Consent Decree Against Delta Pharma

A northern Mississippi judge 6/8 entered a consent decree of permanent injunction against Delta Pharma (Ripley, MS) and two company officials for failing to correct promised deficiencies at the firm’s drug compounding operation. The decree prohibits Delta Pharma and the other defendants from manufacturing, processing, packing, holding or distributing Delta Pharma’s drugs until they comply with FDA regulations. The government’s complaint alleges that Delta Pharma manufactured and distributed purportedly sterile drug products, such as injectable corticosteroids and antihistamines, that were adulterated because the drugs were made under insanitary conditions and in violation of GMP requirements. It also alleges that the compounder manufactured and distributed unapproved new drugs and drugs that were misbranded because their product labels did not include adequate directions for use.