FDA warning letter to Empower Pharmacy: compounded GLP-1 products made 'regularly and in inordinate amounts'

The U.S. Food and Drug Administration issued Warning Letter 738238 on September 18, 2026, to Empower Clinic Services, LLC, doing business as Empower Pharmacy, a 503A compounding pharmacy in Houston, Texas. The letter, signed by Clint L. Narver, JD, Director of the Office of Compounding Quality and Compliance in the Center for Drug Evaluation and Research, follows an FDA inspection of the facility from November 3 through November 14, 2025, and a Form FDA 483 issued on November 14, 2025. FDA acknowledges the firm's written responses dated December 8, 2025, March 18, 2026, and April 30, 2026, and states that the corrective actions described appear deficient.

The central finding is that Empower compounded drug products containing tirzepatide/niacinamide (17/2 mg/mL and 8/2 mg/mL) and semaglutide/cyanocobalamin (5/0.5 mg/mL) that FDA says are essentially copies of commercially available, FDA-approved semaglutide and tirzepatide products, compounded regularly and in inordinate amounts. Monthly order volumes cited in the letter are redacted under exemption (b)(4). FDA says that combination makes the products ineligible for the compounding exemptions of section 503A of the Federal Food, Drug, and Cosmetic Act.

The evidence FDA describes includes orders or prescriptions lacking any prescriber determination of a significant difference from the commercially available product, purported determinations repeated verbatim across many records - suggesting they were pre-generated for selection rather than written for an identified individual patient - and the compounded volumes themselves. The letter notes that generating prescriptions through third-party technology platforms offering pre-selected statements of significant difference can undermine the individualized clinical judgment section 503A requires.

Investigators also reported insanitary conditions and significant CGMP violations: smoke studies not performed adequately under dynamic conditions to show unidirectional airflow in the ISO 5 area, media fills not performed under the most challenging or stressful conditions, and cited violations of 21 CFR 211.42(c)(10)(vi), 211.113(b), 211.22, 211.42(c)(10)(iv) and 211.100(a). On the firm's January 2026 media fill, FDA says the summary claim that no contamination was found cannot be supported because recorded vial counts do not match the summary, records show gaps with unexplained 'N/A' entries, and some original results were transcribed onto a different form revision without a clear audit trail.

FDA states the products are unapproved new drugs and are misbranded because their labeling lacks adequate directions for use, and warns that continued compounding and distribution of ineligible products would be subject to the new drug approval requirement, labeling requirements and CGMP regulations. The letter asks for a written response within fifteen working days and notes that failure to adequately address the violations may result in legal action without further notice, including seizure and injunction.

Context and limits: a warning letter is an enforcement notification, not a final adjudication, and it states the cited violations are not necessarily all-inclusive; the recipient has the opportunity to respond. This brief reports a regulatory action dated September 18, 2026, reviewed and added to this directory on October 18, 2026. It is not medical or legal advice, makes no finding of its own about any product's safety, and does not recommend any pharmacy, prescriber or product. Patients using compounded medicines can verify a pharmacy's license with their state board of pharmacy.