On December 12, 2018, the EPA released its long-awaited Management for Hazardous Waste Pharmaceuticals Rule. The EPA addressed industry concerns by amending the hazardous waste listing for nicotine to exclude nicotine replacement therapies (NRTs) in this rulemaking, but challenges remain in the new management standards.
Here are a few noteworthy takeaways as we continue to analyze the rule and its implications:
The exclusion of NRTs is a big win … so long as states follow suit
FDA-approved, over-the-counter NRTs (nicotine patches, gums, and lozenges) have been removed from the P075 hazardous waste listing. This means that these products will not be considered hazardous waste when discarded. As a p-listed waste, NRTs were classified as acutely hazardous, and just 1 kg of acutely hazardous waste generated per month pushes a facility into the most stringently regulated large quantity generator (LQG) status. Now, NRTs will not impact generator status and can be discarded with a retail store’s municipal waste.
This relief is not without limitation. A state must adopt the P075 amendment for the regulatory relief to apply. States can—and very well may—retain NRTs’ status as acute hazardous waste.
EPA changed its historic point of generation position, potentially creating management challenges
The EPA has historically taken the position—in guidance—that reverse distribution systems do not trigger Resource Conservation and Recovery Act (RCRA) regulation until a credit determination, and a related discard determination, is made. Only at this point does a pharmaceutical become (hazardous) waste. This position has enabled drugs to flow freely to reverse distributors for appropriate processing, without triggering stringent RCRA regulation.
The final rule changes this position for prescription (Rx) drugs, which the EPA now deems solid waste at a health care facility. On the other hand, over-the-counter (OTC) drugs are considered a product (i.e., not waste) until a reverse logistics center makes a discard decision. However, those OTC drugs must have a reasonable expectation of use/reuse. Placing drugs in such multiple regulatory categories at a health care facility may quickly lead to challenges for on-the-ground implementation and management.
The conditional exemption for controlled substances eases compliance burdens and disposal costs
As indicated in the proposed rule, the EPA has finalized a conditional exemption from hazardous waste regulation for those drugs that are both a controlled substance (CS) and hazardous waste upon discard, so long as they are managed and disposed of in compliance with the DEA Disposal Act regulations, at a combustor or incinerator. This exclusion also applies to CSs from ultimate users that are mixed with non-controls and collected by a DEA-registered collector. This exclusion eliminates a challenging EPA/DEA dual regulatory scheme, reducing waste management burdens and disposal costs.
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