FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’

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.

First reported by Biospace.