FDCA and FDASIA

FD&C Act and FDASIA

Federal Food, Drug, and Cosmetic Act (FD&C Act of 1938; FDCA or FFDCA or the Act)

[As Amended Through P.L. 113–5, Enacted March 13, 2013]

You may register and download the following statutes.   The FD&C Act consists of 692 pages (as amended on April 24, 2013).

FEDERAL FOOD, DRUG, AND COSMETIC ACT (FD & C Act or the Act) [As Amended Through P.L. 113–5, Enacted March 13, 2013]

  • CHAPTER I—SHORT TITLE
  • CHAPTER II—DEFINITIONS
  • CHAPTER III—PROHIBITED ACTS AND PENALTIES
  • CHAPTER IV—FOOD
  • CHAPTER V—DRUGS AND DEVICES
  • CHAPTER VII: GENERAL AUTHORITY
  • CHAPTER IX: TOBACCO PRODUCTS
  • SUBCHAPTER IX – TOBACCO PRODUCTS
  • CHAPTER X: MISCELLANEOUS

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Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.

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FDASIA 2012 (12 downloads)

Last Updated: 2020-07-15