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

Summary

Company

Empower Clinic Services, LLC (dba Empower Pharmacy)

Letter number

#738238

Issue date

September 18, 2026

Subject

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Word for word, from the letter of 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.

Section 503A of the FD&C Act describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FD&C Act: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].1 Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A.

In addition, for a compounded drug product to qualify for the exemptions under section 503A, a licensed pharmacist or physician must not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product.2 Section 503A(b)(2) provides that a compounded drug product is not essentially a copy of a commercially available drug product if “there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.” (sections 503A(b)(1)(D) and 503A(b)(2) of the FD&C Act [21 U.S.C. §§ 353a(b)(1)(D) and 353a(b)(2)]).

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.3, 4 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.

According to your firm's records, for example, you compounded and filled orders for the aforementioned drug products in the following quantities:

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.

Furthermore, production records collected during the inspection indicate that your firm compounded these drug products regularly or in inordinate amounts.

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.”

Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026

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