21 CFR 211.196

Distribution records.

Inspections citing it: 72
Of those classified, ended OAI: 43%
Last cited: FY2026

Inspections Citing It by Fiscal Year

Sites in and outside the US, FY2017 to Oct 20, 2026.

42018

12020

32022

62024

12026

Regulation Text

eCFR, as of Nov 6, 2026

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.

Open 21 CFR 211.196 on eCFR

Recently Cited Sites

Newest inspections citing this section; each opens the site

Mountainside Medical Equipment, Inc.United States · Aug 12, 2026
Sani-Care Salon Products, IncUnited States · Jan 17, 2025
Cosco International, Inc.United States · Oct 25, 2024
EnviroServe Chemicals Inc.United States · Sep 17, 2024

Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR