Gavel & Pestle Podcast host – Darshan Kulkarni talks about the effects of non-compliant pharmacies and pharmacy law.
Due to the meningitis outbreak caused by NECC’s products, FDA Commissioner Margaret Hamburg, MD, was twice called to testify before Congress. She explained that the FDA is inadequately empowered to regulate these compounding pharmacies. Most recently, Commissioner Hamburg revealed that inspections by the agency have found appalling conditions in other compounding pharmacies. Inspections carried out from February through April have documented rusty tools, bare-handed employees handling drugs, and black particles in “sterile” solutions. According to the commissioner, these unacceptable conditions cause significant risks to public health.
As a result of the meningitis outbreak and subsequent findings, several bills have been proposed in Congress to improve regulation of compounding pharmacy. Some proposals would let the current structure continue as is, while others would require pharmacies to register and operate as manufacturers. While the former approach ignores the tragedies that occurred, the latter seemingly may take regulations too far.
Darshan Kulkarni has extensive experience handling complex regulatory affairs related to pharmaceuticals, biopharmaceuticals, and medical devices. Darshan can identify FDA compliance risks and work with your organization to develop proactive strategies to mitigate these risks. By working with us as your FDA attorney and regulatory consultant, you earn change management skills and the education to develop the right global regulatory strategies for you.
Phone: 215-703-7842 1001