- Source: Title 21 of the Code of Federal Regulations
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:
Chapter I — Food and Drug Administration
Chapter II — Drug Enforcement Administration
Chapter III — Office of National Drug Control Policy
Chapter I
Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act.
Notable sections:
11 — electronic records and electronic signature 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 fat values
(c)(8)(iv) — Vitamin and mineral 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
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:
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, lasers, x-ray generators); requirements enforced by the Center for Devices and Radiological Health. It also talks about the FDA citizen petition.
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 of milk
Interstate shipment of turtles as pets.
Interstate shipment of African rodents that may carry monkeypox.
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
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
See also
Title 21 of the United States Code - Food and Drugs
EudraLex (medicinal products in the European Union)
References
External links
Title 21 of the Code of Federal Regulations (current "Electronic CFR")
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- Title 21 of the Code of Federal Regulations
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