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Voluntary process leaves FDA in the dark over compounders' identities

This article was originally published in Scrip

Executive Summary

Even though a new law gives the FDA 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 process.

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