The following table shows maximum civil monetary penalties associated with the statutory provisions authorizing civil monetary penalties under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.
Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amounts
| U.S.C. Section | Former maximum penalty amount (in dollars) | Assessment method | Date of last penalty figure or adjustment | Adjusted maximum penalty amount (in dollars) |
|---|---|---|---|---|
| 21 U.S.C. | ||||
| 333(b)(2)(A) | 60,000 | For each of the first two violations in any 10-year period | 2013 | 65,000. |
| 333(b)(2)(B) | 1,200,000 | For each violation after the second conviction in any 10-year period | 2013 | 1,275,000. |
| 333(b)(3) | 120,000 | Per violation | 2013 | 130,000. |
| 333(f)(1)(A) | 16,500 | Per violation | 2008 | 16,500 (not adjusted). |
| 333(f)(1)(A) | 1,200,000 | For the aggregate of violations | 2013 | 1,275,000. |
| 333(f)(2)(A) | 55,000 | Per individual | 2013 | 60,000. |
| 333(f)(2)(A) | 300,000 | Per “any other person” | 2013 | 325,000. |
| 333(f)(2)(A) | 600,000 | For all violations adjudicated in a single proceeding | 2013 | 650,000. |
| 333(f)(3)(A) | 10,000 | For all violations adjudicated in a single proceeding | 2013 | 11,000. |
| 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 | 2013 | 11,000. |
| 333(f)(4)(A)(i) | 250,000 | Per violation | 2013 | 275,000. |
| 333(f)(4)(A)(i) | 1,000,000 | For all violations adjudicated in a single proceeding | 2013 | 1,075,000. |
| 333(f)(4)(A)(ii) | 250,000 | For the first 30-day period (or any portion thereof) of continued violation following notification | 2013 | 275,000. |
| 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 violation | 2013 | 1,075,000. |
| 333(f)(4)(A)(ii) | 10,000,000 | For all violations adjudicated in a single proceeding | 2013 | 10,850,000. |
| 333(f)(9)(A) | 15,000 | Per violation | 2009 | 15,000 (not adjusted). |
| 333(f)(9)(A) | 1,000,000 | For all violations adjudicated in a single proceeding | 2013 | 1,050,000. |
| 333(f)(9)(B)(i)(I) | 250,000 | Per violation | 2013 | 275,000. |
| 333(f)(9)(B)(i)(I) | 1,000,000 | For all violations adjudicated in a single proceeding | 2013 | 1,050,000. |
| 333(f)(9)(B)(i)(II) | 250,000 | For the first 30-day period (or any portion thereof) of continued violation following notification | 2013 | 275,000. |
| 333(f)(9)(B)(i)(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 violation | 2013 | 1,050,000. |
| 333(f)(9)(B)(i)(II) | 10,000,000 | For all violations adjudicated in a single proceeding | 2013 | 10,525,000. |
| 333(f)(9)(B)(ii)(I) | 250,000 | Per violation | 2013 | 275,000. |
| 333(f)(9)(B)(ii)(I) | 1,000,000 | For all violations adjudicated in a single proceeding | 2013 | 1,050,000. |
| 333(f)(9)(B)(ii)(II) | 250,000 | For the first 30-day period (or any portion thereof) of continued violation following notification | 2013 | 275,000. |
| 333(f)(9)(B)(ii)(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 violation | 2013 | 1,050,000. |
| 333(f)(9)(B)(ii)(II) | 10,000,000 | For all violations adjudicated in a single proceeding | 2013 | 10,525,000. |
| 333(g)(1) | 250,000 | For the first violation in any 3-year period | 2013 | 275,000. |
| 333(g)(1) | 500,000 | For each subsequent violation in any 3-year period | 2013 | 550,000. |
| 333 note | 250 | For the second violation (following a first violation with a warning) within a 12-month period by a retailer with an approved training program | 2009 | 250 (not adjusted). |
| 333 note | 500 | For the third violation within a 24-month period by a retailer with an approved training program | 2009 | 500 (not adjusted). |
| 333 note | 2,000 | For the fourth violation within a 24-month period by a retailer with an approved training program | 2009 | 2,000 (not adjusted). |
| 333 note | 5,000 | For the fifth violation within a 36-month period by a retailer with an approved training program | 2009 | 5,000 (not adjusted). |
| 333 note | 10,000 | For the sixth or subsequent violation within a 48-month period by a retailer with an approved training program | 2013 | 11,000. |
| 333 note | 250 | For the first violation by a retailer without an approved training program | 2009 | 250 (not adjusted). |
| 333 note | 500 | For the second violation within a 12-month period by a retailer without an approved training program | 2009 | 500 (not adjusted). |
| 333 note | 1,000 | For the third violation within a 24-month period by a retailer without an approved training program | 2013 | 1,100. |
| 333 note | 2,000 | For the fourth violation within a 24-month period by a retailer without an approved training program | 2009 | 2,000 (not adjusted). |
| 333 note | 5,000 | For the fifth violation within a 36-month period by a retailer without an approved training program | 2009 | 5,000 (not adjusted). |
| 333 note | 10,000 | For the sixth or subsequent violation within a 48-month period by a retailer without an approved training program | 2013 | 11,000. |
| 335b(a) | 300,000 | Per violation for an individual | 2013 | 325,000. |
| 335b(a) | 1,200,000 | Per violation for “any other person” | 2013 | 1,275,000. |
| 360pp(b)(1) | 1,100 | Per violation per person | 2008 | 1,100 (not adjusted). |
| 360pp(b)(1) | 355,000 | For any related series of violations | 2013 | 375,000. |
| 42 U.S.C. | ||||
| 263b(h)(3) | 11,000 | Per violation | 2008 | 11,000 (not adjusted). |
| 300aa-28(b)(1) | 120,000 | Per occurrence | 2013 | 130,000. |