21 CFR 211.196 - Distribution records.

Regulations last checked for updates: Feb 12, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart J [§ 211.180 - § 211.198]

§ 211.196 - Distribution records.

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.

[89 FR 51770, June 18, 2024]

authority: 21 U.S.C. 321,351,352,355,360b,360ddd,360ddd-1,371,374; 42 U.S.C. 216,262,263a,264

source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.

cite as: 21 CFR 211.196