CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL (parts 1 to 99) > PART 17—CIVIL MONEY PENALTIES HEARINGS > 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.
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) 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(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)
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)
Code of Federal Regulations 175
360pp(b)(1) 330,000 For any related series of violations 2008 355,000
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

Code of Federal Regulations

[73 FR 66752, Nov. 12, 2008]

Code of Federal Regulations

§ 17.2 , Nt.

Code of Federal Regulations

Effective Date Note: At 75 FR 73954, Nov. 30, 2010, § 17.2 was revised, effective Apr. 14, 2011. For the convenience of the user, the revised text is set forth as follows: § 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. Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amounts
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).
Code of Federal Regulations 176
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).
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).
Code of Federal Regulations 177
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.
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.”