FDA Warns Empower Pharmacy Over Compounded GLP-1 Drugs
publishers 4articles 4first reported 22 Sep, 20:45 UTCdeveloping since 24 Sep · 3 editions
The Food and Drug Administration has warned Houston-based Empower Pharmacy that it violated federal law by producing copies of popular weight-loss drugs in “inordinate amounts,” CBS News reported. The Sept. 18 warning, posted online Tuesday, gives the company an opportunity to comply with FDA requirements.
Empower said it had “already remediated many of the issues outlined in the Warning Letter” and would continue cooperating with the agency. The pharmacy advertises compounded versions of two widely used medications to health-care providers, not directly to consumers.
Compounding pharmacies traditionally tailor medications for individual patients. Their products do not undergo the FDA review required for approved drugs, and the agency says it cannot provide the same safety assurances. During shortages beginning in 2022, federal rules allowed compounders to make versions of GLP-1 medicines from Eli Lilly and Novo Nordisk. After the FDA declared the shortages over in 2025, federally licensed pharmacies largely stopped making copies of tirzepatide and semaglutide. Some state-licensed pharmacies continued offering modified versions, citing an FDA policy permitting changes that prescribers say make a significant difference for individual patients.
The warning comes amid wider scrutiny of GLP-1 use. NewsNation reported that more than 1.1 million people use the drugs without an FDA-approved reason, while Nature reported that researchers are investigating why the medications do not produce weight loss for some patients.
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