21 CFR 17.2 - Maximum penalty amounts.

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There is 1 rule appearing in the Federal Register for 21 CFR 17. View below or at eCFR (GPOAccess)
§ 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)
1 Maximum penalties assessed under The Family Smoking Prevention and Tobacco Control Act do not have a “former maximum penalty.”
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).
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).
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.
[75 FR 73954, Nov. 30, 2010]

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-02-03; vol. 79 # 22 - Monday, February 3, 2014
    1. 79 FR 6088 - Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Direct final rule.
      This rule is effective June 18, 2014, without further notice, unless FDA receives significant adverse comment by April 21, 2014. If we receive no timely significant adverse comments, we will publish a document in the Federal Register before May 19, 2014, confirming the effective date of the direct final rule. If we receive any timely significant adverse comments, we will publish a document in the Federal Register withdrawing this direct final rule before June 18, 2014.
      21 CFR Part 17

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 17 after this date.

  • 2014-02-03; vol. 79 # 22 - Monday, February 3, 2014
    1. 79 FR 6088 - Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Direct final rule.
      This rule is effective June 18, 2014, without further notice, unless FDA receives significant adverse comment by April 21, 2014. If we receive no timely significant adverse comments, we will publish a document in the Federal Register before May 19, 2014, confirming the effective date of the direct final rule. If we receive any timely significant adverse comments, we will publish a document in the Federal Register withdrawing this direct final rule before June 18, 2014.
      21 CFR Part 17