Drug Compounder Acquitted Of Murder In Fungal Meningitis Outbreak Case
Jury convicts Barry Cadden on racketeering and mail fraud allegations for shipping contaminated methylprednisolone acetate for spinal injection, but clears NECC's head pharmacist on all 25 counts of second degree murder in seminal case that spurred legislation enabling major US FDA crackdown on injectable drug compounding sterility assurance practices.
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Jury convicts Pharmakon CEO of conspiracy to defraud the FDA and nine counts of adulterating drugs. The firm allegedly ignored and tried to cover up dangerously out-of-specification potency testing results for morphine and other compounded drugs. In one case, providers resorted to naloxone to rescue an overdosed infant.
FDA looks to carve out a place for office-use compounding within Section 503B, the new framework created after deadly fungal contamination of products, while industry supports efforts in Congress to allow it under the traditional Section 503A.
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.