USP to clean-up guidelines and standards

By staff reporter

- Last updated on GMT

Related tags Usp United states pharmacopeia United states

The United States Pharmacopeia (USP) is inviting comments on
proposed revisions to guidelines and resources it makes available
in the National Formulary (NF) and Food Chemicals Codex (FCC) with
the aim of making the publications more user friendly.

The changes for General Notices and Requirements​ in USP​ and NF​ and the General Provisions and Requirements​ in Food Chemicals Codex (FCC)​ will be open to public comment between May 21 and August 31, 2007.​ According to USP, the proposed revisions have been tackled in order for users get the most from these resources, and as such it says user comments will help smooth out any flaws. The USP releases the USP-NF publication in two separate compendia entitled 'United States Pharmacopeia and National Formulary'. It is a book of public pharmacopeial standards for methods of preparation and dosage for drugs and dietary supplements. The NF includes standards for botanicals. Under the Federal Food, Drug, and Cosmetics Act, the USP-NF is the official compendia for drugs marketed in the country. The FCC provides standards for food, food chemicals, and food additives - including monographs. Last year USP purchased FCC from the Institute of Medicine and is supporting revisions and updating of the compendium which is scheduled for publication in a sixth edition by February 2008. USP compiled a preliminary draft of revisions, which provided for changes such as clearer definitions and instructions, updating of language from terms that were coined as far back as the 1920s, as well as standards for substances legally marketed outside the US (SALMOUS). Throughout the public comment period, a USP Expert Committee will continue to review the draft and look at any further changes they may deem necessary. Following this process, a revised draft of the General Notices for USP-NF - taking into consideration the public feedback and expert committee decisions - will be published in Pharmacopeial Forum​ according to USP protocol. USP-NF is available in print, online, and CD formats in English version. It is available in Spanish in print only. USP invites public comments through its website.

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