The U.S. Meals and Drug Administration has created a “green list” import alert to cease unapproved and unverified glucagon-like peptide 1 (GLP-1) drug components from coming into the US.
On account of shortages of the FDA-approved GLP-1 medication, like semaglutide and tirzepatide, that are used for sort 2 diabetes and weight administration, some sufferers have used compounded variations of the medication.
These compounded medication are usually not authorised by the FDA, and severe issues with these medication have been recognized, together with dosing errors, unapproved salt varieties, and opposed occasions which have led to hospitalization.
The inexperienced listing contains lively pharmaceutical components (APIs) within the GLP-1 medication which were inspected by the FDA and are decided to be in compliance with FDA requirements. Substances not on the inexperienced listing are topic to detention with out examination on the border.
“This is part of the agency’s decisive steps to safeguard consumers from illegal GLP-1 active ingredients imported from overseas to ensure patient safety and a secure drug supply chain,” the FDA writes in a press release.
Based on the FDA, compounded medication ought to solely be used when an FDA-approved drug doesn’t meet a affected person’s medical wants. Sufferers are suggested to get a prescription from their physician and to fill the prescription at a licensed pharmacy or use the FDA’s BeSafeRx marketing campaign to find out the place to securely purchase drugs on-line.
“Americans should be confident that the prescription drugs they take are safe,” FDA Commissioner Marty Makary, M.D., M.P.H., mentioned in an company assertion.
“By strengthening oversight of imported APIs and cracking down on illegal drugs entering the U.S., we are taking aggressive action to protect consumers from poor-quality or dangerous GLP-1 drugs.”
Quotation:
FDA creates ‘inexperienced listing’ of GLP-1 drug components authorised for entry within the U.S. (2025, September 8)
retrieved 8 September 2025
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