The USP needs to be careful as it amends and prepares to release By Jerry Fahrni on July 29, Is there a conflict between these two guidance documents? Learn more. Last updated: Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture.
Public comment is integral to the standard setting process.
Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures