What is the general rule for assigning CSP BUDs when sterility testing supports extended dating?
QUESTION
Which BUD controls when a CNSP has both a USP default BUD and an ingredient expiration limit?
QUESTION
What must a compounder do to assign a BUD longer than USP default BUDs for a CNSP?
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ANSWER
Use valid stability information or testing to justify it. USP mandates evidence-based justification to extend BUDs beyond defaults for CNSP stability and safety.