May 26, 2015
In 2013, in the wake of infectious outbreaks traced to steroids and repackaged intravitreal Avastin produced at compounding pharmacies, Congress passed the Drug Quality and Security Act, which included the Compounding Quality Act. The law gives the FDA new authorities to regulate the activities of compounding pharmacies, drug repackagers and a new class of “outsourcing manufacturers.”
In subsequent guidance documents, the FDA clarified various requirements regarding the activities of traditional compounders, such as the need to receive a patient-specific prescription for each compounded drug. In a set of draft guidance documents issued in February, the FDA made recommendations on outsourcing facilities, mixing and repackaging, and interstate shipping. Some experts see some of the recommendations as a plus, while others have a less optimistic view.