Regulatory Information

FD&C Act Chapter VII: General Authority

For the most current official legislative enactments, search Title 21 on the Office of Law Revision Counsel, United States Code advanced search or browse the United States Code.

Subchapter VII - General Authority (sections 371 - 379dd-2)

Part A - General Administrative Provisions (sections 371 - 379d-2)

FD&C Act Section NumberTitle
Sec. 701Sec. 371 - Regulations and hearings
Sec. 702Sec. 372 - Examinations and investigations
 Sec. 372a - Transferred
Sec. 703Sec. 373 - Records
Sec. 704Sec. 374 - Inspection
 Sec. 374a - Inspections relating to food allergens
Sec. 705Sec. 375 - Publicity
Sec. 706Sec. 376 - Examination of sea food on request of packer; marking food with results; fees; penalties
 Sec. 377 - Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
Sec. 707Sec. 378 - Advertising of foods
Sec. 708Sec. 379 - Confidential information
Sec. 709Sec. 379a - Presumption of existence of jurisdiction
Sec. 710Sec. 379b - Consolidated administrative and laboratory facility
 Sec. 379c - Transferred
Sec. 711Sec. 379d - Automation of Food and Drug Administration 
Sec. 712Sec. 379d-1 - Conflicts of interest
Sec. 713 Sec. 379d-2 - Policy on the review and clearance of scientific articles published by FDA employees
 Sec. 379d-3 - Streamlined hiring authority
 Sec. 379d-4 - Reporting requirements
 Sec. 379d-5. Guidance document regarding product promotion using the Internet

Part B - Colors (section 379e)

FD&C Act Section NumberTitle
Sec. 721Sec. 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

Part C - Fees (sections 379f - 379j-62)

Subpart 1 - freedom of information fees (section 379f)
FD&C Act Section NumberTitle
Sec. 731Sec. 379f - Recovery and retention of fees for freedom of information requests
Subpart 2 - fees relating to drugs (sections 379g - 379h-2)Subpart 3 - fees relating to devices (sections 379i - 379j-1)
FD&C Act Section NumberTitle
Sec. 735Sec. 379g - Definitions
Sec. 736Sec. 379h - Authority to assess and use drug fees
Sec. 736ASec. 379h-1 - Fees relating to advisory review of prescription-drug television advertising
Sec. 736BSec. 379h-2 - Reauthorization; reporting requirements

Subpart 3 - fees relating to devices (sections 379i to 379j-1)

FD&C Act Section NumberTitle
Sec. 737Sec. 379i - Definitions
Sec. 738Sec. 379j - Authority to assess and use device fees
Sec. 738ASec. 379j-1 - Reauthorization; reporting requirements
Subpart 4 - fees relating to animal drugs (sections 379j-11 - 379j-13)
FD&C Act Section NumberTitle
Sec. 739Sec. 379j-11 - Definitions
Sec. 740Sec. 379j-12 - Authority to assess and use animal drug fees
Sec. 740ASec. 379j-13 - Reauthorization; reporting requirements
Subpart 5 - fees relating to generic new animal drugs (sections 379j-21 - 379j-22)
FD&C Act Section NumberTitle
Sec. 741Sec. 379j-21 - Authority to assess and use generic new animal drug fees
Sec. 742Sec. 379j-22 - Reauthorization; reporting requirements
Subpart 6 - fees related to food (section 379j-31)
FD&C Act Section NumberTitle
Sec. 743Sec. 379j-31 - Authority to collect and use fees
Subpart 7 - fees relating to generic drugs (sections 379j-41 to 379j-43)
FD&C Act Section NumberTitle
 Sec. 379j-41 - Definitions
 Sec. 379j-42 - Authority to assess and use human generic drug fees
 Sec. 379j-43. Reauthorization; reporting requirements
Subpart 8 - fees relating to biosimilar biological products (sections 379j-51 to 379j-53)
FD&C Act Section NumberTitle
 Sec. 379j-51 - Definitions
 Sec. 379j-52 - Authority to assess and use biosimilar biological product fees
 Sec. 379j-53 - Reauthorization; reporting requirements
Subpart 9 - fees relating to outsourcing facilities
FD&C Act Section NumberTitle
 Sec. 379j-61 - Definitions
 Sec. 379j-62 - Authority to assess and use outsourcing facility fees

Part D - Information and Education (sections 379k - 379l)

FD&C Act Section NumberTitle
Sec. 741Sec. 379k - Information system
 Sec. 379k-1 - Electronic format for submissions
Sec. 742Sec. 379l - Education

Part E - Environmental Impact Review (section 379o)

FD&C Act Section NumberTitle
Sec. 746Sec. 379o - Environmental impact

Part F - National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics (sections 379r - 379s)

FD&C Act Section NumberTitle
Sec. 751Sec. 379r - National uniformity for nonprescription drugs
Sec. 752Sec. 379s - Preemption for labeling or packaging of cosmetics

Part G - Safety Reports (section 379v)

FD&C Act Section NumberTitle
Sec. 756Sec. 379v - Safety report disclaimers

Part H - Serious Adverse Event Reports (sections 379aa - 379aa-1)

FD&C Act Section NumberTitle
Sec. 760Sec. 379aa - Serious adverse event reporting for nonprescription drugs
Sec. 761Sec. 379aa-1 - Serious adverse event reporting for dietary supplements

Part I - Reagan-Udall Foundation for the Food and Drug Administration (sections 379dd - 379dd-2)

FD&C Act Section NumberTitle
Sec. 770Sec. 379dd - Establishment and functions of the Foundation
Sec. 771Sec. 379dd-1 - Location of Foundation
Sec. 772Sec. 379dd-2 - Activities of the Food and Drug Administration

 

Page Last Updated: 10/05/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.