As we previously discussed in our September 2, 2015 and September 29, 2015 client updates, the U.S. Environmental Protection Agency (EPA) has published a proposed rule for managing hazardous waste pharmaceuticals. The proposed rule can be found at 80 Fed. Reg. 58014 (Sept. 25, 2015). If finalized in its current form, this rule will significantly change the requirements for the return and/or disposal of unused pharmaceuticals.
The scope of the proposed rule is quite broad, for several reasons. First, the definition of a regulated “healthcare facility” is expansive. Categories of covered entities include: hospitals, ambulatory surgical centers, and psychiatric hospitals; pharmacies; retailers of over-the-counter medicines and dietary supplements; physicians’ offices, optical and dental offices; chiropractors; outpatient care centers, ambulatory health care services; facilities engaged in nursing care; veterinary clinics; and pharmaceutical reverse distributors.
Second, the proposed definition of “pharmaceutical” is also quite broad, applying to medications in all dose forms, including tablets, capsules, medicinal gums or lozenges, medicinal liquids, ointments and lotions, IV or other compounded solutions, vaccines, medicinal shampoos, antiseptics, and skin patches.
The EPA had initially set a comment period of 60 days; i.e., comments would be due by November 24, 2015. Based on numerous requests for additional time, the comment period has been extended by an additional 30 days, until December 24, 2015. This extension was announced at 80 Fed. Reg. 68491 (November 5, 2015).
Because the proposed regulations will create numerous new notification and tracking requirements, we recommend that interested parties use the extended comment period to consider the impact of the proposed rule on current practices, and submit comments to the EPA if there are less cumbersome—and less costly —ways to achieve the goals of the proposed rule.
Currently, the EPA estimates that the rulemaking will be finalized in 2016. However, the process could take longer, depending on the volume and nature of comments submitted to the agency.