21 CFR 211.196 - Distribution Records

What it says

Distribution records must contain the name and strength of the product and a description of the dosage form, the name and address of the consignee, the date and quantity shipped, and the lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers.

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

What it means in practice

• These records are what allows a recall to find where a lot went, so they need to be complete and retrievable.
• A mock recall is a practical test of whether the distribution records are good enough.
• Records should tie each shipment to a specific lot, not just to a product name.

What FDA inspectors look for

• Whether distribution records include each required element.
• Whether a lot can be traced to its consignees quickly.
• Whether records are retained for the required period.

Related regulations