the Federal Register. For the 48 authorized states:

• The prohibition on sewering hazardous waste pharmaceuticals will become effective in all states six months after the rule is published in the Federal Register, 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.
• 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.

 

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This document addresses issues of a general nature related to the federal environmental regulations. Persons evaluating specific circumstances dealing with the environmental 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.