Guides: Food, Drug, and Cosmetic Law Research Guide: Regulations &amp; Administrative Materials

Key to Icons

Georgetown only
On Westlaw
On Lexis
On Bloomberg
PDF
More Info (hover)
Preeminent Treatise
Study Aid

U.S. Food and Drug Administration

The FDA's website provides news and regulatory updates on all the areas overseen by regulations, divided topically:

FDA Materials

Warning Letters
Letters sent to companies or others marketing regulated products when marketed products fail to meet the standards of FDA regulations. Also available on Bloomberg Law.
FDA Initiated Recalls, Market Withdrawals and Safety Alerts
Recalls, market withdrawals, and safety alerts are originally reported in FDA Enforcement Reports. This database provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products for the last 60 days.
Debarment List
List of all debarred entities/individuals. A company that has submitted false research data to the FDA or otherwise severely violated FDA regulations may be "debarred" from future FDA product approvals in the generic drugs program.
Import Refusal Reports
Reports of the temporary suspension of the movement of a particular device or food item pending a full FDA enforcement hearing.
Disqualification Proceedings
The FDA provides a list of disqualification proceedings. Disqualification bans an individual or organization from all future FDA-regulated research.

FDA Enforcement Reports

All recalls monitored by the FDA are included in the weekly Enforcement Reports once they are classified according to the level of hazard involved.

Print
KF3862 .F6 (1981-1985, 1992-2000)
FDA.gov
(2004-2014)
Bloomberg Law
(1990 - current)

FDA Guidance Documents

Guidance documents represent the FDA's current thinking on a topic.

Regulations

Codified federal regulations on food, drugs, and cosmetics can be found in Title 21 of the Code of Federal Regulations.

Where to Find Federal Regulations

For a guide to the federal executive-branch regulatory process and the process of conducting federal administrative law research in general, see the Law Library's Administrative Law Research Guide. Federal agencies' regulations appear in the following publications:

Code of Federal Regulations (C.F.R.) - Westlaw
Index available in the right-hand menu.
Code of Federal Regulations (C.F.R.) - Lexis
The CFR Index is available here.
Code of Federal Regulations / Federal Register Library - HeinOnline
Code of Federal Regulations (C.F.R.) - Free Web (GovInfo) Available via the U.S. GPO's GovInfo.gov. Coverage: 1996 to the Present.
List of CFR Sections Affected (L.S.A.) - Free Web (GovInfo) Lists proposed, new, and amended Federal regulations that have been published in the Federal Register since the most recent revision date of a CFR title. Available via the U.S. GPO's Federal Digital System (FDsys). Coverage: 1997 to the Present.
eCFR - Free Web A currently-updated version of the Code of Federal Regulations (CFR); not an official legal edition of the CFR.
Code of Federal Regulations (C.F.R.) - In Print Call Number: KF70 .A3. Microfiche: 1938 - date (Media Services, Cabinets B13-B14)
Federal Register (Fed. Reg.) - Westlaw
Federal Register (Fed. Reg.) - Lexis
Code of Federal Regulations / Federal Register Library - HeinOnline
Federal Register (Fed. Reg.) - Free Web (GovInfo) Available via the U.S. GPO's Federal Digital System (FDsys). Coverage: 1960 to Present
"Federal Register 2.0" - Free Web An unofficial web edition of the Federal Register (also known as “Federal Register 2.0″ or “FR2″), provided by the Office of the Federal Register. Includes links to related material. Coverage: 1994-present.

Food, Drug, and Cosmetic Law Research Guide

Contents