The law › Title 21, Food and Drugs › Chapter 9

21 U.S.C. 360bbb: Expanded access to unapproved therapies and diagnostics

Created in 1997 by the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115). Changed by 1 later law. 1 bill in this Congress would change it.

8 other sections of the Code cite this one, including 21 U.S.C. 355, 21 U.S.C. 355–1, 21 U.S.C. 360j, 21 U.S.C. 360bbb–0, 21 U.S.C. 360bbb–0a.

1 part of federal rules cite it as their authority, written by Food and Drug Administration, Department of Health and Human Services (1).

How it got hereLaws that created or changed it, newest first

2007National Institutes of Health Reform Act of 2006

1997Food and Drug Administration Modernization Act of 1997added it

21 U.S.C. 360bbbExpanded access to unapproved therapies and diagnostics

(a)Emergency situations

(b)Individual patient access to investigational products intended for serious diseases

(c)Treatment investigational new drug applications and treatment investigational device exemptions

(d)Termination

(e)Definitionsadded to

This CongressBills that change it or would

H.R. 9877Health Equity and Accountability Act of 2026introduced

past change
enacted this Congress
proposed

This Congress

H.R. 9877 Health Equity and Accountability Act of 2026 · introduced · would change (e)

How it got here

2007

Pub. L. 109–482 substituted "section 282(i)(3)" for "section 282(j)(3)" in concluding provisions. (National Institutes of Health Reform Act of 2006) Law text · (c)

Text, outline and history from the official U.S. Code (2024 edition) on GovInfo, published by the Office of the Law Revision Counsel. Changes made after that edition appear under This Congress.