The compounding of medications, both sterile and non-sterile, is an activity that provides patients with specialized medications that might not be commercially available and is an essential competency that every hospital pharmacy must have. As fundamental to patient treatment that compounding is, there are numerous reports in literature and in media that highlight significant morbidity and mortality that can occur when there are breaches in acceptable compounding practices.
Two regulatory chapters, USP Chapter 797, which directs requirements for sterile compounding, and USP Chapter 795, which directs requirements for non-sterile compounding, are the standards in place that direct these activities. These are enforceable standards, but they must be adopted by regulatory bodies in order to be enforced. Of particular importance is USP Chapter 797 because of the risks associated with sterile compounding of medications.
It is important for healthcare organizations to know if they have gaps in compliance with USP Chapter 797 requirements. The majority of state boards of pharmacies have adopted all or part of USP Chapter 797 into their requirements. The Centers for Medicare and Medicaid Services (CMS) has also officially adopted the requirement for compliance with USP Chapter 797. While The Joint Commission has always had requirements that relate to sterile compounding, it currently is in the midst of important changes regarding its survey process regarding sterile compounding. Accordingly, this program provides an overview of USP Chapter 797 and The Joint Commission’s approach to these requirements.
After completing this activity, the participant should be able to:
- Assess their organization's compliance with USP Chapter 797 requirements.
- Identify The Joint Commission's position and survey activities around sterile compounding and USP Chapter 797.
- Recognize how anticipated changes to USP Chapter 800, covering the handling of hazardous drugs, will affect compounding.
This activity is relevant to pharmacists, nurse leaders, physicians, organization leaders, managers and supervisors, and staff responsible for performance improvement (PI), patient safety, and risk management initiatives.
Jeannell M. Mansur, RPh, PharmD, FASHP, FSMSO, CJCP
Principal Consultant, Medication Management and Safety
Joint Commission Resources
Joint Commission International
Brian Johnson, PhD
Health Systems Director of Business Development
The Joint Commission
These presenters do not have any financial arrangements or affiliations with corporate organizations that either provide educational grants to this program or may be referenced in this activity. These presenters have also attested that their discussions will not include any unapproved or off-label use of products.
The Joint Commission is accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
Live activity ACPE #: 0573-0000-17-026-L07-P; Enduring ACPE #: 0573-0000-17-026-H07-P
The Joint Commission is provider approved by the California Board of Registered Nursing, provider number CEP 6381, for 1 contact hour.
The Joint Commission is authorized to award the listed hours of pre-approved ACHE Qualified Education credit for this program toward advancement, or recertification, in the American College of Healthcare Executives. Participants in this program who wish to have the continuing education hours applied toward ACHE Qualified Education credit must self-report their participation. To self-report, participants should log into their MyACHE account and select ACHE Qualified Education Credit.
This activity has been approved by the National Association for Healthcare Quality (NAHQ) for 1.0 Certified Professional Healthcare Quality (CPHQ) credit.
The Joint Commission Enterprise has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).
This education offering qualifies for 1.0 Certified Joint Commission Professional (CJCP) credit hours towards CJCP recertification. In order to obtain CJCP credit hours, an individual must first be certified before they start acquiring CJCP credit hours. CJCP credit hours will not be retroactive.
Full attendance at every session is a prerequisite for receiving full continuing education credits. If a participant needs to leave early, his or her continuing education credits will be reduced.
Successful completion of this CE activity includes the following:
- View the presentation and read the accompanying Resource Guide.
- Complete the online Evaluation Form and Post Test.
- A CE certificate/statement of credit can be printed online following successful completion of the Post Test and the Evaluation Form