21 CFR 17.2 - Maximum penalty amounts.

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§ 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

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