[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.19]

[Page 15]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 201--LABELING--Table of Contents
 
                 Subpart A--General Labeling Provisions
 
Sec. 201.19  Drugs; use of term ``infant''.

    The regulations affecting special dietary foods (Sec. 105.3(e) of 
this chapter) define an infant as a child not more than 12 months old. 
Apart from this, the Food and Drug Administration has not established 
any definition of the term infant. Some question has arisen whether, for 
the purposes of drug labeling, an infant means a child up to 1 year of 
age or a child up to 2 years of age. Until the term is more precisely 
defined by legislation or formal regulation, where the exact meaning of 
the term is significant, manufacturers should qualify any reference to 
``infant'' to indicate whether it refers to a child who is not more than 
1 year of age, or a child not more than 2 years of age.

[40 FR 13998, Mar. 27, 1975, as amended at 42 FR 14091, Mar. 15, 1977; 
44 FR 16006, Mar. 16, 1979]