- March 12, 2019
Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services
A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements. According to the complaint, despite previous warnings from the FDA, Guardian Pharmacy Services continued to violate the law, putting patients at risk.
U.S. Chief District Judge Barbara M.G. Lynn for the Northern District of Texas entered a consent decree of permanent injunction against JMA Partners, Inc., doing business as Guardian Pharmacy Services, located at 7920 Elmbrook Dr., Suite 108, Dallas, Texas, as well as the company’s owner, Jack R. Munn.
“Although compounded drugs can serve an important role for certain patients whose medical needs cannot be met by an FDA approved drug product, compounded drugs can also pose unique risks. They’re not FDA approved and do not undergo premarket review for safety, effectiveness or quality. All drug compounders must comply with certain requirements, which can include current good manufacturing practice requirements, to avoid product quality problems and potential patient harm.
CONTINUE READING ON www.fda.gov