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JANUARY 23, 2024

USP Chapter 797 Compliance Is ‘a Continuous Journey’

By Marcus A. Banks
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Kevin Hansen, PharmD

The newly revised USP General Chapter <797>, which became official on Nov. 1, provides compounders pathways to achieve extended beyond-use dates (BUDs) for compounded sterile preparations, with increasing BUDs corresponding to more rigorous requirements including personnel, environmental and product testing. These were among the key messages at the ASHP 2023 Midyear Clinical Meeting & Exhibition, in Anaheim, Calif.

Another is that compounding