FDA's Hamburg Details Actions on Compounding Pharmacies

The agency has conducted more than 175 inspections during 2013-2014 and has worked to implement the compounding provisions of the Drug Quality and Security Act, which Congress passed last year in response to the NECC fungal meningitis outbreak.

Top officials of the New England Compounding Center Inc. were arrested Dec. 17 and face criminal charges that include racketeering and, in the case of two company officials, second-degree murder of 25 patients in seven states, in connection with the 2012 fungal meningitis outbreak that sickened at least 751 people and killed 64 of them.

Barry Cadden, an NECC founder, owner, and head pharmacist, and supervising pharmacist Glenn A. Chin "face 25 allegations of second-degree murder of patients, in Michigan, Tennesse, Indiana, Maryland, Virginia, Florida, and North Carolina," and the indictment alleges that Cadden and Gregory A. Conigliaro, another founder and owner, deliberately misled federal drug regulators by falsely identifying the company only as a compounding pharmacy, not a drug manufacturer—which would have meant increased federal scrutiny of NECC’s operations, the Boston Globe's John R. Ellement, Kay Lazar, and Martin Finucane reported.

FDA Commissioner Margaret A. Hamburg detailed her agency's actions in response to the meningitis outbreak in a Dec. 17 blog post. She wrote that FDA has conducted more than 175 inspections of compounding facilities during the past two years. "Our findings uncovered a variety of problems with sterile drug production practices at these facilities. As a result of these inspections, numerous firms stopped making sterile drugs and many recalled drug products that had been made under substandard conditions. In some cases, we worked with state officials to revoke or suspend pharmacy licenses. We also issued warning letters to firms that were producing drugs under inadequate conditions, notifying them of violations of the law and the need to take steps to correct the violations and prevent their recurrence," Hamburg wrote. She discussed FDA's work with the Justice Department and its steps to implement the compounding provisions of the Drug Quality and Security Act,a law Congress passed last year in response to the outbreak.

"To implement the compounding statutory provisions, FDA is establishing a policy framework to address compounding by state-licensed pharmacies as well as the new category of outsourcing facilities, which was created under the DQSA. Among other things, outsourcing facilities are facilities that compound sterile drugs and choose to register with FDA as outsourcing facilities, and they must comply with current good manufacturing practice requirements and are subject to FDA inspection on a risk-based schedule," she explained.

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