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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Regulatory Framework for Human Drug Compounding

Step Status
Educational Content
Starts On: Wed, 11/15/23: 12:00 AM EST
Ends On: Sat, 11/14/26: 12:00 AM EST
Type: Enduring Material
Credits: 1
Description: Compounded drugs serve an important medical need for certain populations who cannot be treated with FDA-approved medications, including pediatric patients or patients with allergies requiring drugs made without certain excipients. Although compounded drugs can serve an important medical need for certain patients, they also present a risk. FDA's compounding program aims to protect patients from unsafe, ineffective, and poor-quality compounded drugs, while preserving access to drugs compounded pursuant to provisions established in the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning Human Drug Compounding. This activity provides an overview of human drug compounding and its regulatory framework, differentiates drug compounding from the FDA new drug approval process, describes the bulk drug substance evaluation process, and provides examples.
  • Discuss the basics of human drug compounding.
  • Describe the history and regulatory framework of human drug compounding and the differences between sections 503A and 503B of the FD&C Act.
  • Explain the evaluation process for bulk drug substances nominated for use in compounding in accordance with section 503A of the FD&C Act (503A Bulks List) and bulk drug substances nominated for use in compounding in accordance with section 503B of the FD&C Act (503B Bulks List), and how the evaluation process differs from the new drug approval process.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: SLIDES