A new bill, the Preserving Patient Access to Compounded Medications Act of 2017 (H.R. 2871), was introduced last week by Reps. Morgan Griffith (R-VA) and Henry Cuellar (D-TX) to clarify the Drug Quality & Security Act (DQSA). Proponents say it is intended to strike a balance between patient safety and access to compounded medications. Where those sometimes-competing interests meet has been batted between pharmacy organizations and the FDA for the past several years after the enactment of the DQSA. On one hand, cases like this one and many others stemming from contaminated product has the FDA working hard to provide some guidance for compounded drugs and raising issues around outsourcing, manufacturing, and supply chain security. But it’s been argued that FDA guidance doesn’t cut it when there is so much variance between states when it comes to licensing, enforcement of good manufacturing practices, and training. In the middle sits the patient, for whom compounding pharmacies meet a very real need—and in times of drug shortages, that need could become critical.
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