3 Takeaways From FDA's Drug Compounding Guidances

By Jeff Overley (April 15, 2016, 10:34 PM EDT) -- Newly released U.S. Food and Drug Administration policies would curtail traditional drug compounding that takes place at hospitals, lacks patient-specific prescriptions or occurs in the same location as newer compounding pharmacies subject to stricter oversight, experts say.

The policies emerged Friday in a trio of draft guidance documents on compounding, which involves tweaking drug formulations to accommodate distinct patient needs. Oversight of the entities has been in flux since late 2013, when Congress passed the Drug Quality and Security Act after a fatal outbreak blamed on compounded steroids tainted by fungus.

Generally speaking, there are two types of compounders: traditional ones regulated...

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