FDA Empower Pharmacy warning letter, Sept 2026

What warning letter WL 738238 says

The letter is dated September 18, 2026, and is addressed to Arta Shaun Noorian, Founder and Chief Executive Officer of Empower Clinic Services LLC dba Empower Pharmacy. FDA says investigators inspected the Houston facility from November 3, 2025, through November 14, 2025, collected evidence that drug products failed to meet the conditions of section 503A, and noted serious deficiencies in production practices. FDA issued a Form FDA 483 on November 14, 2025, and says it received facility responses dated December 8, 2025, March 18, 2026, and April 30, 2026. The letter, issued after those responses, says it appears the firm produced drug products that violate the FD&C Act.

Section 503A describes conditions under which a compounded human drug can qualify for exemptions from current good manufacturing practice, from labeling with adequate directions for use, and from FDA approval before marketing. One condition is a valid prescription for an individually identified patient. Another is that a pharmacist or physician must not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. A product is not essentially a copy if a change, made for an identified individual patient, produces a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug.

FDA says the firm compounded products including the three named below regularly and in inordinate amounts, and that those products appear to be essentially copies of FDA-approved semaglutide and tirzepatide products. FDA says it is aware of high demand for compounded versions of those approved products, and that the volume being produced suggests the differences from the approved products are pretextual. The letter then says the products do not meet section 503A and are not eligible for its exemptions, including the approval requirement, adequate directions for use, and CGMP.

Redacted order counts and the prescription findings

The letter says firm records show compounded and filled orders for those three products in July, August, September, and October 2025. Each line says the firm compounded and filled more than a quantity FDA marked (b)(4). The letter does not print the order counts. This guide does not estimate them.

FDA says the evidence includes three kinds of records. Some orders or prescriptions lack any prescriber determination of a significant difference from the commercially available product. Some contain a purported significant-difference determination that appears to be repeated verbatim across many records, which FDA says suggests the language may be pre-generated for selection by the prescriber rather than written for an identified individual patient. FDA also cites the volume of particular products compounded and orders filled. The letter says generating prescriptions in ways that undermine individualized clinical judgment, for example through third-party technology platforms that give prescribers pre-selected menu options for a significant-difference statement, calls the individualized nature of those determinations into question.

A footnote states that FDA previously exercised enforcement discretion for state-licensed pharmacies compounding semaglutide and tirzepatide injection products that are essentially copies of commercially available drug products under section 503A. That period ended for tirzepatide injection products on March 5, 2025, and for semaglutide injection products on April 24, 2025.

Insanitary conditions and the CGMP observations

FDA says drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health. The examples in the letter are a failure to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area, and media fills that were not performed under the most challenging or stressful conditions. FDA says there is a lack of assurance that the firm can aseptically produce drug products in the facility.

For the products FDA calls ineligible for the 503A exemptions, the letter also lists CGMP violations. The examples are an inadequate system for maintaining equipment used to control aseptic conditions, a failure to establish and follow written procedures designed to prevent microbiological contamination of products purporting to be sterile, including validation of aseptic and sterilization processes, a quality control unit that failed to ensure compliance with CGMP and specifications for identity, strength, quality, and purity, an inadequate system for monitoring environmental conditions in aseptic processing areas, and inadequate written procedures for production and process control.

On the firm's responses, FDA says some corrective actions related to insanitary conditions appear adequate, and that others cannot be fully evaluated because supporting documentation was missing. The letter says a smoke study under Rev. 005 was executed March 30 through April 3, 2026, and that the April 2026 study was still under post-execution review and had not been finalized or provided. On a January 2026 aseptic media-fill simulation, FDA says the summary claimed no contamination was observed, and that review of the records found gaps and discrepancies. The vial counts in that discussion are redacted. FDA also says multiple media-fill records were transcribed onto a different form because the original results were documented on the wrong form, and that this raises concerns when the audit trail does not show why the results were rewritten and who authorized it. The letter says insanitary-conditions requirements apply whether or not the products meet section 503A.

The letter says failure to address the violations may result in legal action, including seizure and injunction. It asks for a written response within 15 working days of receipt, sent to compoundinginspections@fda.hhs.gov, referring to warning letter 738238.

What this letter does not say

The letter is a warning letter to one named firm about products and practices FDA says it found there. It is not written as a recall notice for Zepbound, Wegovy, Ozempic, Mounjaro, or every compounded GLP-1. It does not say that every pharmacy compounding any drug is outside section 503A. It says these named products, compounded regularly or in inordinate amounts as essentially copies, do not qualify for the 503A exemptions, and that the insanitary-conditions provisions apply even when a compounded product does meet 503A.

The unredacted text names Empower Clinic Services LLC dba Empower Pharmacy. It does not name a provider listed on Telehealth Ledger. A redacted footnote points to an example marked (b)(6). This guide does not treat a redaction as a hidden provider name, and it does not treat the letter as a finding about any other pharmacy.

A separate FDA announcement, dated March 3, 2026, says the agency issued 30 warning letters to telehealth companies for false or misleading claims about compounded GLP-1 products on their websites. That announcement does not list the 30 company names. It says compounded drugs are not FDA-approved, which means the agency does not review their safety, effectiveness, or quality before they are marketed, and that compounded drugs are not the same as generic drugs, which are FDA-approved. Commissioner Marty Makary is quoted saying compounded drugs can be important for overcoming shortages or meeting unique patient needs, and that compounders should not try to compound drugs in a way that circumvents FDA's approval process. The announcement says the primary violations included claims implying sameness with FDA-approved products, and advertising products under the telehealth firm's name or trademark in a way that implies the telehealth firm is the compounder.

Marketing claims FDA tells telehealth companies to avoid

FDA's page for telehealth companies, content current as of June 15, 2026, says the agency is concerned about promotion of compounded drugs, including GLP-1 receptor agonists, with false or misleading claims. The page says FDA has issued warning letters on those claims and tells readers they can search the warning-letter database for the term telehealth.

The same page lists claim patterns it tells telehealth companies not to use. They are branding that falsely or misleadingly implies the telehealth company is the compounder, describing a compounded drug as a generic version of an FDA-approved drug or as the same as a drug approved by FDA, claiming a compounded drug has been FDA-approved or otherwise evaluated for safety and effectiveness when it has not, describing a compounded drug as clinically proven to produce the same result as the FDA-approved drug, and claiming a compounded drug is sourced from an FDA-approved or FDA-licensed pharmacy or outsourcing facility. The page says FDA does not approve or license any facility, and that a compounded drug is not approved by FDA while a generic drug is approved before marketing.

• Ask which pharmacy will dispense the product, and whether that name is on the prescription and the label.
• Ask for the product identity: ingredient, strength, and container size, rather than a sentence that only says Ozempic, Wegovy, Mounjaro, or Zepbound.
• Ask whether the prescription records a prescriber's determination of a significant difference for that patient, and whether that sentence was chosen from a pre-written menu.
• Treat a claim that the compounded drug is generic, FDA-approved, clinically proven to match the approved drug, or the same as Ozempic or Zepbound as a claim FDA's June 15, 2026 page tells companies not to make.
• Questions about a medicine someone is already using belong with the prescriber and the dispensing pharmacy. This page does not say to start or stop a drug.

A Zepbound price and a compounded price answer different questions

Telehealth Ledger's Zepbound program page, opened October 16, 2026, states Eli Lilly's Lilly Direct regular self-pay price for a one-month supply of the vial or KwikPen: $299 for 2.5 mg, $399 for 5 mg, $499 for 7.5 mg, and $699 for 10 mg, 12.5 mg, and 15 mg. The page says these figures match Lilly's Zepbound terms rechecked on October 15, 2026. It says a $449 purchase offer covers 7.5 mg, 10 mg, 12.5 mg, and 15 mg when the refill is completed within 45 days of the prior delivery or receipt. It says a month is 28 days: four vials or one KwikPen. A direct request for Lilly's full Zepbound terms page on October 16, 2026 stopped at Cloudflare before the terms text loaded, so this article uses that program-page recheck and does not add a Lilly figure from the blocked page.

The same Zepbound page lists telehealth quotes separately from the manufacturer ladder. Rechecked 19 October 2026, four providers publish a calendar-month continuing price, from $299 to $1,399 a month, median $1,234. Sesame Care's $299 is the 2.5 mg medication price with care billed separately at $99 a month, or $59 a month on an annual care plan, checked October 2, 2026. GobyMeds and Eden Health list $1,399, and those figures bundle the drug with the care. Sprout Health's homepage, checked the same day, does not publish a Zepbound price. Those rows are branded Zepbound offers. They are not the compounded products named in the Empower letter.

The compounded tirzepatide program page, also opened October 16, 2026, says prices were checked October 7, 2026, and that continuing monthly prices run from $129 at Embody, checked August 22, 2026, to $399 at MEDGm, checked September 14, 2026, and Willow, checked September 15, 2026. The ranked table lists 22 priced providers. CoreAge Rx's $129 is a prepaid effective rate for $1,548 paid for 12 months up front, checked October 7, 2026, which the page says is a separate charge from a continuing monthly rate. The methodology page stores an introductory price, a continuing monthly price, an upfront charge, a prepaid effective monthly price, commitment length, and medication inclusion separately, and it lists a provider when the visit link can earn a commission. A row in the catalog below is a published commercial offer. It is not a finding that the offer meets section 503A, and it is not a Zepbound price.

Compounded semaglutide, compounded tirzepatide, and Zepbound stay in separate groups in the catalog. A lower compounded price does not make that product the approved brand.