New US restrictions on drugs containing DEG/EG

News - 31 Luglio 2023

The Food & Drug Administration (FDA) acts to ensure the safety, quality and effectiveness of the drug products available to the American public. To this end, all manufacturers of drugs intended for the U.S. market, must meet Current Good Manufacturing Practice (CGMP) requirements and appropriate quality specifications. 

However, following the current epidemic of DEG poisoning in the United States, the FDA has implemented strict safeguards to prevent the importation of products contaminated with diethylene glycol (DEG) or ethylene glycol (EG) into the USA. Special attention has been placed on liquid formulation drugs containing ingredients such as glycerin, propylene glycol, polyethylene glycol, maltitol solution, hydrogenated starch hydrolysate, or sorbitol solution.

It is important to highlight that all FDA-regulated pharmaceutical products imported into the United States must meet the same stringent quality and safety standards as domestic products.

Taking advantage from the multiannual experience, LabAnalysis supports Customers to test raw materials and finished product batches before release accordingly with Pharmacopoeia methods or developing and validating ad hoc methods, in order to confirm the absence of DEG and EG contaminants.

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