FDA Takes Injunctive Action Against Pharmacy Compounding Outsourcing Facility

FDA has given new notice to registered pharmacy outsourcing facilities that it is prepared to take aggressive enforcement action against serious violators. In one of its first major enforcement actions of 2016, a Consent Decree of Permanent Injunction was entered on January 8th against Downing Labs (formerly NuVision), a Dallas, Texas outsourcing facility manufacturing both non-sterile drug products and injectable drugs. The Consent Decree is the culmination of repeated FDA inspections citing serious deficiencies in aseptic controls. FDA’s findings during the inspections prompted a number of recalls of the firm’s injectable drugs. Last October, Downing recalled all unexpired lots of its sterile drug products, and informed FDA it would temporarily suspend production of sterile drugs until corrections are made. Nevertheless, citing public health concerns, FDA sought injunctive relief.
Of interest, the injunctive provisions in the Consent Decree are not limited to Downing’s production of injectable drugs. The Decree requires that Downing suspend all drug production. Downing can resume production only after cGMP compliance is certified by a Third-Party and FDA re-inspects and finds the firm operating in compliance. The Decree even goes a step further by including a series of similar injunctive provisions should Downing decide to discontinue operations as a registered outsourcing facility, and resume operations under the rules governing pharmacy compounders.
The announcement of the Consent Decree is yet another powerful reminder that pharmacy outsourcers must assure that their operations conform to appropriate cGMP requirements and that they have the controls in place to assure the safety and quality of both the sterile and non-sterile drugs they produce. FDA has made it abundantly clear that it expects no less and is prepared to take aggressive enforcement action against violators.