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The New USP <797> BUD Restrictions

Isolator BUD Changes

Allowable BUD

Isolator Location

Current <797>

New <797>

Unclassified Area

Full BUD

Category 1 CSP 12 Hours
(24 Hours if Refrigerated)

Cleanroom Suite (ISO 7 Buffer Room)

Full BUD

Category 2 or 3 CSP Full BUD

In short - pharmacies that have previously relied on extended BUDs from CAIs and CACIs placed in the general unclassified will lose this benefit without a full cleanroom suite. LAFWs and BSCs now offer equal BUDs to CAIs and CACIs placed into equivalent areas.

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