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Controlling Compounding: The Drug Quality and Security Act

In October 2012, a fatal meningitis outbreak killed 64 people in the United States and infected more than 750 in 20 states. The outbreak was traced back to contaminated vials of an injectable painkilling steroid that was compounded by the New England Compounding Center (“NECC”).

Compounding, as the process by which a pharmacist combines drug ingredients per a doctor’s prescription to meet the unique needs of an individual, is nothing new. In recent years, however, the practice has experienced a surge in popularity as more Americans have come to expect tailored medicine and drug shortages create a persistent need to compound unavailable drugs.  Historically, compounding involved a relationship between the compounding pharmacist, physician, and patient – compounding was done at the local pharmacy.  Now, compounding facilities mix and compound mass quantities of product for interstate sale.

As a result of the meningitis outbreak in 2012, many called for increased regulatory oversight of compounding centers like NECC.  Historically, States are responsible for regulating retail pharmacies, while the FDA regulates drug manufacturers.  Compounding centers are somewhat of an anomaly – not fitting into either the retail pharmacy or manufacturer category.  The 2012 meningitis tragedy garnered the attention of Congress and, after several false starts, House Bill 3204 was introduced in September, 2013.  The bill, known as the Drug Quality and Security Act (“DQSA”) passed on November 18, 2013, with President Obama signing the legislation into law last week on November 27th.

The DQSA establishes and regulates a new class of pharmacies known as “outsourcing facilities.”  Outsourcing facilities are newly defined as those engaged in the compounding of sterile drugs that register with the FDA. An outsourcing facility may compound without obtaining individual patient prescriptions. To learn more about the DQSA, visit the blog again on Thursday.

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This article does not constitute legal advice.

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