An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Office of Prescription Drug Promotion

Laws, Regulations, Guidances, and Enforcement Actions

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

Top