Public Comment and Expert Oversight: The Cornerstones of USP Standards Development - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Public Comment and Expert Oversight: The Cornerstones of USP Standards Development
USP exercises a vigorous standards-setting process that draws on both public comments and meticulous scientific review.

Pharmaceutical Technology

Following publication in 2004, as practitioners realized the effect of the revised, now-enforceable General Chapter ‹797› on their daily work, there was a surge of input that had not initially been solicited— about 2000 comments. This outpouring underscored the importance of public comment as well as expert review, and USP started the current revision cycle as quickly as possible. This time we did it quite differently: We held briefings for 16 stakeholder organizations, plus a stakeholder forum meeting. About 60 compounding professionals and other interested parties attended, and we held Webinars for those who could not be there in person. At these sessions, staff reviewed proposed changes and actively sought stakeholder input. In addition, we provided an online mechanism to view and comment on proposed changes to ‹797›. Through these outreach efforts, we got hundreds of comments that went into the revision process.

This marked a first-time, singular outreach program for USP. Why did we go to such lengths? In short, the response of the compounding community to the initial lack of inclusion reminded USP-staff and volunteer experts alike that not actively providing channels for public comment is neither in the interest nor the tradition of USP standards setting. The current revision cycle of General Chapter ‹797›, based on extensive interactions among USP staff, volunteer experts, and the compounding community, is fully supportive of USP's core mission of objective science and transparency. Inclusion can sometimes be messy and it can take time—you'll note that ‹797› has yet to be finalized in official publication. But it will be published, as a result of the kind of dialogue between public and experts that has characterized USP standards setting for nearly 200 years.

I urge members of the extended pharmaceutical community to participate in this well-established, respected, and effective process. Thorough instructions are available on the USP Web site, at, and a diagram illustrating the standards revision process is published in the front matter of every issue of Pharmacopeial Forum. Your participation will help keep the process a model of scientific integrity, thereby helping to ensure good pharmaceutical care for all.

Todd L. Cecil is the vice-president of the Department of Standards Division at the US Pharmacopeia,


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here