12601 Twinbrook Parkway

Rockville, MD 20852

301-881-0666

Contact: Diane M. McGinnis, Assistant Coordinator, Practitioner Reporting System

The U.S. Pharmacopeial Convention (USP) is an private, nonprofit body of 300 delegates representing state and national associations and colleges of medicine, nursing, and pharmacy; industry; and agencies of the federal government. Incorporated in 1900, the purposes of USP are to set standards for health care products in the U.S. and to collect and disseminate product use information to providers and consumers.

Every five years, USP publishes revised standards for drugs in The United States Pharmacopeia and The National Formulary. These standards are recognized as official by the federal government and are enforceable by the FDA. The standards include specifications pertaining to drug strength, quality, purity, packaging, and labeling.

USP provides official drug reference standards, which are highly characterized specimens of drugs, impurities, and degradation products. USP laboratories test and monitor these standards, and develop analytical procedures and tests of proposed revisions of tests and assays. USP publications include USP DI Volume I: Drug Information for the Health Care Provider and USP DI Volume II: Advice for the Patient. Other publications are the consumer edition of the reference volumes About Your Medicines, the bimonthly newsletter About Your Medicines, and various brochures and books.

The Drug Product Problem Reporting Program (DPPR) and the Medical Device and Laboratory Product Problem Reporting Program (PRP) are systems funded by the FDA for identifying and correcting problems associated with prescription and over-the-counter drugs and medical devices, laboratory products, radiopharmaceutical drugs, and radiological devices. Problem reports are usually submitted by practitioners to the USP via toll-free telephone or reporting forms, and are forwarded to the FDA and other appropriate government and industry agents for corrective action. Addressing product quality, DPPR is one of two FDA voluntary drug problem reporting programs (the other is the Drug Experience Reporting program for adverse drug reactions). PRP is the largest single source of device experience information for the FDA's Device Experience Reporting Network.