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Code · BILL · 117th Congress · H.R. 5388 (Introduced in House) — To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceuti... · Sec. 5

Sec. 5. GAO report

192 words·~1 min read·/bill/117/hr/5388/ih/section-5·

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By not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit a report to Congress that includes— an assessment of what is known about active pharmaceutical ingredient manufacturing, including— the time needed to develop and implement domestic manufacturing capabilities; projected costs of developing new manufacturing capabilities for active pharmaceutical ingredients not currently available domestically, as of the date of the report; and projected costs of expanding existing domestic capabilities and policies, as of the date of the report, that may help establish or strengthen domestic manufacturing capacity for active pharmaceutical ingredients, excipients, key starting materials, components, functional ingredients, and finished dosage manufacturing facilities; and an assessment of incentives already offered or being considered for the development or improvement of domestic capacity to manufacture active pharmaceutical ingredients, their intermediates, and their excipients, including— contractual arrangements for existing domestic storage and manufacturing of active pharmaceutical ingredients; guaranteed contracts for initial purchase and replenishment of essential generic medicines; and other policies designed to help in­cen­tiv­ize the relocation of manufacturing facilities to the United States or provide economic incentives for domestic production.
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