Regulatory Information

FD&C Act Chapter VII: General Authority

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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: 03/28/2018
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