Who Regulates Compounding?

State boards of pharmacy—not the FDA—are “typically” asked to regulate compounding practices. However, in light of several tragedies, the FDA has recently been aggressive in asserting its jurisdiction over compounding pharmacies and has issued several 483s and brought court orders against compounding pharmacies. Unlike state agencies, who are often more interested in administrative issues, the FDA aggressively reviews for quality concerns.

It is likely that in the coming days, the jurisdiction will change and the FDA will gain significant oversight over pharmacies.

Preparing for Inspections

The Kulkarni Law Firm can help you prepare for FDA inspections. With a proper plan in place, you may be able to avoid harsh punishments, such as warning letters, fines, or even a complete shut-down.

Contact the Firm today to develop a pre-inspection plan and/or respond appropriately to an FDA 483 or Warning Letter.


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