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Proposed Rule: Management Standards for Hazardous Waste Pharmaceuticals

On September 25, 2015, EPA proposed to add a new subpart to 40 CFR Part 266: “Subpart P – Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities,” which would regulate the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors.

Highlights of the new rule are as follows:

“Potentially Creditable” and “Potentially Non-Creditable” Hazardous Waste Pharmaceuticals

The proposed rule creates separate management standards for “potentially creditable” hazardous waste pharmaceuticals (i.e., wastes eligible for reverse distribution) and “potentially non-creditable” hazardous waste pharmaceuticals (i.e., wastes not eligible for reverse distribution).  The on-site management of potentially creditable hazardous waste pharmaceuticals will simplify current regulatory requirements.  For example, shipments may be made by common carrier, hazardous waste manifests are no longer required, and biennial reporting requirements for LQGs are eliminated.

Non-creditable hazardous waste pharmaceuticals will be managed similarly to current requirements, with the exceptions that they may be accumulated onsite for up to one year and biennial reporting requirements for LQGs are eliminated.

Sewer Ban
The new rule will prohibited the disposal of hazardous waste pharmaceuticals and controlled substances in sinks that enter a municipal sewer system.  Additionally, hazardous waste pharmaceuticals that are also controlled substances must be combusted at a permitted hazardous waste incinerator or municipal solid waste incinerator.

Empty Container Residues

  • Residues in unit-dose containers, dispensing bottles and vials: Residues in these containers will be considered empty and not regulated as hazardous waste if the pharmaceuticals have been removed to the extent possible using standard practices.  Additionally, any container in an original manufacturer’s product package must be destroyed prior to disposal to prevent reuse.
  • Residues in syringes: Residues in syringes will not be regulated as hazardous waste as long as the syringe is managed in accordance with applicable medical waste regulations.
  • Residues in delivery devices: Containers such as IV bags and tubing, inhalers, and nebulizers will continue to be regulated as hazardous waste. However, the residue will not be counted toward generator status.

Proposed rule (Federal Register): http://www.gpo.gov/fdsys/pkg/FR-2015-09-25/pdf/2015-23167.pdf

Comments must be received by EPA by November 24, 2015.

EPA website: http://www2.epa.gov/hwgenerators/proposed-rule-management-standards-hazardous-waste-pharmaceuticals

For more information, contact your EPS consultant.