Texas Compounder Ordered to Stop Production by Federal Court – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
A federal judge has ordered Guardian Pharmacy Services, a Texas-based company, to stop producing compounded drug products intended to be sterile until it complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.
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 in Dallas, Texas, as well as the company’s owner, Jack R. Munn.
According to FDA Commissioner Scott Gottlieb, MD, although compounded drugs can serve a need for certain patients whose medical needs cannot be met by an FDA approved drug product, they do not undergo the same premarket review as FDA approved drug products. All drug compounders are required to comply with requirements, and compounders that violate the law by not adhering to requirements should be held accountable by law.