21 CFR 17.2 - Maximum penalty amounts.
§ 17.2
Maximum penalty amounts.
The following table shows maximum civil monetary penalties associated with the statutory provisions authorizing civil monetary penalties under the act or the Public Health Service Act.
| U.S.C. Section | Former maximum penalty amount(in dollars)1 | Assessment method | Date of last penalty figure or adjustment | Adjusted maximum penalty amount(in dollars) |
|---|---|---|---|---|
| 21 U.S.C. | ||||
| 333(b)(2)(A) | 55,000 | For each of the first two violations in any 10-year period | 2008 | 60,000. |
| 333(b)(2)(B) | 1,100,000 | For each violation after the second conviction in any 10-year period | 2008 | 1,200,000. |
| 333(b)(3) | 110,000 | Per violation | 2008 | 120,000. |
| 333(f)(1)(A) | 16,500 | Per violation | 2008 | 16,500 (not adjusted). |
| 333(f)(1)(A) | 1,100,000 | For the aggregate of violations | 2008 | 1,200,000. |
| 333(f)(2)(A) | 55,000 | Per individual | 2008 | 60,000. |
| 333(f)(2)(A) | 275,000 | Per “any other person” | 2008 | 300,000. |
| 333(f)(2)(A) | 550,000 | For all violations adjudicated in a single proceeding | 2008 | 600,000. |
| 333(f)(3)(A) | 10,000 | For all violations adjudicated in a single proceeding | 2007 | 10,000 (not adjusted). |
| 333(f)(3)(B) | 10,000 | For each day the violation is not corrected after a 30-day period following notification until the violation is corrected | 2007 | 10,000 (not adjusted). |
| 333(f)(4)(A)(i) | 250,000 | Per violation | 2007 | 250,000 (not adjusted). |
| 333(f)(4)(A)(i) | 1,000,000 | For all violations adjudicated in a single proceeding | 2007 | 1,000,000 (not adjusted). |
| 333(f)(4)(A)(ii) | 250,000 | For the first 30-day period (or any portion thereof) of continued violation following notification | 2007 | 250,000 (not adjusted). |
| 333(f)(4)(A)(ii) | 1,000,000 | For any 30-day period, where the amount doubles for every 30-day period of continued violation after the first 30-day period | 2007 | 1,000,000 (not adjusted). |
| 333(f)(4)(A)(ii) | 10,000,000 | For all violations adjudicated in a single proceeding | 2007 | 10,000,000 (not adjusted). |
| 333(f)(9)(A) | 1 N/A | Per violation | 2009 | 15,000 (not adjusted). |
| 333(f)(9)(A) | N/A | For all violations adjudicated in a single proceeding | 2009 | 1,000,000 (not adjusted). |
| 333(f)(9)(B)(i)(I) | N/A | Per violation | 2009 | 250,000 (not adjusted). |
| 333(f)(9)(B)(i)(I) | N/A | For all violations adjudicated in a single proceeding | 2009 | 1,000,000 (not adjusted). |
| 333(f)(9)(B)(i)(II) | N/A | For the first 30-day period (or any portion thereof) of continued violation following notification | 2009 | 250,000 (not adjusted). |
| 333(f)(9)(B)(i)(II) | N/A | For any 30-day period, where the amount doubled for every 30-day period of continued violation after the first 30-day period | 2009 | 1,000,000 (not adjusted). |
|
Code of Federal Regulations
- Page 176
|
||||
| 333(f)(9)(B)(i)(II) | N/A | For all violations adjudicated in a single proceeding | 2009 | 10,000,000 (not adjusted). |
| 333(f)(9)(B)(ii)(I) | N/A | Per violation | 2009 | 250,000 (not adjusted). |
| 333(f)(9)(B)(ii)(I) | N/A | For all violations adjudicated in a single proceeding | 2009 | 1,000,000 (not adjusted). |
| 333(f)(9)(B)(ii)(II) | N/A | For the first 30-day period (or any portion thereof) of continued violation following notification | 2009 | 250,000 (not adjusted). |
| 333(f)(9)(B)(ii)(II) | N/A | For any 30-day period, where the amount doubled for every 30-day period of continued violation after the first 30-day period | 2009 | 1,000,000 (not adjusted). |
| 333(f)(9)(B)(ii)(II) | N/A | For all violations adjudicated in a single proceeding | 2009 | 10,000,000 (not adjusted). |
| 333(g)(1) | 250,000 | For the first violation in any 3-year period | 2007 | 250,000 (not adjusted). |
| 333(g)(1) | 500,000 | For each subsequent violation in any 3-year period | 2007 | 500,000 (not adjusted). |
| 333 note | N/A | For the second violation (following a first violation with warning) within a 12-month period by a retailer with an approved training program | 2009 | 250 (not adjusted). |
| 333 note | N/A | For the third violation within a 24-month period by a retailer with an approved training program | 2009 | 500 (not adjusted). |
| 333 note | N/A | For the fourth violation within a 24-month period by a retailer with an approved training program | 2009 | 2,000 (not adjusted). |
| 333 note | N/A | For the fifth violation within a 36-month period by a retailer with an approved training program | 2009 | 5,000 (not adjusted). |
| 333 note | N/A | For the six or subsequent violation within a 48-month period by a retailer with an approved training program | 2009 | 10,000 (not adjusted). |
| 333 note | N/A | For the first violation by a retailer without an approved training program | 2009 | 250 (not adjusted). |
| 333 note | N/A | For the second violation within a 12-month period by a retailer without an approved training program | 2009 | 500 (not adjusted). |
| 333 note | N/A | For the third violation within a 24-month period by a retailer without an approved training program | 2009 | 1,000 (not adjusted). |
| 333 note | N/A | For the fourth violation within a 24-month period by a retailer without an approved training program | 2009 | 2,000 (not adjusted). |
| 333 note | N/A | For the fifth violation within a 36-month period by a retailer without an approved training program | 2009 | 5,000 (not adjusted). |
| 333 note | N/A | For the six or subsequent violation within a 48-month period by a retailer without an approved training program | 2009 | 10,000 (not adjusted). |
| 335b(a) | 275,000 | Per violation for an individual | 2008 | 300,000. |
| 335b(a) | 1,100,000 | Per violation for “any other person” | 2008 | 1,200,000. |
| 360pp(b)(1) | 1,100 | Per violation per person | 2008 | 1,100 (not adjusted). |
| 360pp(b)(1) | 330,000 | For any related series of violations | 2008 | 355,000. |
|
Code of Federal Regulations
- Page 177
|
||||
| 42 U.S.C. | ||||
| 263b(h)(3) | 11,000 | Per violation | 2008 | 11,000 (not adjusted). |
| 300aa-28(b)(1) | 110,000 | Per occurrence | 2008 | 120,000. |
| 1 Maximum penalties assessed under The Family Smoking Prevention and Tobacco Control Act do not have a “former maximum penalty.” | ||||
[75 FR 73954, Nov. 30, 2010]
Title 21 published on 2012-04-01
no entries appear in the Federal Register after this date.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
