[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.30]

[Page 192-193]
 
                        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 B--Labeling
 
Sec. 107.30  Exemptions.

    When containers of ready-to-feed infant formula, to be sold at the 
retail level, are contained within a multiunit package, the labels of 
the individual containers shall contain all of the label information 
required by section 403 of the Federal Food, Drug, and Cosmetic Act (the 
act), Secs. 107.10 and 107.20, and all appropriate sections of part 101 
of this chapter, except that the labels of the individual containers 
contained within the outer package shall be exempt from compliance with 
the requirements of section 403 (e)(1) and (i)(2) of the act; and 
Secs. 107.10 (a) and (b)(2) and 107.20 (b), (e), and (f), provided that 
(a) the multiunit package meets all the requirements of this part; (b) 
individual containers are securely enclosed within

[[Page 193]]

and are not intended to be separated from the retail package under 
conditions of retail sale; and (c) the label on each individual 
container includes the statement ``This Unit Not Intended For Individual 
Sale'' in type size not less than one-sixteenth inch in height. The word 
``Retail'' may be used in lieu of or immediately following the word 
``Individual'' in the statement.