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Examining Sterile Compounding for Health-Systems: A Look Ahead to 2020

Activity Downloads

To Participate

To participate in this continuing education activity:

  1. Review the activity description and objectives.
  2. View the activity.
  3. Complete the online post-test and activity evaluation.

Note: If you attended the live CE activity AND received CE credit (i.e. a pharmacist CE statement of credit with ACPE UAN 0221-0000-19-501-L07-P), you are NOT allowed to also receive credit for this home-study on-demand web activity.

Activity Description

With the arrival of USP <800> and delay in USP <797>, health-systems continue to have questions about practical implementation and compliance measurement techniques. Data has suggested that 100% compliance to USP <797> standards may not be achieved until 2023. This activity seeks to address lingering questions on implementation and approaches to ensure both patient and healthcare worker safety is enforced, and sterility is maintained. A discussion surrounding the finalized updates to both USP chapters will ensure learners are up to date on necessary compliance elements for their health-systems.  Pharmacists will be provided background on regulatory requirements for 503A and 503B facilities to assist with decision-making between internal compounding versus outsourced compounded sterile products. Methods to identify and train staff to maintain USP <797> and <800> compliance will be shared. Additional environmental testing and monitoring strategies will be discussed to maintain safety and regulatory compliance.

Learning Objectives

The target audience for this activity includes health‐system pharmacists, including chief pharmacy officers and pharmacy directors. At the completion of this activity, the participant will be better able to:

  • Discuss updates to USP <797> and USP <800> and the impact on sterile IV compounding safety.
  • Differentiate between 503A and 503B outsourcing facility requirements for compounded sterile preparations.
  • Identify methods for staff education and training for USP <797> and USP <800> compliance.
  • Outline environmental testing and monitoring strategies to ensure compliance with safe sterile and hazardous compounding regulations.


Louis S. Diorio, RPh, FAPhA
LDT Health Solutions, Inc.
Wayne, New Jersey

Kevin Hansen, PharmD, MS, BCPS
Assistant Director of Pharmacy
Moses H. Cone Memorial Hospital
Greensboro, North Carolina

Fred Massoomi, PharmD, FASHP
Senior Director of Health-System & Hospital Services
Visante, Inc.
Omaha, Nebraska

CE Accreditation


Release Date: 12-09-2019
Expiration Date: 1-8-2021

ProCE, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number 0221-0000-19-501-H07-P has been assigned to this home study knowledge-based activity. This activity is approved for 1.5 contact hours (0.15 CEUs) in states that recognize ACPE providers. The activity is provided at no cost to participants. Participants must complete the online post-test and activity evaluation to receive pharmacy CE credit. Statements of completion will be issued online at and proof of completion will be posted in NABP CPE Monitor profiles. No partial credit will be given.


It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants any significant financial interest or affiliation with companies that manufacture or market products discussed during their presentation. Mr. Diorio is a shareholder of LDT Health Solutions, Inc. Dr. Hansen is a speaker for Baxter, Omnicell, Pharmacy Purchasing & Products, and Salveo, and is an advisory board member for Fresenius Kabi. Dr. Massoomi is a speaker and/or consultant for Baxter, BD, Equashield, and ICU Medical. A portion of grant funds received by ProCE from PharMEDium Services, LLC will be used to compensate the faculty for this presentation.


This activity is provided by ProCE, Inc. and is supported by an educational grant from PharMEDium Services, LLC.

The material presented in this CE activity does not reflect the views of ProCE, LLC or the commercial sponsor. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.