# 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) — Federal civil penalty maximums — current inflation-adjusted amounts across agencies

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, not quoted from the source)_
- **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: appears in the quote below)_
- **Statutory authority:** 333(f)(4)(A)(i) _(verified: appears in the quote below)_
- **Maximum penalty:** 377,701 _(verified: appears in the quote below)_

## 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

## Source

- https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-102/section-102.3

Last verified: 2026-08-10. Review by: 2027-02-26.
Part of [Federal civil penalty maximums — current inflation-adjusted amounts across agencies](https://referencesource.org/federal-civil-penalty-maximums/).