Whitepaper: "Importance of Standards in Assuring Good Quality Food Ingredients and Foods." During the 2005–2010 revision cycle (August 2006), USP purchased the Food Chemicals Codex (FCC) from the Institute of Medicine
(IOM). In February 2008, under the auspices of USP, the sixth edition was published, followed by supplements in February 2009
and August 2009. USP also established a web-based publication, the FCC Forum, for users to review and comment on proposed changes to FCC monographs. This whitepaper indicates that the industry has been
slow to respond to the standards in FCC and discusses potential avenues for enhancing the use and prestige of the FCC on a
The pharmaceutical industry uses the FCC because it contains monograph information for some common ingredients that are used
in drug-product formulation but that are not subjects of USP monographs. The industry needs to monitor the international activities
of the FCC to ensure they are consistent and appropriate.
Whitepaper: "USP's Role in Assuring Global Access to Quality Medicines." During the 2005-2010 revision cycle, USP made concerted efforts to expand its global presence. This whitepaper describes USP's
current international efforts and identifies possible ways to advance this initiative. One unique concept presented in this
white paper is a proposal to establish an independent Global Health Care Secretariat as a means to secure and control global
registrations of products and medicines. As stated in the paper, this initiative would be "based in a vision of a collaborative
global health care secretariat with multiple components, involving representatives from all countries and yielding decisions
suitable for national adoption. The components would focus on a) discovery, b) research and development, c) sound regulatory
decision-making and, when appropriate, rapid registration decisions, d) optimal pricing–payment strategies, e) evidence-based
healthcare delivery based on outcomes/pharmacoeconomic studies, f) quality of care, and g) safe medication use."
Summing it up
What does all of this mean? In April 2010, USPC will convene and vote on resolutions that will effect the next five years
of USP activities. These whitepapers may set the stage for those votes. It is important for industry to read these papers
in their entirety and be prepared to engage in debate on the pros and cons during the open-floor discussion of the convention.
This is the best way to assure that USP will appropriately represent all parties of the pharmaceutical-products process, and
it may be your best opportunity to influence the direction of USP as it strategizes the next five years.
Many of the ideas brought forth in these whitepapers appear to be altruistic. It is hard to argue with the concepts of securing
safe food, providing safe medication, and establishing appropriate standards for the global community. However, other organizations
such as the International Conference on Harmonization and the Pharmaceutical Inspection Cooperation Scheme are trying to address
many these same issues. It would seem appropriate for USP to engage them in dialogue so that efforts are not duplicated and
to prevent a divergent set of standards from evolving.
Susan J. Schniepp is vice-president of quality assurance at Javelin Pharmaceuticals, 125 CambridgePark Drive, Cambridge, MA 02140, tel. 617.499.4709,
1. USP whitepaper, USP's Role in Patient Safety, Sept. 23, 2009.
2. USP whitepaper, Opportunities for Drug Information and Use Standards, Sept. 23, 2009.
3. Performance-based Monographs, Pharmacopeial Forum
35 (3), 2009, 765–770.