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

Register and Download in PDF

Download PDF here >>

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.

Register and Download in PDF

FDASIA 2012 (12 downloads)

Last Updated: 2020-07-15