---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchD"
level: "subchap"
label: "Subchapter D"
heading: "Drugs for Human Use"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchD"
sections_count: 430
---

# Subchapter D — Drugs for Human Use

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

## Contents

- [Part 300 — General](/cfr/21/chI-subchD-part300.md)
- [Part 310 — New Drugs](/cfr/21/chI-subchD-part310.md)
- [Part 312 — Investigational New Drug Application](/cfr/21/chI-subchD-part312.md)
- [Part 314 — Applications for Fda Approval to Market a New Drug](/cfr/21/chI-subchD-part314.md)
- [Part 315 — Diagnostic Radiopharmaceuticals](/cfr/21/chI-subchD-part315.md)
- [Part 316 — Orphan Drugs](/cfr/21/chI-subchD-part316.md)
- [Part 317 — Qualifying Pathogens](/cfr/21/chI-subchD-part317.md)
- [Part 320 — Bioavailability and Bioequivalence Requirements](/cfr/21/chI-subchD-part320.md)
- [Part 328 — Over-The-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol](/cfr/21/chI-subchD-part328.md)
- [Part 329 — Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act](/cfr/21/chI-subchD-part329.md)
- [Part 330 — Over-The-Counter (otc) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded](/cfr/21/chI-subchD-part330.md)
- [Part 331 — Antacid Products for Over-The-Counter (otc) Human Use](/cfr/21/chI-subchD-part331.md)
- [Part 332 — Antiflatulent Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part332.md)
- [Part 333 — Topical Antimicrobial Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part333.md)
- [Part 335 — Antidiarrheal Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part335.md)
- [Part 336 — Antiemetic Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part336.md)
- [Part 338 — Nighttime Sleep-Aid Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part338.md)
- [Part 340 — Stimulant Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part340.md)
- [Part 341 — Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part341.md)
- [Part 343 — Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part343.md)
- [Part 344 — Topical Otic Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part344.md)
- [Part 346 — Anorectal Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part346.md)
- [Part 347 — Skin Protectant Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part347.md)
- [Part 348 — External Analgesic Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part348.md)
- [Part 349 — Ophthalmic Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part349.md)
- [Part 350 — Antiperspirant Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part350.md)
- [Part 352 — Sunscreen Drug Products for Over-The-Counter Human Use [stayed Indefinitely]](/cfr/21/chI-subchD-part352.md)
- [Part 355 — Anticaries Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part355.md)
- [Part 357 — Miscellaneous Internal Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part357.md)
- [Part 358 — Miscellaneous External Drug Products for Over-The-Counter Human Use](/cfr/21/chI-subchD-part358.md)
- [Part 361 — Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research](/cfr/21/chI-subchD-part361.md)
- [Part 369 — Interpretative Statements Re Warnings on Drugs and Devices for Over-The-Counter Sale](/cfr/21/chI-subchD-part369.md)
- [Part 370-499 — Parts 370-499 [reserved]](/cfr/21/chI-subchD-part370-499.md)