FDA and State Officials to Discuss State and Federal Roles Regarding Compounding Pharmacies

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:

  1. Whether states are able to provide the needed oversight of pharmacy compounding and consumer protection;
  2. What should the federal role be in regulating higher risk pharmacy compounding and is there a way to balance federal and state participation in the regulation of pharmacy compounding; and
  3. What is the role for the states in enforcing a federal standard for “non-traditional” compounding.

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