# 21 C.F.R. § 201.19 (2026): Drugs; use of term “infant”

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_19

## Section

- **Citation:** 21 C.F.R. § 201.19 (2026)
- **Heading:** Drugs; use of term “infant”
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 201 / Subpart A / § 201.19: § 201.19   Drugs › use of term “infant”.

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

## Nearby sections

- [21 C.F.R. § 201.1 (2026) § 201.1   Drugs; name and place of business of manufacturer, packer, or distributor.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_1.md)
- [21 C.F.R. § 201.2 (2026) § 201.2   Drugs and devices; National Drug Code numbers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_2.md)
- [21 C.F.R. § 201.5 (2026) § 201.5   Drugs; adequate directions for use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_5.md)
- [21 C.F.R. § 201.6 (2026) § 201.6   Drugs; misleading statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_6.md)
- [21 C.F.R. § 201.10 (2026) § 201.10   Drugs; statement of ingredients.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_10.md)
- [21 C.F.R. § 201.15 (2026) § 201.15   Drugs; prominence of required label statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_15.md)
- [21 C.F.R. § 201.16 (2026) § 201.16   Drugs; Spanish-language version of certain required statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_16.md)
- [21 C.F.R. § 201.17 (2026) § 201.17   Drugs; location of expiration date.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_17.md)
- [21 C.F.R. § 201.18 (2026) § 201.18   Drugs; significance of control numbers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_18.md)
- [21 C.F.R. § 201.19 (2026) § 201.19   Drugs; use of term “infant”.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_19.md)
- [21 C.F.R. § 201.20 (2026) § 201.20   Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_20.md)
- [21 C.F.R. § 201.21 (2026) § 201.21   Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_21.md)
- [21 C.F.R. § 201.22 (2026) § 201.22   Prescription drugs containing sulfites; required warning statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_22.md)
- [21 C.F.R. § 201.23 (2026) § 201.23   Required pediatric studies.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_23.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_19. Check the current official text before relying on it. Not legal advice.