October 21, 2026 MGB Pharmacy Week: 503a vs 503b - A Tale of Two Statutes
“503a vs 503b - A Tale of Two Statutes"
Valerie Nguyen, PharmD
Target Audience
This activity is intended for all clinical, operational, and administrative pharmacists in inpatient, outpatient, and ambulatory care settings as well as all pharmacy technicians working inpatient and outpatient.
Learning Objectives
Upon completion of this activity, participants will be able to:
- Differentiate the regulatory, quality-assurance, and liability obligations of outsourcing facilities (503B) versus traditional compounding pharmacies (503A).
- Evaluate the appropriateness of using a 503B outsourcing facility versus in-house 503A compounding for a specific clinical use case (e.g., shortage management, batch preparation).
- Analyze an FDA warning letter or product recall to identify the compounding practice deficiencies that led to regulatory action.
Additional Information
Massachusetts General Hospital - Department of Pharmacy & Mass General Brigham

Course summary
- 1.00 ACPE Pharmacy
- 1.00 ACPE Technician
- 1.00 Participation
Ramy Elshaboury, PharmD - Course Director
Director of Clinical Pharmacy Services & Graduate Pharmacy Education, Massachusetts General Hospital
Director, Residency Program for PGY-2 Infectious Diseases Pharmacy Residency - Massachusetts General Hospital
Valerie Nguyen, PharmD
PGY-2 Pharmacy Resident, Health System Pharmacy Administration & Leadership Program
Massachusetts General Hospital
In support of improving patient care, Mass General Brigham 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 Designation Statements
Pharmacy
This activity provides 1.00 contact hour (1.00 CEU) of continuing education credit. ACPE Universal Activity Number (UAN): JA0007437-0000-26-025-L03-P
Pharmacy Technicians
This activity provides 1.00 contact hour (1.00 CEU) of continuing education credit. ACPE Universal Activity Number (UAN): JA0007437-0000-26-025-L03-T
Available Credit
- 1.00 ACPE Pharmacy
- 1.00 ACPE Technician
- 1.00 Participation

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