21 U.S.C. § 333 — Penalties

(a) Violating section 331 (1) A first-time violation: up to 1 year in prison, up to a $1,000 fine, or both. (2) If you've already been convicted under this section before, or you meant to defraud or mislead someone, the penalty jumps to up to 3 years in prison, up to a $10,000 fine, or both. (b) Prescription drug marketing violations (1) Anyone who knowingly does one of these things, in violation of section 331(t), faces up to 10 years in prison and up to a $250,000 fine, or both — instead of the penalty in (a): (A) imports a drug illegally under section 381(d)(1); (B) sells, buys, or trades a drug or drug sample, or offers to, in violation of section 353(c)(1); (C) sells, buys, trades, offers to, or counterfeits a coupon in violation of section 353(c)(2); or (D) distributes drugs in violation of section 353(e)(1). (2) A drug manufacturer or distributor that hands out drug samples in person (not by mail or common carrier) can face civil penalties if one of its representatives is convicted of violating section 331(t) through a section 353(c)(1) violation, or of violating a state law banning the sale, purchase, or trade of a drug sample: (A) up to $50,000 for each of the first two such convictions in any 10-year period; (B) up to $1,000,000 for each conviction after the second, in any 10-year period. Multiple convictions coming out of the same event count as just one violation. (3) A manufacturer or distributor that fails to file the report required by section 353(d)(3)(E) faces a civil penalty of up to $100,000. (4) Two safe harbors reduce the company's exposure under paragraph (2): (A) if the manufacturer, distributor, or its own representative supplied the information that led to the representative's conviction, that conviction doesn't count against the company; (B) in a case brought under paragraph (2), the company also escapes liability for a representative's conviction if it proves, with clear and convincing evidence, either that it had already investigated the events, before charges were filed, in a way that would have led to reporting, or that — unless the representative held a supervisory role — it could not reasonably have caught the violation despite diligently running an independent audit and security system. (5) Someone who supplies information leading to a conviction for illegally selling, buying, or trading a drug sample under section 353(c)(1) gets half of the resulting criminal fine, up to $125,000. (6) A prescription drug manufacturer or importer under section 384(b) that knowingly ignores its section 384(e) duties faces up to 10 years in prison and up to a $250,000 fine, or both. (7) Anyone who knowingly and intentionally adulterates a drug — making it adulterated under section 351(a)(1), (b), (c), or (d) — in a way that could reasonably cause serious injury or death faces up to 20 years in prison and up to a $1,000,000 fine, or both. (8) Anyone who knowingly makes, sells, dispenses, or holds for sale a counterfeit drug (violating section 331(i)(3)) or a counterfeit device (violating section 331(fff)(3)) faces up to 10 years in prison and a Title 18 fine, or both. (c) Good-faith exceptions No one faces the basic penalty in (a)(1) for: (1) delivering an article received in interstate commerce in good faith — unless they refuse to name their supplier and hand over related paperwork when an FDA officer asks; (2) violating section 331(a) or (d) if they hold a signed guaranty, from a U.S.-based supplier, stating the article isn't adulterated or misbranded (for an (a) violation) or isn't barred from interstate commerce under section 344 or 355 (for a (d) violation); (3) violating section 331(a) where the only problem is a color additive not from a certified batch, if they hold a guaranty from the additive's manufacturer that it was properly certified; (4) violating section 331(b), (c), or (k) by not meeting section 352(f)'s labeling requirement, for an article where sections 353(a) and 353(b)(1) don't apply, if delivery was in good faith and the labeling matched what was on the article when they received it; (5) violating section 331(i)(2) (making counterfeiting tools) or (i)(3) (using them) in good faith, with no reason to think a drug would be, or was, counterfeit; and (6) the same good-faith defense for the parallel device-counterfeiting rules in section 331(fff)(2) and (3). (d) Misbranded food exception No one faces the (a)(1) penalty for misbranded food if the only problem is that its advertising, not its label, misbrands it under section 343(a)(2). (e) Human growth hormone (1) Anyone who knowingly distributes, or means to distribute, human growth hormone for a human use other than treating a disease or condition that the Secretary has approved under section 355 and a physician has ordered, faces up to 5 years in prison and a Title 18 fine, or both. (2) If the offense involves someone under 18, the maximum rises to 10 years. (3) A conviction under (1) or (2) counts as a felony under the Controlled Substances Act for forfeiture purposes. (4) "Human growth hormone" means somatrem, somatropin, or an analogue of either. (5) The Drug Enforcement Administration may investigate these offenses. (f) Device violations (1)(A) Violating a device-related requirement of this chapter brings a civil penalty of up to $15,000 per violation, capped at $1,000,000 for all violations in one proceeding. An accredited inspector who seriously fails to meet accreditation standards, threatens public health, or acts against the accreditation program's purpose counts as having violated a device requirement. (B) This penalty does not apply to: (i) violations of sections 360i(a) or 360j(f), unless the violation is a significant or knowing departure from the rules or a public health risk; (ii) minor violations of correction-report rules in sections 360i(e) or (g), if the violator is otherwise substantially compliant; or (iii) violations of section 351(a)(2)(A) involving devices that are not actually defective. (2)(A) Introducing adulterated food (adulterated under section 342(a)(2)(B)) into interstate commerce, or ignoring a recall order under section 350l, brings a civil penalty of up to $50,000 for an individual or $250,000 for anyone else, capped at $500,000 per proceeding. (B) This penalty doesn't apply to the farmer who grew the adulterated food. If the Secretary imposes this civil penalty on someone, the Secretary cannot also criminally prosecute them, seize the food under section 334, or seek an injunction under section 332, over the same food. (C) In a hearing on this penalty, the presiding officer can compel testimony and documents the same way as under section 346a(g)(2)(B); one investigative rule under paragraph (5)(A) doesn't apply here. (3)(A) Violating section 331(jj) brings a civil penalty of up to $10,000 total per proceeding. (B) If the violation isn't fixed within 30 days of notice under 42 U.S.C. § 282(j)(5)(C)(ii), an added penalty of up to $10,000 per day applies until it's fixed. (4)(A) A "responsible person" who violates section 355(o), (p), 355–1, or 355c faces a civil penalty of either (i) up to $250,000 per violation, capped at $1,000,000 per proceeding, or (ii) if the violation continues after the Secretary gives written notice, $250,000 for the first 30 days, doubling every following 30 days, capped at $1,000,000 for any 30-day period and $10,000,000 total per proceeding. (B) In setting the amount under (ii), the Secretary must consider whether the person is working to fix the violation. (5)(A) The Secretary sets a civil penalty, or issues a no-tobacco-sale order, under paragraphs (1)–(4) or (9) only after written notice and a hearing, and may subpoena witnesses and evidence during any related investigation. (B) In setting the penalty or the length of a no-tobacco-sale order, the Secretary weighs the violation's nature and seriousness, the violator's ability to pay and stay in business, past violations, culpability, and other relevant factors. A permanent no-tobacco-sale order against a retail outlet must let the outlet ask, after some time, that the Secretary ease, change, or end it. (C) The Secretary may compromise, reduce, or cancel any civil penalty under (1), (2), (3), (4), or (9), and may deduct the agreed amount from money the government owes that person. (D) The Secretary may likewise compromise, modify, or end a no-tobacco-sale order. (6) Anyone who requested a hearing and is unhappy with the resulting penalty or no-tobacco-sale order can ask the D.C. Circuit, or another circuit where they live or do business, to review it — but only within 60 days of the order. (7) If someone doesn't pay a final penalty and hasn't sought review — or loses their review — the Attorney General sues in federal district court to collect the amount plus interest; the court can't reconsider whether the penalty was valid, correct in amount, or appropriate. (8) If the Secretary finds repeated violations of section 387f(d)(5), or of rules issued under section 387f(d), at one retail outlet, the Secretary may bar that outlet from selling tobacco — alongside a civil penalty under (1) — after giving the retailer a hearing, including by phone or at a nearby FDA or government office. (9) Civil penalties for tobacco product violations: (A) generally, up to $15,000 per violation, capped at $1,000,000 per proceeding; (B) enhanced penalties apply for intentional violations of sections 387b(5), 387b(6), 387d, 387h(c), or 387k(a), or of sections 387k(g)(2)(C)(ii) or 387k(i)(1): up to $250,000 per violation (capped at $1,000,000 per proceeding), or, for a continuing violation after notice, $250,000 for the first 30 days, doubling every 30 days after that, capped at $1,000,000 per 30-day period and $10,000,000 per proceeding; the Secretary considers correction efforts in setting these amounts. (g) Direct-to-consumer advertising violations (1) A drug or biologic application holder who runs, or has someone else run, a false or misleading direct-to-consumer ad faces a civil penalty of up to $250,000 for a first violation in any 3-year period, and up to $500,000 for each later violation in that period. No other civil penalty in this chapter — including the one in (f)(4) — applies to the same ad violation. Repeating the same or a similar ad before the Secretary's written notice counts as one violation; after that notice, every violation in a single day counts as one (with each issue of a weekly or monthly publication treated as one day). (2) The Secretary assesses this penalty only after written notice and, if requested, a hearing, and may subpoena witnesses and evidence for the investigation. (3) In setting the penalty, the Secretary considers factors including: whether the ad was submitted for review under section 379h–1 or, if required, section 353c; whether it was disseminated before the 45-day comment period ended; whether the Secretary's comments were incorporated; whether distribution stopped once notice was given; whether qualified medical, regulatory, and legal reviewers checked it first; whether the violation was material; whether the person acted in good faith; whether they were penalized under this provision within the past year; any voluntary remedial steps; and other relevant matters. (4)(A) No penalty applies if the person submitted the ad to the Secretary and incorporated every comment received before distributing it. (B) The Secretary may revise or withdraw earlier comments based on new information, but must give written notice and a reasonable time to fix the ad before seeking a penalty. (5) The Secretary may compromise, reduce, or cancel any penalty under (1), deducting the agreed amount from money owed to that person by the government. (6) A person who requested a hearing and is unhappy with the penalty may seek de novo review in the D.C. Circuit or another circuit where they live or do business, within 60 days of the order. (7) If the penalty isn't paid after becoming final (and isn't being appealed, or the appeal fails), the Attorney General sues in federal district court to collect it plus interest, without the court reconsidering the penalty's validity, amount, or appropriateness.