[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.59]

[Page 83-84]
 
                        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 C--Recalls (Including Product Corrections)--Guidance on Policy, 
                Procedures, and Industry Responsibilities
 
Sec. 7.59  General industry guidance.

    A recall can be disruptive of a firm's operation and business, but 
there are several steps a prudent firm can take in advance to minimize 
this disruptive effect. Notwithstanding similar specific requirements 
for certain products in other parts of this chapter, the following is 
provided by the Food and Drug Administration as guidance for a firm's 
consideration:
    (a) Prepare and maintain a current written contingency plan for use 
in initiating and effecting a recall in accordance with Secs. 7.40 
through 7.49, 7.53, and 7.55.
    (b) Use sufficient coding of regulated products to make possible 
positive lot identification and to facilitate effective recall of all 
violative lots.

[[Page 84]]

    (c) Maintain such product distribution records as are necessary to 
facilitate location of products that are being recalled. Such records 
should be maintained for a period of time that exceeds the shelf life 
and expected use of the product and is at least the length of time 
specified in other applicable regulations concerning records retention.

Subpart D [Reserved]