503B Compounding Pharmacies: Principles, GMPs and Case Studies

Learning Level: Advanced
Time: 1100 - 1300 ET
Session Length: 2 hours

In the early 2010s, there were several scandals with adulterated drugs compounded in pharmacies. Hundreds of patients were infected and several of them died. Inspections in the facilities revealed serious deficiencies in Good Manufacturing Practices (GMPs). Consequently, section 503B was created as part of the drug quality and security act in 2013, putting these facilities under FDA supervision for the first time. This resulted in a big shift in the sector and this webinar will show how the field has developed.

The webinar will include the following:

FDA Compounding Laws and Policies

  • Food and Drug Cosmetic Act 503a and 503b
  • FDA policies on Compounding and other related activities
  • FDA Compounding Documents and Actions
  • Compounding Inspections Frequently Asked Questions

Basic GMPs for sterile products

  • Regulations for aseptic manufacturing for sterile products
  • Compounding, filtration, filling, inspection, packaging
  • Sterilization methods
  • Personnel and training
  • Premises, cleanrooms, barrier systems

Nephron: An Engineering and Production Perspective

Case Study: Fresenius-Kabi Compounding: A QA Perspective

Learning Objectives

  1. Understand the current status of compounding pharmacies in the US
  2. Understand the basics of good manufacturing for sterile products
  3. Learn from case studies of setting up and operation of 503B outsourced facilities



Frances M. Zipp
President & CEO
Lachman Consultant Services, Inc.
Cynthia T. Culmo
Senior Associate in the Compliance Practices
Lachman Consultants Services Inc.
Lou W. Kennedy
CEO and Owner
Nephron Pharmaceuticals
Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Deborah McHugh
Director QA
Fresenius Kabi Compounding, LLC

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