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FDA’s Efforts To Oversee and Mitigate the Risks of Compounded GLP-1 Drugs

Announced on  | Last Modified on  | Project Number: OEI-01-25-00450
Status
Active
Agency
Food and Drug Administration

OBJECTIVE

Recent large-scale compounding of glucagon-like peptide-1 receptor agonists (GLP-1 drugs) has highlighted challenges the Food and Drug Administration (FDA) faces in overseeing the quality of these products and mitigating risks to patients. From 2022 to 2025, certain GLP-1 drugs were on FDA’s drug shortage list, so compounding facilities were allowed to produce copies of these drugs. Although the shortages ended in early 2025, some compounding facilities may still be compounding large quantities of GLP-1 drugs. This study will assess FDA's efforts to oversee the compounding of GLP-1 drugs, including the extent to which FDA inspects compounders and leverages available data to identify and address potential risks.

TIMELINE

  • April 15, 2026
    Announced
  • Today
    Office of Evaluation and Inspections In-Progress
  • Est FY2028
    Estimated Fiscal Year for Project Completion
Work Plan Type
Office of Evaluation and Inspections
HHS Agencies
Food and Drug Administration
Issue Areas
Food, Drug and Device Safety Prescription Drug
Target Groups
-
Financial Groups
Other Funding