Kim Tyrrell-Knott, James A. Boiani
Kim Tyrrell-Knott, a Member of the Firm in the Health Care and Life Sciences practice, in the San Diego and Washington, DC, offices, and James Boiani, an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office, co-wrote an article titled “The Compounding Quality Act.”
Following is an excerpt:
The regulatory landscape for pharmacy compounders is rapidly changing. In October 2012, a compounded drug caused a fungal meningitis outbreak, claiming 64 lives and sickening nearly 700 others across 20 states. Both the Food and Drug Administration and Congress responded to this tragedy.
In just over a year, FDA inspected scores of sterile compounding pharmacies, and found what they believed to be objectionable conditions at over 60 facilities. This resulted in warning letters and more than 20 compounders voluntarily recalling compounded drugs. Congress then passed the Compounding Quality Act (CQA) as part of the Drug Quality and Security Act (DQSA). FDA immediately began to implement the CQA, and FDA officials, including Commissioner Margaret Hamburg, have made it clear that FDA will strictly enforce CQA requirements.