US code governing food and drugs
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).
[1]
It is divided into three chapters:
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
[2]
56 Institutional review boards that oversee
clinical trials
58 Good laboratory practices (GLP) for nonclinical studies
The 100 series are regulations pertaining to food:
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
[3]
820 et seq. Quality system regulations (analogous to
cGMP , but structured like
ISO )
[4]
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.
[5]
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
See also
References
External links
Divisions Major acts Title 21 regulations and rules
Administrative law Federal journal Federal law
Commissioners Society and culture