21 CFR 211.150 - Distribution Procedures

What it says

Written procedures must be established for drug product distribution, including a system to facilitate stock rotation using the oldest approved stock first, and distribution records adequate to facilitate a recall if necessary, identifying the batch and quantity distributed to each consignee.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision is the regulatory anchor for recall readiness - distribution records must be granular enough to actually support tracing a specific batch to specific consignees, not simply aggregate shipment totals.
• Oldest-stock-first rotation is a specific, named expectation, not a generic inventory management suggestion, and deviation from it requires justification.
• Distribution record adequacy is typically tested in practice through mock recall exercises, which is how a site actually demonstrates rather than assumes its distribution records would support a real recall.

What FDA inspectors look for

• Whether distribution records can be queried to identify every consignee that received a specific batch, within a timeframe consistent with an effective recall.
• Whether mock recall exercises are performed periodically and reveal gaps in distribution record completeness before those gaps matter during an actual recall.
• Whether stock rotation practice matches the documented oldest-first procedure, or whether informal practice has drifted from it.

Related regulations