House to vote on compounding bill

The U.S. House of Representatives is expected to vote Saturday on the Drug Quality and Security Act of 2013 (H.R. 3204), a bipartisan bill that would allow voluntary oversight of compounding pharmacies by FDA. Pharmacies compounding sterile drugs or preparing drugs in advance of an individual prescription could elect to register with FDA as "outsourcing facilities," or could choose to continue under state regulators.

FDA oversight of registered facilities would be similar to oversight of drug manufacturers, including risk-based inspections and required adverse event reporting. According to a Senate aide, Congress expects hospitals or physicians are more likely to purchase from registered facilities, and that a single national regulator and user fee may be preferable for some multi-state compounders. Annual FDA user fees would be $5,000 for compounders with annual revenues below $1 million and $15,000 for those with revenues north of $1 million. ...