Section 1 Supply chain reporting
Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amended—
in subsection (a)—
in paragraph (1)(C), by inserting “or any such drug that is critical to the public health during a public health emergency determined under section 319 of the Public Health Service Act” after “during surgery”; and
in the flush text at the end—
by inserting “, or a discontinuance or an interruption in the manufacture of the active pharmaceutical ingredients of such drug,” before “that is likely”; and
by adding at the end the following: “Notification under this subsection shall include disclosure of reasons for the discontinuation or interruption, as applicable; if an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation or interruption, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known by the manufacturer; whether any associated medical devices used for preparation or administration included in the finished dosage form is a reason for, or a risk factor in, such discontinuation or interruption; the expected duration of the interruption; and such other information as the Secretary may require.”; and
by adding at the end the following:
“(j) Additional manufacturer reporting for essential drugs and devices—Each manufacturer of a drug described in subsection (a) shall provide to the Food and Drug Administration, on an annual basis, or more frequently at the request of the Secretary, information related to the manufacturing capacity of such drug. Such information shall include—
“(1) details about—
“(A) all locations of production;
“(B) the sourcing of all component parts;
“(C) the sourcing of any active pharmaceutical ingredients; and
“(D) the use of any scarce or raw materials; and
“(2) any other information determined by the Secretary to be relevant to the security of the supply chain of the drug or device.”