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FDA Seeks Controls on Interstate Compound Distribution

By Elaine Goodman (medical/business Reporter)

Friday, September 14, 2018 | 398 | 0 | 20 min read

The U.S. Food and Drug Administration has proposed greater scrutiny for compounding pharmacies that distribute more than half of their compounded products outside of their home state. But compared to the agency’s previous proposal for monitoring these pharmacies, the FDA is now suggesting a less stringent approach. The agency in 2015 wanted state pharmacy boards to “take action” when pharmacies distributed 30% or more of their compounds out of state. Now, in addition to raising the threshold for what is considered an “inordinate amount” of interstate distributio...

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