USP

2024-07-15 11:06| 来源: 网络整理| 查看: 265

USP鈥揘F's Continuous Revision Process and Superseded Text

The United States Pharmacopeia鈥揘ational Formulary (USP鈥揘F) is continuously revised. Revisions are presented three times a year in the USP-NF as Issues 1, 2, and 3, and as monthly Accelerated Revisions on the USP website. USP uses its Accelerated Revision processes to expedite revisions to the USP鈥揘F. Accelerated Revisions include Revision Bulletins, Interim Revision Announcements (IRAs), and Errata.

Accelerated Revisions: Revision Bulletins, IRAs, & ErrataRevision Bulletins are USP's most expedited revisions and supersede standards published in the USP鈥揘F (print and online versions). A Revision Bulletin posted on the USP website indicates its posting date and official date.IRAs are proposed in PF for a 90-day public comment period. Once comments (if any) are reviewed and the IRA is approved by the appropriate Expert Committee, final IRAs are posted on the USP website. Like Revision Bulletins, IRAs supersede standards published in the print and online USP鈥揘F. IRAs are incorporated into the next available official publication.Errata are considered to be text erroneously published in the USP鈥揘F that does not accurately reflect the intended requirements as approved by the Council of Experts. Errata are posted on the Web site and are official the first day of the following month. Errata are incorporated into the next available official publication.

Once published in the print and online publications, Revision Bulletins and IRAs are official as of the date indicated on the website and are not subject to the general six-month delayed official date for the particular publication.

Learn more by visiting the Accelerated Revision History and the USP Guideline on Use of Accelerated Processes for Revisions to the USP鈥揘F. To receive periodic email updates when USP posts New Official Text, sign up for the free Compendial Updates service.

Harmonization Stage 4

Harmonization Stage 4 includes monographs or general chapters that have completed stages 1-4 of the pharmacopeial harmonization process resulting in approved USP鈥揘F text. Stage 4 adopted text is published so that USP鈥揘F users may become aware of its availability as a pharmacopeial standard and its targeted official date. View current Notices of Stage 4 Harmonization.

Learn more about the harmonization process by visiting the Harmonization鈥擯harmacopeial Discussion Group section of USP's website.

USP Reference Standards Information

Visit the USP Reference Standards Catalog and the online USP Store for a complete listing of available USP RS's and to obtain RS documentation (e.g., USP Certificates, SDS), lot validity, and more. Click here to subscribe to our newsletter, The Standard, to receive a monthly snapshot of new and updated RS's.

Unavailable First Time Official USP Reference Standards (RS) (updated 10-May-2024)

The official dates of any portion of USP鈥揘F tests or assays requiring the use of the following never-before-released USP RS's are postponed until further notice pending availability of the respective RS.

USP Alteplase RS

USP Sargramostim RS

【本文地址】

USP

USP

今日新闻

推荐新闻