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New Laws For Compounding Pharmacies Following Meningitis Outbreak

The contaminated syringes that led to more than 750 cases of fungal meningitis and 60 fatalities were produced by a compounding pharmacy. Such pharmacies existed largely outside of the regulatory authority of the Food and Drug Administration. The tragic outbreak and massive recall of the contaminated products caused legislators to seek ways of monitoring these types of drug manufacturers. President Barack Obama signed the Drug Quality and Security Act last Wednesday. The bill is intended to help prevent similar problems from occurring in the future.

Compounding pharmacies were intended to fill a need in the medical industry. The companies tailored drugs to meet needs that mass-produced medications could not. If a patient had an allergy or required a specific delivery method for a drug, a compounding pharmacy could produce that drug to fit the prescription. Compounding pharmacies were required to produce drugs only to meet individual prescriptions. The company involved in the meningitis outbreak, the New England Compounding Center, was found to be mass producing drugs without specific prescriptions.

Under the new law, the FDA will have greater oversight in reviewing the operations of compounding pharmacies. Such oversight was left almost exclusively to state control prior to the new law. The White House announced that the new law would give more power to the FDA, as well as improving the ways in which drugs are tracked. The tracking method is meant to help officials safeguard the pharmaceutical supply chain and prevent counterfeiting or contamination of drugs.

Source: CBS News, “President signs tougher drug compounding bill into law,” by Ryan Jaslow, 27 November 2013

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