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  6. FDA Drug Topics: Regulatory Framework for Human Drug Compounding - September 26, 2023
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FDA Drug Topics: Regulatory Framework for Human Drug Compounding - September 26, 2023

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Tuesday, September 26, 2023, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: Regulatory Framework for Human Drug Compounding. 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 presentation provided an overview of human drug compounding and its regulatory framework, differentiated drug compounding from the FDA new drug approval process, described the bulk drug substance evaluation process, and provided examples.

Register Here:  FDA Drug Topics: Regulatory Framework for Human Drug Compounding

Download Presentation Slides: FDA Drug Topics: Regulatory Framework for Human Drug Compounding (PDF - 430KB)

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