21 CFR § 211.196 - Distribution records.

---
identifier: "/us/cfr/t21/s211.196"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 211.196 - Distribution records."
title_number: 21
title_name: "Food and Drugs"
section_number: "211.196"
section_name: "Distribution records."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "211"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 355, 360b, 360ddd, 360ddd-1, 371, 374; 42 U.S.C. 216, 262, 263a, 264."
regulatory_source: "43 FR 45077, Sept. 29, 1978, unless otherwise noted."
cfr_part: "211"
---


# 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]