Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine
On this page:
Rule Summary
EPA's Acting Administrator signed the final rule, titled, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine>” on December 11, 2018 and it was published in the Federal Register (FR) on February 22, 2019.
This final rule establishes cost-saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment.
Importantly, this final rule will make our drinking and surface water safer and healthier by reducing the amount of hazardous waste pharmaceuticals entering our waterways by 1,644 to 2,300 tons on an annual basis by prohibiting all facilities subject to the rule from sewering them. This action will help address the issue highlighted by a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.
In addition, under this final rule, Food and Drug Administration-approved, over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums and lozenges) will no longer be considered hazardous waste when discarded, which will result in significant cost savings and burden reduction in the management of these types of nicotine wastes.
Finally, the final rule 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. It also provides regulatory certainty that the Resource Conservation and Recovery Act (RCRA) applies when healthcare facilities send unused, unsaleable prescription hazardous waste pharmaceuticals to reverse distributors to receive manufacturer credit. Simultaneously, the rule incorporates flexibilities to accommodate current reverse distribution business practices to facilitate its implementation.
Webinar Recording and Slides Available
EPA presented a webinar about the contents of the final rule on April 2, 2019 and a recording of that webinar is available. Click the "View Archive" button on the webinar webpage to access the recording. Additionally, the presentation slides from the webinar can be found in the "Webinar Slides" tab on this same page.
Technical Corrections
On August 9, 2023, EPA corrected and clarified technical errors in approximately 50 sections of the hazardous waste regulations. With this rule, EPA fixed typographical errors, incorrect citations, and language that was unintentionally ambiguous in the Hazardous Waste Generator Improvements Rule, the Hazardous Waste Pharmaceuticals Rule, and the Definition of Solid Waste Rule. EPA also identified several other provisions that needed to be corrected that are located in the same sections of the regulations.
This technical corrections rule became effective on December 7, 2023, except for eight amendments that EPA withdrew. The comment period closed on October 10, 2023, and EPA received adverse comments on eight specific amendments. To address these adverse comments, EPA published a notice of withdrawal in the Federal Register on December 6, 2023 that became effective on December 7, 2023.
The eight amendments that EPA withdrew from the direct final rule were related to: 40 CFR section 261.4(e)(1) introductory text, section 262.11(d) introductory text, section 262.11(g), section 262.16(b)(1), section 262.17(a)(8)(i), section 262.17(a)(8)(i)(A), section 262.232(b)(6)(iv), and section 266.508(a)(2)(ii).
On December 11, 2024, EPA finalized five of the withdrawn amendments to the 2016 Hazardous Waste Generator Improvements Rule and the 2019 Hazardous Waste Pharmaceuticals Rule. After evaluating the adverse comments, EPA decided to revise and finalize these amendments to correct and clarify the regulations for generators and handlers of hazardous waste. In this final rule, we respond to the relevant comments and explain what changes we made to the regulations.
On February 5, 2025, EPA delayed until March 21, 2025, the effective date of the five amendments that we finalized on December 11, 2024. Read more in the FR notice.
Rule History
In 2008, EPA proposed to add pharmaceuticals to the types of hazardous wastes that could be managed as Universal Wastes (volume 73 of the FR - starting on page 73520, December 2, 2008). Although commenters supported the idea of new regulations for the management of pharmaceuticals, there were numerous concerns over the lack of notification requirements for those facilities that generate, handle or transport pharmaceutical “universal wastes” 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 pharmaceutical hazardous waste that are generated by healthcare-related facilities.
EPA issued a new proposal for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors on September 25, 2015 (80 FR 58014). This proposal responded to the concerns raised on the universal waste proposal as well as feedback from the RCRA Retail Notice of Data Availability (79 FR 8926, February 14, 2014).
EPA significantly engaged states and other interested parties on these issues over the years and carefully evaluated the comments from states, pharmacies, retailers, healthcare facilities, reverse distributors, environmental organizations, and other members of the public. This final rule incorporates certain significant changes from the proposal to address comments and provide additional flexibilities.
Compliance
Guidance
- EPA's Regulations on Reverse Distribution and Policy on Reverse Logistics.
- Manifesting Non-Creditable Hazardous Waste Pharmaceuticals - New Four Character Code (pdf).
- Memo Regarding Applicability of 40 CFR Part 266 Subpart P to Intermediate Care Facilities (pdf).
- Frequent Questions.
- EPA’s Ban on Sewering Pharmaceuticals: