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Monographs Affected by Revisions to <795> Pharmaceutical Compounding— Nonsterile Preparations and <797> Pharmaceutical Compounding — Sterile Preparations

Type of Posting: Notice of Intent to Revise
Posting Date: 10-June-2019
Targeted Official Date: 1-May-2020
Expert Committee: Various

In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees intend to revise multiple monographs in response to the revision of General Chapters <795> Pharmaceutical Compounding—Nonsterile Preparations and <797> Pharmaceutical Compounding—Sterile Preparations.

General Chapter <795> was proposed for comment in Pharmacopeial Forum 44(3), and General Chapter <797> was proposed for comment in Pharmacopeial Forum 44(5). Both chapters appear in the Second Supplement to USP 42–NF 37 and will be official on December 1, 2019. USP has identified several monographs that reference <795> and <797>, some of which require revisions to modify these references. These references will be updated when the monographs appear in USP 43–NF 38. A list of the monographs that will be modified can be found here

All modifications to the monographs listed will become official on May 1, 2020.

Please also see the Compendial Notice: New Revision Markup for Reference Changes in USP–NF for details on the revision markup used to identify the reference updates.

Interested stakeholders are encouraged to alert USP staff to any impact they may recognize related to the update of these monographs.

Should you have any questions or comments, please contact Jeanne Sun, Manager, Compounding (