Proposed Pharmaceutical Rule Receives Concerns, Some Praise

The comment period on EPA's proposed Management Standards for Hazardous Waste Pharmaceuticals closed on December 24. Comments on the proposed rule raised several concerns, and lauded some of its provisions. The principal item criticized was the rule's classification of pharmaceuticals in the "reverse distribution" process as waste. Healthcare facilities and retailers send unused or unsold pharmaceuticals to a central location, and receive credit from the manufacturer.  Pharmaceuticals received at the location that are determined to be waste are then disposed in a manner compliant with the Resource Conservation and Recovery Act (RCRA). Comments on the proposed rule took the position that it is inappropriate to categorize pharmaceuticals that are in the reverse distribution process as waste until they are determined by the reverse distributor to be waste, on the basis that they are not "discarded" until that point. The EPA proposed rule deems the pharmaceuticals to be