FDA is aware of news reports of devastating, ongoing diethylene glycol (DEG) and ethylene glycol (EG) contamination in children’s cough and cold medicine in India. FDA expects imported liquid cough and cold medicine at risk for DEG and EG contamination from India to be accompanied by test results that confirm the raw materials are free of DEG/EG contamination to help prevent contaminated drugs from entering the U.S. FDA reviews these test results to ensure that imported drugs are compliant with FDA’s safety requirements.
Importers should provide the following information to FDA
- Test results of high-risk components (including glycerin, propylene glycol, sorbitol solution, non-crystallizing sorbitol solution, maltitol solution and hydrogenated starch hydrolysate) reflecting DEG/EG levels below the limits established in the identity section of the applicable U.S. Pharmacopoeia (USP) monograph using the test method as detailed in the respective monograph. Finished drug manufacturers must collect samples from each lot for testing (visit 21 CFR 211.84) to comply with current good manufacturing practice (CGMP) requirements. Federal law requires the sampling and testing of the raw materials to be conducted by the finished dosage manufacturer from samples obtained onsite after receipt of the drugs (21 CFR 211.84).
- Acceptable test results for DEG/EG in other at-risk materials used in the product. These materials include flavoring blends combined with the high-risk components such as glycerin, propylene glycol and sorbitol solution. This testing must be completed by the finished drug manufacturer or a contract laboratory in compliance with CGMP requirements.
Visit Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol for more information.
Alternatively, importers can provide test results showing acceptable results for DEG/EG in the finished drug. Test results should be from a CGMP-compliant laboratory using a validated method that is verified for the specific sample matrix to facilitate importation. Visit Gas Chromatography-Mass Spectrometry (GC-MS) Method for the Determination of Ethylene Glycol (EG) and Diethylene Glycol (DEG) in Cough, Cold, and Allergy Products containing Glycerin for more information.
Examples of flawed evidence of testing
FDA has observed with prior instances of DEG poisoning that many cases have involved manufacturers of the liquid drug products relying on a supplier’s certificates of analysis as evidence of testing. Given this history, FDA expects imports of high-risk components to be accompanied by the actual chemical test report of the high-risk components or finished drug.
