[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.1]

[Page 77-78]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 7--ENFORCEMENT POLICY--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 7.1  Scope.


    This part governs the practices and procedures applicable to 
regulatory enforcement actions initiated by the Food and Drug 
Administration pursuant to the Federal Food, Drug and Cosmetic Act (21 
U.S.C. 301 et seq.) and other laws that it administers. This part also 
provides guidance for manufacturers and distributors to follow

[[Page 78]]

with respect to their voluntary removal or correction of marketed 
violative products. This part is promulgated to clarify and explain the 
regulatory practices and procedures of the Food and Drug Administration, 
enhance public understanding, improve consumer protection, and assure 
uniform and consistent application of practices and procedures 
throughout the agency.

[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]