The Department of Justice filed a complaint in U.S. District Court for the Northern District of Texas alleging that JMA Partners Inc., a compounding pharmacy doing business as Dallas-based Guardian Pharmacy Services, and their owner Jack R. Munn failed to rectify unsanitary conditions at their drug-compounding facility. The District Court for the Northern District of Texas entered a consent decree of permanent injunction which will stop the defendants from “distributing adulterated, misbranded, and unapproved new drugs in violation of the federal Food, Drug, and Cosmetic Act.”
The defendants were allegedly distributing misbranded and unapproved drugs without patient-specific prescriptions. The complaint says the drugs were prepared or stored in unsanitary conditions where they may have been contaminated. It says non-sterile disinfectants were labeled as sterile, and high humidity levels that could have lead to microorganism growth were not rectified.
In 2017, the FDA issued a Compounding Risk Alert concerning 43 patients who were given eye injections of a steroid compounded by Guardian, resulting in various symptoms including vision impairment. This isn’t the first time Guardian has had trouble with a lack of sterility. In 2016 and 2018, the company initiated recalls for similar reasons.
The FDA will have to determine that they have complied with manufacturing standards before the company can distribute sterile drugs again.
“Doctors and patients must be able to rely on the safety and quality of drugs produced by compounding pharmacies,” said Assistant Attorney General Jody Hunt of the Justice Department’s Civil Division via release. “The Department of Justice will continue to work with FDA to enforce the provisions of the Food, Drug, and Cosmetic Act.”
“The Food, Drug, and Cosmetic Act is designed to protect the public health,” said U.S. Attorney Erin Nealy Cox for the Northern District of Texas via release. “Our district is a committed partner in enforcing the provisions of the Act in the interest of public safety.”
“When the FDA finds compounders that continue to violate the law by not adhering to manufacturing requirements, and put patients at risk, we are going to hold them accountable under the law,” said FDA Commissioner Scott Gottlieb, M.D. via release “We’ve continued to see violative behavior among compounding pharmacies, and we’re committed to taking enforcement actions against drug compounders that threaten the public health.”
Confusingly, there is another Guardian Pharmacy of Dallas-Fort Worth which is actually in Arlington and part of a network of Guardian Pharmacy Services based out of Atlanta. The Guardian in this case is not the Atlanta-based Guardian.