Title 21 is the portion of the

Code of Federal Regulations In the law of the United States, the ''Code of Federal Regulations'' (''CFR'') is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. ...

that governs food and drugs within the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country Continental United States, primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., ...

for the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA), the

Drug Enforcement Administration The Drug Enforcement Administration (DEA; ) is a United States federal law enforcement agency under the U.S. Department of Justice tasked with combating drug trafficking and distribution within the U.S. It is the lead agency for domestic en ...

(DEA), and the

Office of National Drug Control Policy The Office of National Drug Control Policy (ONDCP) is a component of the Executive Office of the President of the United States. The Director of the ONDCP, colloquially known as the Drug Czar, heads the office. "Drug Czar" was a term first used i ...

(ONDCP). It is divided into three chapters: * Chapter I —

* Chapter II —

* Chapter III —

Chapter I

Most of the Chapter I regulations are based on the

Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of ...

. Notable sections: * 11 — electronic records and

electronic signature An electronic signature, or e-signature, is data that is logically associated with other data and which is used by the signatory to sign the associated data. This type of signature has the same legal standing as a handwritten signature as long as ...

related * 50 Protection of human subjects in

clinical trials Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dieta ...

* 54 Financial disclosure by clinical investigators * 56 Institutional review boards that oversee

* 58 Good laboratory practices (GLP) for nonclinical studies The 100 series are regulations pertaining to food: * 101, especially 101.9 —

Nutrition facts label The nutrition facts label (also known as the nutrition information panel, and other slight variations) is a label required on most packaged food in many countries, showing what nutrients and other ingredients (to limit and get enough of) are in t ...

related ** (c)(2)(ii) — Requirement to include

trans fat Trans fat, also called trans-unsaturated fatty acids, or trans fatty acids, is a type of unsaturated fat that naturally occurs in small amounts in meat and milk fat. It became widely produced as an unintentional byproduct in the industrial pr ...

values ** (c)(8)(iv) —

Vitamin A vitamin is an organic molecule (or a set of molecules closely related chemically, i.e. vitamers) that is an essential micronutrient that an organism needs in small quantities for the proper functioning of its metabolism. Essential nutrie ...

and

mineral In geology and mineralogy, a mineral or mineral species is, broadly speaking, a solid chemical compound with a fairly well-defined chemical composition and a specific crystal structure that occurs naturally in pure form.John P. Rafferty, ed. (2 ...

values * 106-107 requirements for infant formula * 110 ''et seq.'' cGMPs for food products * 111 ''et seq.'' cGMPs for dietary supplements * 170 food additives * 190

dietary supplements A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order ...

The 200 and 300 series are regulations pertaining to pharmaceuticals : * 202-203 Drug advertising and marketing * 210 ''et seq.'' cGMPs for pharmaceuticals * 310 ''et seq.'' Requirements for new drugs * 328 ''et seq.'' Specific requirements for over-the-counter (OTC) drugs. The 500 series are regulations for animal feeds and animal medications: * 510 ''et seq.'' New animal drugs * 556 Tolerances for residues of drugs in food animals The 600 series covers biological products (e.g. vaccines, blood): * 601 Licensing under section 351 of the Public Health Service Act * 606 ''et seq.'' cGMPs for human blood and blood products The 700 series includes the limited regulations on

cosmetics Cosmetics are constituted mixtures of chemical compounds derived from either natural sources, or synthetically created ones. Cosmetics have various purposes. Those designed for personal care and skin care can be used to cleanse or protec ...

: * 701 Labeling requirements The 800 series are for medical devices: * 803 Medical device reporting * 814 Premarket approval of medical devices * 820 ''et seq.'' Quality system regulations (analogous to cGMP, but structured like ISO) * 860 ''et seq.'' Listing of specific approved devices and how they are classified The 900 series covers mammography quality requirements enforced by

CDRH The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safe ...

. The 1000 series covers radiation-emitting device (e.g.

cell phone A mobile phone, cellular phone, cell phone, cellphone, handphone, hand phone or pocket phone, sometimes shortened to simply mobile, cell, or just phone, is a portable telephone that can make and receive telephone call, calls over a radio freq ...

laser A laser is a device that emits light through a process of optical amplification based on the stimulated emission of electromagnetic radiation. The word "laser" is an acronym for "light amplification by stimulated emission of radiation". The ...

x-ray generator An X-ray generator is a device that produces X-rays. Together with an X-ray detector, it is commonly used in a variety of applications including medicine, X-ray fluorescence, electronic assembly inspection, and measurement of material thicknes ...

s); requirements enforced by the

Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safe ...

. It also talks about the

FDA citizen petition An FDA citizen petition is a process provided by the United States Food and Drug Administration (FDA) for individuals and community organizations to make requests to the FDA for changes to health policy. It is described in Title 21 of the Code of ...

. The 1100 series includes updated rules deeming items that statutorily come under the definition of "tobacco product" to be subject to the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. The items affected include E-cigarettes, Hookah tobacco, and pipe tobacco. The 1200 series consists of rules primarily based in laws other than the Food, Drug, and Cosmetic Act: * 1240 Rules promulgated under 361 of the Public Health Service Act on interstate control of communicable disease, such as: ** Requirements for

pasteurization Pasteurization or pasteurisation is a process of food preservation in which packaged and non-packaged foods (such as milk and fruit juices) are treated with mild heat, usually to less than , to eliminate pathogens and extend shelf life. ...

milk Milk is a white liquid food produced by the mammary glands of mammals. It is the primary source of nutrition for young mammals (including breastfed human infants) before they are able to digest solid food. Immune factors and immune-modulat ...

** Interstate shipment of

turtle Turtles are an order of reptiles known as Testudines, characterized by a special shell developed mainly from their ribs. Modern turtles are divided into two major groups, the Pleurodira (side necked turtles) and Cryptodira (hidden necked t ...

s as pets. ** Interstate shipment of African

rodents Rodents (from Latin , 'to gnaw') are mammals of the order Rodentia (), which are characterized by a single pair of continuously growing incisors in each of the upper and lower jaws. About 40% of all mammal species are rodents. They are na ...

that may carry

monkeypox Monkeypox (also called mpox by the WHO) is an infectious viral disease that can occur in humans and some other animals. Symptoms include fever, swollen lymph nodes, and a rash that forms blisters and then crusts over. The time from exposu ...

. ** Sanitation on interstate conveyances (i.e. airplanes and ships) * 1271 Requirements for human cells, tissues, and cellular and tissue-based products (i.e. the cGTPs).

Chapter II

Notable sections: * 1308 — Schedules of controlled substances ** 1308.03(a) —

Administrative Controlled Substances Code Number Administrative Controlled Substances Code Number (ACSCN) is a number assigned to drugs listed on the schedules created by the US Controlled Substances Act (CSA). The ACSCN is defined in 21 CFR § 1308.03(a). Each chemical/drug on one of the schedu ...

** 1308.11 —

List of Schedule I drugs This is the list of Schedule I drugs as defined by the United States Controlled Substances Act. 21 CFRbr>1308.11(CSA Sched I) with changes through (Oct 18, 2012). Retrieved September 6, 2013. The following findings are required for drugs to be pla ...

** 1308.12 — List of Schedule II drugs ** 1308.13 — List of Schedule III drugs ** 1308.14 —

List of Schedule IV drugs This is the list of Schedule IV controlled substances as defined by the United States Controlled Substances Act. The following findings are required for substances to be placed in this schedule: retrieved October 2, 2007 # The drug or other substan ...

** 1308.15 — List of Schedule V drugs

References

External links

Title 21 of the Code of Federal Regulations
(current "Electronic CFR") {{DEFAULTSORT:Title 21 Of The Code Of Federal Regulations 21 Drug control law in the United States Food law Regulation of medical devices

Chapter I

Chapter II

See also

References

External links