Opportunity for Public Comment: Revisions to USP 797Pharmaceutical Compounding - Sterile Preparations

On September 25, 2015, the U.S. Pharmacopeial Convention (USP) Compounding Expert Committee pre-posted revisions to General Chapter <797> Pharmaceutical Compounding – Sterile Preparations for public comment. The purpose of these revisions is to clarify requirements, reflect stakeholder feedback, and incorporate new information. The proposed revisions will be published for public comment in Pharmacopeial Forum (PF) 41(6) [Nov.–Dec. 2015] on November 2, 2015.

The USP will hold an open microphone web meeting on Wednesday, October 21, 2015 at 2:00 pm – 4:00 pm Eastern to discuss the proposed revisions.

Partner organizations are encouraged to review the proposed revisions and provide comment as you see fit.

Important Links:

• More information about the proposed revisions and how to submit public comments can be found on the USP website.
• The proposed revisions with line numbers can be viewed here [PDF - 803 KB].
• Registration information for the open microphone meeting can be found here.