View source for 21 CFR

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==Overview==
'''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 &mdash; [[Food and Drug Administration]]
* Chapter II &mdash; [[Drug Enforcement Administration]]
* Chapter III &mdash; [[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:

* [[Title 21 CFR Part 11|11]] &mdash; 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 &mdash; [[Nutrition facts label]] related
** (c)(2)(ii) &mdash; Requirement to include [[trans fat]] values
** (c)(8)(iv) &mdash; [[Vitamin]] and [[mineral]] values
* 106-107 requirements for infant formula
* 110 ''et seq.'' [[cGMP]]s 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.'' [[cGMP]]s 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.'' [[cGMP]]s 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 are classified

The 900 series covers mammography quality requirements enforced by [[CDRH]].

The 1000 series covers radiation emitting device (e.g. [[laser]]s, [[cell phone]]s) 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 (i.e. airplanes and ships)
* 1271 Requirements for human cells, tissues, and cellular and tissue-based products (i.e. the c[[GTP]]s).

==Chapter II==
Notable sections:

* 1308 &mdash; Schedules of controlled substances
** 1308.03(a) &mdash; [[Administrative Controlled Substances Code Number]]
** 1308.11 &mdash; [[List of Schedule I drugs]]
** 1308.12 &mdash; [[List of Schedule II drugs]]
** 1308.13 &mdash; [[List of Schedule III drugs]]
** 1308.14 &mdash; [[List of Schedule IV drugs]]
** 1308.15 &mdash; [[List of Schedule V drugs]]

==Chapter III==
Notable sections:

* 1405 Governmentwide requirements for drug-free workplaces

== See also ==
* [[EudraLex]] (Europe)

==External links==
* [http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200521 Title 21 of the Code of Federal Regulations] (revised [[April 1]], [[2005]])
*[http://www.smartpdf.com/21CFR/ Current 21 CFR Books in Digital Format]

[[Category:Drugs]]
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