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

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:

 


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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.