Skip to main content
Find a Lawyer

21 U.S.C. § 360bbb-0 - U.S. Code - Unannotated Title 21. Food and Drugs § 360bbb-0. Expanded access policy required for investigational drugs

Current as of January 01, 2024 | Updated by Findlaw Staff

(a)In general

The manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section 360bbb(b) of this title for provision of such a drug.

(b)Public availability of expanded access policy

The policies under subsection (a) shall be made public and readily available, such as by posting such policies on a publicly available Internet website. Such policies may be generally applicable to all investigational drugs of such manufacturer or distributor.

(c)Content of policy

A policy described in subsection (a) shall include--

(1) contact information for the manufacturer or distributor to facilitate communication about requests described in subsection (a);

(2) procedures for making such requests;

(3) the general criteria the manufacturer or distributor will use to evaluate such requests for individual patients, and for responses to such requests;

(4) the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests; and

(5) a hyperlink or other reference to the clinical trial record containing information about the expanded access for such drug that is required under section 282(j)(2)(A)(ii)(II)(gg) of Title 42.

(d)No guarantee of access

The posting of policies by manufacturers and distributors under subsection (a) shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

(e)Revised policy

Nothing in this section shall prevent a manufacturer or distributor from revising a policy required under this section at any time.

(f)Application

This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the earlier of--

(1) the first initiation of a phase 2 or phase 3 study (as such terms are defined in section 312.21(b) and (c) of title 21, Code of Federal Regulations (or any successor regulations)) with respect to such investigational drug; or

(2) as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 356 of this title.

Previous Part of Code Next Part of Code
Back to Chapter List

Cite this article: FindLaw.com - 21 U.S.C. § 360bbb-0 - U.S. Code - Unannotated Title 21. Food and Drugs § 360bbb-0. Expanded access policy required for investigational drugs - last updated January 01, 2024 | https://codes.findlaw.com/us/title-21-food-and-drugs/21-usc-sect-360bbb-0/

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.

Was this helpful?

Welcome to FindLaw's Cases & Codes

A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.

Go to Learn About the Law

Latest Blog Posts

For Legal Professionals

Learn About The Law

Get help with your legal needs

FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.

Go to Learn About the Law

Need to Find an Attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)

Copied to clipboard