Management Standards for Hazardous Waste Pharmaceuticals (Renewal)

Section 3001 of the Resource Conservation and Recovery Act (RCRA) of 1976, as amended, requires the Environmental Protection Agency (EPA) to identify which solid wastes are hazardous wastes and therefore must be managed as hazardous waste during treatment, storage, or disposal. Under this authority, EPA established four hazardous waste characteristics (toxicity, reactivity, ignitability, and corrosivity), and listed specific wastes that must be managed as hazardous wastes. EPA is revising the regulations to improve management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions are also intended to clarify regulation of the reverse distribution mechanism used by healthcare facilities for management of unused and/or expired pharmaceuticals. EPA is adding a new subpart P under part 266. This new subpart is a tailored, sector-specific regulatory framework for managing hazardous waste pharmaceuticals at healthcare facilities and reverse distributors. Healthcare facilities that are currently small quantity generators (SQGs) or large quantity generators (LQGs) and all reverse distributors, regardless of RCRA generator category, will be required to manage hazardous waste pharmaceuticals under this new subpart P of part 266, in lieu of part 262. That is, the final standards are not an optional alternative to managing hazardous waste pharmaceuticals under part 262, they are mandatory standards. Healthcare facilities will have different management standards for their non-creditable and potentially creditable hazardous waste pharmaceuticals. Non-creditable hazardous waste pharmaceuticals will be managed on-site similar to how they would have been under the 2008 Universal Waste proposal for pharmaceutical waste. When they are shipped off-site, they must be transported as hazardous wastes and sent to a RCRA interim status or permitted hazardous waste facility. On the other hand, healthcare facilities will continue to be allowed to send potentially creditable hazardous waste pharmaceuticals to reverse distributors for verification of manufacturer credit. EPA is finalizing standards to ensure the safe and secure delivery of the potentially creditable hazardous waste pharmaceuticals to reverse distributors. EPA is also finalizing standards for the accumulation of the hazardous waste pharmaceuticals at reverse distributors. The standards regard reverse distributors as a new type of hazardous waste entity called reverse distributors. The key provisions of EPAs final rule are: 1)Hazardous waste pharmaceuticals managed under the new rule are not counted toward a facilitys RCRA generator status; 2) Reverse distributors must comply with LQG-like standards regardless of the quantity of hazardous waste pharmaceuticals that they manage; 3) FDA approved over-the-counter nicotine replacement therapies, such as patches, gums, and lozenges, will no longer by managed as hazardous waste; and 4) Sewer disposal of hazardous waste pharmaceuticals is prohibited.

The latest form for Management Standards for Hazardous Waste Pharmaceuticals (Renewal) expires 2022-05-31 and can be found here.