Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 17  /  Sec. 17.2 Maximum penalty amounts.

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----------------------------------------------------------------------------------------------------------------

Former maximum Date of last Adjusted maximum

U.S.C. Section penalty amount Assessment method penalty figure or penalty amount

(in dollars) adjustment (in dollars)----------------------------------------------------------------------------------------------------------------

21 U.S.C.----------------------------------------------------------------------------------------------------------------333(b)(2)(A).................... 60,000............ For each of the 2013.............. 65,000.

first two

violations in any

10-year period.333(b)(2)(B).................... 1,200,000......... For each violation 2013.............. 1,275,000.

after the second

conviction in any

10-year period.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 2013.............. 1,275,000.

of violations.333(f)(2)(A).................... 55,000............ Per individual.... 2013.............. 60,000.333(f)(2)(A).................... 300,000........... Per ``any other 2013.............. 325,000.

person''.333(f)(2)(A).................... 600,000........... For all violations 2013.............. 650,000.

adjudicated in a

single proceeding.333(f)(3)(A).................... 10,000............ For all violations 2013.............. 11,000.

adjudicated in a

single proceeding.333(f)(3)(B).................... 10,000............ For each day the 2013.............. 11,000.

violation is not

corrected after a

30-day period

following

notification

until the

violation is

corrected.333(f)(4)(A)(i)................. 250,000........... Per violation..... 2013.............. 275,000.333(f)(4)(A)(i)................. 1,000,000......... For all violations 2013.............. 1,075,000.

adjudicated in a

single proceeding.333(f)(4)(A)(ii)................ 250,000........... For the first 30- 2013.............. 275,000.

day period (or

any portion

thereof) of

continued

violation

following

notification.333(f)(4)(A)(ii)................ 1,000,000......... For any 30-day 2013.............. 1,075,000.

period, where the

amount doubles

for every 30-day

period of

continued

violation after

the first 30-day

violation.333(f)(4)(A)(ii)................ 10,000,000........ For all violations 2013.............. 10,850,000.

adjudicated in a

single proceeding.333(f)(9)(A).................... 15,000............ Per violation..... 2009.............. 15,000 (not

adjusted).

333(f)(9)(A).................... 1,000,000......... For all violations 2013.............. 1,050,000.

adjudicated in a

single proceeding.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 2013.............. 1,050,000.

adjudicated in a

single proceeding.333(f)(9)(B)(i)(II)............. 250,000........... For the first 30- 2013.............. 275,000.

day period (or

any portion

thereof) of

continued

violation

following

notification.333(f)(9)(B)(i)(II)............. 1,000,000......... For any 30-day 2013.............. 1,050,000.

period, where the

amount doubles

for every 30-day

period of

continued

violation after

the first 30-day

violation.333(f)(9)(B)(i)(II)............. 10,000,000........ For all violations 2013.............. 10,525,000.

adjudicated in a

single proceeding.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 2013.............. 1,050,000.

adjudicated in a

single proceeding.333(f)(9)(B)(ii)(II)............ 250,000........... For the first 30- 2013.............. 275,000.

day period (or

any portion

thereof) of

continued

violation

following

notification.333(f)(9)(B)(ii)(II)............ 1,000,000......... For any 30-day 2013.............. 1,050,000.

period, where the

amount doubles

for every 30-day

period of

continued

violation after

the first 30-day

violation.333(f)(9)(B)(ii)(II)............ 10,000,000........ For all violations 2013.............. 10,525,000.

adjudicated in a

single proceeding.333(g)(1)....................... 250,000........... For the first 2013.............. 275,000.

violation in any

3-year period.333(g)(1)....................... 500,000........... For each 2013.............. 550,000.

subsequent

violation in any

3-year period.333 note........................ 250............... For the second 2009.............. 250 (not

violation adjusted).

(following a

first violation

with a warning)

within a 12-month

period by a

retailer with an

approved training

program.333 note........................ 500............... For the third 2009.............. 500 (not

violation within adjusted).

a 24-month period

by a retailer

with an approved

training program.333 note........................ 2,000............. For the fourth 2009.............. 2,000 (not

violation within adjusted).

a 24-month period

by a retailer

with an approved

training program.333 note........................ 5,000............. For the fifth 2009.............. 5,000 (not

violation within adjusted).

a 36-month period

by a retailer

with an approved

training program.333 note........................ 10,000............ For the sixth or 2013.............. 11,000.

subsequent

violation within

a 48-month period

by a retailer

with an approved

training program.333 note........................ 250............... For the first 2009.............. 250 (not

violation by a adjusted).

retailer without

an approved

training program.333 note........................ 500............... For the second 2009.............. 500 (not

violation within adjusted).

a 12-month period

by a retailer

without an

approved training

program.333 note........................ 1,000............. For the third 2013.............. 1,100.

violation within

a 24-month period

by a retailer

without an

approved training

program.333 note........................ 2,000............. For the fourth 2009.............. 2,000 (not

violation within adjusted).

a 24-month period

by a retailer

without an

approved training

program.333 note........................ 5,000............. For the fifth 2009.............. 5,000 (not

violation within adjusted).

a 36-month period

by a retailer

without an

approved training

program.333 note........................ 10,000............ For the sixth or 2013.............. 11,000.

subsequent

violation within

a 48-month period

by a retailer

without an

approved training

program.

335b(a)......................... 300,000........... Per violation for 2013.............. 325,000.

an individual.335b(a)......................... 1,200,000......... Per violation for 2013.............. 1,275,000.

``any other

person''.360pp(b)(1)..................... 1,100............. Per violation per 2008.............. 1,100 (not

person. adjusted).360pp(b)(1)..................... 355,000........... For any related 2013.............. 375,000.

series of

violations.----------------------------------------------------------------------------------------------------------------

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.---------------------------------------------------------------------------------------------------------------- [79 FR 6090, Feb. 3, 2014]