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.
The complaint filed with the consent decree alleges that Delta Pharma manufactured and distributed purportedly sterile drug products, such as injectable corticosteroids and antihistamines, that were adulterated under the FD&C Act because the drugs were made under insanitary conditions and in violation of current good manufacturing practice (CGMP) requirements. The complaint also alleges that Delta Pharma manufactured and distributed unapproved new drugs and drugs that were misbranded because their product labels did not include adequate directions for use.
The consent decree requires Delta Pharma to cease operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company is complying with the FD&C Act and CGMP requirements. Under the consent decree, Delta Pharma cannot resume operations until it receives authorization from the FDA.
Delta Pharma is registered as an outsourcing facility under section 503B of the FD&C Act. The Drug Quality and Security Act, signed into law on Nov. 27, 2013, added a new section – 503B – to the FD&C Act. Under section 503B, a compounder can elect to register as an outsourcing facility. Outsourcing facilities must comply with CGMP requirements and are inspected by the FDA according to a risk-based schedule. They must also meet certain other conditions, such as reporting adverse events and providing the FDA with certain information about the products they compound.
The complaint was filed by the U.S. Department of Justice on behalf of the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: U.S. Food and Drug Administration (FDA.gov)