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Member Memo

May, 28 2009

Dear USP Convention Delegates and Executive Officers of Member Organizations:

Delegate's Virtual Notebook – Documents related to the USP Convention's 2010 Membership Meeting are available via the USP Member Web Page. The Virtual Notebook will be updated continuously and will include logistical information, program updates, committee reports, and more. New postings will be announced in future Member Memoranda. Delegates will be able to pick up binders with print copies of all the documents at meeting registration beginning Wednesday, April 21, 2010.

Constitution and Bylaws Amendments —The Constitution and Bylaws (C&B) Committee wishes to thank members who submitted comments on the draft Amended and Restated Bylaws. The C&B Committee is preparing its final report, which will be posted in the Virtual Notebook in February 2010.

USP Seeks Nominations for Council of Experts – Inform Your Constituents! — USP is counting on you to spread the word. Any qualified individual is encouraged to apply or recommend qualified candidates for the 2010–2015 Council of Experts (chairs of USP's Expert Committees). USP's recruiting is global, so please reach beyond our borders to all experts. The deadline for Council of Experts nominations is December 18, 2009.

June Workshop Focuses on Food Safety — Tell your constituents about the Food Protein Workshop on June 16–17, 2009, at USP Headquarters in Rockville, MD. Anyone who analyzes, produces, buys, or trades food ingredients based on their protein content, as well as those responsible for food quality and safety, are encouraged to attend. Because protein is a nutritious and desirable component for food ingredients, unfortunately, an incentive for adulteration has begun to emerge. Many of you may recall that milk products were found to be adulterated with melamine (to increase their apparent protein content), resulting in widespread illness and a number of child deaths. Current tests did not detect the adulteration, and new methods are called for to help prevent another such tragedy. Workshop participants will hear the latest thinking on how to detect falsified protein levels and join leading domestic and international scientists from the food industry, academia, governments, and trade associations to explore which tools work best to measure food protein.

Control and Safety of Excipients Highlighted in July Workshop — Spread the word to your colleagues about USP's International Excipient Workshop on July 20–21, 2009 at USP Headquarters. This workshop will benefit those who work with excipients as well as regulators, scientists, researchers, and manufacturers. Diethylene glycol (DEG) adulteration caused more than 80 deaths in Nigeria in 2008. USP worked with the FDA to address this crisis and a proactive approach is being taken to detect adulteration of glycerin and other at–risk excipients with DEG or ethylene glycol (EG). Experts will discuss excipient supply chain integrity and global sourcing, challenges in developing excipient monographs for the 21st century, and the effective use of harmonized monographs to reduce the testing burden for pharmaceutical excipients.

Public Comments Sought on Proposal for Performance Based Monographs — USP is seeking public comments on its proposed Performance–Based Monograph  (2.4MB) (PBM) approach. USP's main publication, the United States Pharmacopeia–National Formulary (USP–NF) contains General Chapters and monographs for drug substances, excipients, and drug products. USP monographs typically include four universal tests and certain specific tests, with accompanying procedures and acceptance criteria. In contrast to the current monograph approach, a PBM would provide a specification for a drug substance that includes a test and acceptance criteria, but the procedure would define only the criteria needed to show that the procedure used is acceptable. The proposal has been published in Pharmacopeial Forum 35–3. Comments may be submitted to until August 15, 2009.

USAID, USP Program Assists in Accreditation of Peru's Official Laboratories – Peru's National Center for Quality Control—the Centro Nacional de Control de Calidad (CNCC)—has attained internationally recognized ISO/IEC 17025:2005 accreditation for testing and calibration laboratories. USP, through its Drug Quality and Information Program funded by the US Agency for International Development, provided technical assistance to the laboratory toward achieving the accreditation. This accreditation certifies that CNCC is providing valid and trustworthy data to the Peruvian Ministry of Health, helping to ensure the distribution of good quality medicines to the country's citizens.

Pharmacopeial Education Bulletin — The USP Pharmacopeial Education Bulletin brings you the latest information on upcoming courses and seminars created and taught by USP experts. Sign up for this and other free information about the latest products and services from USP.

USP CEO Receives Honorary Doctorate from Long Island University – In recognition of his efforts to advance the health of people around the world through the development and dissemination of public standards, Long Island University awarded an honorary doctorate to USP chief executive officer Roger L. Williams, M.D. on May 15. Dr. Williams also delivered the commencement address to the Arnold & Marie Schwartz College of Pharmacy and Health Sciences Class of 2009.

2009 Summer Interns Selected— USP is pleased to announce the selection of three undergraduate chemistry and pharmaceutical sciences students for the 2009 USP Summer Intern Program:

  • Jessica Moreno has a B.S.E. in Chemical Engineering, is studying for her Pharm.D. at the University of Michigan, and is interning in the Documentary Standards Division.
  • Erin Webster is working towards a B.S. in Chemistry at the University of Maryland and is interning in the Analytical Research and Development Laboratory.
  • Emily Vernamonti is pursuing a B.S. in Chemistry at Mount St. Mary's University and is interning in the Reference Standards Laboratory

The students will spend 12 weeks at USP working on defined projects related to USP's standards–setting and public health mission. The intern experience will include meetings with USP staff and hands–on activities to gain a better understanding of the scope and importance of USP programs and services. The interns were chosen in a competitive selection process from a pool of more than 50 applicants from around the world.

Copy to Executive Officers 09–09