Title 21 of the Code of Federal Regulations
Encyclopedia
Title 21 is the portion of the Code of Federal Regulations
that governs food and drugs within the United States
for the Food and Drug Administration
(FDA), the Drug Enforcement Administration
(DEA), and the Office of National Drug Control Policy
(ONDCP).
It is divided into three chapters:
.
Notable sections:
The 100 series are regulations pertaining to food:
The 200 and 300 series are regulations pertaining to pharmaceuticals :
The 500 series are regulations for animal feeds and animal medications:
The 600 series covers biological products (e.g. vaccines, blood):
The 700 series includes the limited regulations on cosmetics
:
The 800 series are for medical devices:
The 900 series covers mammography quality requirements enforced by CDRH.
The 1000 series covers radiation-emitting device (e.g. cell phones, laser
s, x-ray generators); requirements enforced by the Center for Devices and Radiological Health
.
The 1200 series consists of rules primarily based in laws other than the Food, Drug, and Cosmetic Act:
Code of Federal Regulations
The Code of Federal Regulations is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.The CFR is published by the Office of the Federal Register, an agency...
that governs food and drugs within the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
for the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA), the Drug Enforcement Administration
Drug Enforcement Administration
The Drug Enforcement Administration is a federal law enforcement agency under the United States Department of Justice, tasked with combating drug smuggling and use within the United States...
(DEA), and the Office of National Drug Control Policy
Office of National Drug Control Policy
The White House Office of National Drug Control Policy , a former cabinet level component of the Executive Office of the President of the United States, was established in 1989 by the Anti-Drug Abuse Act of 1988...
(ONDCP).
It is divided into three chapters:
- Chapter I — Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
- Chapter II — Drug Enforcement AdministrationDrug Enforcement AdministrationThe Drug Enforcement Administration is a federal law enforcement agency under the United States Department of Justice, tasked with combating drug smuggling and use within the United States...
- Chapter III — Office of National Drug Control PolicyOffice of National Drug Control PolicyThe White House Office of National Drug Control Policy , a former cabinet level component of the Executive Office of the President of the United States, was established in 1989 by the Anti-Drug Abuse Act of 1988...
Chapter I
Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic ActFederal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
.
Notable sections:
- 11Title 21 CFR Part 11Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration guidelines on electronic records and electronic signatures in the United States...
— electronic records and electronic signatureElectronic signatureAn electronic signature, or e-signature, is any electronic means that indicates either that a person adopts the contents of an electronic message, or more broadly that the person who claims to have written a message is the one who wrote it . By comparison, a signature is a stylized script...
related - 50 Protection of human subjects in clinical trials
- 54 Financial Disclosure by Clinical Investigators
- 56 Institutional Review Boards that oversee clinical trials
- 58 Good Laboratory Practices (GLP) for nonclinical studies
The 100 series are regulations pertaining to food:
- 101, especially 101.9 — Nutrition facts label related
- (c)(2)(ii) — Requirement to include trans fatTrans fatTrans fat is the common name for unsaturated fat with trans-isomer fatty acid. Because the term refers to the configuration of a double carbon-carbon bond, trans fats are sometimes monounsaturated or polyunsaturated, but never saturated....
values - (c)(8)(iv) — VitaminVitaminA vitamin is an organic compound required as a nutrient in tiny amounts by an organism. In other words, an organic chemical compound is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on...
and mineralMineralA mineral is a naturally occurring solid chemical substance formed through biogeochemical processes, having characteristic chemical composition, highly ordered atomic structure, and specific physical properties. By comparison, a rock is an aggregate of minerals and/or mineraloids and does not...
values
- (c)(2)(ii) — Requirement to include trans fat
- 106-107 requirements for infant formula
- 110 et seq. cGMPs for food products
- 170 food additives
- 190 dietary supplements
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
Cosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, towelettes, permanent waves, colored contact lenses, hair colors, hair sprays and...
:
- 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 1000 series covers radiation-emitting device (e.g. cell phones, laser
Laser
A laser is a device that emits light through a process of optical amplification based on the stimulated emission of photons. The term "laser" originated as an acronym for Light Amplification by Stimulated Emission of Radiation...
s, x-ray generators); requirements enforced by the Center for Devices and Radiological Health
Center for Devices and Radiological Health
The Center for Devices and Radiological Health is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices...
.
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 pasteurizationPasteurizationPasteurization is a process of heating a food, usually liquid, to a specific temperature for a definite length of time, and then cooling it immediately. This process slows microbial growth in food...
of milkMilkMilk is a white liquid produced by the mammary glands of mammals. It is the primary source of nutrition for young mammals before they are able to digest other types of food. Early-lactation milk contains colostrum, which carries the mother's antibodies to the baby and can reduce the risk of many... - Interstate shipment of turtles as pets.
- Interstate shipment of African rodents that may carry monkeypoxMonkeypoxMonkeypox also known as cockpox is an exotic infectious disease caused by the monkeypox virus. The disease was first identified in laboratory monkeys, hence its name, but in its natural state it seems to infect rodents more often than primates...
. - Sanitation on interstate conveyances (i.e. airplanes and ships)
- Requirements for pasteurization
- 1271 Requirements for human cells, tissues, and cellular and tissue-based products (i.e. the cGTPsCurrent Good Tissue PracticesCurrent Good Tissue Practice , also known as Good Tissue Practice , is a term that is one of the "GxP" requirements derived from cGMP. The rule was written and is enforced by the U.S. Food and Drug Administration , specifically the Center for Biologics Evaluation and Research...
).
Chapter II
Notable sections:- 1308 — Schedules of controlled substances
- 1308.03(a) — Administrative Controlled Substances Code NumberAdministrative Controlled Substances Code NumberThe Administrative Controlled Substances Code Number is a number assigned to drugs listed on the schedules created by the Controlled Substances Act. The ACSCN is defined in 21 CFR § 1308.03....
- 1308.11 — List of Schedule I drugs
- 1308.12 — List of Schedule II drugs
- 1308.13 — List of Schedule III drugs
- 1308.14 — List of Schedule IV drugs
- 1308.15 — List of Schedule V drugs
- 1308.03(a) — Administrative Controlled Substances Code Number
See also
- Title 21 of the United States CodeTitle 21 of the United States CodeTitle 21 of the United States Code governs Food and Drugs in the United States Code.-Title 21 — Food and Drugs:Title 21 has 26 chapters: — Adulterated or Misbranded Foods or Drugs — [Teas] — Filled Milk...
- Food and Drugs - EudraLexEudraLexEudraLex is the collection of rules and regulations governing medicinal products in the European Union.-Volumes:EudraLex consists of 10 volumes:*Concerning Medicinal Products for Human use:**Volume 1 - Pharmaceutical Legislation....
(medicinal products in the European Union)
External links
- Title 21 of the Code of Federal Regulations (current “Electronic CFR”)