Description: 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. 

Microsoft Teams Webinar link to register for the live session: Register Here

Speakers: 

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

Objectives: ​​ 

• 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.

Target Audience:​ Advocate Pharmacists and Pharmacy Technicians

Disclosure:​ The planner(s) and speaker(s) have indicated that there are no relevant financial relationships with any ineligible companies to disclose. 

Materials:  Single Activity Flyer - Live-Haywood Rosen.pdf

Pharmacist UAN: JA0006327-0000-26-014-L04-P
Pharmacy Technician UAN: JA0006327-0000-26-014-L04-T