BREAKING NEWS: EPA issues final Hazardous Waste Pharmaceutical Rule
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December 13, 2018
BREAKING NEWS: EPA issues final Hazardous Waste Pharmaceutical Rule

Signed by the EPA Administrator on December 11, 2018, EPA announced today 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 P075 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.

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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, gums, 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 and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed.

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 BLR’s Environmental News in the coming days.


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