Based on multiple FDA inspections and observations over many years, both brand pharma and generic companies have learned how to be better prepared for an FDA inspection and what to expect from an FDA inspection. However, judging by the numerous Warning Letters that have been issued to Compounding Pharmacies in the last 2 years to 503A (43 total) and 503B (37 total), it appears that this segment need to update and expedite their learning and preparedness for such inspections. FDA intends to continue proactive and “for cause” inspections of Compounding Pharmacies regardless if they are a 503A or a 503B facility. FDA clearly plans to take aggressive actions, including enforcement actions, as appropriate, to protect the public health.
The FDA has gone so far as to name Julie Dohm (former FDA litigator at the Department of Justice) to the position of CDER Senior Science Advisor for Compounding. In this capacity, she will be the Agency lead on Compounding Pharmacies, developing and managing teams to implement regulations, perform inspections, prepare enforcement actions, develop policy, and conduct outreach to stakeholders.
Compounding Pharmacies need to tap into the knowledge of the Pharma Industry regarding FDA inspection preparedness. How better a way than to seek the counsel of the GMP/FDA expert consultants that the pharmaceutical industry consistently uses. If you have questions or would like further information on how to prepare your Compounding Pharmacy for an FDA inspection, please contact Lachman Consultants at 516-222-6222 or at www.lachmanconsultants.com.