Compounding – 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 – and 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 have been 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, H.R. 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 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 soon.
Clay B. Wortham
McBrayer, McGinnis, Leslie & Kirkland, PLLC