Compounding Research

External 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:

• NASEM Study on the Clinical Utility of Treating Patients with Compounded “Bioidentical” Hormone Therapy”
• NASEM Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams

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.

• UMD CERSI Study on the Clinical Use of Drugs Including Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities, as well as an expanded information initiative.
• JHU CERSI Study on Bulk Drug Substances Used to Compound Drugs for Patients with Autism Spectrum Disorder (ASD)

Related Content

• FDA announces new and expanded compounding research projects
• FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients
• FDA policies related to bulk drug substances that may be compounded by outsourcing facilities

Related Publications and Articles

• 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
• Outsourcing Facility Information Resource, September 2017
• Compounding Progress Report, January 2017