Federal Food Drug and Cosmetic Act

FD&C Act, FDAMA, FDASIA, BPCIA and PHSA

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

To search the FD&C Act (Title 21 United States Code), it can be accessed on the Office of the Law Revision Counsel (OLRC) website below.

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Register and Download in PDF

Download “FD&C Act (Updated 2013)” 2013-FDC-Act.pdf – Downloaded 338 times – 2 MB

Food and Drug Administration Modernization Act (“FDAMA”) of 1997

Download in PDF (85 pages) 

Download “FDAMA 1997” UCM089145.pdf – Downloaded 113 times – 399 kB 

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 

Download “FDASIA 2012” FDASIA-BILLS-112s3187enr.pdf – Downloaded 137 times – 493 kB

Public Health Service Act (“PHSA”)

  • PDF download is available at https://www.govinfo.gov/content/pkg/COMPS-8773/pdf/COMPS-8773.pdf

Biologics Price Competition and Innovation Act of 2009 (“BPCIA”)

LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR INTERCHANGEABLE.—Section 351 of the Public Health Service Act (PHSA) (42 U.S.C. 262)

Download BPCIA in PDF 

Download “BPCIA” ucm216146.pdf – Downloaded 68 times – 122 kB

Last Updated: 2020-06-18