Drug compounding—the creation of medicines for patients whose clinical needs cannot be met by commercially available, FDA-approved products—has always been a part of pharmacy practice. But dramatic expansion of the sector in recent decades has resulted in production conditions on a scale closer to pharmaceutical manufacturing yet without the same oversight or quality standards. In fact, since 2001, compounding errors have been associated with more than 1,500 reported adverse events for patients, including at least 116 deaths.
In 2012, a nationwide outbreak of fungal meningitis linked to contaminated injections compounded by a pharmacy in Massachusetts resulted in a renewed focus on compounding oversight. The ensuing 2013 federal law governing compounding, the Drug Quality and Security Act, established a new regulatory category for those pharmaceutical compounders that supply sterile medicines for use in hospitals, doctors' offices, and clinics. These "outsourcing facilities" are subject to higher quality and safety standards—current good manufacturing practices—enforced by the Food and Drug Administration.
States continue to regulate traditional pharmacy compounding that occurs outside of the outsourcing facility category. They are responsible for ensuring that pharmacy compounders meet appropriate quality standards and identifying compounding operations that exceed pharmacy practice and should be regulated by FDA.