Empower Clinic Services, LLC dba Empower Pharmacy
FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy (Houston, TX) following a November 2025 inspection, finding that the pharmacy compounded tirzepatide and semaglutide combination products in massive volumes that failed to meet section 503A exemption conditions — specifically by producing essentially copies of FDA-approved GLP-1 drugs regularly and in inordinate amounts, with prescriber 'significant difference' determinations appearing pre-generated rather than individualized. The compounded products were also found adulterated due to insanitary sterile manufacturing conditions (inadequate smoke studies, deficient media fills, poor environmental monitoring) and CGMP violations, and misbranded for lacking adequate directions for use. FDA demands a written corrective action response within 15 working days and warns that failure to comply may result in seizure or injunction.
Flagged claims (4)
Generating prescriptions through means that undermine the individualized nature of a prescriber's clinical judgment (for example through third-party technology platforms that provide prescribers with pre-selected menu options for choosing a statement of significant difference) call the individualized nature of those determinations into question
orders/prescriptions with purported prescriber determinations of "significant difference" that appear to be repeated verbatim across many records, suggesting that they may be pre-generated for selection by the prescriber, rather than written by the prescriber for an identified individual patient
TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML), SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML), and TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML), which appear to be essentially copies of FDA-approved semaglutide and tirzepatide products
The volume of products you are producing suggests that differences between products you are compounding and the FDA-approved products are pretextual.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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