Federal Court Enters Consent Decree Against Florida Compounder

FDA announced on Sept. 17, 2021 that the US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibitingFlorida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions, including drugs intended to be sterile. Under the consent decree, Premier Pharmacy is required to not engage in compounding operations or distribution until corrective actions are completed and the company and its facility are in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). It must also establish and implement a comprehensive quality control system and receive authorization from FDA before it can resume operations.

“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, in a press release. “We will continue to take appropriate enforcement actions to ensure that companies follow important safety requirements to avoid putting patients’ health at risk.”

FDA previously inspected the company’s facility in 2014, which resulted in a warning letter. A follow up inspection in 2016 led to a regulatory meeting with the company in 2018. Premier Pharmacy recalled affected sterile injectable products in April 2018, and another follow-up inspection was conducted by FDA in April 2019, which resulted in additional products recalled by the company in June 2019. The company deregistered as an outsourcing facility for compounded drugs in 2019.