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)
- Part B - Colors (section 379e)
- Part C - Fees (sections 379f - 379j-62)
- Subpart 1 - freedom of information fees (section 379f)
- Subpart 2 - fees relating to drugs (sections 379g - 379h-2)
- Subpart 3 - fees relating to devices (sections 379i - 379j-1)
- Subpart 4 - fees relating to animal drugs (sections 379j-11 - 379j-13)
- Subpart 5 - fees relating to generic new animal drugs (sections 379j-21 - 379j-22)
- Subpart 6 - fees related to food (section 379j-31)
- Subpart 7 - fees relating to generic drugs (sections 379j-41 to 379j-43)
- Subpart 8 - fees relating to biosimilar biological products (sections 379j-51 to 379j-53)
- Subpart 9 - fees relating to outsourcing facilities
- Part D - Information and Education (sections 379k - 379l)
- Part E - Environmental Impact Review (section 379o)
- Part F - National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics (sections 379r - 379s)
- Part G - Safety Reports (section 379v)
- Part H - Serious Adverse Event Reports (sections 379aa - 379aa-1)
- Part I - Reagan-Udall Foundation for the Food and Drug Administration (sections 379dd - 379dd-2)
Part A - General Administrative Provisions (sections 371 - 379d-2)
FD&C Act Section Number | Title |
---|---|
Sec. 701 | Sec. 371 - Regulations and hearings |
Sec. 702 | Sec. 372 - Examinations and investigations |
Sec. 372a - Transferred | |
Sec. 703 | Sec. 373 - Records |
Sec. 704 | Sec. 374 - Inspection |
Sec. 374a - Inspections relating to food allergens | |
Sec. 705 | Sec. 375 - Publicity |
Sec. 706 | Sec. 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. 707 | Sec. 378 - Advertising of foods |
Sec. 708 | Sec. 379 - Confidential information |
Sec. 709 | Sec. 379a - Presumption of existence of jurisdiction |
Sec. 710 | Sec. 379b - Consolidated administrative and laboratory facility |
Sec. 379c - Transferred | |
Sec. 711 | Sec. 379d - Automation of Food and Drug Administration |
Sec. 712 | Sec. 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 Number | Title |
---|---|
Sec. 721 | Sec. 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 Number | Title |
---|---|
Sec. 731 | Sec. 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 Number | Title |
---|---|
Sec. 735 | Sec. 379g - Definitions |
Sec. 736 | Sec. 379h - Authority to assess and use drug fees |
Sec. 736A | Sec. 379h-1 - Fees relating to advisory review of prescription-drug television advertising |
Sec. 736B | Sec. 379h-2 - Reauthorization; reporting requirements |
Subpart 3 - fees relating to devices (sections 379i to 379j-1)
FD&C Act Section Number | Title |
---|---|
Sec. 737 | Sec. 379i - Definitions |
Sec. 738 | Sec. 379j - Authority to assess and use device fees |
Sec. 738A | Sec. 379j-1 - Reauthorization; reporting requirements |
Subpart 4 - fees relating to animal drugs (sections 379j-11 - 379j-13)
FD&C Act Section Number | Title |
---|---|
Sec. 739 | Sec. 379j-11 - Definitions |
Sec. 740 | Sec. 379j-12 - Authority to assess and use animal drug fees |
Sec. 740A | Sec. 379j-13 - Reauthorization; reporting requirements |
Subpart 5 - fees relating to generic new animal drugs (sections 379j-21 - 379j-22)
FD&C Act Section Number | Title |
---|---|
Sec. 741 | Sec. 379j-21 - Authority to assess and use generic new animal drug fees |
Sec. 742 | Sec. 379j-22 - Reauthorization; reporting requirements |
Subpart 6 - fees related to food (section 379j-31)
FD&C Act Section Number | Title |
---|---|
Sec. 743 | Sec. 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 Number | Title |
---|---|
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 Number | Title |
---|---|
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 Number | Title |
---|---|
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 Number | Title |
---|---|
Sec. 741 | Sec. 379k - Information system |
Sec. 379k-1 - Electronic format for submissions | |
Sec. 742 | Sec. 379l - Education |
Part E - Environmental Impact Review (section 379o)
FD&C Act Section Number | Title |
---|---|
Sec. 746 | Sec. 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 Number | Title |
---|---|
Sec. 751 | Sec. 379r - National uniformity for nonprescription drugs |
Sec. 752 | Sec. 379s - Preemption for labeling or packaging of cosmetics |
Part G - Safety Reports (section 379v)
FD&C Act Section Number | Title |
---|---|
Sec. 756 | Sec. 379v - Safety report disclaimers |
Part H - Serious Adverse Event Reports (sections 379aa - 379aa-1)
FD&C Act Section Number | Title |
---|---|
Sec. 760 | Sec. 379aa - Serious adverse event reporting for nonprescription drugs |
Sec. 761 | Sec. 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 Number | Title |
---|---|
Sec. 770 | Sec. 379dd - Establishment and functions of the Foundation |
Sec. 771 | Sec. 379dd-1 - Location of Foundation |
Sec. 772 | Sec. 379dd-2 - Activities of the Food and Drug Administration |