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 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: Drug Master File (Red Polyethylene Folder) can be found here: https://bookstore.gpo.gov/products/sku/017-012-00404-1 Drug Master File (Blue Polyethylene Folder) can be found here: https://bookstore.gpo.gov/products/sku/017-012-00405-9 Minor Species Index File FDA Drug Folder (Purple Polyethylene) can be found here: https://bookstore.gpo.gov/products/sku/017-012-00406-7 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 Drugs can be found here: https://bookstore.gpo.gov/products/health-united-states-2013-special-feature-prescription-drugs

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 version is the Official U.S. Federal Government Code of Federal Regulations edition. 21 CFR Part 170 to 199 contains food additives, production, processing, and handling of food, indirect food additives, such as paper, cardboard, and hand sanitizers, dietary supplements, and more. Keywords: 21 CFR 170-199; 21 CFR Parts 170-199; cfr 21 parts 170-199; cfr 21 Parts 170-199; food additives, substances prohibited from use in human food; indirect food substances affirmed as generally recognized as safe; food ingredients; food and drug administration; fda; FDA; U.S. Food and Drug Administration;

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.

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.

Title 21 presents regulations promulgated by the Food and Drug Administration, the Drug Enforcement Administration, and the Office of the National Drug Control Agency in the area of food and drugs. These regulations encompass food and drugs for human and animal use, biologics, cosmetics, medical devices, radiological health, and controlled substances. Additions and revisions to this section of the code are posted annually by April. Publication follows within six months.