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

• FDA announces new and expanded compounding research projects
• A pharmacist-driven Food and Drug Administration incident surveillance and response program for compounded drugs, American Journal of Health-System Pharmacy (AJHP), April 23, 2021
• Systemic Adverse Events Associated with Compounded Topical Pain Products, Drug Safety (October 20, 2020)
• Letter to the Editor: Clinically Significant Hyperthyroidism and Hypothyroidism Following Exposure to Compounded Thyroid Products, Thyroid (September 18, 2020)
• Toward Better-Quality Compounded Drugs — An Update from the FDA, New England Journal of Medicine (NEJM), December 28, 2017

• Content current as of:

  12/27/2024

Source