The New England Compounding Center mess has certainly made it tough for compounders to continue to fly under the radar, especially when they are effectively acting a small pharma companies as the widespread meningitis outbreak attests.
Massachuesetts Congressman Ed Markey has introduced the Verifying Authority and Legality in Drug (VALID) Compounding Act which would clearly give FDA powers to oversee compounders activities and remove any doubt/gray area.
"Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory. The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies," said Markey.
The FDA and MA authorities have been heavily criticized for their inaction in this case -- given NECC was clearly acting like a small pharma compnay selling interstate meds to many States. However, Markey did recognize the FDA since 2001 had issued warning letters to dozens of pharmacies seen to be operating outside the law -- apparently to no effect. If VALID passes, maybe FDA will have a bigger hammer.
Posted by Bruce Lehr Nov 8th 2012.