[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.1]

[Page 97-98]
 
                        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.




                      Subpart A_General Provisions

Sec.
7.1 Scope.
7.3 Definitions.
7.12 Guaranty.
7.13 Suggested forms of guaranty.

Subpart B [Reserved]

 Subpart C_Recalls (Including Product Corrections)_Guidance on Policy, 
                Procedures, and Industry Responsibilities

7.40 Recall policy.
7.41 Health hazard evaluation and recall classification.
7.42 Recall strategy.
7.45 Food and Drug Administration-requested recall.
7.46 Firm-initiated recall.
7.49 Recall communications.
7.50 Public notification of recall.
7.53 Recall status reports.
7.55 Termination of a recall.
7.59 General industry guidance.

Subpart D [Reserved]

                      Subpart E_Criminal Violations

7.84 Opportunity for presentation of views before report of criminal 
          violation.

[[Page 98]]

7.85 Conduct of a presentation of views before report of criminal 
          violation.
7.87 Records related to opportunities for presentation of views 
          conducted before report of criminal violation.

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264.

    Source: 42 FR 15567, Mar. 22, 1977, unless otherwise noted.



    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 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]