Penalty for any responsible person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355-1 (REMS) · 333(f)(4)(A)(i)
For Penalty for any responsible person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355-1 (REMS), statutory authority is 333(f)(4)(A)(i); agency is HHS; maximum penalty is 377,701, recorded from its source on 2026-08-10.
- Agency
- HHS our reading
- Violation
- Penalty for any responsible person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355-1 (REMS) verified
- Statutory authority
- 333(f)(4)(A)(i) verified
- Maximum penalty
- 377,701 verified
Values marked our reading are our classification of what the source says — the source does not print them in those words. The quote below is the evidence for each one; judge it yourself.
What the source says
333(f)(4)(A)(i) | | FDA | Penalty for any responsible person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355-1 (REMS) | 2024 | 368,137 | 377,701
— ecfr.gov, retrieved 2026-08-10
Source
- ecfr.govhttps://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-102/section-102.3