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U.S. Department of Health and Human Services

About FDA

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OPDP Regulatory Information

 

Laws, Regulations, Guidances, and Enforcement Actions

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Federal Food, Drug and Cosmetic Act
Code of Federal Regulations
Guidances
Enforcement Actions 

Federal Food, Drug and Cosmetic Act

Chapter II - Definitions (Sec. 201 [321] (g)(1), (k), (m), (n), & (p))

Chapter III - Prohibited Acts and Penalties (Secs. 301 [331], 302 [332], 303 [333], & 304 [334])

Chapter V - Drugs and Devices (Sec. 502. [352] (a), (e), (f), & (n))

Code of Federal Regulations

The following links go to the Government Printing Office web site.

21 CFR 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices

21 CFR 200 - General (Secs. 5, 7, & 200)

21 CFR 201 - Labeling Secs. 10, 100, & 200)

21 CFR 202 - Prescription Drug Advertising

21 CFR 312 - Investigational New Drug Application (Sec. 7)

21 CFR 314 - Applications to Market New Drug or Antibiotic (Secs. 81, 550, & 560)

Guidances

 

 

Enforcement Actions 

Enforcement Letters
2014

2013

2012

2011

2010

2009

 2008 

 2007 

2006

2005