[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: 21CFR17.1]

[Page 171-172]
 
                        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.  17.1  Scope.

    This part sets forth practices and procedures for hearings 
concerning the administrative imposition of civil money penalties by 
FDA. Listed below are the statutory provisions that authorize civil 
money penalties that are governed by these procedures.
    (a) Section 303(b)(2) and (b)(3) of the Federal Food, Drug, and 
Cosmetic Act (the act) authorizing civil money penalties for certain 
violations of the act that relate to prescription drug marketing 
practices.
    (b) Section 303(f)(1) of the act authorizing civil money penalties 
for certain violations of the act that relate to medical devices and 
section 303(f)(2) of the act authorizing civil money penalties for 
certain violations of the act that relate to pesticide residues.

[[Page 172]]

    (c) Section 307 of the act authorizing civil money penalties for 
certain actions in connection with an abbreviated new drug application 
or certain actions in connection with a person or individual debarred 
under section 306 of the act.
    (d) Section 539(b)(1) of the act authorizing civil money penalties 
for certain violations of the act that relate to electronic products.
    (e) Section 351(d)(2) of the Public Health Service Act (the PHS Act) 
authorizing civil money penalties for violations of biologic recall 
orders.
    (f) Section 354(h)(3) of the PHS Act, as amended by the Mammography 
Quality Standards Act of 1992 and the Mammography Quality Standards Act 
of 1998, authorizing civil money penalties for failure to obtain a 
certificate and failure to comply with established standards, among 
other things.
    (g) Section 2128(b)(1) of the PHS Act authorizing civil money 
penalties for intentionally destroying, altering, falsifying, or 
concealing any record or report required to be prepared, maintained, or 
submitted by vaccine manufacturers under section 2128 of the PHS Act.

[60 FR 38626, July 27, 1995, as amended at 69 FR 43301, July 20, 2004]