[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]
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