McGoogan Library of Medicine

Laws and Regulations Pertaining to Pharmaceuticals

General Texts
Boards of Pharmacy
U.S. Federal Laws and Regulations
Nebraska State Laws and Regulations


General Texts

Pharmacy Practice and the Law, 2d ed.
Reference Bookcase QV 33 AA1 A2p 2001

Boards of Pharmacy

(U.S.) National Association of Boards of Pharmacy
http://www.nabp.net/

  • Information on licensure of pharmacists.
  • "Pharmacist and Pharmacy Achievement and Discipline (PPAD)" database.
  • Contact information for Boards of Pharmacy in the United States, Canada, Australia and New Zealand, including links to websites of individual boards

U.S. Federal Laws and Regulations

Web Resources

CDER Handbook -- new drug approval process
http://www.fda.gov/cder/handbook/index.htm
Publication of the U.S. Food and Drug Administration Center for Drug Evaluation and Research. Sections on New Drug Development and Review, Post Drug Approval Process, Generic Drug Review, Over-the-Counter Drug Review, etc.
Code of Federal Regulations
http://www.gpoaccess.gov/cfr/index.html
U.S. Federal regulations by subject. Search entire code or selected titles. Coordinate with a search of the Federal Register for the most up-to-date regulations.
Federal Register
http://www.gpoaccess.gov/fr/index.html
Published every Federal working day, this is the official publication for U.S. Federal regulations and legal notices. Browse tables of contents or search. Provides most up-to-date regulatory information. Coordinate with a search of the Code of Federal Regulations on your subject.
Food and Drug Administration
http://www.fda.gov/
Provides alternative access to regulations published in the Federal Register/Code of Federal Regulations. Provides dockets of pending regulations and petitions.

Print Resources

Code of Federal Regulations. Title 21. Food and drugs. (updated annually)
Reference Bookcase KF 70 A3 C66
U.S. Federal regulations by subject. Search entire code or selected titles. Coordinate with a search of the Federal Register (http://www.gpoaccess.gov/fr/index.html) for the most up-to-date regulations.
Drugs and the Pharmaceutical Sciences-- v.56
Located in Journal Stacks under Drugs and the Pharmaceutical Sciences ; v. 56
Information concerning the new drug approval process. Edited by Richard A. Guarino. c1993.
USP DI.
Reference Bookcase QV 740 AA1 U601ap
 Approved drug products and legal requirements

Nebraska State Laws and Regulations

Nebraska legislature website
Text of statutes and bills of Nebraska and other state legislative information.
Selected State Laws Pertaining to the Practice of Pharmacy in Nebraska
Reference Bookcase QV 32 AN1 S464 [supplement to USP DI, vol III]
Statutes, Rules and Regulations Relating to Pharmacy
Nebraska Collection QV 32 AN1 N362s 1994

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Last updated: January 4, 2007