Management Standards for Hazardous Waste Pharmaceuticals (Renewal)

Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. In 2019 EPA promulgated regulations for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors (84 FR 5816, February 22, 2019). Healthcare facilities (for both humans and animals) and reverse distributors now manage their hazardous waste pharmaceuticals under a new set of sector-specific standards in lieu of the existing hazardous waste generator regulations. These regulations are found in 40 CFR 266, Subpart P, and are mandatory. The new requirements include labeling containers holding non-creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals with the words Hazardous Waste Pharmaceuticals. Healthcare facilities and reverse distributors must also track or manage rejected shipments by sending a copy of the manifest to the designated facility that returned or rejected the shipment. Additionally, healthcare facilities and reverse distributors must submit exception reports for a missing copy of a manifest. Reverse distributors are required to amend their contingency plan under 40 CFR 262 Subpart M. A reverse distributor must submit an unauthorized hazardous waste report if it receives waste it is not authorized to receive.

The latest form for Management Standards for Hazardous Waste Pharmaceuticals (Renewal) expires 2027-03-31 and can be found here.