Medication - Sterile Compounding - Extending Beyond Use Dates (BUD) with Closed System Transfer Devices (CSTD)
Can a Closed System Transfer Device be utilized to extend the beyond use date of a single dose container ?
Any examples are for illustrative purposes only.
The Joint Commission would evaluate compliance with the use of a closed system transfer device (CSTD) based on the FDA approved indications of a device. Based on feedback received directly from the FDA, the extension of a beyond use date beyond 6 hours for a single dose vial has not been approved as an indication.
The Joint Commission is aware of published articles which supports the use of these devices to extend beyond use dating longer than the 6 hours allowed for a single dose vial. However, this has not been approved by the FDA and is not supported as a standard of practice.
The Joint Commission would evaluate compliance with the use of a closed system transfer device (CSTD) based on the FDA approved indications of a device. Based on feedback received directly from the FDA, the extension of a beyond use date beyond 6 hours for a single dose vial has not been approved as an indication.
The Joint Commission is aware of published articles which supports the use of these devices to extend beyond use dating longer than the 6 hours allowed for a single dose vial. However, this has not been approved by the FDA and is not supported as a standard of practice.
Manual:
Hospital and Hospital Clinics
Chapter:
Medication Management MM
First published date: January 23, 2018
This Standards FAQ was first published on this date.
This page was last updated on November 05, 2024
with update notes of: Editorial changes only
Types of changes and an explanation of change type:
Editorial changes only: Format changes only. No changes to content. |
Review only, FAQ is current: Periodic review completed, no changes to content. |
Reflects new or updated requirements: Changes represent new or revised requirements.
Get Extra Help with Books and E-books
Browse our gallery of books and e-books to find trusted prep and readiness resources, practical checklists and toolkits, and resources on specialized health care topics.
Stay Informed with Online Education
Online education is the most convenient and cost-effective way to educate your staff and minimize expenses without the need to leave your organization.
Reach Your Safety Goals with eProducts
Assessing and sustaining compliance with accreditation standards or CMS CoPs can be a challenge, but it doesn’t have to be. Rely on our proven software solutions developed by our team of industry experts.
Joint Commission Virtual Assistant