December 4, 2012
The FDA will host an intergovernmental meeting with state representatives to discuss a variety of issues regarding the FDA and state roles in the oversight of compounding pharmacies. Topics include:
The Notice stated, “FDA believes the focus should be shifted from attempting to draw a bright line between traditional pharmacy compounding and other manufacturing to clearly defining traditional pharmacy compounding that should be primarily overseen by the States and higher risk non-traditional pharmacy compounding that would require compliance with Federal standards.”
On Dec. 19, FDA and state representatives will host a public meeting to discuss the results. The public can submit comments regarding the issues listed above, until the deadline of Jan. 18, 2013.
If you have any questions regarding the regulation of compounding pharmacies or the upcoming public meeting, please contact one of the authors listed below.
Official Notice: 77 Fed. Reg. 71009