Last November, the Compounding Quality Act (‘‘Act’’) became law after a yearlong national debate about whether—and how—to regulate compounding pharmacies after a tainted injectable prepared at a Massachusetts compounding facility sparked a public health crisis that impacted more than 750 individuals in 20 states, and caused 64 deaths in the fall of 2012.

In the months since the Act’s passage, the U.S. Food and Drug Administration (‘‘FDA’’) has issued guidance on the law, ranging from proposed current good manufacturing practices to requests for nominations of drug substances that may be used at compounding facilities to technical guidance on registering as an outsourcing pharmacy. This article will discuss the history of compounding leading up to the Act’s passage, recap key provisions of the Act, and will discuss the steps that have been taken to date to interpret the new law.

Originally published in BNA’s Health Care Policy Report on September 22, 2014.