Evaluation of 503B Outsourcing Facilities – Going Beyond the Checklist

ACPE Numbers: 0204-0000-20-127-H07-P/T
Content Release Date: June 30, 2020
Expiration Date: June 29, 2023
Activity Type: Application-based
CE Credits: 1.00 hour (ACPE only)
Activity Fee: Members / Non-Member – Free

Activity Overview

This session will assist the learner to differentiate USP standards from cGMP. Learn how to apply citations in FDA 483s to current practice as well as how to design a plan to evaluate an outsourcing facility. 


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

Target Audience

This activity was planned to meet the educational needs of Pharmacists and Pharmacy technicians with an interest in sterile compounding.

Learning Objectives

  • Differentiate USP standards from cGMP.
  • Apply citations in FDA 483s to current practice.
  • Design a plan to evaluate an outsourcing facility.

Schedule of Activities

  • Introduction and Announcements
  • Presentation with self-assessment


Mr. Kenneth G. Jozefczyk, M.S., R.Ph., FASHP, Director, Centralized Pharmacy Services BayCare Health System, Clearwater, FL


In accordance with the ACPE's and ACCME's Standards for Commercial Support, anyone in a position to control the content of the educational activity is required to disclose to the accredited provider their relevant financial relationships. In accordance with these Standards, all potential conflicts of interest have been resolved. An individual has a relevant financial relationship if he or she (or spouse/domestic partner) has a financial relationship in any amount occurring in the last 12 months with a commercial interest whose products or services are discussed in the activity content over which the individual has control.

As defined by ACCME, a commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The Standards for Commercial Support do not consider providers of clinical service directly to patients to be commercial interests. The existence or non-existence of relevant financial relationships will be disclosed to the activity audience. All identified conflicts of interest must be resolved prior to the activity.

Methods and CE Requirements

This activity consists of a recording of a faculty slide presentation with embedded self- assessment. Participants must participate in the activity in its entirety to claim continuing pharmacy education credit online at ASHP eLearning Portal. 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. Claim your CE at http://elearning.ashp.org. 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.