Title 21

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Title 21 is the section of the U.S. Code of Federal Regulations that primarily governs food and drugs, including the oversight of the Food and Drug Administration (FDA).

All labels observed (2)

Label Occurrences
Title 21 canonical 1
Title 21 of the United States Code 1

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Statements (48)

Predicate Object
instanceOf federal regulation
part of Code of Federal Regulations
alsoInvolvesAgency United States Department of Health and Human Services
surface form: Department of Health and Human Services

Drug Enforcement Administration
appliesTo distributors of FDA-regulated products
healthcare product sponsors
importers of FDA-regulated products
manufacturers of FDA-regulated products
chapter Chapter I – Food and Drug Administration
Drug Enforcement Administration
surface form: Chapter II – Drug Enforcement Administration

Office of National Drug Control Policy
surface form: Chapter III – Office of National Drug Control Policy
codifiedIn annual edition of the Code of Federal Regulations
contains biologics licensing regulations
color additive regulations
controlled substances scheduling regulations
current good manufacturing practice regulations
dietary supplement regulations
food additive regulations
medical device premarket approval regulations
medical device premarket notification regulations
new drug application regulations
over-the-counter drug regulations
tobacco product regulations
country United States of America
surface form: United States
governs animal drugs
animal feed
biologics
cosmetics
drugs
food
medical devices
tobacco products
jurisdiction federal law of the United States
language English
legalAuthorityFrom Controlled Substances Act
Federal Food, Drug, and Cosmetic Act
Public Health Service Act
United States Congress
legalForm administrative regulation
partOf Code of Federal Regulations
primaryRegulatoryAgency Food and Drug Administration
surface form: U.S. Food and Drug Administration
publisher Office of the Federal Register
purpose to implement and interpret federal food and drug statutes
region United States territories
surface form: United States and its territories
regulates Food and Drug Administration–regulated products
structure divided into chapters
divided into parts
updatedIn Federal Register

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Referenced by (2)

Full triples — surface form annotated when it differs from this entity's canonical label.

CFR hasPart Title 21
subject surface form: Code of Federal Regulations
Federal Food, Drug, and Cosmetic Act titleNumber Title 21
this entity surface form: Title 21 of the United States Code