Management of Hazardous Waste Pharmaceuticals
2013 Proposal to Address the Management of Hazardous Waste Pharmaceuticals
The Agency is in the process of developing a new proposal to establish appropriate standards for the management and disposal of hazardous waste pharmaceuticals generated by healthcare facilities. This most recent effort is a continuation of the December 2, 2008 proposal to add hazardous waste pharmaceuticals to the Universal Waste Program. Public comment on the December 2008 proposal revealed numerous concerns over the lack of notification requirements for those facilities that generate, handle or transport “universal waste” pharmaceuticals as well as for the lack of tracking requirements for the shipment of these wastes. Therefore, the Agency decided to not finalize the 2008 proposed rule, but rather develop another proposal for new standards for the management and disposal of hazardous waste pharmaceuticals that are generated by healthcare-related facilities. With the new rule, the concerns raised by the public comments regarding notification and tracking issues can be more fully addressed as well as other hazardous waste pharmaceutical management issues that are more specific to healthcare facilities. This new proposed rulemaking will only pertain to those pharmaceutical wastes the meet the current definition of a RCRA hazardous waste and that are generated by healthcare-related facilities.
2013 Proposal Status
The new proposal for healthcare facility-specific management standards for hazardous waste pharmaceuticals is currently under development. We anticipate that the proposed rule will be published and available for public comment in August 2013. For information on the development of regulations, please see: The Basics of the Regulatory Process.
How Are Hazardous Waste Pharmaceuticals Currently Regulated?
Until the newly proposed rule is finalized and adopted by authorized states, healthcare facilities and other business entities that generate hazardous waste pharmaceuticals must manage these wastes in accordance with the RCRA Subtitle C generator requirements.
Hazardous Waste Pharmaceutical Resources
- Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the United States; revised August 2008.
Guidance Memos and Letters
- Scope of Hazardous Waste Listing P046 (Phentermine)
- Containers that Once Held P-listed Pharmaceuticals
- Unused discarded nicotine patches, gum and lozenges are P075; used discarded nicotine patches are not P075
- Residual P- and U-listed pharmaceuticals left in used syringes have been used for their intended purpose and are not listed hazardous wastes
- Scope of Hazardous Waste Listing P042 (Epinephrine)
- Medicinal nitroglycerine that does not exhibit the reactivity characteristic (D003) is not P081
- Chloral hydrate can be U034
- Epinephrine residue in a syringe is not P042
- Cyclophosphamide monohydrate can be U058
Hazardous Waste Pharmaceuticals Wiki
- The Hazardous Waste Pharmaceutical Wiki public platform for healthcare professionals to share their expertise regarding whether pharmaceuticals are hazardous waste when discarded.
Healthcare Environmental Resource Center
Pharmaceutical Collection Programs and Events
- Pharmaceutical collection programs and events FAQs
- EPA's Recommendation for Incinerating Pharmaceuticals from Take-Back Events
2008 Universal Waste Proposal
On December 2, 2008, EPA proposed to add hazardous waste pharmaceuticals to the Universal Waste Program in order to facilitate their proper management and disposal. However, due to the adverse public comments received regarding the lack of notification and tracking requirements under the Universal Waste program, the Agency has decided not to finalize the 2008 proposal. Instead EPA is utilizing the comments received on the 2008 proposal to re-focus its efforts by proposing new healthcare facility-specific standards for the management of hazardous waste pharmaceuticals.
For historical purposes, please see the following links for the Federal Register notices for the December 2, 2008 proposal to add hazardous waste pharmaceuticals to the federal Universal Waste program and the notice for the extension of the comment period.
- Federal Register Notice | PDF Version (26 pp, 345K, about PDF) - Proposed Rule - December 2, 2008
- Federal Register Notice | PDF Version (1 pg, 61K, about PDF) - Extension of the Comment Period - January 30, 2009
- Select Docket Search
- Select "Environmental Protection Agency" from the Agency drop-down menu
- In the Docket ID box, type in the docket number (EPA-HQ-RCRA-2007-0932) and press the "Submit" button to receive search results