News release: “With the meningitis outreak death toll reaching 25 and 344 more sickened by injectable steroids manufactured at the New England Compounding Center (NECC), Congressman Edward J. Markey (D-Mass.) today released a new comprehensive report documenting more than a decade of violations and problems at compounding pharmacies throughout the nation. Rep. Markeys report, Compounding Pharmacies, Compounding Risk describes the nature of regulatory oversight and gaps in legal authority that, even before the current meningitis outbreak, led to at least 23 deaths and 86 serious illnesses or injuries in at least 34 states. Violations at compounding facilities included compounding pharmacies selling copies of commercially-available drugs, selling drugs made using ingredients that were not Food and Drug Adminsitration (FDA)-approved or were recalled for safety or effectiveness reasons, cases where sterile facilities were visibly dirty and contamination of the drug product was known to have occurred, and either selling drug products without a valid prescription or manufacturing large quantities of drug products.”
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