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Glossary of Terms

Useful terms to know.

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Public Laws (PL) – Congress regulates interstate commerce and enacts federal statutes or public laws on food and drugs. Enacted bills and joint resolutions of Congress can be accessed at:

https://www.congress.gov/public-laws/116th-congress 
(from 1973 to the present)

https://www.govinfo.gov/app/collection/plaw 
(from 1994 to the present with marginal notes and citations)

https://www.govinfo.gov/app/collection/statute
The United States Statutes at Large (1951 to 2013)

https://www.loc.gov/law/help/statutes-at-large/index.php
The United States Statutes at Large (from 1789 to 1950)

The United States Code (U.S.C.) – The United States Code is a consolidation and codification by subject matter of the general and permanent laws of the United States, prepared by the Office of the Law Revision Counsel of the United States House of Representatives. The laws are organized by subject under 54 title headings. Title 21 is for food and drugs, and the FD&C Act is found in Sections 321 to 399i of Title 21. The U.S.C. can be accessed at: 

https://uscode.house.gov/
(current)

https://www.govinfo.gov/app/collection/uscode
(annual editions from 1994 to 2018)

The Federal Register (FR) – The FDA is charged with implementing statutes through regulations. Regulations interpret laws and describe how they will be enforced. New regulations or changes to existing regulations are announced in the Federal Register. The Federal Register is the official daily publication for rules, proposed rules, and notices of federal agencies and organizations and can be accessed at: 

https://www.govinfo.gov/app/collection/fr
(from 1936 to the present)

Code of Federal Regulations (CFR) – The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the federal government. It is divided into 50 titles that represent broad areas subject to federal regulation. Regulations for food and drugs are found in CFR Title 21, and can be accessed at:

https://www.ecfr.gov/cgi-bin/ECFR?page=browse
(e- CFR, current edition, but not the official version)

https://www.govinfo.gov/app/collection/cfr/
(annual editions from 1996 to 2020)

FDA Guidance Documents – Guidance documents convey FDA’s “current thinking” or enforcement priorities to establish regulatory principles or practices aligned with that thinking. Guidance documents do not have the force of law and are not legally binding. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. FDA guidance documents are available at:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents

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