[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
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]
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