On June 8, 2018, the Northern District of Mississippi entered a consent decree of permanent injunction between the United States and Delta Pharma, Inc. of Ripley, Mississippi, and the company’s president, 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 prohibited Delta Pharma and the other defendants from, among other things, manufacturing, processing, packing, holding, or distributing Delta Pharma’s drugs until they complied with the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA regulations.
The complaint filed with the consent decree alleged that Delta Pharma manufactured and distributed purportedly sterile drug products, such as injectable corticosteroids and antihistamines, which were adulterated under the FDCA because the drugs were made under insanitary conditions and in violation of current good manufacturing practice (CGMP) requirements. The complaint also alleged 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 required Delta Pharma to cease operations until it completed corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company is complying with the FDCA and CGMP requirements. Under the consent decree, Delta Pharma cannot resume operations until it receives authorization from the FDA.
Delta Pharma was registered as an outsourcing facility under section 503B of the FDCA. The Drug Quality and Security Act, signed into law on November 27, 2013, added a new section – 503B – to the FDCA. 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.
See the FDA Announcement
See also Medical Risk Law Report: Compounded Drugs: Mix of Risk and Liability
See also Medical Risk Law Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Risk Law Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians