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USP <800>: Effective date pushed back to 2019, but experts urge early adoption

Medical Environment Update, December 1, 2017

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Without the ‘body counts’ that bolstered USP <797>, will regulators feel the pinch to make USP <800> mandatory?

The U.S. Pharmacopeia Convention (USP) published standards in 2016 to protect workers who handle hazardous drugs. Those standards, contained in the chapter known as USP <800>, were slated to become fully enforceable on July 1, 2018, but USP announced in late September that it would postpone that date by 17 months, to December 1, 2019.

The delay was made “to provide a unified approach to quality compounding” by aligning USP <800> with the timeline of an earlier chapter already in force, USP <797>, the organization said in a statement announcing the postponement. The next round of revisions to USP <797>, which aims primarily to protect patients by addressing sterile preparations in pharmaceutical compounding, is expected to be published for public comment in fall 2018 with an effective date on December 1, 2019—though organizations could have longer to implement certain sections.

The new deadline might seem like it’s a long way off, and it remains unclear exactly which authorities having jurisdiction (AHJ) will require compliance with USP <800>. But USP and others encourage healthcare organizations to adopt these standards early, especially since they’re not expected to change and they represent the culmination of more than three decades of work to protect healthcare workers and foster safe environments despite the presence and use of dangerous drugs.

This is an excerpt from a member only article. To read the article in its entirety, please login or subscribe to Medical Environment Update.