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USP publishes official quality standards for medicines in the UnitedStates Pharmacopeia-National Formulary (USP-NF) and has worked with FDA forover 100 years in a unique public-private partnership that helps assure thequality of medicines in the United States. Following a recall in January ofsuspect heparin products, FDA in March asked USP to assist in re-assessingcurrent tests and possibly developing new methods for detecting over-sulfatedchondroitin in the heparin drug substance before it is made into a finalproduct. This work is ongoing and will result in updated heparin monographs.Heparin has been sold in the United States since the 1940s and has had a USPmonograph since 1950, which has been updated several times.
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According to Roger L. Williams, M.D., USP's chief executive officer, "Itis difficult for analytical procedures to detect and identify all adulterants.USP monographs are designed to test for known impurities that result frommanufacture or degradation, not for unknown contaminants that may be addedeither accidentally or deliberately. USP will continue to work closely withFDA and other partners to develop the most effective approaches to assure thesafety of heparin."
The availability of a good public monograph in the USP with alliedreference materials is one of a series of safety nets that work to assure thatU.S. patients and practitioners have access to good quality medicines. Othersafety nets include dedicated and trusted drug ingredient and productmanufacturers who follow good manufacturing practices (GMPs) and soundsampling protocols in support of batch release testing. Oversight from FDA isalso key in assuring product quality along complicated and at times lengthysupply and distribution pathways.
USP will provide further information as its work evolves. For updates onthe availability of this information, please contact Laura Provan [email protected] or 301-816-8268.
USP -- Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a private, non-profit,standards-setting organization that advances public health by helping toensure the quality and consistency of medicines, food ingredients, and dietarysupplements, promoting the safe and proper use of medications, and verifyingingredients in drugs and dietary supplements. Its standards, which arerecognized worldwide, are developed by a unique process of public involvementthrough the contributions of volunteers representing pharmacy, medicine, andother health care professions, as well as science, academia, government, thepharmaceutical and food industries, and consumer organizations. For moreinformation about USP and its public health programs, visitwww.usp.org/newscenter.
SOURCE U.S. Pharmacopeia
