21 CFR § 211.196 - Distribution records.

Link to an amendment published at 89 FR 51770, June 18, 2024.

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.

(Approved by the Office of Management and Budget under control number 0910-0139)

[49 FR 9865, Mar. 16, 1984]