21 CFR § 213.196 - Distribution records.

---
identifier: "/us/cfr/t21/s213.196"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 213.196 - Distribution records."
title_number: 21
title_name: "Food and Drugs"
section_number: "213.196"
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: "213"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES"
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, 353, 355, 360b, 360ddd, 360ddd-1, 371, 374."
regulatory_source: "89 FR 51770, June 18, 2024, unless otherwise noted."
cfr_part: "213"
---


# 213.196 Distribution records.

Distribution records shall contain the name of the medical gas, lot or batch number, name and address of the consignee, and date and quantity shipped. For medically appropriate combinations of designated medical gases, the distribution record shall include the percentage of each gas.