USP Modifies Glycerin Monograph: More Requirements for Pharma

The U.S. Pharmacopeial (USP) Convention has updated its monograph for glycerin to require manufacturers using its standards to prove that pharmaceutical preparations are free of diethylene glycol.

“This change will require drug product manufacturers — not just the glycerin manufacturer — to prove that diethylene glycol is not present,” the standards-setting body said.

Last year, the FDA warned manufacturers, compounders and repackagers to conduct appropriate tests for diethylene glycol to ensure the poison was not inadvertently used in pharmaceutical liquids such as cough syrups. Diethylene glycol is a common ingredient in 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,” USP said.

Diethylene glycol was responsible for 107 poisoning deaths in 1937 when S.E. Massengill mixed its antibiotic sulfanilamide with the chemical to make a liquid form of sulfanilamide. The incident eventually led to the enactment of the Food, Drug and Cosmetic Act in 1938.

USP’s updated monograph will be published in June as Supplement 2 to USP 31-NF 26, but the new standard takes effect May 15.