Usp 797 medium risk beyond use dating
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.Radiopharmaceuticals as CSPs Highly particulate generating materials, like lead containers, are required to be used for the protection of handlers.ISO Class 8 air is permitted because it is hard to maintain air cleanliness with all of the lead shielding being used.CSPs include drugs, nutrients, biologics, diagnostics and radiopharmaceuticals.The guideline requires environmental controls to include a separate area for compounding that meets a definite level of cleanliness, and monitoring to guarantee that control is maintained.
The standard applies to anyone who prepares CSPs and all places where they are prepared.
Therefore, when preparing these CSPs the guidelines are: Allergen Extracts as CSPs Unpreserved allergen extracts must fully comply with 797, but most allergen extracts are highly preserved.
Preparations using preserved allergen extracts are exempt from certain aspects of USP 797 under certain conditions involving: Environmental Quality and Control The related revisions deal with environmental designs and primary engineering control areas, including CAIs (barrier isolators), HEPA filters, buffer and anterooms, and cleanrooms.
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.
Low-risk compounding includes using sterile needles and syringes to transfer sterile liquids from manufacturer-sealed ampules or vials to sterile devices or other sterile packages.