FDA Warns Empower Pharmacy Over Compounded Tirzepatide and Semaglutide Products

The FDA has issued a warning letter to Empower Clinic Services, doing business as Empower Pharmacy, following an inspection of its Houston facility conducted in November 2025. According to the FDA warning letter, investigators found that the firm compounded drug products, including combinations such as tirzepatide with niacinamide and semaglutide with cyanocobalamin, that appear to be essentially copies of FDA approved semaglutide and tirzepatide products.

Under section 503A of the Food, Drug, and Cosmetic Act, compounded drugs can be exempt from standard manufacturing and approval requirements only when prepared for an individually identified patient and only when they are not essentially copies of a commercially available product, unless a prescriber documents a significant patient specific difference. The letter states the firm compounded and filled large volumes of these products across July through October 2025, and that the volume suggests any claimed differences from the approved versions were pretextual. It also cites orders lacking any documented prescriber rationale for a significant difference.

This letter is a compliance action, not a clinical finding about the compounds themselves, and it does not evaluate safety or effectiveness of tirzepatide or semaglutide as approved medications. It is a reminder that compounded versions of GLP-1 drugs remain under close regulatory scrutiny.

This article is for education only. It is not medical advice. Compounds discussed here are sold for research purposes. Talk to a licensed clinician before making health decisions.