# 21 CFR § 107.3: Definitions

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-107.3

## Section

- **Citation:** 21 CFR § 107.3
- **Heading:** Definitions
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION > PART 107—INFANT FORMULA > Subpart A—General Provisions

## Text

The following definitions shall apply, in addition to the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act):
Exempt formula. An exempt infant formula is an infant formula intended for commercial or charitable distribution that is represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems.
Manufacturer. A person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula or packages or labels the product in a container for distribution. The term “manufacturer” does not include a person who prepares, reconstitutes, or mixes infant formula exclusively for an infant under his/her direct care or the direct care of the institution employing such person.
References. References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
[50 FR 48186, Nov. 22, 1985, as amended at 79 FR 8074, Feb. 10, 2014]

## Nearby sections

- [21 CFR § 107.1 § 107.1 Status and applicability of the regulations in part 107.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.1.md)
- [21 CFR § 107.3 § 107.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.3.md)
- [21 CFR § 107.10 § 107.10 Nutrient information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.10.md)
- [21 CFR § 107.20 § 107.20 Directions for use.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.20.md)
- [21 CFR § 107.30 § 107.30 Exemptions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.30.md)
- [21 CFR § 107.50 § 107.50 Terms and conditions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.50.md)
- [21 CFR § 107.100 § 107.100 Nutrient specifications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.100.md)
- [21 CFR § 107.200 § 107.200 Food and Drug Administration-required recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.200.md)
- [21 CFR § 107.210 § 107.210 Firm-initiated product removals.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.210.md)
- [21 CFR § 107.220 § 107.220 Scope and effect of infant formula recalls.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.220.md)
- [21 CFR § 107.230 § 107.230 Elements of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.230.md)
- [21 CFR § 107.240 § 107.240 Notification requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.240.md)
- [21 CFR § 107.250 § 107.250 Termination of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.250.md)
- [21 CFR § 107.260 § 107.260 Revision of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.260.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-107.3. Check the current official text before relying on it. Not legal advice.