EPA finalizes hazardous waste pharmaceuticals regs for healthcare

Regulations take effect 6 months after publication in Federal Register

Posted December 17, 2018

EPA Acting Administrator Andrew Wheeler has signed a rule finalizing standards for managing hazardous waste pharmaceuticals in the healthcare sector.

The rule creates a new Part 266 Subpart P for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. Healthcare facilities (for both humans and animals) and reverse distributors will manage their hazardous waste pharmaceuticals under the new set of sector-specific standards in lieu of the generator regulations in Part 262.

Specifically, the rule:

  • Prohibits the disposal of hazardous waste pharmaceuticals down the drain.
  • Eliminates the dual regulation of Resource Conservation and Recovery Act (RCRA) hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances by finalizing a conditional exemption.
  • Maintains the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take-back programs and events, while ensuring their proper disposal.
  • Clarifies that FDA-approved, over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums, and lozenges) will no longer be considered hazardous waste when discarded.
  • Reaffirms EPA’s long-standing policy that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed are not solid waste.

The final rule will take effect six months after publication in the Federal Register.


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