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Considerations for Outsourcing Sterile Preparations: Introducing an Updated ASHP Outsourcing Vendor Assessment Tool

ACPE Activity Number: 0204-0000-22-574-H07 P/T
Release Date: 8/16/2022
Expiration Date: 08/02/2025
Activity Type: Knowledge-based   
CE Credits: 1 contact hour 
Activity Fee: Free of charge 

 This activity is a recording from a live webinar and those that claim credit for the live webinar should not claim credit for this activity.

Activity Overview

Institutions are turning to 503B Outsourcing Facilities to manage workforce and drug shortages. Recent draft FDA guidance further supports outsourcing, particularly for products prepared in advance of a prescription or order. Several high-profile 503B recalls and facility closures may lead purchasers to question how to evaluate the quality of outsourced products. This one-hour live activity will review applicable standards and guidance and introduce the updated ASHP Outsourcing Vendor Assessment Tool. Two members of the ASHP Outsourcing Vendor Assessment Tool expert panel will share their perspectives: one expert panel member will review important outsourcing considerations from the health-system perspective, and the other will review important considerations from the 503B perspective.

Accreditation

The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This activity is intended for pharmacists and pharmacy purchasers who are interested in understanding how to evaluate outsourcing vendors for meeting institutional needs and for compliance with regulatory guidance and/or compounding standards.

At the conclusion of this activity, participants should be able to:

1. Explain FDA compounding guidance related to hospitals and health systems.

2. Describe the purpose for outsourcing compounded preparations within applicable USP standards and FDA guidance.

3. Discuss ways the ASHP Outsourcing Vendor Assessment Tool can help purchasers make decisions about outsourcing vendors.

Schedule of Activities

* Introduction

* Presentation

* Q&A

Michael Ganio, PharmD, MS, FASHP
Senior Director, Pharmacy Practice and Quality
ASHP Center on Medication Safety and Quality
Columbus, Ohio

Ben Lopez, Pharm.D., MS, MHA, BCPS
Director of Pharmacy Operations
The Ohio State University Wexner Medical Center
Columbus, Ohio

Kenneth Jozefczyk, BSPharm, MS, RPh, BCSCP
Director of Centralized Pharmacy Services
BayCare Health System
Tampa, Florida

Relevant Financial Relationship Disclosure

No one in control of the content of this activity has a relevant financial relationship (RFR) with an ineligible company.

As defined by the Standards of Integrity and Independence in Accredited Continuing Education definition of ineligible company. All relevant financial relationships have been mitigated prior to the CPE activity.

Methods and CE Requirements

This activity consists of recordings of faculty slides presentations, active learning activities, discussion, and handouts. Participants must participate in the activity in its entirety to claim continuing pharmacy education credit online at ASHP Learning Center. Follow the prompts online to complete the evaluation, claim credit and view the statement of credit immediately after completing the activity. Per ACPE requirements, CPE credit must be claimed within 60 days of being earned. Once you have processed and claimed your CE credit, we encourage you to check your NABP eProfile account to verify your credits were transferred successfully before the ACPE 60-day deadline. It is an electronic direct-report process so your credits should appear in your account within a few minutes. After the 60 day deadline, ASHP will no longer be able to report your credit(s) for this activity.