[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: 21CFR106.1]

[Page 183]
 
                        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.  106.1  Status and applicability of the quality control procedures 
regulation.




                      Subpart A_General Provisions

Sec.
106.1 Status and applicability of the quality control procedures 
          regulation.
106.3 Definitions.

 Subpart B_Quality Control Procedures for Assuring Nutrient Content of 
                             Infant Formulas

106.20 Ingredient control.
106.25 In-process control.
106.30 Finished product evaluation.
106.90 Coding.

                      Subpart C_Records and Reports

106.100 Records.

                   Subpart D_Notification Requirements

106.120 New formulations and reformulations.

    Authority: 21 U.S.C. 321, 350a, 371.

    Source: 47 FR 17025, Apr. 20, 1982, unless otherwise noted.



    (a) The criteria set forth in Sec. Sec.  106.20, 106.25, 106.30, 
106.90, and 106.100 shall apply in determining whether an infant formula 
meets the safety, quality, and nutrient requirements of section 412 of 
the act and the requirements of regulations promulgated under section 
412(a)(2) of the act.
    (b) The failure to comply with any regulation set forth in 
Sec. Sec.  106.20, 106.25, 106.30, 106.90, and 106.100 applicable to the 
manufacturing, processing, and packaging of an infant formula shall 
render such formula adulterated under section 412(a)(1)(C) of the act.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.

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