Pending Monographs

  1. What is the objective of the Pending Monographs approach?

    The United States Pharmacopeial Convention (USP) Pending Monographs approach enables Web-based publication of monographs for articles (e.g., drug substances, excipients, and dosage forms) based on information in FDA applications and filings. The purpose of Pending Monographs is to have an official USP or NF monograph ready as soon as possible after FDA grants final product approval. The Pending Monographs approach enables monograph development to begin before FDA’s approval process is complete, resulting in an official USP or NF monograph more rapidly than would be possible if monograph development started only after final FDA approval. Pending Monographs are considered authorized rather than official text because they are approved by the USP Council of Experts as Pending, but are not part of the official USP or NF unless, or until, an Expert Committee approves them for inclusion.

  2. What if there is an official USP–NF monograph?

    If there is an existing official USP or NF monograph, then information from the Authorized Pending Monograph will be merged with the existing monograph, as appropriate, to create a monograph that reflects all FDA-approved articles (see the Guideline for Submitting Requests for Revision to USP–NF). This revision to the existing monograph will advance to official status in the USP–NF via a Revision Bulletin and will be official immediately upon posting consistent with USP’s Guideline on Use of Accelerated Processes for Revisions to the USP–NF.

  3. Can my company label its product as “USP” to indicate compliance to a Pending Monograph?

    A company is not permitted to label their article as "USP", "NF" or "USP–NF" on the basis of adherence to a Draft or Authorized Pending Monograph. Use of the "USP", "NF" or "USP–NF" labeling is permitted only in reference to official USP–NF monographs.

  4. Can Pending Monographs be revised?

    Yes, Pending Monographs can be revised and follow the same process as an initial proposal and are subject to a 90-day public review and comment period.

  5. Pending Monographs are not included in formal publications so how are the versions maintained and cited?

    Each Pending Monograph will be specified as either Draft (a proposal available for a 90-day public review and comment period) or Authorized (a proposal that has completed a 90-day public review and comment period and has been approved by the assigned USP Expert Committee(s)) along with a version number (e.g, USP Pending Monographs, Draft 1–For Public Comment). Authorized Pending Monographs include an authorized date (e.g., Authorized USP Pending Mongoraph, version 2, November 1, 2011).