Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Insanitary Conditions at Compounding Facilities.'' Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events in patients, including death. FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions.