Docket Number:
FDA-2019-D-1768
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Veterinary Medicine

This guidance assists applicants and drug master file (MF) holders in the initiation of either revisions to an existing monograph(s) or development of a new monograph(s) under the United States Pharmacopeial Convention Pending Monograph Process (USP-PMP) during FDA’s evaluation of a drug master file or drug product application.2 This guidance describes the process that allows for the revision of compendial standards that are harmonized with the approved quality and labeling requirements for a drug product application.

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All written comments should be identified with this document's docket number: FDA-2019-D-1768 .