FDA Warns Pharmacy About Illegal GLP-1 Compounding

The FDA issued a warning letter this month to Empower Pharmacy over its mass production of compounded GLP-1 weight-loss and diabetes drugs, citing illegal copycat manufacturing and insanitary conditions.

Following a facility inspection in November 2025, the agency determined that Empower produced large quantities of drugs that were “essentially copies of FDA-approved semaglutide [Ozempic, Wegovy] and tirzepatide [Mounjaro, Zepbound] products,” in violation of Section 503A of the Federal Food, Drug, and Cosmetic Act.

“The volume of products you are producing suggests that differences between products you are compounding and the FDA-approved products are pretextual,” the FDA wrote in the letter, dated Sept. 18.

Under Section 503A, licensed compounding pharmacies are permitted to tailor customized medications for individual patient needs. However, they are prohibited from regularly compounding “in inordinate amounts” any drugs that copy commercially available products without a documented, individualized clinical rationale from a prescriber.

Compounded formulations cited in the letter combined active GLP-1 ingredients with added B vitamins — specifically tirzepatide mixed with niacinamide, and semaglutide mixed with cyanocobalamin.

Because Empower failed to meet Section 503A conditions, its products lost statutory exemptions and were reclassified as unapproved new drugs and misbranded products.

Additionally, FDA inspectors found that sterile drug products were prepared, packed, or held under insanitary conditions and thereby could be “contaminated with filth or rendered injurious to health.” Other key violations included:

• Failure to perform smoke studies under dynamic conditions to confirm proper airflow in ISO 5 clean room areas
• Performing media fills under non-stressful conditions, therefore not guaranteeing aseptic technique
• Inadequate environmental monitoring, equipment maintenance, and quality control unit oversight

Some of Empower’s subsequent corrective actions were adequate while others were deficient, the FDA noted. The compounder has 15 working days to respond.

The warning letter follows intensified efforts to crack down on GLP-1 compounding this year. The surge in GLP-1 compounding began a few years ago when high demand triggered widespread shortages. However, shortages of tirzepatide (resolved in December 2024) and semaglutide (resolved in February 2025) have since ended.