Main FDA website

What's New @ CDER

The Food, Drug & Cosmetic Act (FDCA)

Full text

  • §201 [21 USC 321] Definitions
  • §301  [21 USC 331] Prohibited Acts
  • §302 [21 USC 332] Injunction Proceedings
  • §303 [21 USC 333] Penalties
  • §304 [21 USC 334] Seizure
  • §502 [21 USC 352] Misbranded Drugs and Devices
  • §503B [21 USC 353b] Prereview of television advertisements

21 Code of Federal Regulations  (CFR)

Full text (searchable)

  • §1.21 Failure to reveal material facts
  • §200.5 Mailing of important information about drugs
  • §200.7  Supplying pharmacists with indications and dosage information
  • §200.200 Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers
  • §201.5 Drugs; adequate directions for use
  • §201.6 Drugs; misleading statements
  • §201.56 Requirements on content and format of labeling for human prescription drug and biological products
  • §201.57 Specific requirements on content and format of labeling for human prescription drug and biological products [Physican Labeling Rule (PLR) requirements]
  • §201.100 Exemptions From Adequate Directions for Use
  • §201.128 Meaning of "intended uses"
  • §201.200 Disclosure of drug efficacy study evaluations in labeling and advertising
  • §202.1 Prescription-drug Advertisements
  • §312.6 Labeling of an investigational new drug
  • §312.7 Promotion of investigational drugs
  • §314.81 Other postmarketing reports [2253 submission requirements]
  • §314.126 Adequate and well-controlled studies
  • §314.550 Promotional materials [“Accelerated approval”]
  • §314.560 Termination of requirements [“Accelerated approval”]