A pre-publication draft of a proposed rule by EPA may clarify hazardous waste requirements for obsolete or defective pharmaceuticals.  EPA proposes a new Subpart P entitled “Hazardous Waste Pharmaceuticals” to 40 CFR Part 266 of its RCRA regulations.  The rule provides tailored, sector-specific standards for the management of hazardous waste pharmaceuticals by healthcare facilities (including pharmacies), transporters and reverse distributors.

The proposed rule creates management requirements for two categories of hazardous waste pharmaceuticals:  “potentially creditable” and “non-creditable.”  The distinction between “potentially creditable” and “non-creditable” hazardous waste pharmaceuticals is that the “potentially creditable” category has the potential to receive manufacturer’s credit upon return and is (i) unused or unadministered, and (ii) unexpired or less than one year past expiration date.  Non-creditable pharmaceuticals are those pharmaceuticals for which no manufacturer’s credit is anticipated.

“Potentially creditable” hazardous waste pharmaceuticals are subject to relaxed standards.  For example, no manifest is required, common carriers may be used for transportation and biennial reporting is eliminated.  “Non-creditable” hazardous waste pharmaceuticals are subject to standards generally applicable to small quantity generators.  However, these wastes may be accumulated for up to a year, and biennial reporting is eliminated.

The proposed rule also evidences certain policy changes at EPA regarding management of pharmaceutical wastes.  For example,

• The discharge of “hazardous waste pharmaceuticals” into a public sewer system would be banned;
• Pharmaceuticals regulated as a controlled substance by the Drug Enforcement Agency (DEA) would be exempt from the regulations provided they are disposed of in compliance with DEA regulations and meet other requirements;
• Health care facilities would be subject to onsite management requirements for potentially creditable hazardous waste pharmaceuticals, and a new tracking system would be required for those materials shipped to a reverse distributor.
• Dose containers and dispensing bottles or vials and residues inside the containers escape regulation if the container is “empty” as defined by the proposed rule; and
• Large quantity generator requirements as a classification are eliminated for healthcare facilities in certain circumstances, i.e., the weight of pharmaceutical waste would not count toward a facility’s generator status.

If promulgated as a final regulation, the rule would provide welcome relief to pharmacies and healthcare facilities now faced with uncertainties associated with managing hazardous waste pharmaceuticals.  Comments on the proposed rule are due within 60 days of publication in the Federal Register.

A pre-publication version of the proposed rule may be found here.