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

Federal Food, Drug and Cosmetic Act

The following links go to the FDA web site.

• 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

• Guidances for Industry: Advertising (search Advertising under Topics)

Enforcement Actions

• Warning Letters and Untitled Letters