FDA Drug Topics: Regulatory Framework for Human Drug Compounding - September 26, 2023 Tuesday, September 26, 2023 2:00:00 PM ART - 3:15:00 PM ART

https://collaborationcqpub1.fda.gov/content/connect/c1/7/en/events/event/shared/94630851/event_registration.html?_charset_=utf-8&connect-session=breezbreez3no7tpeydqqet4fa&sco-id=262625629&utm_medium=email&utm_source=govdelivery Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. 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 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.