USP Announces Revised Glycerin Monograph ( New Monograph Strengthens Safety Ne...)

USP Announces Revised Glycerin Monograph

Date:3/17/2008

New Monograph Strengthens Safety Nets to Prevent Serious Health Hazards

Associated with Diethylene Glycol

ROCKVILLE, Md., March 17 /PRNewswire/ -- The U.S. Pharmacopeial (USP) Convention today announced a revised Glycerin monograph in the United States Pharmacopeia (USP), an official compendium of the United States. The revision strengthens safety nets to prevent serious and potentially fatal health hazards associated with diethylene glycol-contaminated glycerin. Glycerin is used as a sweetener in formulations of many pharmaceutical syrups and in other consumer articles as well, such as toothpaste. Diethylene glycol is a poisonous chemical used in industrial solvents and antifreeze. Over many years, accidental or intentional adulteration of drugs with diethylene glycol has occurred many times and in many countries, most recently in Panama in 2007 and, notably for the United States, in 1938. The 1938 episode killed over 100 American citizens, many of them children, and led to passage of the Federal Food, Drug and Cosmetic Act. Since that time, FDA and USP have worked together to prevent other such disastrous events.

In May 2007, FDA issued a "Guidance for Industry Testing of Glycerin for Diethylene Glycol." This Guidance emphasized the importance of screening ingredients and products for the presence of diethylene glycol. FDA and USP also worked together to change the current Glycerin monograph in USP. This change will require drug product manufacturers using glycerin -- not just the glycerin manufacturer -- to prove that diethylene glycol is not present, using the USP Glycerin monograph.

"This change in the USP Glycerin monograph is one of many safety nets that help assure U.S. citizens that the drugs they use are of good quality," said Roger L. Williams, M.D., USP's executive vice president and chief executive officer. "In some areas, these safety nets still need strengthening. For example, other useful ingredients s
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USP Announces Revised Glycerin Monograph( New Monograph Strengthens Safety Ne...)