A federal judge today ordered a Weeki Wachee, Florida compounding pharmacy and its owner to stop distributing adulterated and unapproved new drugs in violation of the Food, Drug and Cosmetic Act (FDCA).
In a complaint filed in U.S. District Court for the Middle District of Florida on Sept. 9, the government alleged that Premier Pharmacy Labs Inc. and its owner, Vern A. Allen, failed to adequately address insanitary conditions and violations of current good manufacturing practice requirements at their drug compounding facility. For example, the complaint alleged that the defendants failed to conduct adequate investigations into discrepancies that may have had an impact on the quality and safety of their sterile drug products; failed to conduct sterility testing, endotoxin testing and visual checks for particles before releasing products; and failed to ensure that aseptic processing areas provided adequate conditions to prevent contamination of sterile products. The defendants agreed to a consent decree of permanent injunction that was filed with the complaint. The Department of Justice filed the case at the request of the U.S. Food and Drug Administration (FDA).
“Compounding pharmacies must follow applicable laws and regulations so that patients and doctors can rely on the safety of the drugs they produce,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The Department of Justice will continue to work with FDA to enforce the FDCA’s critical public health provisions.”
“The quality and safety of compounded medications is vitally important to the residents of our district,” said Acting U.S. Attorney Karin Hoppmann of the Middle District of Florida. “This injunction will ensure that pharmacies comply with the requirements of law in manufacturing products regulated by the FDA.”
“Premier Pharmacy and its owner placed patients at significant risk. Outsourcing facilities must follow good manufacturing practice to ensure patients are not exposed to poor quality, potentially harmful drugs,” said Director Donald D. Ashley, J.D. of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We will continue to take appropriate enforcement actions to ensure that companies follow important safety requirements to avoid putting patients’ health at risk.”
Premier stopped manufacturing drugs following an FDA inspection in June 2019. Under the permanent injunction, Premier cannot resume operations unless and until it completes corrective actions to ensure that its drugs are manufactured in compliance with the FDCA. According to the complaint, Premier has stated that it does not intend to resume operations.
Premier previously received a warning letter after a 2014 FDA inspection found that the facility operated under insanitary conditions and violated current good manufacturing practice requirements. After a 2016 follow-up inspection and a related January 2018 regulatory meeting with FDA, the company recalled affected sterile injectable drugs in April 2018 due to a potential lack of sterility assurance. Premier recalled all unexpired drugs intended to be sterile in June 2019 following another FDA inspection.
The case was handled by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch, with the assistance of Assistant U.S. Attorney Randy Harwell from the U.S. Attorney’s Office for the Middle District of Florida and Associate Chief Counsel for Enforcement James Allred of the FDA’s Office of the Chief Counsel.
For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at https://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Middle District of Florida, visit its website at https://www.justice.gov/usao-mdfl.