21 CFR §211.196
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers.