21 U.S. Code § 360bbb - Expanded access to unapproved therapies and diagnostics
The Secretary may, under appropriate conditions determined by the Secretary, authorize the shipment of investigational drugs or investigational devices for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations.
The Secretary may, at any time, with respect to a sponsor, physician, manufacturer, or distributor described in this section, terminate expanded access provided under this section for an investigational drug or investigational device if the requirements under this section are no longer met.
In this section, the terms “investigational drug”, “investigational device”, “treatment investigational new drug application”, and “treatment investigational device exemption” shall have the meanings given the terms in regulations prescribed by the Secretary.
2007—Subsec. (c). Pub. L. 109–482 substituted “section 282(i)(3)” for “section 282(j)(3)” in concluding provisions.
Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of Title 42, The Public Health and Welfare.