# Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples — Federal civil penalty maximums — current inflation-adjusted amounts across agencies

For Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples, agency is HHS; statutory authority is 333(b)(3); maximum penalty is 262,614, recorded from its source on 2026-08-10.

- **Agency:** HHS _(our reading, not quoted from the source)_
- **Violation:** Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples _(verified: appears in the quote below)_
- **Statutory authority:** 333(b)(3) _(verified: appears in the quote below)_
- **Maximum penalty:** 262,614 _(verified: appears in the quote below)_

## What the source says

> 333(b)(3) | | FDA | Penalty for failure to make a report required by <https://www.govinfo.gov/link/uscode/21/353> 21 U.S.C. 353(d)(3)(E) relating to drug samples | 2024 | 255,964 | 262,614

## 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/).