On August 4, the U.S. Food & Drug Administration will publish a draft guidance in the Federal Register, Insanitary Conditions at Compounding Facilities.  Click here to view a pdf of the draft guidance.

In the announcement, the FDA states:

“FDA is issuing this guidance to assist compounding facility in identifying insanitary conditions so that they can implement appropriate corrective actions.  This guidance is also intended to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious to health.”

Stakeholders have 60 days to submit comments before the FDA finalizes the guidance.  Comments can be submitted electronically or in written form.  All submissions must include Docket No. FDA-2016-D-2268 for “Insanitary Conditions at Compounding Facilities.”  Starting tomorrow you can access the draft guidance and instructions for submitting comments at https://www.federalregister.gov/articles/2016/08/04/2016-18461/guidance-insanitary-conditions-at-compounding-facilities.

The FisherBroyles Pharmacy Law team will continue to follow the developments regarding this guidance and will provide updates as they become available.  Please contact any one of the following attorneys:

Brian E. Dickerson

Nicole Hughes Waid

Anthony J. Calamunci

Amy L. Butler