March 27, 2015

RCRA regulation of hazardous waste pharmaceuticals –proposed rule forthcoming this summer

From: Association of Corporate Counsel

Elise N. Paeffgen | Alston & Bird LLP

On March 19, 2015, EPA sent its proposed rule, “Management Standards for Hazardous Waste Pharmaceuticals,” to the White House Office of Management and Budget (OMB) for pre-publication review.  This review may take up to 90 days (barring a one-time 30-day extension).  Unless OMB returns the rule to EPA for reconsideration, we expect the proposed rule to be released this summer.  This rule will have major implications for the pharmaceutical reverse distribution industry and the management of non-dispensable pharmaceuticals at health care facilities.

The fall 2014 Unified Agenda states that the rule is “intended to clarify regulation of a major mechanism used by health care facilities for management of unused and/or expired pharmaceuticals, known as reverse distribution.”  This “clarity” and the path forward for the pharmaceutical reverse distribution industry hinges predominantly on two facets of the rule:

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