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