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.
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.
• Sections 503A and 503B,
• FDCA & various FDA documentation concerning this topic
• Outsourcing facility registration and reporting
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Hospitals or stand-alone pharmacies
• Pharmacy state boards
• Health care professionals
• Compliance officers
• Documentation specialists
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national companies. Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety/pharmacovigilance and medical information systems
At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.
Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets like Canada, USA, EU, China, Japan, Australia and New Zealand.