Code of Federal Regulations, Title 21, Food and Drugs, Pt. 300-499, Revisedas of

Code of Federal Regulations, Title 21, Food and Drugs, Pt. 300-499, Revised as of April 1, 2016

Agency Publisher: National Archives and Records Administration, Office of the Federal Register
USA List Price:
$35.00 Display International Price
Availability:
In Stock
GPO Stock Number: 869-084-00071-9 ISBN: 9780160932731
Price: $35.00

Description

CFR 21 Parts 300-499 include rules, regulations, and procedures about new drugs, investigational new drug application, diagnostic radiopharmaceuticals, over-the-counter drug products intended for oral ingestion that contain alcohol, and more.

Table of Contents:

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 330.14 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 NTICARIES 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]

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Audience: Target audience are pharmacists, medical practitioners, drug and pharmaceutical manufacturers, and anyone in the general public with an interest in regulations regarding over-the-counter drugs.

Keywords: 21CFR 300-499, 21cfr 300-499, Code of Federal Regulations Title 21 Food and Drugs Parts 300-499, CFR, Code of Federal Regulations, otc medications, OTC medications, over the counter medications, over-the-counter medications, safety of over the counter medications, otc medication regulations, over the counter medication regulations

Product Details

GPO Stock Number:
869-084-00071-9
ISBN:
9780160932731
Availability Details:
In Stock - Warehouse and Retail (Priced)
USA Price:
$35.00
International Price:
$49.00
Publisher:
National Archives and Records Administration, Office of the Federal Register
Author:
 
Year/Pages:
2016: 386 p.
Note:
 
Key Phrases:
CFR Title 21
SuDocs Class:
 
Weight:
1 lb.
Quantity Price:
Discount
Binding:
Paperback
Cover:
Paper
Subject Bibliography:
 
Unit of Issue (U.S.):
Each
Item Available Date:
07/15/2016
Last Status Update:
03/13/2017