As part of its efforts to ensure the safety of compounded pharmaceuticals since a Hepatitis A outbreak was traced in 2012 to a drug compounding facility in New England, the U.S. Food and Drug Administration (FDA) sought and obtained a permanent injunction against Med Prep Consulting, Inc. after an investigation revealed the presence of mold in some of its sterile drug products which were manufactured for some 70 hospitals and health care facilities. United States v. Med Prep Consulting, Inc., No. 13-3856 (U.S. Dist. Ct., D.N.J., filed June 21, 2013).
FDA’s complaint alleged that its inspection revealed insanitary conditions at the company’s New Jersey facility and “numerous violations of current good manufacturing practice requirements for drugs.” FDA also apparently found mold in injectable drug products and products that did not include sufficient active ingredients. The agency further contended that the company “produced and distributed numerous drug products without receiving patient-specific prescriptions and without having an approved new drug application or approved abbreviated new drug application.” According to FDA, the court entered a consent decree of permanent injunction against the company and its president and owner. Under the agreement Med Prep cannot manufacture, hold and distribute drug products until it complies with the law. In March 2013, the company voluntarily recalled all of its sterile products after it received notice from a customer that “floating particles were observed in a magnesium sulfate injectable drug product that was labeled as sterile.” See FDA News Release, June 28, 2013