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Growing America’s Pharmaceutical Supply Act

H.R. 7528 · 119th Congress · Feb 12, 2026 · Lineage

A BILL

To amend section 503B of the Federal Food, Drug, and Cosmetic Act to enhance the ability of outsourcing facilities to mitigate drug shortages by allowing a short-term period to continue supplying the market after a drug is in shortage.

Section 1 Short title

This Act may be cited as the “Growing America’s Pharmaceutical Supply Act” or the “GAP Supply Act”.

Sec. 2 Providing for a tail period for outsourcing facilities to compound and distribute drugs in shortage

Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b) is amended—
(1)
in subsection (a)(2)(A)(ii), by striking “at the time” and inserting “within 180 calendar days”; and
(2)
in subsection (d)(2)(A), by striking “at the time” and inserting “within 180 calendar days”.