Florida Compounding Pharmacy Punished by Federal Court
On September 17, the U.S. Food and Drug Administration (FDA) issued a press statement about disciplinary actions being taken against a Florida-based compounding pharmacy. The U.S. District Court for the Middle District of Florida has issued a consent decree placing a permanent injunction prohibiting a Florida-based company from producing or distributing any drugs until the company complies with requirements set forth in the consent decree.
This lawsuit was filed by the U.S. Department of Justice on behalf of the FDA against the Florida-based compounding pharmacy company, Premier Pharmacy Labs Inc., as well as the company’s owner, Vern A. Allen.
A compounding pharmacy is a facility that creates custom medicines that are made in small batches and broadly face less regulation. Compounding pharmacies can be helpful for patients with allergies to medications, or who need a pill in liquid form.
The complaint alleged that Premier Pharmacy’s facility manufactured and distributed drugs that were made under unsanitary conditions despite multiple warnings from the FDA. Premier Pharmacy manufactured and distributed drugs that were intended to be sterile, that were contaminated and in violation of good manufacturing practice requirements under the FD&C Act. Unsanitary conditions can cause a compounded drug to become contaminated or otherwise cause patient harm.
Premier stopped manufacturing drugs after an FDA inspection in June 2019. The permanent injunction came after the FDA found that the compounding pharmacy was not making these medications in a sterile environment.
To worsen the matter, Premier Pharmacy was operating as an outsourcing facility. Under section 503B of the Federal Food, Drug, and Cosmetic Act, a compounding facility can become an outsourcing facility, which allows the facility to produce medication en masse like any other bulk manufacturer.
Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, Donald D. Ashley, J.D., weighed in on the injunction stating, “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.”
In addition to contaminating sterile drugs, Premier Pharmacy also manufactured and distributed drugs that were neither approved nor exempt from the approval process because the products did not meet the statutory requirements for outsourcing facilities.
The consent decree requires Premier Pharmacy to not engage in any compounding operations or distribution until it establishes and implements a comprehensive quality control system and receives authorization from the FDA.