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Compounding ALERT: USP Seeks Public Comments on Draft Revisions of Chapter <795>

For the first time, proposed revisions to USP General Chapter <795> will go through a public comment process. Comments can be submitted through a form on USP’s website no later than July 31, 2018.

USP General Chapter <795> governs standards for non-sterile compounding pharmacies, describing the requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training.

Frier Levitt highly recommends commenting during this open public forum as these standards will have a direct impact on your non-sterile compounding business. If you have questions regarding the commenting process, or would like assistance in drafting a comment, contact Frier Levitt today.