Isomeric Enters Drug GMP Consent Decree As FDA's Crackdown On Drug Compounders Continues
Drug compounding pharmacy Isomeric has entered a consent decree after turning a blind eye to a multitude of GMP problems with its injectable and ophthalmic drugs. This brings to six the number of consent decrees the Justice Department has reached with compounding pharmacies since the New England Compounding Center tragedy in 2012.
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A Little Rock, Arkansas, outsourcing pharmacy continued to defy FDA even after the agency went to court for an injunction to shut down the pharmacy's drug compounding operations over continued lack of sterility. Cantrell Drug Co. could have accepted proposed consent decree terms but instead countered in federal bankruptcy court with an injunction request of its own.
More than half of last year’s 110 drug GMP warning letters went to compounding pharmacies as US FDA’s crackdown on poor aseptic practices in sterile compounding continued. The complexity surrounding GMP applicability continued to complicate the enforcement landscape in 2016 despite FDASIA distinction between traditional and outsourcing compounders, final article in our four-part series reports.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”