FDA creates import alert system for GLP-1 ingredients to protect patients

Investing.com -- The U.S. Food and Drug Administration established a "green list" import alert on Friday to block potentially dangerous GLP-1 active pharmaceutical ingredients from unverified foreign sources entering the U.S. market.

This measure aims to protect consumers from illegal GLP-1 ingredients imported from overseas, ensuring patient safety and maintaining a secure drug supply chain.

GLP-1 drugs like semaglutide and tirzepatide are FDA-approved for treating type 2 diabetes and in some cases, chronic weight management. The agency has noticed patients turning to compounded versions of these drugs that lack FDA approval.

The new green list will include GLP-1 active pharmaceutical ingredients from facilities the FDA has inspected or evaluated that meet the agency’s standards. Ingredients from other sources will be subject to detention without physical examination.

"Americans should be confident that the prescription drugs they take are safe," said FDA Commissioner Marty Makary, M.D., M.P.H. "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."

The FDA has previously identified serious issues with compounded versions of these medications, including dosing errors, use of unapproved salt forms, and adverse events that sometimes required hospitalization.

"Our priority is protecting public health by ensuring all active ingredients used in GLP-1 drugs are obtained from compliant manufacturers," said George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research. "Targeting illegal foreign GLP-1 active ingredients at the border is a critical part of this work."

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The agency plans to continue working with state regulators, monitor the market, and take enforcement actions as needed to prevent unsafe or fraudulent GLP-1 drugs from reaching U.S. consumers.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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