FDA proposes purging "gender" from Title 21 regulations
- Date
- Actor
- HHS / Food and Drug Administration
- Agency
- Food and Drug Administration (FDA)
- Type
- Proposed rule
Summary
FDA publishes "Modification of Certain Terminology in Title 21" (doc. 2026-08826), proposing to remove "gender" terminology throughout Title 21 CFR and replace it with "sex," implementing EO 14168 across FDA's regulatory corpus (drug labeling, clinical-trial demographic provisions, and related regulations). Original comment period ran to July 6, 2026; on August 3, 2026 FDA reopened the comment period (doc. 2026-15671). (see also sections 2, 12)
Status
Pending; comment period reopened August 3, 2026.
As recorded in the data of . Check the sources for anything newer.
Documents
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Modification of Certain Terminology in Title 21
Modification of Certain Terminology in Title 21, 91 Fed. Reg. 24,380 (proposed May 6, 2026) (to be codified at 21 C.F.R. pts. 10, 56, 106, 201, 251, 310, 312, 314, 329, 600, 803, 862, 866, 870, 882, 1114).
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Modification of Certain Terminology in Title 21; Reopening of the Comment Period
Modification of Certain Terminology in Title 21; Reopening of the Comment Period, 91 Fed. Reg. 48,785 (proposed Aug. 3, 2026) (to be codified at 21 C.F.R. pts. 10, 56, 106, 201, 251, 310, 312, 314, 329, 600, 803, 862, 866, 870, 882, 1114).