---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchD/part310"
level: "part"
label: "Part 310"
heading: "New Drugs"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchD-part310"
sections_count: 37
---

# Part 310 — New Drugs

Title 21 C.F.R. — Food and Drugs › Chapter I — Food and Drug Administration, Department of Health and Human Services › Subchapter D — Drugs for Human Use

## Contents

- [Subpart A — General Provisions](/cfr/21/chI-subchD-part310-subpartA.md)
- [Subpart B — Specific Administrative Rulings and Decisions](/cfr/21/chI-subchD-part310-subpartB.md)
- [Subpart C — New Drugs Exempted From Prescription-Dispensing Requirements](/cfr/21/chI-subchD-part310-subpartC.md)
- [Subpart D — Records and Reports](/cfr/21/chI-subchD-part310-subpartD.md)
- [Subpart E — Requirements for Specific New Drugs or Devices](/cfr/21/chI-subchD-part310-subpartE.md)