Empower Pharmacy — FDA Warning Letter (September 18, 2026)

From November 3, 2025, through November 14, 2025, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Empower Clinic Services, LLC dba Empower Pharmacy, located at 7601 N. Sam Houston Pkwy W., Ste. 100, Houston, TX 77064. During the inspection, the investigators collected evidence indicating that drug products you produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 353a] for exemption from certain provisions of the FD&C Act. In addition, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk.

FDA issued a Form FDA 483 to your firm on November 14, 2025. FDA acknowledges receipt of your facility’s responses, dated December 8, 2025, March 18, 2026, and April 30, 2026. Based on this inspection, it appears that you produced drug products that violate the FD&C Act.

During the inspection, the FDA investigators collected evidence indicating that drug products produced by your firm failed to meet the conditions of section 503A. For example, the investigators collected evidence indicating that your firm compounded drug products that are essentially copies of commercially available drug products regularly and in inordinate amounts. Specifically, your firm compounded products including 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. FDA is aware of high demand for compounded versions 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.

Evidence collected includes (1) orders/prescriptions that lack any prescriber determination of significant difference from the commercially available product; (2) 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; and (3) the volume of particular products compounded and orders filled. 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, potentially undermining claims that such prescriber determinations of significant difference are sufficient to meet the conditions of section 503A.

Therefore, you compounded drug products that do not meet the conditions of section 503A and are not eligible for the exemptions in that section, including the FDA approval requirement of section 505 of the FD&C Act, the requirement under section 502(f)(1) of the FD&C Act that labeling bear adequate directions for use, and the requirement of compliance with CGMP under section 501(a)(2)(B) of the FD&C Act. In the remainder of this letter, we refer to your drug products that do not qualify for exemptions under section 503A as the “ineligible drug products.”