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ForwardFrom Crisis to Confidence: The Rise of 503B and Modern Standards Recorded Presentation
This presentation traces the evolution of sterile compounding regulation through the passing of the FDA Modernization Act and impact of the 2012 New England Compounding Crisis. Attendees will gain a clear understanding of how federal, state, and accrediting-body reforms shape expectations for compounding practices and modern standards for safety, quality, and compliance. The session also highlights the role of Group Purchasing Organization in today’s compounding landscape.
If you attended From Crisis to Confidence: The Rise of 503B and Modern Standards on 5/07/2026, you will not be able to claim credit again for this course. However, you are welcome to still watch the content.
Target Audience
This course is intended for Advocate Pharmacists and Pharmacy Technicians
Learning Objectives
At the completion of this activity, the participant will be able to
- Discuss how the FDA Modernization Act of 1997, development of USP <797>, and 2012 New England Compounding Center (NECC) meningitis outbreak shaped modern sterile compounding standards
- State the roles, requirements, and risk profiles of 503A traditional compounding pharmacies and 503B outsourcing facilities
- Explain how federal, state, and USP regulatory frameworks work together to govern compounding practice and prevent patient harm
- Recognize a Group Purchasing Organization’s (GPO) influence on health-system purchasing decisions and quality expectations for 503B facilities.
Faculty
Justin Haywood, PharmD, M.B.A, M.S, PGY1/2 HSPAL Resident – Atrium Health Wake Forest Baptist
Nicholas Rosen, PharmD, PGY1 Pharmacy Resident – Atrium Health Wake Forest Baptist
Disclosure
The planner(s) and speaker(s) have indicated that there are no relevant financial relationships with any ineligible companies to disclose.
Accreditation Statement
In support of improving patient care, Advocate Health is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Credit Statement(s)
Accreditation Council for Pharmacy Education (ACPE)
Advocate Health designates this enduring activity for a maximum 1.00 hours of CPE credit for pharmacists and pharmacy technicians. CPE credit can be claimed on the AAH CE platform within 60 days of activity completion and information will be provided to CPE Monitor. Participants should only claim credit commensurate with the extent of their participation in the activity.
Pharmacy UAN: JA0006327-0000-26-094-H01-P
Pharmacy Technician UAN: JA0006327-0000-26-094-H01-T
Available Credit
- 1.00 AttendanceAttendance Credit
- 1.00 Continuing Pharmacy Education (CPE)Aurora Health Care Department of Pharmacy Services is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
- 1.00 Continuing Pharmacy Education (CPE) Pharmacy TechnicianAurora Health Care Department of Pharmacy Services is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Price
How to Register
Click “Take Course” to complete this program.
Participation Options
This course is available to Advocate Health providers (employed and independent) and team members only.
If you attended From Crisis to Confidence: The Rise of 503B and Modern Standards on 5/7/2026, you will not be able to claim credit again for this course. However, you are welcome to still watch the content.
For Further Information
Contact the AH Continuing Pharmacy Education team at [email protected] if you have any questions or need assistance.
If you have any questions regarding registration, please contact the IPCE Office at [email protected]
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