FDA: Empower Pharmacy Illegally Compounding GLP-1s

An 11/3-11/14/2025 FDA inspection at Empower Clinic Services, doing business as Empower Pharmacy, a compounding pharmacy in Houston, TX, found that the pharmacy is compounding GLP-1 drugs that don’t meet legal requirements for such compounding. A 9/16 Warning Letter says the agency investigators collected evidence that drug products produced by Empower were essentially copies of commercially available drug products and were compounded in inordinate amounts.

“FDA is aware of high demand for compounded versions of FDA-approved semaglutide and tirzepatide products,” the letter says. “The volume of products you are producing suggests that differences between products you are compounding and the FDA-approved products are pretextual.”

FDA also lists these current good manufacturing practice (CGMP) regulation violations:

• failure to establish an adequate system for maintaining equipment used to control aseptic conditions;
• failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
• failure of the quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity;
• failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas; and
• failure to establish adequate written procedures for production and process control designed to assure that the manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess.

The letter says Empower does not have any FDA-approved applications for the ineligible drug products that it compounded and that its ineligible products are misbranded because their labeling doesn’t contain adequate directions for their intended uses.

“FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design procedures, personnel, processes, maintenance, materials, and systems,” the letter says. “In particular, the review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting the comprehensive evaluation.”

Empower was told to correct the violations promptly and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with copies of related documentation and a schedule for completing the corrections.