[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: 21CFR107.3]

[Page 189]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 107_INFANT FORMULA--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  107.3  Definitions.




                      Subpart A_General Provisions

Sec.
107.3 Definitions.

                           Subpart B_Labeling

107.10 Nutrient information.
107.20 Directions for use.
107.30 Exemptions.

                    Subpart C_Exempt Infant Formulas

107.50 Terms and conditions.

                     Subpart D_Nutrient Requirements

107.100 Nutrient specifications.

                    Subpart E_Infant Formula Recalls

107.200 Food and Drug Administration-required recall.
107.210 Firm-initiated product removals.
107.220 Scope and effect of infant formula recalls.
107.230 Elements of an infant formula recall.
107.240 Notification requirements.
107.250 Termination of an infant formula recall.
107.260 Revision of an infant formula recall.
107.270 Compliance with this subpart.
107.280 Records retention.

    Authority: 21 U.S.C. 321, 343, 350a, 371.

    Source: 50 FR 1840, Jan. 14, 1985, unless otherwise noted.



    The following definitions shall apply, in addition to the 
definitions contained in section 201 of the Federal Food, Drug, and 
Cosmetic Act (the act):
    Exempt formula. An exempt infant formula is an infant formula 
intended for commercial or charitable distribution that is represented 
and labeled for use by infants who have inborn errors of metabolism or 
low birth weight, or who otherwise have unusual medical or dietary 
problems.
    Manufacturer. A manufacturer is a person who prepares, 
reconstitutes, or otherwise changes the physical or chemical 
characteristics of an infant formula or packages the infant formula in 
containers for distribution.
    References. References in this part to regulatory sections of the 
Code of Federal Regulations are to chapter I of title 21, unless 
otherwise noted.

[50 FR 48186, Nov. 22, 1985]