21 C.F.R. § 17.2 Maximum penalty amounts.
Title 21 - Food and Drugs
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. [69 FR 43301, July 20, 2004; 69 FR 49807, Aug. 12, 2004]
Title 21: Food and Drugs
PART 17—CIVIL MONEY PENALTIES HEARINGS
§ 17.2 Maximum penalty amounts.
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---------------------------------------------------------------------------------------------------------------- (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----------------------------------------------------------------------------------------------------------------
