USP Members

Member Memo

July 23, 2009

Dear USP Convention Delegates and Executive Officers of Member Organizations:

USP Seeks Comments on General Chapter <795> – Inform Your Constituents – Revised General Chapter <795> Pharmaceutical Compounding-Nonsterile Preparations has been published for public comment in the July-August edition of Pharmacopeial Forum (PF). The General Chapter has been re-written to incorporate text from General Chapter <1075> Good Compounding Practices, which will eventually be omitted from the USP-NF. Your constituents can participate in the standards setting process by submitting by October 15, 2009.

USP CEO Dr. Roger Williams and Convention Delegate Ms. Diane Dorman Discuss Biologic Medicines on AARP TV's Inside E Street – Biologic drugs, their costs, and the need for generics are discussed by USP CEO Roger L. Williams, M.D. and Ms. Diane Dorman, USP Convention Delegate from the National Organization for Rare Diseases, in an interview on AARP's Inside E-Street. To learn more, view the video, "Cooling Down Drug Prices."

USP Agreement with Nine Southeast Asian Countries Promotes Good Quality Medicines – USP has signed a cooperative agreement with nine countries belonging to the Association of Southeast Asian Nations  (46KB) (ASEAN), including Cambodia, Laos, Myanmar, Singapore, Vietnam, Indonesia, Malaysia, the Philippines, and Thailand. Areas of potential collaboration under the agreement include working toward WHO and ISO measurement standards for medicines; promoting ISO certification for ASEAN drug quality control laboratories; support for joint studies and scientist exchange programs; and mutual development of ways to combat counterfeit and substandard medicines.

Vietnamese Drug Authority Teams with USP – Viet Nam achieved an important milestone toward securing its supply of medicines as Dr. Nguyen Van Tuu, chairman of the Vietnamese Pharmacopeia Commission signed a memorandum of understanding (MOU) with USP. Potential collaborative activities may include standards development, reference standards testing, scientist exchange programs, and other projects.

USP Donation to Pharmacist in Afghanistan, Future Chinese Translation of USP-NF, and More in Latest Issue of The Standard – The Spring/Summer issue of The Standard  (3MB), USP's quarterly newsletter, is now available on the USP Web site.

Article by Dr. Tina Morris of USP Explains Importance of Biological Potency Assays – In a recent BioPharm International article, USP Expert Committee and Advisory Panel efforts to modernize and expand the bioassay requirements in USP standards are explained by Dr. Tina S. Morris, USP Vice President of Biologics and Biotechnology. Biological assays are used to determine biological potency in the development, registration, and control of biological and biotechnology-derived products.

Traditional Chinese Medicines are Focus of Article by USP's Dr. James Griffiths – The July 2009 edition of Pharmaceutical Technology includes an article on traditional Chinese medicines (TCMs) by Dr. James C. Griffiths, USP Vice President of Food, Dietary Supplement, and Excipient Standards. The article explores regulatory options and USP's standards setting role.

Tell Your Members About the September 21^st Workshop in Toronto Focusing on Medication Safety in Healthcare Institutions – Pharmacy directors, risk managers, patient safety officers, medication safety officers, and other health care professionals will want to know about the upcoming USP/ISMP Canada workshop, Analyzing Medication Incidents Effectively to Enhance Medication Safety. The workshop will be held prior to the 2009 USP Annual Scientific Meeting in Toronto, Canada.

USP Publishes New Tool to Help Dietary Supplements Manufacturers Ensure Quality Products – USP has published the USP Dietary Supplements Compendium (DSC), a first-of-its kind collection of quality standards for dietary supplements and their ingredients. The DSC includes standards for the identity, strength, purity, and performance characteristics (e.g., dissolution, disintegration) of more than 500 dietary supplements and ingredients. Order by August 31, 2009 to receive a special discount.

Consumers Will Benefit from New Standard Proposed for Soybean Oil – A new soybean oil that will improve functionality in food processing and add taste and nutritional value for consumers is the subject of a proposed new standard intended to help ensure the oil's quality once it is incorporated into food production. This standard for unhydrogenated high-oleic soybean oil will be included in the Food Chemicals Codex (FCC), and has been published for public comment in the latest FCC Forum. may be sent through September 30, 2009.

Copy to Executive Officers 09-11