A newly published analysis of federal oversight of large-scale compounding pharmacies found two things that are more striking together than apart. Of 48 outsourcing facilities that registered with the Food and Drug Administration over roughly five years, only 11 were inspected. Every one of those 11 had at least two significant violations documented in inspection reports.
The study, published in a pharmacy journal, examined facilities registered between January 1, 2020 and April 30, 2025. Beyond the low inspection rate of about 23 percent, it found that the mean gap between a facility registering and being inspected ran more than two years. The authors concluded that these are "critical gaps" in oversight, with the greatest risk in sterile drug production.
