FDA sets meeting on bulk substances: 3 notes

The FDA’s Pharmacy Compounding Advisory Committee is set to meet Dec. 4 to address regulatory questions on compounding practices, according to an Oct. 25 news release from the agency. 

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Here are three notes: 

  1. Comments for discussion are due by Dec. 3, with a focus on the inclusion of certain bulk substances in compounding exemptions under Section 503A of the FD&C Act. 
  2. The committee will review substances such as AOD-9604 for obesity and Thymosin alpha-1 for various infections. 
  3. The event will include presentations from both FDA staff and public participants, who can join in person or online.

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