21 CFR 211.196 - Distribution records.

Regulations last checked for updates: May 02, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

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

§ 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]

authority: 21 U.S.C. 321,351,352,355,360b,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