U.S. District Judge Neal B. Biggers for the Northern District of Mississippi entered a consent decree of permanent injunction today between the United States and Delta Pharma, Inc. of Ripley, Mississippi, and the company’s president Tommy T. Simpson and Charles Michael Harrison, vice president and pharmacist-in-charge. According to the complaint, despite Delta Pharma’s repeated promises to correct deficiencies, Delta Pharma continued to violate the law.
"The FDA is committed to help ensuring that compounded drugs are made under appropriate production standards and that we’re fulfilling the public health goals of the Drug Quality and Security Act," said FDA Commissioner Scott Gottlieb, M.D. "That legislation envisioned an important role for outsourcing facilities to help supply providers with compounded medicines, but it also required that these firms meet good manufacturing practice requirements. When we find outsourcing facilities that continue to violate the law by not adhering to these manufacturing requirements, and put patients at risk, we’re going to hold them accountable under the law. At the same time, we’re also pursuing new policy steps to help make it more feasible for compounders to meet the requirements of becoming an outsourcing facility. We’re committed to ensuring that we balance the need to preserve access to appropriately compounded drugs with our commitment to help protect patients from drugs compounded under substandard conditions."
The consent decree prohibits Delta Pharma and the other defendants from, among other things, manufacturing, processing, packing, holding or distributing Delta Pharma’s drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.
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