Advancing the science of a compendium is an exciting opportunity for USP, because it carries on the distinguished efforts of IOM’s Committee on Food Chemicals Codex. A compendium of quality standards is, necessarily, a living document. It must account for new ingredients, changes in the manufacturing process of ingredients, development of new analytical procedures, and new safety concerns that may arise. Measurement science has advanced remarkably in the past 50 years. This science evolves in many ways, including contributions by national metrology institutes such as NIST. USP is expanding applications of modern measurement science (metrology) to both its documentary standards and RMs, and this expansion will include applications to official articles in FCC and food ingredient RMs.8
USP is proud to become involved with FCC. USP has a longstanding public health mission, and inclusion of FCC in this mission extends USP beyond its primary focus on drugs into the realm of documentary and RM standards for foods. USP’s practitioner-based approaches for foods can address consumers’ interests not only in the United States but also in other countries. FCC is an official compendium of food ingredients for Australia, Canada, and New Zealand, and it may be used by other countries. In advancing FCC, USP thanks and congratulates IOM and its Committee on Food Chemicals Codex for their remarkable efforts. Manufacturing and measurement science and technology for foods and food ingredients are advancing rapidly. Yet, at the same time, so is the risk of contaminated and adulterated foods. Public safety networks need strengthening to protect consumers from dangerous foods. USP intends for FCC to be an important part of the approaches needed to ensure good quality foods and food ingredients.
Dr. Ebert is chair of the Food Ingredients Expert Committee, USP Council of Experts; Dr. Abernethy is chief scientific officer; Miller is counsel; Sheehan is director of excipients and FCC; and Dr. Williams is chief executive officer and executive vice president, all at the U.S. Pharmacopeia. To reach them, contact Dr. Williams at [email protected] or at (301) 816-8300. Dr. Kuznesof is president of pmKuznesof, LLC; reach him at (301) 585-1253 or [email protected].
References
- U.S. Food and Drug Administration. 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act. Washington, D.C.: U.S. Food and Drug Administration; 1958.
- U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act: Sec. 501 [21 USC 351(b)]. Washington, D.C.: U.S. Food and Drug Administration; 1938.
- National Institute of Standards and Technology. Guidance on federal conformity assessment activities. NIST, Fed. Reg. 65: 48894-48902. Gaithersburg, Md.: National Institute of Standards and Technology; 2000.
- Bhattacharyya L, Cecil T, Dabbah R, et al. The value of USP public standards for therapeutic products. Pharm Res. 2004;21(10):1725-1731.
- U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act: Sec 501 [21 USC 351(b)]. Washington, D.C.: U.S. Food and Drug Administration; 1938.
- U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act: Sec 502 [21 USC 352(e)(1)(B)(3)(C)]. Washington, D.C.: U.S. Food and Drug Administration; 1938.
- United States Pharmacopeial Convention. Guideline for submitting requests for revision to USP–NF. Available at: www.usp.org/pdf/EN/USPNF/ introduction.pdf. Last accessed November 22, 2007.
- Williams RL; 2000–2005 Reference Standards Committee of the USP Council of Experts and Its Advisory Panel; USP Staff and Consultant. Official USP Reference Standards: metrology concepts, overview, and scientific issues and opportunities. J Pharm Biomed Anal. 2006;40(1):3-15.
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