The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction that prohibits Premier Pharmacy Labs Inc., 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.
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. The company had previously received multiple violation warnings as well as a recall that affected sterile injectable products due to potential lack of sterility assurance.
