Polsinelli - FDA Regulatory
         

  

March 2014

  

Breaking News: FDA Testifies Before Senate HELP Committee, Questioned on Recent Compounding Quality Act Enforcement

  

 
 

  

     

  

 
 

FDA Regulatory Practice Leaders:

  

Melissa Gilmore

202.626.8373

mgilmore@polsinelli.com

  

  

  

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Today Senator Lamar Alexander (R-TN), member of the Senate HELP Committee asked FDA Commissioner Margaret Hamburg what FDA's policy was with regard to asserting jurisdiction over 503A traditional compounding pharmacies. He specifically questioned FDA's enforcement of the new Compounding Quality Act beyond the intent of the legislation. We have analyzed the Committee's questions and FDA's responses, and are preparing a summary for members of the Coalition for Responsible Compounding. The CRC will also hold a member meeting on Tuesday, March 18 at 10P/11M/12C/1E.

For More Information

This story is still developing, please email for additional information on the summary and the call:

 
 

  

     

  

 

 

  

     

  

 
 

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