Kim Tyrrell-Knott Peer Reviewed “Regulating Compounding Pharmacies” in Health AffairsMay 1, 2014
Kim Tyrrell-Knott, a Member of the Firm in the Health Care and Life Sciences practice, in the San Diego and Washington, DC, offices, peer reviewed an article titled "Regulating Compounding Pharmacies." In addition, an article she co-wrote for Bloomberg BNA's Pharmaceutical Law & Industry Report titled "The Compounding Quality Act" was used an a resource for writing the article.
Following is an excerpt:
Outraged over a 2012 fungal meningitis outbreak traced back to Framingham, Massachusetts-based drug compounder New England Compounding Center (NECC) that left sixty-four people dead and more than 700 sickened, Congress passed the Compounding Quality Act, which was signed into law on November 27, 2013. The law is designed to plug a regulatory gap that existed because drug compounding pharmacies have traditionally been regulated by the states, not the federal government, in many cases even when they grew bigger and crossed the line from "compounding" to "manufacturing." Compounding is the traditional way to make drugs stretching back centuries and is still used to create individualized medicines for patients with specific needs; for example, people who must take their medicine in a liquid form rather than a pill or are allergic to a particular dye or other substance and need a drug made without the allergen.