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.
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 "
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-FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1-99, 100-169, 170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 to end. The first eight volumes, containing parts 1-1299, comprise Chapter I-Food and Drug Administration, Department of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II-Drug Enforcement Administration, Department of Justice, and Chapter III-Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 2017.
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.
