Voluntary process leaves US FDA in the dark over compounders' identities; draft guidance released
This article was originally published in SRA
Executive Summary
Even though a new law gives the US Food and Drug Administration new oversight authorities over certain compounding pharmacies, known as outsourcing facilities, the Drug Quality and Security Act (DQSA) falls short of helping regulators track down firms engaged in mixing large quantities of medicines without a prescription and marketing those products without going through the federal regulatory process1,2.