[Title 21 CFR 107.240]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 107 - INFANT FORMULA]
[Subpart E - Infant Formula Recalls]
[Sec. 107.240 - Notification requirements.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  2
  1996-04-01
  1996-04-01
  false
  
  107.240
  Sec. 107.240
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED
    FOOD FOR HUMAN CONSUMPTION
    INFANT FORMULA
    Infant Formula Recalls
  


Sec. 107.240   Notification requirements.

    (a) Notification of a violative infant formula. A manufacturer shall 
promptly notify the Food and Drug Administration when the manufacturer 
has knowledge (as defined in section 412(e)(2) of the Federal Food, 
Drug, and Cosmetic Act (the act)) that reasonably supports the 
conclusion that an infant formula that has been processed by the 
manufacturer and that has left an establishment subject to the control 
of the manufacturer:
    (1) May not provide the nutrients required by section 412(i) of the 
act and by regulations promulgated under section 412(i)(2) of the act; 
or
    (2) May be otherwise adulterated or misbranded.
    (b) Method of notification. The notification made pursuant to 
Sec. 107.240(a) shall be made, by telephone, to the Director of the 
appropriate Food and Drug Administration district office specified in 
Sec. 5.115 of this chapter. After normal business hours (8 a.m. to 4:30 
p.m.), FDA's emergency number, 202-857-8400, shall be used. The 
manufacturer shall send written confirmation of the notification to the 
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, and to the 
appropriate Food and Drug Administration district office specified in 
Sec. 5.115 of this chapter.
    (c) Reports about an infant formula recall--(1) Telephone report. 
When a determination is made that an infant formula is to be recalled, 
the recalling firm shall telephone within 24 hours the appropriate Food 
and Drug Administration district office listed in Sec. 5.115 of this 
chapter and shall provide relevant information about the infant formula 
that is to be recalled.
    (2) Initial written report.  Within 14 days after the recall has 
begun, the recalling firm shall provide a written report to the 
appropriate Food and Drug Administration district office. The report 
shall contain relevant information, including the following cumulative 
information concerning the infant formula that is being recalled:
    (i) Number of consignees notified of the recall, and date and method 
of notification, including, for a recall pursuant to Sec. 107.200 
information about the notice provided for retail display and the request 
for its display.
    (ii) Number of consignees responding to the recall communication and 
quantity of recalled infant formula on hand at the time it was received.
    (iii) Quantity of recalled infant formula returned or corrected by 
each consignee contacted and the quantity of recalled infant formula 
accounted for.
    (iv) Number and results of effectiveness checks that were made.
    (v) Estimated timeframes for completion of the recall.
    (3) Status reports. The recalling firm shall submit to the 
appropriate Food and Drug Administration district office a written 
status report on the recall at least every 14 days until the recall is 
terminated. The status report shall describe the steps taken by the 
recalling firm to carry out the recall since the last report and the 
results of these steps.

[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996]