Title 21 of the Code of Federal Regulations: Difference between revisions

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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 — 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 ^[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:

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 ^[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
- 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

References

^ "CFR Title 21". US FDA. Retrieved February 10, 2014.
^ Food and Drug Administration (2008). "Subchapter A — General: Financial Disclosure by Clinical Investigators". Retrieved 9 April 2009.
^ Food and Drug Administration (2008). "Subchapter H — Medical Devices: Part 814 Premarket Approval of Medical Devices". Retrieved 9 April 2009.
^ Food and Drug Administration (2008). "Subchapter H — Medical Devices: Part 820 Quality System Regulation". Retrieved 9 April 2009.
^ "Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah". FDA.gov. United States Food and Drug Administration. Retrieved 11 May 2016.

External links

Title 21 of the Code of Federal Regulations (current "Electronic CFR")

[1] "CFR Title 21". US FDA. Retrieved February 10, 2014.

[sagf-2] Food and Drug Administration (2008). "Subchapter A — General: Financial Disclosure by Clinical Investigators". Retrieved 9 April 2009.

[p814-3] Food and Drug Administration (2008). "Subchapter H — Medical Devices: Part 814 Premarket Approval of Medical Devices". Retrieved 9 April 2009.

[p820-4] Food and Drug Administration (2008). "Subchapter H — Medical Devices: Part 820 Quality System Regulation". Retrieved 9 April 2009.

[5] "Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah". FDA.gov. United States Food and Drug Administration. Retrieved 11 May 2016.

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[2]

[3]

[4]

[5]

@@ Line 1: / Line 1: @@
+{{main|Code of Federal Regulations}}
+{{Short description|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).<ref>{{cite web |url= http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm| title=CFR Title 21
-| publisher= US FDA| accessdate= February 2014}}</ref>
+| publisher= US FDA| access-date= February 10, 2014}}</ref>
 It is divided into three chapters:
-*Chapter I — [[Food and Drug Administration]]
+* Chapter I — [[Food and Drug Administration]]
-*Chapter II — [[Drug Enforcement Administration]]
+* Chapter II — [[Drug Enforcement Administration]]
-*Chapter III — [[Office of National Drug Control Policy]]
+* Chapter III — [[Office of National Drug Control Policy]]
-==Chapter I==
+== 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]] — electronic records and [[electronic signature]] related
+* [[Title 21 CFR Part 11|11]] — electronic records and [[electronic signature]] related
-*50 Protection of human subjects in [[clinical trials]]
+* 50 Protection of human subjects in [[clinical trials]]
-*54 Financial Disclosure by Clinical Investigators <ref name=sagf>{{cite web
+* 54 Financial disclosure by clinical investigators <ref name=sagf>{{cite web
- | last = [[Food and Drug Administration]]
+ | last = Food and Drug Administration
+ | author-link = Food and Drug Administration
- | first =
- | authorlink =
- | coauthors =
  | title = Subchapter A — General: Financial Disclosure by Clinical Investigators
- | work =
- | publisher =
  | year = 2008
  | url = http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54&showFR=1
+ | access-date = 9 April 2009 }}</ref>
- | format =
+* 56 Institutional review boards that oversee [[clinical trials]]
- | doi =
+* 58 Good laboratory practices (GLP) for nonclinical studies
- | accessdate = 9 April 2009 }}</ref>
-*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
+* 101, especially 101.9 — [[Nutrition facts label]] related
-**(c)(2)(ii) — Requirement to include [[trans fat]] values
+** (c)(2)(ii) — Requirement to include [[trans fat]] values
-**(c)(8)(iv) — [[Vitamin]] and [[mineral]] values
+** (c)(8)(iv) — [[Vitamin]] and [[mineral]] values
-*106-107 requirements for infant formula
+* 106-107 requirements for infant formula
-*110 ''et seq.'' [[current good manufacturing practice|cGMP]]s for food products
+* 110 ''et seq.'' [[current good manufacturing practice|cGMP]]s for food products
-*111 ''et seq.'' [[current good manufacturing practice|cGMP]]s for Dietary Supplements
+* 111 ''et seq.'' [[current good manufacturing practice|cGMP]]s for dietary supplements
-*170 food additives
+* 170 food additives
-*190 [[dietary supplements]]
+* 190 [[dietary supplements]]
 The 200 and 300 series are regulations pertaining to pharmaceuticals :
-*202-203 Drug advertising and marketing
+* 202-203 Drug advertising and marketing
-*210 ''et seq.'' [[current good manufacturing practice|cGMP]]s for pharmaceuticals
+* 210 ''et seq.'' [[current good manufacturing practice|cGMP]]s for pharmaceuticals
-*310 ''et seq.'' Requirements for new drugs
+* 310 ''et seq.'' Requirements for new drugs
-*328 ''et seq.'' Specific requirements for over-the-counter (OTC) 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
+* 510 ''et seq.'' New animal drugs
-*556 Tolerances for residues of drugs in food animals
+* 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
+* 601 Licensing under section 351 of the Public Health Service Act
-*606 ''et seq.'' [[current good manufacturing practice|cGMP]]s for human blood and blood products
+* 606 ''et seq.'' [[current good manufacturing practice|cGMP]]s for human blood and blood products
 The 700 series includes the limited regulations on [[cosmetics]]:
-*701 Labeling requirements
+* 701 Labeling requirements
 The 800 series are for medical devices:
-*803 Medical Device Reporting
+* 803 Medical device reporting
-*814 Premarket Approval of Medical Devices <ref name=p814>{{cite web
+* 814 Premarket approval of medical devices <ref name=p814>{{cite web
- | last = [[Food and Drug Administration]]
+ | last = Food and Drug Administration
+ | author-link = Food and Drug Administration
- | first =
- | authorlink =
- | coauthors =
  | title = Subchapter H — Medical Devices: Part 814 Premarket Approval of Medical Devices
- | work =
- | publisher =
  | year = 2008
  | url = http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814&showFR=1
+ | access-date = 9 April 2009 }}</ref>
- | format =
+* 820 ''et seq.'' Quality system regulations (analogous to [[current good manufacturing practice|cGMP]], but structured like [[International Organization for Standardization|ISO]]) <ref name=p820>{{cite web
- | doi =
+ | last = Food and Drug Administration
- | accessdate = 9 April 2009 }}</ref>
+ | author-link = Food and Drug Administration
-*820 ''et seq.'' Quality system regulations (analogous to [[current good manufacturing practice|cGMP]], but structured like [[International Organization for Standardization|ISO]]) <ref name=p820>{{cite web
- | last = [[Food and Drug Administration]]
- | first =
- | authorlink =
- | coauthors =
  | title = Subchapter H — Medical Devices: Part 820 Quality System Regulation
- | work =
- | publisher =
  | year = 2008
  | url = http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1
+ | access-date = 9 April 2009 }}</ref>
- | format =
+* 860 ''et seq.'' Listing of specific approved devices and how they are classified
- | doi =
- | accessdate = 9 April 2009 }}</ref>
-*860 ''et seq.'' Listing of specific approved devices and how they are classified
 The 900 series covers mammography quality requirements enforced by [[CDRH]].
@@ Line 97: / Line 81: @@
 The 1000 series covers radiation-emitting device (e.g. [[cell phone]]s, [[laser]]s, [[x-ray generator]]s); 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.<ref>{{cite web|title=Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah|url=http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395.htm|website=FDA.gov|publisher=United States Food and Drug Administration|accessdate=11 May 2016}}</ref>
+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.<ref>{{cite web|title=Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah|url=https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395.htm|website=FDA.gov|publisher=United States Food and Drug Administration|access-date=11 May 2016}}</ref>
 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:
+* 1240 Rules promulgated under 361 of the Public Health Service Act on interstate control of communicable disease, such as:
-**Requirements for [[pasteurization]] of [[milk]]
+** Requirements for [[pasteurization]] of [[milk]]
-**Interstate shipment of [[turtle]]s as pets.
+** Interstate shipment of [[turtle]]s as pets.
-**Interstate shipment of African [[rodents]] that may carry [[monkeypox]].
+** Interstate shipment of African [[rodents]] that may carry [[monkeypox]].
-**Sanitation on interstate conveyances (i.e. airplanes and ships)
+** Sanitation on interstate conveyances (i.e. airplanes and ships)
-*1271 Requirements for human cells, tissues, and cellular and tissue-based products (i.e. the [[Current Good Tissue Practices|cGTPs]]).
+* 1271 Requirements for human cells, tissues, and cellular and tissue-based products (i.e. the [[Current Good Tissue Practices|cGTPs]]).
-==Chapter II==
+== Chapter II ==
 Notable sections:
-*1308 — Schedules of controlled substances
+* 1308 — Schedules of controlled substances
-**1308.03(a) — [[Administrative Controlled Substances Code Number]]
+** 1308.03(a) — [[Administrative Controlled Substances Code Number]]
-**1308.11 — [[List of Schedule I drugs]]
+** 1308.11 — [[List of Schedule I drugs]]
-**1308.12 — [[List of Schedule II drugs]]
+** 1308.12 — [[List of Schedule II drugs]]
-**1308.13 — [[List of Schedule III drugs]]
+** 1308.13 — [[List of Schedule III drugs]]
-**1308.14 — [[List of Schedule IV drugs]]
+** 1308.14 — [[List of Schedule IV drugs]]
-**1308.15 — [[List of Schedule V drugs]]
+** 1308.15 — [[List of Schedule V drugs]]
-==Chapter III==
+== See also ==
+* [[Title 21 of the United States Code]] - Food and Drugs<!--note, CFR and USC section numbers don't always match up.-->
-Notable sections:
+* [[EudraLex]] (medicinal products in the European Union)
-*1405 Governmentwide requirements for drug-free workplaces
-==See also==
-*[[Title 21 of the United States Code]] - Food and Drugs<!--note, CFR and USC section numbers don't always match up.-->
-*[[EudraLex]] (medicinal products in the European Union)
-==Notes==
+== References ==
 {{Reflist}}
-==External links==
+== External links ==
-*[http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?sid=5aeedc221664e582064ded32ce1b3deb&c=ecfr&tpl=/ecfrbrowse/Title21/21tab_02.tpl Title 21 of the Code of Federal Regulations] (current "Electronic CFR")
+* [https://www.ecfr.gov/cgi-bin/text-idx?sid=5aeedc221664e582064ded32ce1b3deb&c=ecfr&tpl=/ecfrbrowse/Title21/21tab_02.tpl Title 21 of the Code of Federal Regulations] (current "Electronic CFR")
-{{Food and Drug Administration}}
+{{Food and Drug Administration|state=expanded}}
+{{United States Department of Health and Human Services}}
 {{DEFAULTSORT:Title 21 Of The Code Of Federal Regulations}}
-[[Category:Code of Federal Regulations]]
+[[Category:Titles of the Code of Federal Regulations| 21]]
 [[Category:Drug control law in the United States]]
 [[Category:Food law]]

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