C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 17—CIVIL MONEY PENALTIES HEARINGS

21 C.F.R. § 17.2

Maximum penalty amounts

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The maximum civil money penalties associated with the statutory provisions authorizing civil money penalties under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act can be found at 45 CFR part 102. The table of these maximum civil money penalties can be found at 45 CFR 102.3.

[81 FR 62358, Sept. 9, 2016]
Notes of Decisions
Cited in 3 cases, 2009–2018 · leading case: Orton Motor, Inc. v. U.S. Dep't of Health & Human Servs., 884 F.3d 1205 (D.C. Cir. 2018).
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Orton Motor, Inc. v. U.S. Dep't of Health & Human Servs., 884 F.3d 1205 (D.C. Cir. 2018). “This amount derives from the FDA's regulations at 21 C.F.R. § 17.2 (2014), which provided at the time for a $500 maximum civil money penalty for "3 [Violations] within a 24 month period.”
TMJ Implants, Inc. v. United States Dep't of Health & Human Servs., 584 F.3d 1290 (10th Cir. 2009). · cites it 2× “21 C.F.R. § 17.2 . Liability for civil penalties requires proof that the violation was either a significant or knowing departure from the law, or that the violation posed a risk to public health.”
Orton Motor, Inc. v. HHS (D.C. Cir. 2018). “This amount derives from the FDA’s regulations at 21 C.F.R. § 17.2 (2014), which provided at the time for a $500 maximum civil money penalty for “3 [Violations] within a 24 month period.”
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