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Opened or needle-punctured single-dose containers must be used within one hour if opened in worse than ISO Class 5 air quality and remaining contents discarded.
Opened single-dose ampuls must be discarded and may not be stored for any time period.
States Board of Pharmacy Positions The PA State Board posts a Special Notice on their web site which, in part, states that “the provisions of the USP are not part of the Pharmacy Act’s substantive sections or Board regulations.” It further states, “The Board is not authorized to provide advisory opinions or interpretations except through promulgating regulations and adjudicating disciplinary actions, therefore the Board cannot offer any guidance to pharmacists on how to proceed with the new standards set by USP 797 and takes no position on USP 797.” However, in the second half of their statement they caution, “Section 5(a)(12) of the Pharmacy Act provides that the departure from, or failure to conform to, the standards of acceptable and prevailing pharmacy practice is grossly unprofessional conduct.
While the Board cannot definitely say that pharmacists will face disciplinary action for the failure to follow USP 797, the possibility does exist.” USP 797 has been accepted and adopted by several states. States have the choice to implement 797 exactly or to edit the standards into pharmacy regulations.
Without performing a sterility test, CSPs should not be stored longer than 48 hours at a controlled room temperature, 14 days in refrigerated settings or 45 days if frozen solid at -20 degrees Fahrenheit or colder.
You can choose to ignore them however, you will then fall into USP 71 jurisdiction which then requires that sterility testing be done.The BUD for opened or entered multiple-dose containers is 28 days, unless otherwise specified by the manufacturer.Additionally, in Multiple-dose and single-dose sterile products or CSPs for use as multiple-dose applications, combining is forbidden.Barring exemptions for immediate-use ( Single-Dose vs.Multiple Dose Containers Single dose vials (SDV), if opened or punctured in a better than ISO 5 area, may be used for up to 6 hours.