Regulatory Developments

Final Hazardous Waste Pharmaceutical Rule Issued by EPA

Signed by the EPA Administrator on December 11, 2018, EPA announced on December 13 that it is issuing the long-awaited final rule to manage hazardous waste pharmaceuticals generated by healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and reverse distributors.

Three years after it was proposed, the final rule, now entitled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P0875 Listing for Nicotine” will likely be published in the Federal Register (FR) by the end of this month and go into effect 6 months after its publication in the FR.

The most significant change from the proposed rule is that the final rule adds provisions so that FDA-approved, over-the-counter nicotine replacement therapies (e.g., nicotine patches, gun, and lozenges) will no longer be considered hazardous waste when discarded. The second notable change from the proposed rule is an establishment of EPA’s policy on the regulatory status of unsold retail items, including nonprescription pharmaceuticals managed ad reverse logistics.

For a pre-publication version of the final rule, visit the EPA’s site. For an in-depth analysis of the final rule, keep your eye on the EHS Daily Advisor in the coming days.

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