Laws, Regulations, Guidances, and Enforcement Actions
Resources related to prescription drug advertising and promotional labeling
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)