On February 22, 2019, the US Environmental Protection Agency (the EPA) published in the Federal Register its final rule for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors, Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P076 Listing for Nicotine (the Waste Pharmaceuticals Rule). 84 Fed. Reg. 5816 (Feb. 22, 2019). The Waste Pharmaceuticals Rule, which the EPA announced in pre-publication form on December 11, 2018, contains three separate sets of requirements, each with its own implementation deadlines and conditions. For more information regarding the history of the Waste Pharmaceuticals Rule, see our January 8, 2019 alert.
- The first part of the rule creates new sector-specific standards under the Resource Conservation and Recovery Act (RCRA) for healthcare facilities and reverse distributors (now codified at 40 C.F.R. Part 266, Subpart P). Subpart P prohibits healthcare facilities and reverse distributors from disposing of hazardous waste pharmaceuticals down the toilet or drain (sewering) but also provides additional flexibility for the management of hazardous waste pharmaceuticals compared to the general RCRA hazardous waste generator regulations in 40 C.F.R. Part 262, under which they were previously regulated.
- The second part of the Rule provides regulatory certainty for reverse logistics and distribution systems by codifying the EPA’s existing policy that nonprescription pharmaceuticals that are sent through reverse logistics are not solid waste at the healthcare facility if there is a reasonable expectation the pharmaceuticals will be legitimately used/reused (i.e., lawfully redistributed for their intended purpose) or reclaimed. In contrast, prescription pharmaceuticals sent from healthcare facilities to reverse distributors are regulated as solid waste at the healthcare facility because they are not reasonably expected to be used/reused or reclaimed.
- The third part of the Rule provides that over-the-counter nicotine replacement therapies (such as nicotine patches, gums and lozenges) approved by the US Food and Drug Administration (the FDA) are not hazardous waste when discarded.
The effective date of the Waste Pharmaceuticals Rule is six months after publication, or August 21, 2019. However, because under Section 3006 of RCRA, 42 U.S.C. § 6926, the EPA may authorize individual states to operate their hazardous waste programs in lieu of the federal program, the effective date for many parts of the Waste Pharmaceuticals Rule will vary by state, and some aspects of the Rule may never become effective certain states. In general, the following deadlines apply.
- The probation on sewering of hazardous waste pharmaceuticals will be effective nation wide beginning August 21, 2019. The remainder of new Subpart P does not become effective in authorized states until it is incorporated into the state hazardous waste programs. In addition, states are only required to incorporate provisions of Subpart P that are more stringent than existing federal requirements and may elect not to adopt provisions that are less stringent. States also may adopt additional requirements that are more stringent than the federal ones. Authorized states must have until July 1, 2021 to adopt the Subpart P requirements or, if a statutory amendment is required, until July 1, 2022.
- The distinction between reverse logistics of non-prescription pharmaceuticals and reverse distribution of prescription pharmaceuticals codifies the EPA’s existing position that products in such systems are solid wastes unless there is a reasonable expectation that they will be legitimately used/reused or reclaimed and is effective immediately.
- Authorized states are not required to adopt the exclusion for over-the-counter nicotine replacement therapies approved by the FDA, which is less stringent than current federal requirements.
Industry sources report that they are continuing to evaluate the Waste Pharmaceutical Rule and have not reached any decision as to potential challenges, but the varying requirements that will exist among the states during the implementation period is a potentially significant concern.