Today, EPA released its proposed Management Standards for Hazardous Waste Pharmaceuticals Rule.  A pre-publication copy is available here.

The proposed rule, if finalized, will add a subpart P under 40 CFR part 266, which applies to the management of hazardous waste (HW) pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors.  All pharmaceutical reverse distributors will be required to manage HW pharmaceuticals under this subpart, not 40 CFR part 262.  Subpart P creates a new category of hazardous waste entities, pharmaceutical reverse distributors – such entities will no longer be regulated a hazardous waste generators under 40 CFR part 262 or as TSDFs under 40 CFR parts 264, 265 and 270.

At the healthcare facility level, there will be different standards for a “potentially creditable hazardous waste pharmaceutical” and a “non-creditable hazardous waste pharmaceutical”—two terms defined in the proposed rule.  A potentially creditable HW pharmaceutical must meet three criteria: it must 1) have the potential to receive manufacturer’s credit; 2) be unused or unadministered; 3) and be unexpired or less than on year past the expiration date.  Potentially creditable HW pharmaceuticals can be sent to a reverse distributor, in accord with certain standards.  Non-creditable HW pharmaceuticals are not expected to be eligible for manufacturer’s credit.  Such pharmaceuticals must be managed onsite, at the healthcare facility, transported as hazardous waste, and sent to a hazardous waste RCRA interim status or permitted facility.  In other words, it cannot be sent to a pharmaceutical reverse distributor.

As the proposed rule is more stringent than existing federal standards, states with authorized RCRA programs will be required to modify their programs to adopt the amendments. When a state adopts the new subpart P, if elements of the state program are more stringent, the state will have the option of retaining those more stringent elements. States also have the option of adding elements to their programs that are more stringent or broader in scope than the new subpart.  If the rule is finalized, Florida and Michigan, which have added HW pharmaceuticals to its universal waste programs, will have to modify their programs and remove the HW pharmaceuticals from their universal waste program.   No state will be able to add HW pharmaceuticals to their universal waste programs (non-hazardous pharmaceuticals, on the other hand, may be added).  Therefore, while the proposed rule does much to level the playing field of state-by-state regulation in this area, the door remains open for additional, more stringent regulation at the state level.