[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR106.25]

[Page 184-185]
 
                        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 B_Quality Control Procedures for Assuring Nutrient Content of 
                             Infant Formulas
 
Sec.  106.25  In-process control.

    (a) For each infant formula, a master manufacturing order shall be 
prepared and approved by a responsible official of the manufacturer. The 
manufacturer shall establish a quality control system that assures and 
verifies the addition of each ingredient specified in the manufacturing 
order.
    (b) Unless each batch of finished product is analyzed as specified 
in Sec.  106.30(b)(1), the manufacturer shall analyze each in-process 
batch for:
    (1) Solids;
    (2) Protein, fat, and carbohydrates (carbohydrates either by 
analysis or by mathematical difference);
    (3) The indicator nutrient(s) in each nutrient premix;
    (4) Each nutrient added independently of nutrient premixes during 
formulation of the product, except for linoleic acid, vitamin D, vitamin 
K, choline, inositol, and biotin; and

[[Page 185]]

    (5) Solids or an appropriate nutrient to confirm proper dilution 
when final dilution is made after performance of the analyses in 
paragraph (b) (1) through (4) of this section.