RCRA Pharmaceutical Waste Rule Goes Into Effect; EPA Posts Maps Showing Where Rule Is In Effect

On February 22, 2019, EPA issued the final Resource Conservation and Recovery Act (RCRA) rule streamlining standards for managing hazardous waste pharmaceuticals. 84 Fed. Reg. 5816. The rule took effect on August 21, 2019.

Certain pharmaceuticals are regulated as hazardous waste under RCRA when discarded. The final rule removes these pharmaceuticals from full RCRA regulation and creates a new Part 266 Subpart P for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. Healthcare facilities (for both humans and animals) and reverse distributors will manage their hazardous waste pharmaceuticals under this new set of sector-specific standards in lieu of RCRA generator regulations in Part 262. The new rule also prohibits the disposal of hazardous waste pharmaceuticals down the drain (sewering) and eliminates the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances. The rule maintains the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take-back programs and events.

The new Subpart codifies EPA’s prior policy on the regulatory status of nonprescription pharmaceuticals going through reverse logistics. Specifically, the rule reaffirms that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being used/reused or legitimately reclaimed are not solid or hazardous waste.

EPA also is amending the P075 acute hazardous waste listing of nicotine and salts to exclude certain U.S. Food and Drug Administration (FDA) approved over-the-counter (OTC) nicotine replacement therapies  (i.e., nicotine patches, gums and lozenges).  The rule exempts these therapies from the P075 hazardous waste listing.

The final rule also establishes a policy on the regulatory status of unsold retail items that are not pharmaceuticals and are managed via reverse logistics. 

EPA on September 4, 2019, posted an online, interactive map displaying the states and territories where the rule is in effect. There are two maps that show:

• Locations where the management standards for hazardous waste pharmaceuticals (40 C.F.R. Part 266 Subpart P) are in effect; and
•  Locations where the amendment to the P075 listing for nicotine (40 C.F.R. § 261.33) is in effect.

Underneath the map is a table with this state adoption and authorization information, and links to the state and federal regulations. As states adopt these regulations, EPA will update the maps.