[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR106.3]

[Page 190]
 
                        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 A_General Provisions
 
Sec.  106.3  Definitions.

    The definitions and interpretations contained in section 201 of the 
act are applicable to such terms when used in this part. The following 
definitions shall also apply:
    (a) Indicator nutrient. An indicator nutrient is a nutrient whose 
concentration is measured during the manufacture of an infant formula to 
confirm complete addition and/or uniform distribution of a premix or 
other substance of which the indicator nutrient is a part.
    (b) In-process batch. An in-process batch is a combination of 
ingredients at any point in the manufacturing process before packaging.
    (c) Manufacturer. A manufacturer is a person who prepares, 
reconstitutes, or otherwise changes the physical or chemical 
characteristics of an infant formula and/or packages the product in a 
container for distribution.
    (d) Nutrient. A nutrient is any vitamin, mineral, or other substance 
required in accordance with the table set out in section 412(g) of the 
act or by regulations promulgated under section 412(a)(2)(A) of the act.
    (e) Nutrient premix. A nutrient premix is a combination of 
ingredients containing two or more nutrients. A nutrient premix either 
may be received from a supplier or be prepared by an infant formula 
manufacturer.