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. 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. 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/sku/017-012-00402-4 Investigational New Drug Application (Red Polyethylene Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00401-6 Investigational New Drug Application (Orange Paper Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00403-2 New Drug Application: Statistics Section (Green Paper Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00386-9 New Drug Application: Pharmacology Section (Yellow Paper Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00390-7 New Drug Application: Microbiology (White Paper Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00388-5 New Drug Application: Chemistry Section (Red Paper Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00391-5 New Drug Application: Field Submission Chemistry Section (Maroon Paper Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00385-1 New Drug Application: Clinical Data Section, (Tan Paper Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00387-7 New Drug Application: Pharmacokinetic Section (Orange Paper Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00389-3 New Drug Application: Biologic Licensing Application, Archival Copy (Blue Polyethylene Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00392-3 Minor Species Index File FDA Drug Folder (Purple Polyethylene) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00406-7 Health United States 2013 With Special Feature on Prescription Drugs can be found here: https: //bookstore.gpo.gov/products/sku/017-022-01621-4 "