Code of Federal Regulations, Title 21 Food and Drugs 500 - 599, 2022

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

Format: Paperback / softback
Length: 1 pages
Publication date: 18 July 2023
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 updated and revised on an annual basis, with the latest additions and revisions being published by April. Following this publication, the regulations take effect within six months.

Title 21 plays a crucial role in ensuring the safety, effectiveness, and security of food and drugs in the United States. It sets forth specific guidelines and standards for the manufacture, distribution, and administration of these products, aiming to protect public health and welfare. The regulations encompass a diverse range of topics, including the approval process for new drugs and medical devices, the regulation of dietary supplements and herbal products, the enforcement of drug laws and regulations, and the prevention of drug abuse and trafficking.

One of the key aspects of Title 21 is its emphasis on the safety of food and drugs. The FDA is responsible for overseeing the safety of food and drugs throughout their entire lifecycle, from the initial development and testing to the final distribution and consumption. The agency employs a rigorous scientific and regulatory framework to ensure that products are safe, effective, and properly labeled. This includes conducting extensive pre-market testing, reviewing drug applications, and monitoring post-market surveillance to identify and address any safety concerns.

Similarly, the DEA is responsible for enforcing drug laws and regulations at the federal level. The agency works to prevent the illegal distribution and abuse of controlled substances, including drugs such as heroin, cocaine, and marijuana. The DEA employs a variety of strategies to combat drug trafficking, including drug enforcement operations, intelligence gathering, and education and awareness campaigns.

In addition to these regulatory agencies, Title 21 also includes provisions for the regulation of cosmetics, medical devices, and radiological health. The FDA is responsible for regulating cosmetics, ensuring that they are safe and properly labeled. The agency conducts rigorous testing and reviews of cosmetic products to ensure that they do not pose any health risks to consumers. Similarly, the FDA regulates medical devices, including implants, surgical instruments, and medical equipment, to ensure that they are safe and effective for use in healthcare settings.

The regulation of radiological health is also important to ensure the safety of individuals and the environment. The ONDCP is responsible for overseeing the use of radioactive materials in healthcare, research, and other industries. The agency conducts inspections and audits to ensure that facilities are complying.

Overall, Title 21 is a complex and comprehensive set of regulations that play a critical role in protecting public health and welfare in the United States. By ensuring the safety, effectiveness, and security of food and drugs, the regulations help to promote the well-being of individuals and communities across the country.

Weight: 1046g
Dimension: 228 x 152 x 36 (mm)
ISBN-13: 9781636711928