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REVISED PHARMACEUTICAL REGULATIONS ARE COMING!

Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine

PA’s Acting Administrator signed the final rule, titled, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” on December 11, 2018 and it was published in the Federal Register (FR) on February 22, 2019.

Under this final rule, FDA-approved, over-the-counter nicotine replacement therapies such as; nicotine patches, gums and lozenges will no longer be considered hazardous waste when discarded, which will result in significant cost savings and burden reduction in the management of these types of nicotine wastes.

This final rule reaffirms EPA’s long-standing policy that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed are not solid waste. It also provides regulatory certainty that the Resource Conservation and Recovery Act (RCRA) applies when healthcare facilities send unused, unsaleable prescription hazardous waste pharmaceuticals to reverse distributors to receive manufacturer credit. Simultaneously, the rule incorporates flexibilities to accommodate current reverse distribution business practices to facilitate its implementation.

Please utilize the link below to read more on this Final Rule. And feel free to contact should you require additional information or if you would like to discuss this topic.

Sincerely,

Kandy M. Miller-Boyer, President

https://www.epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075

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