Code of Federal Regulations, Title 21 Food and Drugs 500-599, 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: 670 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. The DEA is responsible for overseeing the illegal drug trade and enforcing drug laws and regulations. The ONDCP plays a key role in coordinating national drug control policies and initiatives, including drug prevention, education, and research.

The regulations under Title 21 are subject to ongoing review and revision to ensure that they remain up-to-date with the latest scientific advancements and changing societal needs. This process involves a rigorous scientific and regulatory review, as well as public input and feedback. By incorporating these updates and revisions, Title 21 continues to evolve and adapt to the evolving landscape of food and drug regulation.

In conclusion, Title 21 is a critical component of the U.S. food and drug regulatory system. It provides a comprehensive framework for ensuring the safety, effectiveness, and security of various food and drug products. Through its regulations and guidelines, the FDA, DEA, and ONDCP strive to protect consumers, healthcare professionals, and the public from potential harm. The ongoing review and revision process ensures that Title 21 remains an effective tool for promoting public health and well-being in the United States.

Weight: 885g
Dimension: 229 x 152 x 34 (mm)
ISBN-13: 9781636718385