viernes, 8 de julio de 2016

FDA Issues Two Draft Guidances on Compounding - Drug Information Update

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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

Today the FDA issued two draft guidances describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products:
The public comment period on these draft guidance documents closes in 90 days.

The agency also posted a statement related to these two guidances:
For more information on pharmacy compounding go to FDA's Information on Compounding.

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