---
kind: "section"
citation: "21 U.S.C. § 360bbb–0"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–0"
heading: "Expanded access policy required for investigational drugs"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-0"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–0. Expanded access policy required for investigational drugs

- (a) **In general—** The [manufacturer](/usc/21/360hh.md?p=3) or distributor of one or more investigational [drugs](/usc/21/321.md?p=g-1) for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the [manufacturer](/usc/21/360hh.md?p=3) or distributor on evaluating and responding to requests submitted under [section 360bbb(b) of this title](/usc/21/360bbb.md?p=b) for provision of such a [drug](/usc/21/321.md?p=g-1).
- (b) **Public availability of expanded access policy—** The policies under [subsection (a)](#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](/usc/21/321.md?p=g-1) of such [manufacturer](/usc/21/360hh.md?p=3) or distributor.
- (c) **Content of policy—** A policy described in [subsection (a)](#a) shall include—
  - (1) contact information for the [manufacturer](/usc/21/360hh.md?p=3) or distributor to facilitate communication about requests described in [subsection (a)](#a);
  - (2) procedures for making such requests;
  - (3) the general criteria the [manufacturer](/usc/21/360hh.md?p=3) or distributor will use to evaluate such requests for individual patients, and for responses to such requests;
  - (4) the length of time the [manufacturer](/usc/21/360hh.md?p=3) 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](/usc/21/321.md?p=g-1) that is required under [section 282(j)(2)(A)(ii)(II)(gg) of title 42](/usc/42/282.md?p=j-2-A-ii-II-gg).
- (d) **No guarantee of access—** The posting of policies by [manufacturers](/usc/21/360hh.md?p=3) and distributors under [subsection (a)](#a) shall not serve as a guarantee of access to any specific investigational [drug](/usc/21/321.md?p=g-1) by any individual patient.
- (e) **Revised policy—** Nothing in this section shall prevent a [manufacturer](/usc/21/360hh.md?p=3) or distributor from revising a policy required under this section at any time.
- (f) **Application—** This section shall apply to a [manufacturer](/usc/21/360hh.md?p=3) or distributor with respect to an investigational [drug](/usc/21/321.md?p=g-1) 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](/usc/21.md), Code of Federal Regulations (or any successor regulations)) with respect to such investigational [drug](/usc/21/321.md?p=g-1); or
  - (2) as applicable, 15 days after the [drug](/usc/21/321.md?p=g-1) receives a designation as a breakthrough therapy, fast track [product](/usc/21/360eee.md?p=13), or regenerative advanced therapy under subsection [(a)](#a), [(b)](#b), or (g), respectively, of [section 356 of this title](/usc/21/356.md).

## Source credit

(June 25, 1938, ch. 675, § 561A, as added Pub. L. 114–255, div. A, title III, § 3032, Dec. 13, 2016, 130 Stat. 1100; amended Pub. L. 115–52, title VI, § 610(c), Aug. 18, 2017, 131 Stat. 1053.)

## Notes

### Editorial Notes

### Amendments

2017—Subsec. (f). Pub. L. 115–52 substituted “earlier” for “later” in introductory provisions, added par. (2), redesignated former par. (2) as (1), and struck out former par. (1) which read as follows: “the date that is 60 calendar days after December 13, 2016; or”.