21 CFR 201.19
§ 201.19 Drugs; use of term “infant”.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 201.19, § 201.19 Drugs; use of term “infant”, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85759
- Permanent ID
ys:prov:85759@1- SHA-256
bcaa00a13bdddcf27b41b652d5d349c8a06adc0167c67757ced2abc94f3c2360
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
The regulations affecting special dietary foods (§ 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.