Compounded GLP-1s: FDA status and safety
Also known as:
Compounded semaglutide and tirzepatide
What changed when the shortages ended, and the safety issues to discuss with patients.
Written and reviewed by Farhan Tahir, MD · Last reviewed
VIDEO LESSON
Regulatory status
FDA removed tirzepatide (December 2024) and semaglutide (February 2025) from its drug shortage list, ending the shortage-based allowance for widespread compounding of copies of these drugs. Compounded products are not FDA-approved and are not reviewed for safety, effectiveness or quality.
Safety concerns
• Dosing errors from unfamiliar concentrations and syringes, which FDA has warned about
• Salt forms such as semaglutide sodium or acetate, which are not the approved active ingredient
• Variable purity and potency
Counseling
Recommend FDA-approved products, including lower-cost manufacturer direct-to-patient options where available, and report adverse events to FDA MedWatch.
Key studies and references
Educational content only, written and reviewed by Farhan Tahir, MD. It does not replace individual medical advice. For sudden chest pain, trouble breathing or stroke symptoms, call 911.
AT A GLANCE
Section
Prescribing & monitoring
Also known as
Compounded semaglutide and tirzepatide
Reviewed by
Farhan Tahir, MD
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