The FDA's message to compounding pharmacies is clear: Keep your drugs sterile or face the consequences. After failing to do the former, New Jersey-based compounding firm Med Prep Consulting will be doing the latter, as a federal judge slapped the company and its owner with a consent decree.
Back in March, the FDA warned doctors that 5 bags of Med Prep's magnesium sulfate intravenous solution had been found to contain mold, and the compnay voluntarily shut down for inspection. According to the FDA's latest release, the agency found unsanitary conditions and "numerous violations of current good manufacturing practice requirements" during a recent inspection of the company's Tinton Falls, NJ, facility. In addition to discovering mold in products labeled as sterile, inspectors found that some products did not contain enough of their active ingredients. The FDA is also blaming Med Prep for producing and distributing several drug products without the required patient-specific prescriptions or new-drug approvals.
Under the consent decree, the company, which made sterile drug products for hospitals and other healthcare facilities, will be forced to comply with FDA requirements before it can resume manufacturing and distribution. "Med Prep put patients' health at risk by producing contaminated drugs under unacceptable conditions," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in the release.
The FDA has been paying special attention to compounders since the New England Compounding Center was charged last year with manufacturing a steroid that triggered a deadly fungal meningitis outbreak. And Med Prep, which also received warning letters in 2001 and 2010 for not following FDA regulations, was not about to escape the agency's watch.
"Those who violate the Federal Food, Drug, and Cosmetic Act risk serious consequences," said Melinda K. Plaisier, the FDA's acting associate commissioner for regulatory affairs. "This consent decree shows that the FDA will take aggressive enforcement actions to ensure the safety of drugs."
Previously, Congress has criticized the FDA for failing to take a more aggressive stance. But the agency says it has completed nearly 60 inspections of state-licensed plants that produce high-risk sterile products and overseen 14 voluntary recalls, all since September 2012. "While not all the right laws are in place to provide the FDA with appropriate and efficient oversight of these facilities, the FDA will continue using its existing authorities to protect public health," Woodcock said.
- read the FDA's release