21 U.S.C. § 356e
Drug shortage list
United States · Title 21 — FOOD AND DRUGS · Status: effective
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- Citation
- 21 U.S.C. § 356e, Drug shortage list, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454252
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Full text
The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States.
For each drug on such list, the Secretary shall include the following information:
The reason for the shortage, as determined by the Secretary, selecting from the following categories:
Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available.
Nothing in this section alters or amends section 1905 of title 18 or section 552(b)(4) of title 5.
The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or section 356c(c) of this title if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of drug products to patients).
Not later than 180 days after March 27, 2020, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the current drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services.
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- Food and Drug Administration Safety and Innovation ActHouse: no recorded tallySenate: 96–1
- 21st Century Cures ActHouse: no recorded tallySenate: no recorded tally
- CARES Act