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HealthTrust presents…“An Alternative Channel of Drug Manufacturing: 503B Outsourcing Explained”

503B Outsourcing Facilities supply the marketplace with sterile and non-sterile compounded pharmaceutical products. Historical patient safety events have led to increased scrutiny in this sector of pharmaceutical manufacturing.  The Food and Drug Administration (FDA) continues to address these events by providing guidance documents to the industry with respect to Current Good Manufacturing Practices (cGMP). 503B manufacturers must work diligently to adopt the FDA’s guidance, or product quality may suffer, and increase the risk to the end-user. This presentation seeks to provide the audience with an understanding of 503B guidance, and how to effectively assess 503B facilities.

Learning Objectives for Pharmacists, Pharmacy Technicians & Supply Chain  |  At the end of this session, participants should be able to:

1. Discuss the standards of the 503B Current Good Manufacturing Practices.
2. Outline the regulations that determine what drugs can be manufactured in 503B facilities.
3. Describe the 503B audits that were conducted by the FDA.

Presenter:

Bradley S. Merrill, PharmD, PGY2 Corporate Pharmacy Leadership Resident  |  HealthTrust

Target Audience:  Pharmacists, Pharmacy Techs & Supply Chain Professionals

Continuing Education Information: 1.0 contact hours approved for Pharmacists and Pharmacy Techs. Belmont University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The ACPE Universal Activity Numbers for this activity are 0863-9999-21-032-L07-P and 0863-9999-21-032-L07-T. This program is approved by the Association for Health Care Resource & Materials Management (AHRMM) for 1.0 contact hour of continuing education.

Note about CE credit: If you plan to obtain credit for a live session, stay until the end of the presentation to receive the verification code you will need to obtain the continuing education credit. CE credit is individual. No group credit is available. Each person must register for a webinar and attend the webinar in its entirety in order to receive an email after the event with instructions on how to apply for continuing education credit. Attendees should not share the code or forward the email to others who did not actually attend the program. If they are not able to be verified on our webinar provider reports and registration list they will not receive credit. If you are joining only by phone, you will not be eligible for credit. You must also log in and join the visual portion of the webinar to be part of our CE provider-required reporting.