Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions
The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction that prohibits a Florida-based company from producing or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.
According to the complaint, filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration (FDA), Premier Pharmacy Labs Inc. and the company’s owner, Vern A. Allen, manufactured and distributed drugs made under insanitary conditions at Premier Pharmacy’s facility, despite multiple warnings from the FDA. Premier stopped manufacturing drugs following an FDA inspection in June 2019.
“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 Donald D. Ashley, J.D., director 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.”
The consent decree requires Premier Pharmacy to not engage in any compounding operations or distribution until it completes corrective actions, to ensure the company and its facility are in compliance with the FD&C Act. Under the consent decree, Premier Pharmacy may not resume compounding operations until it establishes and implements, among other things, a comprehensive quality control system and receives authorization from the FDA.
The complaint alleged that Premier Pharmacy manufactured and distributed drugs, including drugs that were intended to be sterile, that were adulterated because the drugs were made under insanitary conditions and in violation of good manufacturing practice requirements under the FD&C Act. Insanitary conditions can cause a compounded drug to become contaminated or otherwise cause patient harm. According to the complaint, Premier Pharmacy also manufactured and distributed drugs that were neither approved nor exempt from approval because the products did not meet all statutory requirements for outsourcing facilities.
In the spring of 2014, the FDA conducted an inspection of Premier Pharmacy that resulted in a warning letter for insanitary conditions and other violations of the FD&C Act. The FDA conducted a follow-up inspection in June 2016, leading to a regulatory meeting with the company in January 2018. In April 2018, Premier Pharmacy recalled affected sterile injectable products due to potential lack of sterility assurance. The FDA conducted another follow-up inspection which started in April 2019. In June 2019, following the April inspection and the FDA’s recommendation to recall, Premier Pharmacy recalled all unexpired drugs intended to be sterile. Premier Pharmacy had been registered as an outsourcing facility for compounded drugs; however, the company deregistered in 2019 and has since stopped compounding drugs.
Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. Compounded drugs are not approved by the FDA and, therefore, have not been evaluated for safety or efficacy.