[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.220]

[Page 197]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 107--INFANT FORMULA--Table of Contents
 
                    Subpart E--Infant Formula Recalls
 
Sec. 107.220  Scope and effect of infant formula recalls.

    (a) The requirements of this subpart apply:
    (1) When the Food and Drug Administration has determined that it is 
necessary to remove from the market a distributed infant formula that is 
in violation of the laws and regulations administered by the Food and 
Drug Administration and that poses a risk to human health; or
    (2) When a manufacturer has determined that it is necessary to 
remove from the market a distributed infant formula that:
    (i) Is no longer subject to the manufacturer's control;
    (ii) Is in violation of the laws and regulations administered by the 
Food and Drug Administration and against which the agency could initiate 
legal or regulatory action; and
    (iii) Does not present a human risk.
    (b) The Food and Drug Administration will monitor continually the 
recall action and will take appropriate actions to ensure that the 
violative infant formula is removed from the market.