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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
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  5. Compounding Research
  1. Human Drug Compounding

Compounding Research

Research Partnerships

FDA is engaged with the following institutions to conduct research to help inform the public and the agency’s policies regarding compounded drugs:

National Academies of Science, Engineering, and Medicine (NASEM) Partnership

FDA has engaged NASEM to conduct two studies related to compounded drug products:

Centers of Excellence in Regulatory Science and Innovation (CERSI) Partnerships

FDA is collaborating with the University of Maryland (UMD) and Johns Hopkins University (JHU), two of the agency’s CERSI partners, to gather and analyze information that will inform FDA’s policies on bulk drug substances that may be used in compounding by outsourcing facilities and help promote public awareness and understanding.

Additional Information

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