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Sterile Compounding: 503b Outsourcing Facilities, Hospital Pharmacist Intro

With the challenges of increasing costs to hospital pharmacies to upgrade and validate facilities, qualify sterile compounding personnel, and manage daily work load, a 503b outsourcing facility can be used to fill the gap between traditional pharmacy compounding and the ability to produce larger scale batch size of commonly used medication for health system organizations.

This module (0.5 CE), along with the other three MCPHS sterile compounding CE modules, ‘Parenteral Nutrition CSPs-2020 Update' (2.0 CE), ‘History and Basics - Aseptic Technique USP 797, 2019/20' (1.5 CE), and 'What's the Hazard? USP 800 Review' (1.0 CE), total to 5.0 credits of sterile compounding.

Learning Objectives

Upon completion of this activity, the participant should be able to:

  • Compare the key differences between 503a vs 503b
  • Define cGMP.
  • Explain the pharmacist’s role in 503a vs 503b.
  • Identify who has regulatory oversight of 503a vs 503b.
  • Determine how to choose a 503b facility.


Kathleen McTiernan, PharmD, BCSCP, CNSC: Kathleen McTernan, is a production pharmacist; she received her BS in Pharmacy and Doctorate of Pharmacy from Massachusetts College of Pharmacy, Boston. In her prior positions, Kathy was a member of a manufacturing team, and was responsible for ensuring the facility and staff adhered to required quality systems and Good Manufacturing Practice. Kathleen has over 15 years of compounding experience. She has held positions as Pharmacy Manager and Clinical Manager for 2 National Home Infusion organizations and has lectured on the topic of aseptic processing.


ACPE logo

Release Date: December 19, 2019
Expiration Date: December 19, 2020
Contact Hours: 0.5
Universal Activity Number: 0026-0000-19-032-H03-P
ACPE Topic Designator: Law

MA licensed pharmacists, please refer to MA BOP policy 2018-03 section VI for further information on the use CE credits designated for pharmacy law (03) and compounding (07) to meet annual licensure requirements. Pharmacists licensed outside of MA should refer to their own state boards of Pharmacy for more information. Registration Fee: Free to MCPHS Alumni and full-time employees; $12.00 for all other professionals.