Sharps Compliance’s White Paper Explains the EPA’s New Hazardous Waste Pharmaceutical Rule – Is Your Facility Ready?


EPA’s New Pharmaceutical Rule – Takes Effect 08/21/19

The EPA’s recently finalized Pharmaceutical Rule is effective on August 21, 2019 – six months after being published in the Federal Register. This final rule, referred to as Subpart P, and titled Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” is a sector-based rule for the healthcare industry. Continue reading “EPA’s New Pharmaceutical Rule – Takes Effect 08/21/19”


P-Listed Hazardous Waste

P-listed waste, or “acutely toxic” waste, is formally defined by the EPA as “pure and commercial grade formulations of certain unused chemicals that are being disposed.”  To meet this definition, the unused chemical must be listed under 40 CFR 261.33 and be part of a commercial chemical product, such as a medication.

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USP <800> Compliant Hazardous Drug Spill Control Kits from Sharps Compliance

Beginning December 1, 2019, compounding pharmacies and other healthcare facilities that handle hazardous drugs (HD) must have USP <800> compliant spill kits on-site. This is an effort to protect workers in the event of accidental spills of HDs. The requirement is part of USP General Chapter 800, which “describes the practice and quality standards for handling hazardous drugs.”  Sharps Compliance is introducing the Hazardous Drug Spill Control Kit™ for the safe cleanup and disposal of spilled chemotherapy and other hazardous drugs.

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EPA’s New Pharmaceutical Rule – Origin and Reason for the Rule

The Environmental Protection Agency’s (EPA) long-awaited final rule for managing hazardous waste pharmaceuticals generated by healthcare facilities was finalized and published in the Federal Register on February 22, 2019. This rule had its origins in the EPA’s 2008 Universal Waste proposal for pharmaceutical waste – and perhaps even earlier based on comments to the EPA from retailers.

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