jueves, 4 de agosto de 2016

Insanitary Conditions at Compounding Facilities Guidance for Industry

Insanitary Conditions at Compounding Facilities Guidance for Industry

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

The FDA today issued draft guidance on insanitary conditions at compounding facilities. The draft guidance is intended to assist compounding facilities in identifying insanitary conditions so they can implement appropriate corrective actions. It is also intended to assist state regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions.
The FDA also posted a statement on the draft guidance. 
The public comment period for the draft guidance will be open for 60 days. For information on how to submit comments to the public docket, see the notice in the Federal Register
For more information on pharmacy compounding, visit FDA's Information on Compounding web site.

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