The Food and Drug Administration issued Sept. 5 an import alert that it said aims to help stop imports of potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients from unverified foreign sources.
The FDA states that it has approved several GLP-1 drug products for treatment of patients with type 2 diabetes and chronic weight management for obese and certain overweight patients, along with other indications. However, the FDA is aware that some patients and health care professionals may seek unapproved GLP-1 drug products, such as those containing the active ingredients semaglutide and tirzepatide.
In addition, shortages of approved GLP-1 drug products have led to increased compounding of such products using APIs from foreign sources, including China, India, and Europe. FDA onsite inspections and remote regulatory assessments found that 21 percent of API sites were noncompliant. The FDA has also encountered a pattern of sites that register as GLP-1 API manufacturers, offer such APIs for import, refuse to answer FDA requests for records, and then de-register, all within a short period of time.
The new import alert therefore advises FDA divisions that they may detain without physical examination shipments of GLP-1 APIs offered for entry other than the products and firms identified on the green list of the alert, which appear to be in compliance with relevant requirements.
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