21 U.S.C. § 360bbb–0 — Expanded access policy required for investigational drugs

(a) In general A manufacturer or distributor of one or more investigational drugs meant to diagnose, monitor, or treat one or more serious diseases or conditions must make available its policy for evaluating and responding to expanded-access requests made under section 360bbb(b). (b) Public availability of expanded access policy This policy must be made public and easy to find — for example, by posting it on a public website. One policy can cover all of a company's investigational drugs generally. (c) Content of policy The policy must include: (1) contact information to help people communicate about requests; (2) the procedures for making such requests; (3) the general standards the company will use to judge individual-patient requests, and to decide how it responds; (4) how long the company expects it will take to acknowledge that it received a request; and (5) a link, or other reference, to the clinical trial record containing expanded-access information for the drug, as required under 42 U.S.C. 282(j)(2)(A)(ii)(II)(gg). (d) No guarantee of access Posting this policy does not guarantee that any specific patient will get access to any specific investigational drug. (e) Revised policy Nothing here stops a manufacturer or distributor from revising its required policy at any time. (f) Application This section starts applying to a manufacturer or distributor, for a given investigational drug, at the earlier of: (1) the first start of a phase 2 or phase 3 study (as those terms are defined in 21 C.F.R. 312.21(b) and (c), or any rule that replaces it) for that drug; or (2) as applicable, 15 days after the drug is designated a breakthrough therapy, fast track product, or regenerative advanced therapy under section 356(a), (b), or (g).