BioCentury
ARTICLE | Politics & Policy

States seek clarity on FDA authority over compounding

December 20, 2012 1:32 AM UTC

The majority of state representatives said on Wednesday that there is a role for federal regulation of certain types of higher risk non-traditional pharmacy compounding, but asked FDA to more clearly define what would require federal oversight. The comments came during an intergovernmental meeting held by FDA with representatives from all 50 states to discuss the role of FDA and states in the oversight of compounding pharmacies. The states asked FDA to create concrete federal definitions of "manufacturing," "low-risk vs. high-risk" and "traditional vs. non-traditional" compounding. The states also asked for greater transparency and communication from FDA, including the reporting to state regulators of warning letters sent to facilities. Comments are due Jan. 18, 2013. ...