Sec. 2. Essential medicines list update
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The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall establish and maintain a list of essential medicines. The list under subsection
(a)shall consist of drugs and active pharmaceutical ingredients that— are reasonably likely to be required to respond to a public health emergency or to a chemical, biological, radiological, or nuclear threat; or the shortage of which would pose a significant threat to the United States health care system or at-risk populations. The Secretary shall select drugs and active pharmaceutical ingredients for inclusion on the list under subsection (a)— based on the criteria specified in subsection (b); and from the list of essential medicines, medical countermeasures, and critical inputs developed by the Food and Drug Administration in response to Executive Order 13944 (85 Fed. Reg. 49929) and other relevant assessments or lists. Before finalizing the list under subsection
(a)or any update to such list, the Secretary shall— publish a proposed list or update, as applicable; and provide an opportunity for public comment on the proposed list or update. The Secretary shall— publish the proposed initial list under subsection
(a)not later than 6 months after the date of enactment of this Act; and publish the final initial list under subsection
(a)not later than 1 year after such date of enactment. The Secretary shall regularly review the list under subsection
(a)to determine whether any updates should be made pursuant to paragraph (1). The participation of the Secretary in establishing, maintaining, and updating the list under subsection
(a)shall be deemed to be full satisfaction of the requirements applicable to the Secretary under section 3 of Executive Order 13944 (85 Fed. Reg. 49929).
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- 85 FR 49929
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