Updates on the Pharmaceutical Waste Legislative and Regulatory Efforts
California State Sen. Hannah-Beth Jackson’s (D-Santa Barbara) bill, SB 1014, which would implement a statewide pharmaceutical drug take-back program, failed to pass the Senate Business, Professions and Economic Development Committee. Jackson’s legislation was modeled after an Alameda County ordinance, which is currently pending review in the Ninth Circuit. The bill would have required drug manufacturers to develop and finance a statewide system for collecting and disposing of unwanted pharmaceuticals. Despite approval by 100 local government and environmental groups, the pharmaceutical industry and many state senators opposed the bill. Jackson plans to reintroduce the bill next year, and, in the meantime, plans to issue guidance to help local governments implement their own drug take-back programs.
Also of note, EPA released its 2015 FY budget justification detailing high priority regulations it will continue to pursue under RCRA. A high priority EPA identifies is the promulgation and implementation of final regulations on the management of pharmaceutical wastes. The regulations will apply to the management and disposal of hazardous waste pharmaceuticals generated by “healthcare facilities.” They are expected to address notice and tracking concerns and clarify the regulation of reverse distribution under RCRA. More generally, it should clarify application of RCRA to pharmaceuticals – a goal supported by retailers, in light of recent enforcement actions. This proposed rule, which is expected August 2014, is certainly one to keep an eye on.
The Drug Enforcement Administration (DEA) has yet to take action to implement the Secure and Responsible Drug Disposal Act of 2010, despite pressure from Sen. Amy Klobuchar (D-MN). As we discussed in a blog here, DEA was expected to issue regulations last month.
Written by Elise Paeffgen, Associate, Alston & Bird LLP | Follow us on Twitter