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USP-NF Development Process

USP develops - and publishes in the USP–NF - public standards to provide quality oversight for FDA-approved drugs and related articles. Public input and interaction are vital to the development of these standards. The standards originate from pharmaceutical manufacturers–from the draft monographs and data they provide. USP's scientific staff and volunteer experts review this input, conduct necessary laboratory tests, and ensure that the information is subject to a process of public review and comment. The public process helps to refine and finalize this information for publication in the USP–NF. A USP Expert Committee comprising of volunteer scientists elected on the basis of their knowledge and expertise makes the final decisions to publish standards in the USP–NF.

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

Pharmacopeial Forum lets you participate

Pharmacopeial Forum (PF) is USP's bimonthly journal, in which all proposals for additions and changes to USP–NF are first published for public review and comment. A summary of public comments received and USP's responses to these are also published in PF. Scan the table of contents of current and past PF issues to determine if there are revision proposals that impact you.

Contact USP scientists about revisions

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

Graphic of development process


What's New

Changes to the Dissolution Performance Verification Test (11/20/09)

PF 35(6) Errata (10/30/09)

New official Text for October: 15 Revisions Bulletins (10/30/09)

Pending Standards for the month of October (10/30/09)

PF 35(6), November-December 2009: Highlights and Stimuli Articles (10/23/09)

Admission Criteria and Safety Classification for Dietary Supplements Guideline (10/22/09)

Elemental Impurities Hot Topics information updated (10/13/09)

General Chapter <1151> Pharmaceutical Dosage Forms (10/06/09)

Heparin Hot Topics information updated (10/02/09)

PF Redesign

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