21 USC 360bbb-0 - Expanded access policy required for investigational drugs

U.S Code last checked for updates: Nov 22, 2024

§ 360bbb–0.

Expanded access policy required for investigational drugs

(a)

In general

(b)

Public availability of expanded access policy

(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

(e)

Revised policy

(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.

(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.)

cite as: 21 USC 360bbb-0