FDA GMP Warning Letters Review: Compounding Pharmacies Drew The Most Letters In 2016
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.
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Julie Dohm, who led a wide range of initiatives to bolster FDA's oversight of compounding pharmacies, will be joining Covington & Burling after leaving the agency March 29. A replacement has not yet been announced.
Will lessons from New England Compounding Center ever be learned? Top FDA officials say that compounding pharmacies need up their game and do a better job of producing quality sterile drugs as way too many facilities are failing GMP inspections and producing drugs that are sickening – and even killing – patients. Officials say forthcoming final guidance and final USP standard should turn this situation around.
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.