Compounding pharmacies chafe at FDA's disciplinary actions
- The FDA has been cracking down on compounding pharmacies in the wake of a highly publicized meningitis outbreak linked to tainted steroids from a compounder. The agency has also found multiple cGMP violations in subsequent inspections. But compounders are balking at the tighter regulations and enforcement, according to the WSJ's Ed Silverman.
- In 2012, 64 patients died from a fungal meningitis outbreak connected to a New England compounding pharmacy.
- The FDA is attempting to impose stricter guidelines, including new laws that would cap interstate shipments at 30%, as well as a law that would require any biologic that is mixed, diluted or repackaged by a compounder be administered within four hours, or be thoroughly tested for microbial contamination.
The problem here is although that the fungal meningitis outbreak at the New England Compounding Center is a very dramatic example of what can go wrong when there is not sufficient oversight during the compounding and distribution process, there are many other examples of compounding facilities that fail to meet cGMP standards.
Most onlookers concur that it is just a matter of time before compounding pharmacies have to deal with more regulatory oversight, not unlike the oversight that traditional drug makers face. Ultimately, things like microbial testing, shipment guidelines and the need to strictly adhere to cGMP will help compounding pharmacies regain public trust—which has been waning in light of all of the negative publicity.