USP 797 Tip: Beyond Use Dating

USP 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 miss the “unless otherwise specified by the manufacturer” part of the section.


USP 797 Tip:Caulk Ceiling Tiles

From an article by Eric Kastango in Pharmacy Purchasing and Products magazine:

“Chapter 797 requires that ceiling tiles be caulked in place to ensure they do not move, become dislodged, or get damaged during cleaning. The presence of caulked ceiling tiles is especially important in negative pressure ISO Class 7 buffer areas to mitigate the introduction of dirty, unfiltered air from the ceiling plenum. This design element is an easily identified requirement and is frequently cited by board of pharmacy and department of health inspectors.”