USP 797 FAQ: Dating Multi-dose Vials

From Eric Kastango’s article in the recent Cleanrooms & Compounding issue of Pharmacy Purchasing & Products magazine (unfortunately, it doesn’t appear to be online yet – but several other excellent article related to USP 797 are available online):

There continues to be significant confusion regarding the storage period for multi-dose vials subsequent to their initial puncture. Many organizations have been cited by The Joint Commission, state boards of pharmacy, and departments of health for not discarding multi-dose vials after 28 days. The Multiple-dose Containers Section of USP Chapter <797> states that the “BUD for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days (see Antimicrobial Effectiveness Testing <51>), unless otherwise specified by the manufacturer.” Many organizations have missed the “unless otherwise specified by the manufacturer” part of the section. The CDC’s Vaccine Storage and Handling Toolkit is an excellent resource on the storage and handling of vaccines. The CDC states, “a vaccine or diluent may be used up to and including the date on the vial unless otherwise stated in the product package insert.”


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