USP Quality Matters Blog Entries
Thank you for helping Quality Matters spread the word in 2015 about USP quality standards and the important role our work plays in industry, public health and lives around the world. These five posts are the ones that you, our readers, found to be the most engaging and useful in 2015.USP Leadership
1. What Is Pharmacopeial Forum and Where Can It Be Found?
Did you know standards for drugs, excipients, and dietary supplements found in the United States Pharmacopeia–National Formulary (USP–NF) are continuously revised through a process involving public participation? The vehicle through which the United States Pharmacopeial Convention (USP) publishes its proposed standards revisions for public review and comment is called Pharmacopeial Forum (PF).
First published as a print journal in 1975, PF is now a free, bimonthly online publication that can be accessed here: www.usp.org/usp-nf/pharmacopeial-forum.
2. Types of Revisions and Information Available for Public Review and Comment in PF
Proposed Revisions: Generally referred to as in-process revisions, these are new or revised USP–NF standards targeted for adoption through USP’s Standard Revision Process, which calls for publication of a proposed revision in PF for a 90-day notice and comment period. After the comment period and subsequent review of comments and approval by the relevant USP Expert Committee, the official standard is published in the next available USP–NF or Supplement. If comments received are significant, or if the Expert Committee's consideration of comments results in significant additional changes, the Expert Committee may determine that republishing in PF is necessary prior to the revision becoming official.
Proposed Interim Revision Announcements (IRAs): IRAs are revisions that become official through an accelerated process in accordance with USP’s Guideline on Accelerated Revisions. IRAs allow for a revision to become official prior to the next USP–NF or Supplement. IRAs are first presented for a 90-day public comment period in the Proposed Interim Revision Announcement section of the PF. (NOTE: Final IRAs, as well as Errata, and Revision Bulletins, which also are defined in the Accelerated Revision Guideline, are not published in PF but can be found online here.)
Stage 4 Harmonization: PF also features revision proposals from the Pharmacopoeial Discussion Group (PDG), which comprises the European Pharmacopoeia, the Japanese Pharmacopoeia, and USP. The Stage 4 draft and the briefing are published in the forum of each pharmacopeia for public comment.
Stimuli to the Revision Process: Through PF, you can also comment on Stimuli, articles on standards development topics authored by the USP Council of Experts, USP staff, or other interested parties on which USP desires public input prior to further development.
3. How to Comment on Revisions via PF
Log in to PF to view proposed revisions in the most current volume and edition of PF. (Note: a one-time registration is required.)
Review material and prepare your comments. For comments that request the accommodation of an FDA-approved article in a revision, a general description of the types and amount of information expected in a Request for Revision is available in the Guideline for Submitting Requests for Revision to the USP–NF.
Submit your comments within 90 days of the PF publication in which the standard was proposed (or per the comment deadline listed in the Briefing section). To submit comments on in-process revisions, IRAs and Stage 4 proposals:
- Click on the Email Comments (envelope) icon at the top right corner of the screen on the proposed revision page.
- Click on the contact name hyperlink. An email window will open up in your default email client.
- Create and send your email, attaching any related documents, as needed.
- You will receive a confirmation email for your submission.
To comment on Stimuli articles, please see the footnotes section of each article for contact and submission information.
4. What Happens to Submitted Comments?
USP welcomes comments and data on proposed revisions. A summary of comments received, along with USP’s responses, will be published in the Proposal Status/Commentary section of the USP website. The chart below shows the public review and comment process and its relationship to standards development. (Click on image for enlarged view.)
5. Tools to help users view content in the latest PF
USP offers several resources to help users quickly view and find topics in the latest edition of PF:
- The PF Table of Contents with hyperlinks can be viewed and accessed from inside the online publication and publicly on the USP website: www.usp.org/usp-nf/pharmacopeial-forum/pf-table-contents.
- The PF Alert—a pre-recorded complimentary video from USP Pharmacopeial Education—allows users to view highlights of selected topics in the current PF. A new video is produced bimonthly with the release of each new PF. Learn more and access the latest PF Alert at https://uspharmacopeia.csod.com.
Pharmacopeial Forum (PF) is the vehicle through which USP publishes proposed revisions to USP–NF standards for public review and comment. Learn about PF and how you can use it to help shape standards for drugs, excipients and dietary supplements.Pharmaceuticals
The USP Verified Mark and the Good Housekeeping Seal help consumers find quality products in the marketplace. But did you know these two seals enjoy a shared history? Each is the legacy of the work of pioneering consumer activist and “Father of the Pure Food and Drug Act”—Harvey W. Wiley, M.D.Dietary Supplements
Global food and dietary supplement experts to gather Dec. 3–4 for workshop on economically motivated adulterationa and fraud. Organized by USP, American Botanical Council, and Food Protection and Defense Institute, the event will feature new tools and standards for identification and mitigation.Food
Tainted “lifestyle supplements" may outnumber products free from drugs and their unapproved synthetic analogs. Learn how proposed new screening methods in USP General Chapter <2251> Adulteration of Dietary Supplements with Drugs and Drug Analogs can help detect these adulterants and protect public health.Dietary Supplements