Guides: Food, Drug, and Cosmetic Law Research Guide: Home

Subject Headings

The following subject headings can be used to search in library catalogs for relevant materials:

United States. Food and Drug Administration
Food law and legislation -- United States
Drugs -- Law and legislation -- United States
Pharmacy -- Law and legislation -- United States
Pharmaceutical industry -- United States
Drug development -- United States
Cosmetics -- Law and legislation -- United States

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Introduction

This guide is designed to provide an introduction to researching the area of Food, Drug, and Cosmetic Law, and focuses heavily on the U.S. Food and Drug Administration (FDA) (e.g., regulations, guidance, administrative decisions), the administrative agency primarily tasked with enforcing food, drug, and cosmetic law and regulations. The FDA is an agency within the Department of Health and Human Services and consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations.

Getting Started

The following sources provide a good introduction to food, drug, and cosmetic law:

Federal Procedure, Lawyer's Edition: Chapter 35
Chapter 35 (Food, Drugs, and Cosmetics) of Federal Procedure provides an overview of agency procedures and citations to in-depth research references. Print is available (KF8835 .F43 1981) but updates were cancelled in 2014.
Food and Drug Administration (4th ed., updated in 2020)
This two-volume treatise by James T. O'Reilly is updated regularly and overviews the organization of the FDA, FDA enforcement procedures, as well as general overviews of relevant regulatory areas. Appendixes also include forms and tables of cases, statutes, and regulations. Print version of the 3rd edition is available (KF3871 .O7 2007).
Food and Drug Law : Federal Regulation of Drugs, Biologics, medical devices, foods, dietary supplements, personal care, veterinary and tobacco products
This food and drug law...book is organized...in order to comprehend a complex area of federal regulatory law. There is a separate volume for each subject based on regulation under the United States Federal Food, Drug and Cosmetic Act (FDCA) and related laws all contained in this bound book. [This book] is organized into subject specific titled volumes with a concise introduction to provide a particular focus for the reader."
Pharmaceutical Law: Regulation of Research, Development, and Marketing
This source, edited by Michael E. Clark, focuses on the complex world of pharmaceutical drugs from development to marketing. It includes a breakdown of the various processes involved, as well as discussion of relevant statutes and regulations. Older editions available in print. (KF2915.P4 P495).
A Practical Guide to FDA's Food and Drug Law and Regulation
Kenneth R. Piña and Wayne L. Pines (5th ed. 2017), KF1900.Z9 P73 2017. One-volume guide published by the Food and Drug Law Institute.

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U.S. Food and Drug Administration

The FDA's website is a great resource for consumers and industry professionals. It provides news and regulatory updates on all the areas overseen by the regulation divided topically:

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Update History

Updated 5/2013 (ET)
Updated 6/2014 (SG)
Updated 3/2021 (MK)

Food, Drug, and Cosmetic Law Research Guide

Contents