USP's Work Plan and New Revision Approaches - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

USP's Work Plan and New Revision Approaches
Following its 2005 Convention, USP is adopting new approaches to develop monographs and products and to carry out the organization's ambitious work plans.


Pharmaceutical Technology


Finally, the Council of Experts endorsed and USP's Board of Trustees has approved an initiative titled Standards for Articles Legally Marketed Outside the US (SALMOUS). Under this program, USP will develop monographs for medicines legally marketed outside the United States to treat neglected diseases such as malaria (7), provided that such medicine has been approved and is legally marketed in a country with a stringent regulatory authority. These monographs will be posted on USP's Web site (first in draft for public comment and then in final form), but they will not appear in USP–NF.

Line extensions

USP continues to make information available to a wide variety of constituents in user-friendly formats. For example, USP is undertaking a major redesign and simplification of the format of monographs (8), and USP–NF will soon be offered in three volumes to accommodate the increasing content. USP already has launched two new publications and is planning others:

  • USP Pharmacists' Pharmacopeia (launched in 2005);
  • USP–NF Spanish Edition (launched in 2005);
  • USP Veterinary Compendium;
  • USP Dietary Supplements Compendium.

For compounding pharmacists, the USP Pharmacists' Pharmacopeia contains both legally enforceable official text from USP–NF and authorized text of supporting information. A scientifically exact translation of USP 29–NF 24 into Spanish is available. The process of developing this book has provided USP with experience that facilitates other translations. For example, USP is working on a Russian-language translation of USP–NF and anticipates that other translations will follow.

Conclusion

This article has reviewed some of the new and unique approaches USP is taking toward the development of monographs and General Chapters as well as the launch of some new publications. USP has established a vigorous work plan for the 2005–2010 revision cycle and is making the necessary procedural changes to expedite the realization of these goals. USP welcomes the extraordinary contributions of its volunteer constituents as the organization strives throughout the remaining years of this cycle to fulfill its mission of improving public healthcare.

Todd L. Cecil, PhD, is the vice-president of the Department of Standards Development at the US Pharmacopeia. Roger L. Williams, MD, is a member of Pharmaceutical Technology's Editorial Advisory board and the executive vice-president and CEO of the US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8255,

References

1. United States Pharmacopeia 29–National Formulary 24 (US Pharmacopeial Convention, Rockville, MD, 2006), p. v.

2. T. Layloff et al., "The FDA Regulatory Methods Validation Program for New and Abbreviated New Drug Applications," Pharm. Technol. 24 (1), 30–42, 84 (2000).

3. L. Bhattacharyya et al., USP Council of Experts Executive Committee, "The Value of USP Public Standards for Therapeutic Products," Pharm. Res. 21 (10), 1725–1731 (2004).

4. USP, USP Guideline for Submitting Requests for Revision to USP–NF. Available at: http://www.usp.org/pdf/EN/USPNF/revisionGuide.pdf, accessed Sept. 14, 2006.

5. USP Council of Experts, Expert Committee Members, and USP Staff, "The United States Pharmacopeia's Council of Experts 2005–2010: Work Plans, New Revision Approaches, and Other Enhancements," The AAPS J. Accepted for publication.

6. USP, "Recent Modifications to the USP Standards-Setting Process," Pharm. Forum. 32 (4), 1010 (2006), Available at: http://www.usp.org/USPNF/notices/uspStandardsSetting.html, accessed Sept. 14, 2006.

7. Council of Experts Executive Committee, Ad Hoc Council of Experts Committee, and USP Staff, "Development of a New Official Compendium, Separate from USP–NF, for Articles Not Legally Marketed in the US," Pharm Forum. 30 (5), 1877–1883 (2004).

8. T. Cecil. "Monograph Redesign Proposal," Pharm. Forum. 32 (6), in press (2006).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here