A State of Revision

In an effort to make the monograph creation and revision process more efficient, the United States Pharmacopeia-National Formulary's Prescription-Non-Prescription Stakeholders Forum created a number of project teams in 2000, several of which were directed to provide recommendations about the content and presentation of drug substance monographs. The Non-Complex Actives Drug Substance, Complex Actives, and Excipient Project Teams contributed to the creation of a guideline to aid parties who were interested in submitting requests for revisions to USP-NF. After multiple iterations and as a result of noteworthy collaborative efforts involving USP's core staff and members of USP's Council of Experts, USP recently released its "USP Guideline for Submitting Requests for Revision to the USP-NF". This 75-page document provides helpful information about submitting new monographs and revising existing monographs for noncomplex substances and products, biological and biotechnology substances and products, excipients, and vaccines.