Policies & Guidelines

General Notices

The General Notices and Requirements section (General Notices) of the United States Pharmacopeia and the National Formulary (USP–NF) presents the basic assumptions, definitions and default conditions for the interpretation and application of the USP–NF.  Learn more and download.

Guidelines

  • Monograph Submission Guideline

    USP's Guideline for Submitting Requests for Revision to the USP–NF (Monograph Submission Guideline) provides recommendations to Sponsors submitting information to support revisions to the USP–NF. View complete guideline.

  • USP Guideline on Use of Accelerated Processes for Revisions to the USP–NF

    The Guideline on Use of Accelerated Processes delineates the circumstances under which Errata, IRAs, and Revision Bulletins can be utilized to make revisions to the USP–NF official more quickly than through USP's standard revision process. View complete guideline.

  • USP Guideline on Drugs Approved for Inclusion

    Under the Social Security Act, the Medicare program provides reimbursement for certain medical and other health services, including drugs and biologicals that cannot be self-administered and are provided in a physician's offices as part of a physician's professional service. The Act defines the term "drugs and biologicals" to include those drugs and biologicals that are included or approved for inclusion in the United States Pharmacopeia (USP), the National Formulary, or those approved by a hospital's pharmacy and drug therapeutics committee. View complete guideline.

  • Pending Monographs Guideline

    The 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. View complete guideline; version 2.7, effective November 1, 2011.

  • Non-U.S. Monographs Guideline

    USP allows the creation of documentary standards (monographs) for drug products and their ingredients that have been approved in and are legally marketed in countries other than the U.S. and are intended to treat neglected diseases. These monographs are not part of the USP–NF compendia. Non–U.S. Monographs will be transitioned into the Medicines Compendium (www.usp-mc.org), which is USP's online compendium of international standards. View complete guideline.

  • USP Guideline for Suppliers of Reference Standards

    USP’s Reference Standard program relies on the generosity of donors, who, as experts in the field, provide high-quality candidate materials intended for use as official public standards. This guideline describes the general requirements for supplying such materials to USP. View complete guideline.