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)
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), agency is HHS; statutory authority is 333(f)(4)(A)(i); 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 <https://www.govinfo.gov/link/uscode/21/355> 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), <https://www.govinfo.gov/link/uscode/21/355> 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or <https://www.govinfo.gov/link/uscode/21/355> 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