Even if you Don't Register as an Outsourcing Facility with the FDA, the FDA May Still Be Knocking on Your Door Soon

•FDA has been conducting inspections of compounding pharmacies for cause (in response to serious adverse event reports, reports of quality problems, and state requests)

•FDA has also been conducting proactive inspections to identify pharmacies with deficient sterile practices

•FDA will continue these efforts as available resources permit

quoted from - Compounding Pharmacies - Erika Butler, Drug Specialist, U.S. Food and Drug Administration