FDA Hits Empower Pharmacy With Fifth Warning Letter

FDA has sent Empower Clinic Services, LLC — the Houston-based pharmacy doing business as Empower Pharmacy — its fifth warning letter since 2017, this time over the scale and sameness of its compounded GLP-1 lineup. The letter, numbered 738238 and dated September 18, 2026, was posted to FDA's warning-letter database and reported publicly on September 22. It accuses Empower of producing tirzepatide and semaglutide formulations that are essentially copies of Eli Lilly's and Novo Nordisk's approved drugs, and of backing them with prescriber paperwork that reads like a template rather than a patient record.

The core finding: volume as evidence

Compounding pharmacies operating under Section 503A of the Federal Food, Drug & Cosmetic Act may prepare a drug for an individual patient without going through FDA's new-drug approval process — but only when the compounded product is not "essentially a copy" of a commercially available, FDA-approved drug, and only to meet an identified patient need. FDA's letter argues Empower's GLP-1 production fails that test on its face: the sheer volume of tirzepatide and semaglutide products it compounds, the letter states, "suggests that differences between products you are compounding and the FDA-approved products are pretextual." Empower mixes B vitamins into its tirzepatide and semaglutide formulations and offers them in dosage forms FDA has not approved — differences the agency treats as cosmetic rather than clinically necessary.

Prescriber records that read like a template

The letter's second major finding cuts at the other pillar of the 503A exemption: that compounding responds to an individual prescriber's determination of a specific patient's need. FDA investigators found that the "determinations" attached to patient records — the clinical justification a prescriber is supposed to write for that patient — appeared identically, word for word, across hundreds of separate files. Pre-loaded, selectable language standing in for an individualized clinical judgment is not what the exemption contemplates, and the letter treats the pattern as evidence the prescribing process itself is not doing what the statute requires.

Manufacturing deficiencies layered on top

Beyond the essentially-copies and individualization findings, the letter also raises sterile-manufacturing concerns from the same inspection: gaps in airflow studies, media fills, environmental monitoring and aseptic processing — the routine controls that keep an injectable sterile between compounding and administration. None of the three findings stands alone; together they read as a facility whose scale, documentation and sterile controls have not kept pace with the volume of GLP-1 product it is compounding.

A fifth letter, and a lawsuit in the background

This is not Empower's first encounter with FDA enforcement: the September 18 letter is the fifth warning letter the agency has sent the company since 2017, following prior letters in 2017, 2018, 2021 and 2025. Empower is also the named defendant in a lawsuit Eli Lilly filed in April 2025 in the U.S. District Court for the District of New Jersey, alleging the pharmacy kept compounding tirzepatide copies of Zepbound and Mounjaro after the FDA-declared shortage that had permitted such compounding ended; Empower has disputed the "copies" characterization, and the case has partly survived a motion to dismiss.

Empower's response

CEO Shaun Noorian said in a statement that Empower "takes its compliance obligations seriously," adding: "We have already remediated many of the issues outlined in the Warning Letter, and look forward to working with the FDA to address the remaining matters expeditiously and comprehensively to the agency's satisfaction." Noorian noted Empower has been FDA-registered for more than a decade and said the company views regulatory oversight as essential to safe compounding.

What it means for compounders

The letter arrives as GLP-1 compounding remains under sustained FDA scrutiny even after the shortage-based exemptions that once covered large-scale production of semaglutide and tirzepatide copies expired. For 503A and 503B operators still compounding GLP-1 formulations, the letter is a reminder that FDA is willing to treat production volume itself as evidence against an essentially-copies defense, and that prescriber documentation built on templated, non-patient-specific language is a discrete, citable finding — not a paperwork footnote to a manufacturing problem.

Frequently asked questions

What did FDA cite Empower Pharmacy for?

A warning letter (No. 738238, dated September 18, 2026, posted September 22) finds Empower's compounded tirzepatide and semaglutide products are essentially copies of FDA-approved drugs from Eli Lilly and Novo Nordisk, produced in volumes that make any formulation differences look pretextual; prescriber "determinations" of individual patient need that appeared copy-pasted verbatim across hundreds of records; and sterile-manufacturing deficiencies in airflow studies, media fills, environmental monitoring and aseptic processing.

Is this Empower's first warning letter?

No — it is the fifth FDA has sent the Houston compounder since 2017, following letters in 2017, 2018, 2021 and 2025.

What is the legal basis for the violations?

FDA found the products do not qualify for the Section 503A compounding exemption, which requires compounding for an individual patient's identified need rather than in volumes and formulations that mirror a commercially available, FDA-approved drug. That makes the products unapproved new drugs, and FDA also cited them as adulterated and misbranded.

How has Empower responded?

CEO Shaun Noorian said in a statement that Empower "takes its compliance obligations seriously," that the company has "already remediated many of the issues outlined in the Warning Letter," and that it looks forward to working with FDA to resolve the remaining matters.