Code of Federal Regulations, Title 21, Food and Drugs, Pt. 300-399, Revised as of April 1, 2018
Editat de Office of the Federal Register (U.S.), National Archives and Records Administration (U.S.)en Limba Engleză Paperback – 26 apr 2018 – vârsta de la 18 până la 95 ani
The
Code
of
Federal
Regulations
is
a
codification
of
the
general
and
permanent
rules
published
in
the
Federal
Register
by
the
Executive
departments
and
agencies
of
the
United
States
Federal
Government.
This
print
ISBN
is
the
official
U.S.
Federal
Government
edition.
Title 21 CFR, Parts 300-499, includes updated rules, regulations, procedures and administrative procedures associated with the Food and Drug Administration and Health and Human Services (drugs for human use), investigational new drug applications, diagnostic radiopharmaceuticals, orphan drugs, bioavailability and bioequivalence requirements, over-the-counter (OTC) drug products indtended for oral ingestion that contain alcohol, OTC human drugs generally recognized as safe and effective and not misbranded, OTC digestion-related drugs, OTC antimicrobials, OTC sleep aid drugs, OTC stimulant drugs, OTC skin protectant drugs, OTC antipersperants, OTC miscellaneaous internal and external drug products, and more...
Audience: Physicians, pharmacists, medical practitioners, drug and pharmaceutical manufacturers, and the general public may be interested in this regulatory volume.
Other related products:
Health United States 2016 editionis available here: https://bookstore.gpo.gov/products/health-united-states-2016-chartbook-long-term-trends-health-and-health-united-states-2016
Drug Master File (Red Polyethylene Folder)can be found here:https://bookstore.gpo.gov/products/drug-master-file-red-polyethylene-folder-0
Drug Master File (Blue Polyethylene Folder)can be found here:https://bookstore.gpo.gov/products/drug-master-file-blue-polyethylene-folder-0
Minor Species Index File FDA Drug Folder (Purple Polyethylene)can be found here:https://bookstore.gpo.gov/products/minor-species-index-file-fda-drug-folder-purple-polyethylene
Investigational New Drug Application (Green Paper Folder)can be found here:https://bookstore.gpo.gov/products/investigational-new-drug-application-green-paper-folder
Investigational New Drug Application (Red Polyethylene Folder)can be found here: https://bookstore.gpo.gov/products/investigational-new-drug-application-red-polyethylene-folder
Investigational New Drug Application (Orange Paper Folder)can be found here: https://bookstore.gpo.gov/products/investigational-new-drug-application-orange-paper-folder
New Drug Application: Statistics Section (Green Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-statistics-section-green-paper-folder
New Drug Application: Pharmacology Section (Yellow Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-pharmacology-section-yellow-paper-folder
New Drug Application: Microbiology (White Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-microbiology-white-paper-folder
New Drug Application: Field Submission Chemistry Section (Maroon Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-field-submission-chemistry-section-maroon-paper-folder
New Drug Application: Chemistry Section (Red Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-chemistry-section-red-paper-folder
New Drug Application: Clinical Data Section (Tan Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-clinical-data-section-tan-paper-folder
New Drug Application: Pharmacokinetic Section (Orange Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-pharmacokinetic-section-orange-paper-folder
New Drug Application: Biologic Licensing Application, Archival Copy (Blue Polyethylene Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-biologic-licensing-application-archival-copy-blue-polyethylene-folder
Minor Species Index File FDA Drug Folder (Purple Polyethylene)can be found here: https://bookstore.gpo.gov/products/minor-species-index-file-fda-drug-folder-purple-polyethylene
Health United States 2013 With Special Feature on Prescription Drugscan be found here:https://bookstore.gpo.gov/products/health-united-states-2013-special-feature-prescription-drugs
Title 21 CFR, Parts 300-499, includes updated rules, regulations, procedures and administrative procedures associated with the Food and Drug Administration and Health and Human Services (drugs for human use), investigational new drug applications, diagnostic radiopharmaceuticals, orphan drugs, bioavailability and bioequivalence requirements, over-the-counter (OTC) drug products indtended for oral ingestion that contain alcohol, OTC human drugs generally recognized as safe and effective and not misbranded, OTC digestion-related drugs, OTC antimicrobials, OTC sleep aid drugs, OTC stimulant drugs, OTC skin protectant drugs, OTC antipersperants, OTC miscellaneaous internal and external drug products, and more...
Audience: Physicians, pharmacists, medical practitioners, drug and pharmaceutical manufacturers, and the general public may be interested in this regulatory volume.
Other related products:
Health United States 2016 editionis available here: https://bookstore.gpo.gov/products/health-united-states-2016-chartbook-long-term-trends-health-and-health-united-states-2016
Drug Master File (Red Polyethylene Folder)can be found here:https://bookstore.gpo.gov/products/drug-master-file-red-polyethylene-folder-0
Drug Master File (Blue Polyethylene Folder)can be found here:https://bookstore.gpo.gov/products/drug-master-file-blue-polyethylene-folder-0
Minor Species Index File FDA Drug Folder (Purple Polyethylene)can be found here:https://bookstore.gpo.gov/products/minor-species-index-file-fda-drug-folder-purple-polyethylene
Investigational New Drug Application (Green Paper Folder)can be found here:https://bookstore.gpo.gov/products/investigational-new-drug-application-green-paper-folder
Investigational New Drug Application (Red Polyethylene Folder)can be found here: https://bookstore.gpo.gov/products/investigational-new-drug-application-red-polyethylene-folder
Investigational New Drug Application (Orange Paper Folder)can be found here: https://bookstore.gpo.gov/products/investigational-new-drug-application-orange-paper-folder
New Drug Application: Statistics Section (Green Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-statistics-section-green-paper-folder
New Drug Application: Pharmacology Section (Yellow Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-pharmacology-section-yellow-paper-folder
New Drug Application: Microbiology (White Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-microbiology-white-paper-folder
New Drug Application: Field Submission Chemistry Section (Maroon Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-field-submission-chemistry-section-maroon-paper-folder
New Drug Application: Chemistry Section (Red Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-chemistry-section-red-paper-folder
New Drug Application: Clinical Data Section (Tan Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-clinical-data-section-tan-paper-folder
New Drug Application: Pharmacokinetic Section (Orange Paper Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-pharmacokinetic-section-orange-paper-folder
New Drug Application: Biologic Licensing Application, Archival Copy (Blue Polyethylene Folder)can be found here: https://bookstore.gpo.gov/products/new-drug-application-biologic-licensing-application-archival-copy-blue-polyethylene-folder
Minor Species Index File FDA Drug Folder (Purple Polyethylene)can be found here: https://bookstore.gpo.gov/products/minor-species-index-file-fda-drug-folder-purple-polyethylene
Health United States 2013 With Special Feature on Prescription Drugscan be found here:https://bookstore.gpo.gov/products/health-united-states-2013-special-feature-prescription-drugs
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Specificații
ISBN-13: 9780160945434
ISBN-10: 0160945437
Dimensiuni: 146 x 232 x 19 mm
Greutate: 0 kg
Ediția:Revizuită
Editura: Us Independent Agencies and Commissions
Colecția Office of the Federal Register
ISBN-10: 0160945437
Dimensiuni: 146 x 232 x 19 mm
Greutate: 0 kg
Ediția:Revizuită
Editura: Us Independent Agencies and Commissions
Colecția Office of the Federal Register
Cuprins
Table
of
Contents:
Title 21 → Chapter I → Subchapter D
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER D—DRUGS FOR HUMAN USE
300300.50 to 300.100 GENERAL
310310.3 to 310.548 NEW DRUGS
312312.1 to 312.320 INVESTIGATIONAL NEW DRUG APPLICATION
314314.1 to 314.650 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
315315.1 to 315.6 DIAGNOSTIC RADIOPHARMACEUTICALS
316316.1 to 316.52 ORPHAN DRUGS
317317.1 to 317.2 QUALIFYING PATHOGENS
320320.1 to 320.63 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
328328.1 to 328.50 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
329329.100 NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
330330.1 to 330.15 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331331.1 to 331.80 ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332332.1 to 332.31 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
333333.101 to 333.350 TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
335335.1 to 335.50 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
336336.1 to 336.80 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338338.1 to 338.50 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
340340.1 to 340.50 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341341.1 to 341.90 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343343.1 to 343.90 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
344344.1 to 344.52 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
346346.1 to 346.52 ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347347.1 to 347.60 SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348348.1 to 348.50 EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349349.1 to 349.80 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
350350.1 to 350.60 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352352.1 to 352.77 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
355355.1 to 355.70 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
357357.101 to 357.850 MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
358358.101 to 358.760 MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
361361.1 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369369.1 to 369.21 INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
370-499 [RESERVED]
Title 21 → Chapter I → Subchapter D
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER D—DRUGS FOR HUMAN USE
300300.50 to 300.100 GENERAL
310310.3 to 310.548 NEW DRUGS
312312.1 to 312.320 INVESTIGATIONAL NEW DRUG APPLICATION
314314.1 to 314.650 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
315315.1 to 315.6 DIAGNOSTIC RADIOPHARMACEUTICALS
316316.1 to 316.52 ORPHAN DRUGS
317317.1 to 317.2 QUALIFYING PATHOGENS
320320.1 to 320.63 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
328328.1 to 328.50 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
329329.100 NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
330330.1 to 330.15 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331331.1 to 331.80 ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332332.1 to 332.31 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
333333.101 to 333.350 TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
335335.1 to 335.50 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
336336.1 to 336.80 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338338.1 to 338.50 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
340340.1 to 340.50 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341341.1 to 341.90 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343343.1 to 343.90 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
344344.1 to 344.52 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
346346.1 to 346.52 ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347347.1 to 347.60 SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348348.1 to 348.50 EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349349.1 to 349.80 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
350350.1 to 350.60 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352352.1 to 352.77 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
355355.1 to 355.70 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
357357.101 to 357.850 MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
358358.101 to 358.760 MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
361361.1 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369369.1 to 369.21 INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
370-499 [RESERVED]