T 21 Pts (300-499) Cover Only; Code Of Federal Regulations(2022)

This is the cover only. You will receive this year’s new CFR cover to add to your CFR subscription collection since there have been no recent changes in the CFR since the last printing.

This cover indicates no revised or updated changes since the previously published print volume. For the Official Government Edition CFR print subscription subscribers, GPO furnishes the "cover only" or "jacket only" placement holder so this year's CFR colored cover can be placed over the previous print volume content within your print CFR collection.

To become a GPO Official Code of Federal Regulations (CFR) print subscription subscriber, you can purchase the printed volume here.

Note: GPO's Official CFR (Code of Federal Regulations) print subscription consists of an irregularly issued subscription service that includes one copy of each printed volume with Revisions per quarter.    

Subchapter D Drugs for Human Use 300 – 499

Part 300 General 300.50 – 300.200

Part 310 New Drugs 310.3 – 310.548

Part 312 Investigational New Drug Application 312.1 – 312.320

Part 314 Applications for FDA Approval to Market a New Drug 314.1 – 314.650

Part 315 Diagnostic Radiopharmaceuticals 315.1 – 315.6

Part 316 Orphan Drugs 316.1 – 316.52

Part 317 Qualifying Pathogens 317.1 – 317.2

Part 320 Bioavailability and Bioequivalence Requirements 320.1 – 320.63

Part 328 Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol 328.1 – 328.50

Part 329 Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act 329.100

Part 330 Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded 330.1 – 330.15

Part 331 Antacid Products for Over-the-Counter (OTC) Human Use 331.1 – 331.80

Part 332 Antiflatulent Products for Over-the-Counter Human Use 332.1 – 332.31

Part 333 Topical Antimicrobial Drug Products for Over-the-Counter Human Use 333.101 – 333.350

Part 335 Antidiarrheal Drug Products for Over-the-Counter Human Use 335.1 – 335.50

Part 336 Antiemetic Drug Products for Over-the-Counter Human Use 336.1 – 336.80

Part 338 Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use 338.1 – 338.50

Part 340 Stimulant Drug Products for Over-the-Counter Human Use 340.1 – 340.50

Part 341 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use 341.1 – 341.90

Part 344 Topical Otic Drug Products for Over-the-Counter Human Use 344.1 – 344.52

Part 346 Anorectal Drug Products for Over-the-Counter Human Use 346.1 – 346.52

Part 347 Skin Protectant Drug Products for Over-the-Counter Human Use 347.1 – 347.60

Part 348 External Analgesic Drug Products for Over-the-Counter Human Use 348.1 – 348.50

Part 349 Ophthalmic Drug Products for Over-the-Counter Human Use 349.1 – 349.80

Part 350 Antiperspirant Drug Products for Over-the-Counter Human Use 350.1 – 350.60

Part 352 Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely] 352.1 – 352.77

Part 355 Anticaries Drug Products for Over-the-Counter Human Use 355.1 – 355.70

Part 357 Miscellaneous Internal Drug Products for Over-the-Counter Human Use 357.101 – 357.850

Part 358 Miscellaneous External Drug Products for Over-the-Counter Human Use 358.101 – 358.760

Part 361 Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research 361.1

Part 369 Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale 369.1 – 369.21

Parts 370-499 [Reserved]

Lawyers, law librarians and law students should be familiar with the Code of Federal Regulations.