The FDA says the prescriptions that made this compounding legal were copy-pasted

On 18 September 2026 the FDA issued warning letter 738238 to Empower Clinic Services, LLC, trading as Empower Pharmacy, of Houston, Texas — one of the largest compounding pharmacies in the country. It follows an inspection carried out between 3 and 14 November 2025, and the firm has fifteen working days from receipt to respond.

Three products are named: two strengths of tirzepatide combined with niacinamide, and semaglutide combined with cyanocobalamin. The combinations are the point of the story, and they need explaining before the allegation makes sense.

A compounding pharmacy operating under section 503A of the Food, Drug and Cosmetic Act may not regularly produce what the statute calls essentially a copy of a commercially available drug. Tirzepatide and semaglutide are both commercially available and approved. A compounded version can escape that bar if a prescriber determines that the compounded product is significantly different from the approved one for that particular patient — which is what adding a vitamin to the vial is for. Niacinamide is vitamin B3. Cyanocobalamin is vitamin B12. The difference creates the exemption.

What the FDA alleges is that the determination was not being made. The letter describes prescriptions carrying prescriber determinations of significant difference that "appear to be repeated verbatim across many records, suggesting that they may be pre-generated for selection" — language offered from a list rather than written about a person. It adds that generating prescriptions by means that undermine the individualised nature of a prescriber's clinical judgement calls those determinations into question, and that against the volumes involved the differences look, in the agency's word, pretextual.

The volumes themselves are redacted. The letter says the firm filled more than a withheld number of orders of each product between July and October 2025, with the figures removed under the exemptions that apply to commercial information. What survives redaction is the shape of the argument: a difference asserted patient by patient, across an order book large enough that the agency does not believe it.

A second set of findings has nothing to do with paperwork. The letter alleges insanitary conditions, smoke studies that did not demonstrate unidirectional airflow in the ISO 5 areas where sterile products are filled, media fills not run under stressful conditions, and media fill records with unexplained gaps in vial counts and data transcribed onto the wrong forms. These are sterility assurance failures in injectable products, and they are cited separately under the adulteration provisions.

It is worth being careful about what a warning letter is. It states the agency's position after an inspection. It is not a court finding, the firm has not yet responded publicly, and it can be contested. Treat every allegation above as an allegation.

The reason this matters beyond one pharmacy is that compounding is the route being discussed for peptides generally. In July an FDA advisory committee recommended six peptides for the 503A bulks list, and we wrote at the time that a recommendation opens a prescription filled by a pharmacy rather than anything you can buy. This letter is about what that route looks like when it operates at scale. The legal basis for compounding is the individualised prescription; the FDA is alleging that the individualisation was a dropdown.

Our own index supplies the comparison the coverage does not make. The two molecules named in this letter are sold without any prescription at all by a large part of the market we read: as of today we hold confirmed listings for tirzepatide from 32 vendors and semaglutide from 27, priced per milligram and shipped on a research label. The regulatory argument is about whether a pharmacist may add vitamin B12 to a vial for an identified patient. It is happening alongside a market that skips the pharmacist, the patient and the determination.

Two things this does not touch. It says nothing about a research-labelled vial, which is outside the compounding framework entirely and was never inside it. And it does not change the July recommendation, which still requires notice-and-comment rulemaking before it changes anything in law.