---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchA/part1/subpartJ"
level: "subpart"
label: "Subpart J"
heading: "Establishment, Maintenance, and Availability of Records"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchA-part1-subpartJ"
sections_count: 13
---

# Subpart J — Establishment, Maintenance, and Availability of Records

Title 21 C.F.R. — Food and Drugs › Chapter I — Food and Drug Administration, Department of Health and Human Services › Subchapter A — General › Part 1 — General Enforcement Regulations

## Sections

- [§1.326. Who is subject to this subpart?](/cfr/21/1.326.md)
- [§1.327. Who is excluded from all or part of the regulations in this subpart?](/cfr/21/1.327.md)
- [§1.328. What definitions apply to this subpart?](/cfr/21/1.328.md)
- [§1.329. Do other statutory provisions and regulations apply?](/cfr/21/1.329.md)
- [§1.330. Can existing records satisfy the requirements of this subpart?](/cfr/21/1.330.md)
- [§1.337. What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?](/cfr/21/1.337.md)
- [§1.345. What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?](/cfr/21/1.345.md)
- [§1.352. What information must transporters establish and maintain?](/cfr/21/1.352.md)
- [§1.360. What are the record retention requirements?](/cfr/21/1.360.md)
- [§1.361. What are the record availability requirements?](/cfr/21/1.361.md)
- [§1.362. What records are excluded from this subpart?](/cfr/21/1.362.md)
- [§1.363. What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?](/cfr/21/1.363.md)
- [§1.368. What are the compliance dates for this subpart?](/cfr/21/1.368.md)