Consent Decree Entered into with Texas Compounder

On March 12, 2019, FDA announced that US 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. The court ordered the Texas-based company to stop producing compounded sterile products until the company complies with the Federal Food, Drug, and Cosmetic Act, completes corrective actions, and implements a comprehensive quality control system.

FDA stated in a press release that the company manufactured and distributed products made under “insanitary conditions” and were misbranded because the labels “did not include adequate directions for patient use, which describe how to use a drug safely and effectively for its intended purposes. Some of Guardian’s drugs were also misbranded because their labels were false or misleading.”

FDA inspected the company in 2016 and issued a warning letter for insanitary conditions. Several adverse events related to Guardian’s products, including vision impairment, were reported to FDA in 2017.

“According to the complaint, despite previous warnings from the FDA, Guardian Pharmacy Services continued to violate the law, putting patients at risk,” the agency stated in the press release.

Source: FDA

Editor's Note: Guardian Pharmacy Services in Dallas is not affiliated with Guardian Pharmacy of Dallas-Fort Worth in Arlington, a member of the national long-term care Guardian Pharmacy Services headquartered in Atlanta.