Code of Federal Regulations, Title 21 Food and Drugs 100-169, Revised as of April 1, 2021

Title 21 of the Code of Federal Regulations governs food and drugs, including human and animal use, biologics, cosmetics, medical devices, radiology, and controlled substances. Updates are published annually by April, with publication expected within six months.

Format: Paperback / softback
Length: 782 pages
Publication date: 30 April 2022
Publisher: Rowman & Littlefield

Title 21 is a comprehensive set of regulations established by the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of the National Drug Control Agency (ONDCP). These regulations cover a wide range of food and drug-related areas, including human and animal use, biologics, cosmetics, medical devices, radiological health, and controlled substances. The regulations are subject to periodic updates and revisions, with new additions and modifications being published annually by April. These updates are then made available to the public through publication, which typically takes place within six months of the announcement.

Title 21 serves as a crucial framework for ensuring the safety, effectiveness, and security of various food and drug products. It encompasses a wide array of regulations and guidelines that aim to protect consumers, healthcare professionals, and the public from potential harm. By implementing these regulations, the FDA, DEA, and ONDCP strive to maintain a high standard of quality and integrity in the industry, promoting public health and well-being.

The regulations under Title 21 cover a diverse range of topics, including the manufacturing, distribution, and marketing of food and drugs. They establish specific requirements for the production, testing, and labeling of these products, as well as guidelines for their storage, transportation, and disposal. The regulations also address the safety and efficacy of medical devices, such as implants, surgical instruments, and pharmaceutical products.

In addition to these regulatory provisions, Title 21 includes provisions related to drug control and enforcement. It establishes procedures for the investigation and prosecution of individuals and organizations involved in the illegal production, distribution, and trafficking of controlled substances. The regulations also provide for the seizure and forfeiture of illegal drugs and drug-related assets.

The implementation and enforcement of Title 21 are critical to maintaining public safety and health. The FDA, DEA, and ONDCP work closely with regulatory agencies, healthcare professionals, and other stakeholders to ensure that the regulations are effectively implemented and enforced. This includes conducting inspections, conducting investigations, and taking enforcement actions against those who violate the regulations.

Overall, Title 21 is a comprehensive set of regulations that play a vital role in protecting the public's health and well-being. By implementing these regulations, the FDA, DEA, and ONDCP ensure that food and drug products are safe, effective, and secure for use by consumers and healthcare professionals alike.

Weight: 1025g
Dimension: 219 x 155 x 38 (mm)
ISBN-13: 9781636718347