Civil Money Penalties Increased

November 20, 2008
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration issued a direct final rule last week to adjust for inflation the maximum civil money penalty amounts for various civil money penalty authorities under the agency's jurisdiction.

Rockville, MD (Nov. 20)-The US Food and Drug Administration issued a direct final rule last week to adjust for inflation the maximum civil money penalty amounts for various civil money penalty authorities under the agency’s jurisdiction. The rule is meant to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended, which calls for civil money penalties to be adjusted every four years. The rule does not adjust the civil money provisions enacted by the FDA Amendments Act of 2007 (FDAAA), according to the Nov. 12 Federal Register announcement of the final rule.

FCPIAA defines a civil monetary penalty as ‘‘any penalty, fine, or other sanction that-(A)(i) is for a specific monetary amount as provided by Federal law; or (ii) has a maximum amount provided for by Federal law; and (B) is assessed or enforced by an agency pursuant to Federal law; and (C) is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal Courts (28 USC 2461 note, section 3(2)),” according to Federal Register.

The new direct final rule revises the current list of statutory monetary penalties in 21 CFR Part 17 to include new penalties prescribed by the Federal Food, Drug, and Cosmetic Act, as amended by FDAAA in 2007. FDAAA penalties now account for inflation between June 2004 (the year of the last adjustment) and June 2007.

View a table showing the increased maximum penalties here.
 
The rule takes effect Mar. 27, 2009. Comments on the rule are due Jan. 26, 2009 and can be sent in writing to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852 or submitted electronically on www.regulations.gov.