[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.2]

[Page 172-173]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 17_CIVIL MONEY PENALTIES HEARINGS--Table of Contents
 
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 act or the Public Service Act.

          Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amounts
----------------------------------------------------------------------------------------------------------------
                                              Former Maximum                        Date of     Adjusted Maximum
   U.S.C. Section        Description of       Penalty Amount   Assessment Method      Last       Penalty Amount
                            Violation          (in dollars)                         Penalty       (in dollars)
----------------------------------------------------------------------------------------------------------------
(a) 21 U.S.C.
----------------------------------------------------------------------------------------------------------------
  (1) 333(b)(2)(A)    Violation of certain       50,000        For each of the           2004       55,000
                       requirements of the                      first two
                       Prescription Drug                        violations in
                       Marketing Act                            any 10-year
                       (PDMA)                                   period
----------------------------------------------------------------------------------------------------------------
  (2) 333(b)(2)(B)    Violation of certain    1,000,000        For each                  2004    1,100,000
                       requirements of the                      violation after
                       PDMA                                     the second
                                                                conviction in
                                                                any 10-year
                                                                period
----------------------------------------------------------------------------------------------------------------
  (3) 333(b)(3)       Violation of certain      100,000        Per violation             2004      110,000
                       requirements of the
                       PDMA
----------------------------------------------------------------------------------------------------------------
  (4) 333(f)(1)(A)    Violation of certain       15,000        Per violation             2004       16,500
                       requirements of the
                       Safe Medical
                       Devices Act (SMDA)
----------------------------------------------------------------------------------------------------------------
  (5) 333(f)(1)(A)    Violation of certain    1,000,000        For the aggregate         2004    1,100,000
                       requirements of the                      of violations
                       SMDA
----------------------------------------------------------------------------------------------------------------
  (6) 333(f)(2)(A)    Violation of certain       50,000        Per individual            2004       55,000
                       requirements of the
                       Food Quality
                       Protection Act of
                       1996 (FQPA)
----------------------------------------------------------------------------------------------------------------
  (7) 333(f)(2)(A)    Violation of certain      250,000        Per ``any other           2004      275,000
                       requirements of the                      person''
                       FQPA
----------------------------------------------------------------------------------------------------------------

[[Page 173]]


  (8) 333(f)(2)(A)    Violation of certain      500,000        For all                   2004      550,000
                       requirements of the                      violations
                       FQPA                                     adjudicated in a
                                                                single
                                                                proceeding
----------------------------------------------------------------------------------------------------------------
  (9) 335b(a)         Violation of certain      250,000        Per violation for         2004      275,000
                       requirements of the                      an individual
                       Generic Drug
                       Enforcement Act of
                       1992 (GDEA)
----------------------------------------------------------------------------------------------------------------
  (10) 335b(a)        Violation of certain    1,000,000        Per violation for         2004    1,100,000
                       requirements of the                      ``any other
                       GDEA                                     person''
----------------------------------------------------------------------------------------------------------------
  (11) 360pp(b)(1)    Violation of certain        1,000        Per violation per         2004        1,100
                       requirements of the                      person
                       Radiation Control
                       for Health and
                       Safety Act of 1968
                       (RCHSA)
----------------------------------------------------------------------------------------------------------------
  (12) 360pp(b)(1)    Violation of certain      300,000        For any related           2004      330,000
                       requirements of the                      series of
                       RCHSA                                    violations
----------------------------------------------------------------------------------------------------------------
(b) 42 U.S.C.
----------------------------------------------------------------------------------------------------------------
  (1) 263b(h)(3)      Violation of certain       10,000        Per violation             2004       11,000
                       requirements of the
                       Mammography Quality
                       Standards Act of
                       1992 and the
                       Mammography Quality
                       Standards Act of
                       1998
----------------------------------------------------------------------------------------------------------------
  (2) 300aa-28(b)(1)  Violation of certain      100,000        Per occurrence            2004      110,000
                       requirements of the
                       National Childhood
                       Vaccine Injury Act
                       of 1986
----------------------------------------------------------------------------------------------------------------


[69 FR 43301, July 20, 2004; 69 FR 49807, Aug. 12, 2004]