Both USP and FDA have mechanisms in place for interested parties to make comments on proposed documents.
1. Guidance Documents
FDA’s proposed guidance documents are written using good guidance practices and published for comment per 21 CFR 10.115. They are easily accessible to the public via our Web site and through the Federal Register. FDA’s Division of Dockets Management is the office responsible for receiving all comments on proposed guidance. Interested parties can read and submit comments via FDA’s Dockets Management Web site. FDA reviews all received public comments, makes appropriate modifications, and publishes a final document.
2. USP Monographs
USP publishes proposed chapters or monographs in the Pharmacopeial Forum, a publication that is issued bimonthly. USP subscribers have access to these publications and can send comments (within a 90-day post publication comment period) for consideration by the USP. Finalized proposals (official revisions, new chapters, or monographs) are published in subsequent supplements to or editions of the Pharmacopeia.
