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GAP Supply Act: Amending Drug Shortage Regulations

This bill amends section 503B of the Federal Food, Drug, and Cosmetic Act. It allows outsourcing facilities to compound and distribute drugs for 180 days after a drug has been on a shortage list, rather than requiring the drug to be in shortage at the specific time of distribution.
Key points
Changes the timing requirement from 'at the time' to 'within 180 calendar days' regarding drug shortages.
Allows outsourcing facilities a tail period to continue supplying the market after a drug shortage.
Amends section 503B of the Federal Food, Drug, and Cosmetic Act.
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Status: Introduced
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Additional Information
Print number: 119_HR_7528
Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1]
Process start date: 2026-02-12