FDA warning letter hits Empower Pharmacy over GLP-1 copies, insanitary conditions
The Sept. 18 letter followed a November 2025 inspection and cites tirzepatide-niacinamide and semaglutide-cyanocobalamin blends as essentially copies of approved products.
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By Daniel Okafor · Regulatory Correspondent
Sep 23 16:51 ETSource: MedPage Today
The wire
- 01FDA told Empower Pharmacy its mass-produced compounded semaglutide and tirzepatide violate Section 503A, saying the volume suggests differences from approved products are 'pretextual,' and that sterile products were held under insanitary conditions.
- 02Compounders adding B vitamins to incretins to claim a significant difference are now on notice; losing 503A exemptions reclassifies those products as unapproved new drugs and misbranded.
- 03Empower has 15 working days to respond; FDA called some corrective actions adequate and others deficient. Semaglutide and tirzepatide shortages ended in 2025.
From the source
Read at medpagetoday.comFDA Warns Pharmacy About Illegal GLP-1 Compounding
— Agency's letter flagged issues with copycat manufacturing and sterility
