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119th CONGRESS
2d Session |
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.
Mr. Carter of Georgia introduced the following bill; which was referred to the Committee on Energy and Commerce
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.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
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”.