[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR106.120]

[Page 190-191]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 106_INFANT FORMULA QUALITY CONTROL PROCEDURES--Table of Contents
 
                   Subpart D_Notification Requirements
 
Sec.  106.120  New formulations and reformulations.


    (a) Information required by section 412(b)(2) and (3) of the act 
shall be submitted to Center for Food Safety and Applied Nutrition (HFS-
830), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740.
    (b) The manufacturer shall promptly notify the Food and Drug 
Administration when the manufacturer has knowledge (as defined in 
section 412(c)(2) of 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 may not provide the nutrients required by section 412(g) of 
the act and by regulations promulgated under section 412(a)(2) of the 
act, or when there is an infant formula that is otherwise adulterated or 
misbranded and that may present risk to human health. This notification 
shall be made,

[[Page 191]]

by telephone, to the Director of the appropriate Food and Drug 
Administration district office specified in part 5, subpart M of this 
chapter. After normal business hours (8 a.m. to 4:30 p.m.) the FDA 
emergency number, 301-443-1240, shall be used. The manufacturer shall 
send a followup written confirmation to the Center for Food Safety and 
Applied Nutrition (HFS-605), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, and to the appropriate Food and 
Drug Administration district office specified in part 5, subpart M of 
this chapter.

[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989; 
61 FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 
6, 2001; 69 FR 17291, Apr. 2, 2004]