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]