Title 21 of the Code of Federal Regulations Totally Explained

Everything about Title 21 Of The Code Of Federal Regulations totally explained

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

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

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 (for example 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

820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO)

860 et seq. Listing of specific approved devices and how they're classified The 900 series covers mammography quality requirements enforced by CDRH.
The 1000 series covers radiation emitting device (for example lasers, cell phones) requirements enforced by CDRH.
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 (for example airplanes and ships)

1271 Requirements for human cells, tissues, and cellular and tissue-based products (for example 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

Chapter III

Notable sections:

1405 Governmentwide requirements for drug-free workplacesFurther Information

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