FDA Warning Letter Says Empower Pharmacy's Compounded Semaglutide and Tirzepatide Appear to Be Copies

What happened / Why it matters

What happened. In a warning letter dated Sept. 18, 2026, FDA told Empower Clinic Services, LLC, doing business as Empower Pharmacy, that compounded semaglutide and tirzepatide products it made with added ingredients “appear to be essentially copies” of FDA-approved drugs. The letter also cites sterile-manufacturing problems found at the company’s Houston facility.

Why it matters. The letter shows how FDA reads the rules that let pharmacies compound drugs that are also sold as approved products. It states FDA’s position as of its date. It is not a court ruling, and we have not verified the company’s response or any later action.

What does the letter say?

The warning letter follows an FDA inspection of the Houston facility from Nov. 3 to Nov. 14, 2025. It was issued by the Office of Compounding Quality and Compliance in FDA’s drug center (CDER). The company had responded to FDA’s inspection observations in December 2025 and in March and April 2026.

Copies of approved drugs. Per the letter, section 503A of the Federal Food, Drug, and Cosmetic Act lets licensed pharmacists and physicians compound drugs for individual patients without FDA approval, if conditions are met. One condition is that they do not compound “regularly or in inordinate amounts” drug products that are essentially copies of commercially available drugs. A compounded product is not a copy if the prescriber makes a change for an identified patient that produces a “significant difference” for that patient.

FDA said the products it cited, which included tirzepatide with niacinamide and semaglutide with cyanocobalamin, “appear to be essentially copies of FDA-approved semaglutide and tirzepatide products.” It said:

• The volume of products “suggests that differences between products you are compounding and the FDA-approved products are pretextual.” The monthly order figures in the published letter are redacted.
• Some orders and prescriptions lacked any prescriber determination of a significant difference.
• Other prescriptions contained “significant difference” statements that “appear to be repeated verbatim across many records,” which FDA said may be pre-generated for the prescriber to select rather than written for an individual patient.
• FDA said that generating prescriptions through third-party platforms that offer pre-selected menu options “call[s] the individualized nature of those determinations into question.”

Sterile manufacturing. FDA said drugs intended to be sterile were prepared under insanitary conditions, whereby they may have become contaminated. It cited inadequate smoke studies in the sterile area and media fills not performed under the most challenging conditions, and listed five examples of violations of current good manufacturing practice (CGMP). FDA said these conditions caused the drugs to be adulterated.

Unapproved and misbranded. Because it concluded the products did not qualify for the section 503A exemptions, FDA said they are unapproved new drugs and are misbranded because their labeling lacks adequate directions for use.

The company’s response. FDA said some of Empower’s corrective actions appeared adequate, some could not be fully evaluated, and some, including a January 2026 media fill report, appeared deficient because of discrepancies in the records.

Next steps in the letter. FDA asked for a written response within 15 working days and warned that failure to address the violations “may result in legal action without further notice, including, without limitation, seizure and injunction.” That is a warning, not an action taken.

What does the letter not say?

• It is not a ruling. A warning letter states FDA’s findings and position. We use “FDA said” and “appear to be” because that is how the letter is written.
• It does not say compounding semaglutide or tirzepatide is always barred. The letter concerns these products, with these added ingredients, at this volume, with these prescription practices. FDA has said elsewhere that whether an added ingredient makes a product a copy depends on the route and concentration, unless the prescriber documents a significant difference for an individual patient.
• It does not report patient injuries. FDA says the deficiencies it found “put patients at risk,” but the letter describes manufacturing and compliance findings, not injuries.
• It does not name other companies. We make no claim about other pharmacies.

Does the new HHS peptide policy change this?

No. The HHS interim policy published Oct. 30 applies to peptide bulk substances that are not components of an FDA-approved drug and are listed in its Appendix A. Semaglutide and tirzepatide are not in that appendix. The six peptides it does cover are BPC-157, TB-500, epitalon, semax, KPV and MOTS-c.

What does this mean for patients?

• Compounded semaglutide and tirzepatide are not FDA-approved, and FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed.
• FDA’s page for telehealth companies says compounded drugs should not be described as generic versions of approved drugs, and notes that FDA does not approve or license pharmacy facilities.
• Patients prescribed a compounded product can ask their prescriber why a compounded version is being recommended instead of an approved one, and what the evidence is for the specific product.
• Approved semaglutide and tirzepatide products have labels and trial evidence. Compounded versions do not carry that review.

Regulatory status verified Oct. 31, 2026. We did not check Empower’s reply to the letter or any later FDA action; this article will be updated if either is published.