FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.”
The FDA has sent Empower Clinic Services a warning letter detailing failures to comply with rules on drug compounding.
FDA inspectors visited the company, which does business as Empower Pharmacy, in November 2025. During an inspection of a site in Houston, the FDA found sterile products were “prepared, packed or held under insanitary conditions.” The conditions could result in products becoming “contaminated with filth or rendered injurious to health,” the FDA said.
Inspectors also collected evidence indicating that Empower was failing to meet the conditions needed to compound drug products under Section 503A of the Federal Food, Drug and Cosmetic Act. The law bars pharmacists and physicians from compounding copies of commercial products regularly or in inordinate amounts.
The evidence showed Empower compounded tirzepatide and semaglutide products that “appear to be essentially copies” of FDA-approved products, according to the federal agency. Eli Lilly markets the GLP-1/GIP receptor agonist tirzepatide as Mounjaro and Zepbound, while Novo sells the GLP-1 drug semaglutide as Ozempic and Wegovy. As of Sept. 24, Empower continues to list tirzepatide and semaglutide products for sale on its website.
Empower’s manufacturing volumes suggested that “differences between products you are compounding and the FDA-approved products are pretextual,” the agency said. “Pretextual” is defined as “a purpose or motive alleged or an appearance assumed in order to cloak the real intention or state of affairs.”
The FDA cited multiple pieces of evidence to support its argument. Some orders to Empower lacked a prescriber determination of significant difference from the commercially available product, the FDA said. Other orders included purported prescriber determinations of “significant difference” that appeared to be repeated verbatim across many records, suggesting they may be pre-generated, the FDA said.
Generating orders via third-party technology platforms that give prescribers pre-selected menu options for choosing a statement of significant difference calls “the individualized nature of those determinations into question,” the FDA said.
The agency’s concerns about insanitary conditions apply regardless of whether Empower’s drugs meet the conditions of Section 503A. Empower’s response to the FDA’s concerns about insanitary conditions, which were communicated in a Form 483 at the end of the inspection, failed to satisfy the agency. The FDA noted “gaps and discrepancies” in paperwork Empower submitted to address the concerns.
The warning letter is dated Sept. 18. The FDA has given Empower 15 working days to respond in writing, detailing the specific steps it has taken to address any violations. Empower should include an explanation of each step being taken to prevent the recurrence of violations, the FDA said.
