Pharmacy Compounding: Draft insanitary conditions guidance available for comment- Drug Information Update

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

The FDA today issued draft guidance on insanitary conditions at compounding facilities. The draft guidance is intended to assist compounding facilities in identifying insanitary conditions so they can implement appropriate corrective actions.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The FDA also posted a statement on the draft guidance. 

The public comment period for the draft guidance will be open for 60 days.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.