Development Process

USP-NF Development Process

USP develops—and publishes in the United States Pharmacopeia and the National Formulary (USP–NF)—monographs and general chapters that provide public quality standards for drugs, excipients, and dietary supplements. Public input and interaction are vital to the development of these standards. The standards generally originate from sponsors who provide draft standards and supporting data to either create new or revise existing monographs and general chapters. USP's scientific staff and volunteer experts review this input, conduct laboratory tests (if necessary), and forward the new or revised monograph or general chapter to Pharmacopeial Forum (PF) for public review and comment. The public process helps to refine USP standards for publication as official text in the USP–NF. Prior to publication as official text, all monograph and general chapter proposals must be approved by a USP Expert Committee, which comprise volunteer scientists, academicians, practitioners, and other professionals elected on the basis of their knowledge and expertise.

USP also may publish standards through Accelerated Revision processes when appropriate.

See how you can get involved in the USP–NF standards-setting process.

Comment on USP's Proposed Standards in Pharmacopeial Forum

Pharmacopeial Forum (PF) is the bimonthly online journal through which USP develops and revises standards for the USP–NF by a process of public review and comment. Changes and additions to USP–NF standards are first proposed in PF to invite public comment. To encourage and broaden participation in the standards-setting process, PF is a freely available resource. New issues are posted online every two months and the comment period is 90 days. The comment period ends on the last day of the month (View current PF Publication and Comment Schedule).

Access the free, online PF to determine if there are revision proposals that impact you.

Contact USP Scientists

Email your questions about proposed revisions in specific areas to the right USP scientific staff.

USP–NF Development Process Chart

The chart below shows the public review and comment process and its relationship to standards development. (Click the image to view.)

USP's standards-setting public review and comment process

USP's standards-setting public review and comment process

USP's standards-setting public review and comment process