503B eLearning Course

CriticalPoint has expanded its online offerings to now include 503B eLearning.  The web-based curriculum will ensure participants acquire a comprehensive understanding of how and why 503B practice evolved. These lessons also summarize each of the FDA draft and final guidances so that learners know where to seek guidance for 503B practice. Successful completion of this course will prepare pharmacists to fulfill the role required by the Compounding Quality Act (known as the Drug Quality and Safety Act or DQSA) which requires that drugs are compounded in compliance with the cGMPs under the direct supervision of a licensed pharmacist.

The 503B eLearning Course is made of 3 lessons worth a total of 5 hours of Law Continuing Education.

History Leading up to 503B (1 hour law CE) 

- Correlate the history of compounding mishaps with the evolution of compounding standards of practice and sterile compounding regulations

- Discuss the current compounding regulations including continuing ambiguities and controversies

- Outline the elements of the Compounding Quality Act

- Explain the difference between 503A and 503B entities

What are cGMPs? (21 CFR Part 211) (2 hour law CE) 

- Explain the history, evolution and significance of FDA 21 CFR 211 (known as the cGMPs)

- Articulate the differences in how cGMPs are applied to 503A and 503B entities

- Implement the keys to success in implementation and compliance in your own 503B practice

Review of FDA 503B Draft and Final Guidance (2 hours law CE) 

- Discuss the FDA 503B Draft and Final Guidance documents

- Describe what would be expected of a 503B Outsourcer during an FDA inspection

- Differentiate the elements of 21 CFR 211 that are applied to a 503B as compared to traditional big pharma