The Food and Drug Administration announced on Apr. 2 that it will restrict the use of glucagon-like peptide-1 (GLP-1) active pharmaceutical ingredients in compounded products that are not approved by the agency.
This move comes after the FDA sent warning letters in fall 2025 to companies promoting their non-FDA-approved compounded products as generic versions of approved drugs. The agency said these actions were misleading to consumers.
The FDA plans to take additional steps against false advertising related to unapproved GLP-1 compounded products. According to the statement, entities involved in producing, distributing, or marketing these unapproved products who do not address violations cited by the agency may face legal action.
These measures are part of ongoing efforts by the FDA to ensure public safety and prevent misleading information about drug products. The restrictions aim to protect patients from potential risks associated with unapproved medications.
More details can be found in a statement from the FDA.
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