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 “discarded”, and therefore waste, at the point that healthcare facilities or retailers send them to a reverse distributor.  Concern was raised that such a categorization reverses 30 years of EPA policy, and imposes unnecessary waste management practices on healthcare facilities and retailers.

Concern was also raised regarding the rule’s proposal to remove waste codes for pharmaceuticals on RCRA manifests.  Comments from the commercial hazardous waste management industry indicated that compliance with hazardous waste classification requirements should remain with the generator of the waste and not be shifted to waste management facilities.

Commenters praised the rule’s proposals to amend the current classification of low concentration nicotine products as acutely hazardous waste; to provide a conditional exemption for hazardous waste pharmaceuticals that are also controlled substances because Drug Enforcement Administration rules govern their disposal; to ban disposal of pharmaceuticals in sewage discharges; and to exempt pharmaceuticals managed pursuant to the rule’s waste management standards from counting toward a facility’s hazardous waste generator status.

For more information on the proposed pharmaceuticals rule or on the management of waste pharmaceuticals generally, contact Steve O’Day or Phillip Hoover.

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