CFR 21(PTS300-499):2019
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Code of Federal Regulations, Title 21, Food and Drugs, Part 300-499,
09-04-2024
31-10-2019
300
300.50 to 300.100
GENERAL
310
310.3 to 310.548
NEW DRUGS
312
312.1 to 312.320
INVESTIGATIONAL NEW DRUG APPLICATION
314
314.1 to 314.650
APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
315
315.1 to 315.6
DIAGNOSTIC RADIOPHARMACEUTICALS
316
316.1 to 316.52
ORPHAN DRUGS
317
317.1 to 317.2
QUALIFYING PATHOGENS
320
320.1 to 320.63
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
328
328.1 to 328.50
OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
329
329.100
NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
330
330.1 to 330.15
OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331
331.1 to 331.80
ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332
332.1 to 332.31
ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
333
333.101 to 333.350
TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
335
335.1 to 335.50
ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
336
336.1 to 336.80
ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338
338.1 to 338.50
NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
340
340.1 to 340.50
STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341
341.1 to 341.90
COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343
343.1 to 343.90
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
344
344.1 to 344.52
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
346
346.1 to 346.52
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347
347.1 to 347.60
SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348
348.1 to 348.50
EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349
349.1 to 349.80
OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
350
350.1 to 350.60
ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352
352.1 to 352.77
SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
355
355.1 to 355.70
ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
357
357.101 to 357.850
MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
358
358.101 to 358.760
MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
361
361.1
PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369
369.1 to 369.21
INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
370-499
[RESERVED]
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.