A determination that the drug is the same may not be taken back
Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, section 6703, Sec. 6703.
Written by .
A determination that the drug is the same may not be taken back
The document says “shall not”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6703 in the PDF
What the document says
“the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless--”
Where the Secretary determines the drug is the same, that determination may not be changed or withdrawn after the abbreviated application is submitted, unless the listed drug's formulation has changed and the Secretary has found the prior formulation was withdrawn for reasons of safety or effectiveness, or the Secretary makes a written determination that an error has been identified. Where the second applies, the Secretary must give notice and a copy of the written determination to the requester.
What the document actually says
“the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless--”
That sentence, in plain words
Once the health chief says the drug is the same, that answer stands. It may be taken back only in the cases named next.
What this is about
A maker builds its plans on that answer. Pulling it back later would waste years of work. Two narrow exceptions remain.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
Consolidated Appropriations Act, 2026, Public Law 119-75, sec. 6703, 140 Stat. 737 (2026). https://www.govinfo.gov/content/pkg/PLAW-119publ75/html/PLAW-119publ75.htm
This page
“A determination that the drug is the same may not be taken back,” Consolidated Appropriations Act, 2026, section 6703, Sec. 6703. Read the Mandate, https://readthemandate.org/consolidated-appropriations-act-2026/proposal/sec6703-no-rescission/ (retrieved October 10, 2026).
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