Code of Federal Regulations, Title 21 Food and Drugs 170-199, 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, 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: 09 May 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. Following publication, the regulations take effect within six months.

Title 21 plays a pivotal role in safeguarding public health and ensuring the safety of various consumer products. It sets forth specific guidelines and standards for the manufacturing, distribution, and marketing of food, drugs, and medical devices. These regulations aim to prevent harm to individuals and promote the well-being of the general population.

The scope of Title 21 is extensive, covering a wide range of products and industries. It includes regulations related to the production, processing, packaging, labeling, and advertising of food and drugs. It also addresses the safety and effectiveness of medical devices, such as implants, surgical instruments, and diagnostic tools. Additionally, Title 21 regulates the distribution and control of controlled substances, such as narcotics, stimulants, and hallucinogens, to prevent drug abuse and trafficking.

The regulations under Title 21 are developed through a rigorous scientific and regulatory process. The FDA, DEA, and ONDCP collaborate with experts in various fields to ensure that the regulations are based on the latest scientific evidence and public health concerns. The process involves extensive research, public comment periods, and peer review to ensure that the regulations are fair, effective, and in the best interest of the public.

Enforcing Title 21 is a critical responsibility of the federal government. The FDA, DEA, and ONDCP work closely with law enforcement agencies to investigate and prosecute individuals and organizations that violate these regulations. Penalties for violations can include fines, imprisonment, and other legal consequences.

In conclusion, Title 21 is a crucial regulatory framework that governs the food and drug industry in the United States. It plays a vital role in protecting public health, ensuring the safety of consumer products, and promoting the well-being of the general population. The regulations under Title 21 are developed through a rigorous scientific and regulatory process, and they are enforced by the federal government to ensure compliance and prevent harm.

Weight: 948g
Dimension: 229 x 152 x 34 (mm)
ISBN-13: 9781636718354