October 15, 2015

Summary of Pharmaceutical Waste Management Proposal

On September 25, 2015, EPA proposed standards for hazardous waste pharmaceuticals generated and managed in the healthcare industry. [80 FR 58014] If finalized, the management standards will be codified in a new Subpart P to Part 266. The proposed rule would regulate two different entities: 1) healthcare facilities, and 2) reverse distributors, as discussed below.

Healthcare facilities

Healthcare facilities would include hospitals, surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners, medical examiners, and pharmacies. Such facilities would be subject to two different sets of standards when managing hazardous waste pharmaceuticals, based on whether they are “potentially creditable” or not. Potentially creditable hazardous waste pharmaceuticals would be pharmaceuticals that 1) have the potential to receive manufacturer’s credit, 2) are unused or un-administered, and 3) are unexpired or are less than one year past expiration date.

Potentially creditable hazardous waste pharmaceuticals

The proposed rule would allow healthcare facilities to continue sending potentially creditable hazardous waste pharmaceuticals to reverse distributors, provided they meet a few requirements. These requirements would primarily include standards to ensure their proper delivery, although no manifest would be required. The agency believes that creditable pharmaceuticals are less likely to be released to the environmental 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

There would be a long list of requirements applicable to the management of non-creditable hazardous waste pharmaceuticals, similar to the standards for traditional hazardous wastes managed at a small quantity generator:

Reverse distributors

Reverse distribution facilities that receive and manage potentially creditable hazardous waste pharmaceuticals would have their own set of requirements under Part 266, Subpart P. They would be similar to those applicable to traditional hazardous wastes managed at a large quantity generator:

Other key requirements

The following additional requirements are part of the September 2015 pharmaceutical proposal:

EPA has provided a summary of the proposed rule and answers to frequent questions. Comments on the proposal must be received by November 24, 2015.


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