FDA Develops 'Green List' Alert to Prevent Entry of GLP1 APIs From Unverified Sources
The FDA is developing a list, called a "green list," aimed at preventing the importation of glucagon-like peptide-1 (GLP-1) active pharmaceutical ingredients (APIs) from unverified foreign sources, according to an agency release.
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"Certain GLP-1 drugs, including semaglutide and tirzepatide, are FDA-approved for specific uses such as treating type 2 diabetes and, in certain cases, chronic weight management. However, the agency is aware that some patients are turning to compounded versions of these drugs, which are not approved by the FDA," the FDA said. "To protect patients who use these compounded drugs, the green list will include GLP-1 APIs from facilities the agency has inspected or evaluated that appear to be in compliance with the FDA’s rigorous standards -- standards applicable to all APIs manufactured in the U.S. APIs from other sources are subject to detention without physical examination."
The green list was included in new FDA Import Alert 66-80, which was issued Sept. 5, though the names of the green listed companies are redacted in the import alert.