We love reading other regulatory pieces, and particularly liked the one written by Regulatory Focus’ Michael Mezher (here) concerning the “agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.” While this may provide a better focus for the FDA to coordinate efforts through CDER resources, it could also mean a tougher enforcement stance from the Agency.
We postulate this based on past efforts like the Unapproved Prescription Drug Initiative beginning in 2006 and culminating in the issuance of the publication of a new compliance policy guide in 2011 (here). The number of enforcement actions spiked during and for a few years after that period of time. Now, with the consolidation of resources and the continued frequency of warning letters being issued to 503A compounders and 503B registered outsourcers, perhaps we can expect to continue to see a more concerted effort to inspect and report on compounders in an effort to prevent a repeat of the 2012 fungal meningitis outbreak disaster at the New England Compounding Center.
Only time will tell!
