This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.
Section 503A provides conditions under which certain compounded human drug products are exempted from requirements such as compliance with current good manufacturing practices (CGMPs), labeling with adequate directions for use and FDA market approval. New section 503B of the FDCA enables a compounder to register with FDA to become an “outsourcing facility.” Outsourcing facilities are exempt from the above label compliance and FDA market approval requirements but are still subject to CGMP compliance, risk based FDA inspections and certain reporting requirements such as adverse event reporting.
This training seeks to inform hospital or stand-alone pharmacies, pharmacy state boards, pharmacists, health care professionals, hospitals on the various FDA documents including the latest developments concerning this topic.
Why Should You Attend:
Do you know of sections 503A and 503B of the Federal Food, Drug and Cosmetic Act (FDCA) as it relates to drug compounding?Section 503A provides conditions under which certain compounded human drug products are exempted from requirements such as compliance with current good manufacturing practices (CGMPs), labeling with adequate directions for use and FDA market approval. New section 503B of the FDCA enables a compounder to register with FDA to become an “outsourcing facility.” Outsourcing facilities are exempt from the above label compliance and FDA market approval requirements but are still subject to CGMP compliance, risk based FDA inspections and certain reporting requirements such as adverse event reporting.
This training seeks to inform hospital or stand-alone pharmacies, pharmacy state boards, pharmacists, health care professionals, hospitals on the various FDA documents including the latest developments concerning this topic.
Learning Objectives:
To practice pharmacy drug compounding under a state of quality compliance and without violation of the law.Areas Covered in the Webinar:
- Sections 503A and 503B, FDCA & various FDA documentation concerning this topic
- Outsourcing facility registration and reporting
Who Will Benefit:
- Hospitals or stand-alone pharmacies
- Pharmacy state boards
- Pharmacists
- Health care professionals
- Compliance officers
- Documentation specialists
Course Provider
Rachelle D Souza,
