# 21 CFR § 1.83: Definitions

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-1.83

## Section

- **Citation:** 21 CFR § 1.83
- **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 A—GENERAL > PART 1—GENERAL ENFORCEMENT REGULATIONS > Subpart E—Imports and Exports

## Text

For the purposes of regulations prescribed under section 801(a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act:
(a) The term owner or consignee means the person who makes entry under the provisions of section 484 of the Tariff Act of 1930, as amended (19 U.S.C. 1484), namely, the “importer of record.”
(b) The term division director means the director of the division of the Food and Drug Administration having jurisdiction over the port of entry through which an article is imported or offered for import, or such officer of the division as he or she may designate to act on his or her behalf in administering and enforcing the provisions of section 801(a), (b), and (c).
[42 FR 15553, Mar. 22, 1977, as amended at 81 FR 85872, Nov. 29, 2016; 85 FR 50781, Aug. 18, 2020]

## Nearby sections

- [21 CFR § 1.1 § 1.1 General.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.1.md)
- [21 CFR § 1.3 § 1.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.3.md)
- [21 CFR § 1.4 § 1.4 Authority citations.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.4.md)
- [21 CFR § 1.20 § 1.20 Presence of mandatory label information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.20.md)
- [21 CFR § 1.21 § 1.21 Failure to reveal material facts.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.21.md)
- [21 CFR § 1.23 § 1.23 Procedures for requesting variations and exemptions from required label statements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.23.md)
- [21 CFR § 1.24 § 1.24 Exemptions from required label statements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.24.md)
- [21 CFR § 1.70 § 1.70 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.70.md)
- [21 CFR § 1.71 § 1.71 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.71.md)
- [21 CFR § 1.72 § 1.72 Data elements that must be submitted in ACE for articles regulated by FDA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.72.md)
- [21 CFR § 1.73 § 1.73 Food.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.73.md)
- [21 CFR § 1.74 § 1.74 Human drugs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.74.md)
- [21 CFR § 1.75 § 1.75 Animal drugs and veterinary devices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.75.md)
- [21 CFR § 1.76 § 1.76 Medical devices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.76.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-1.83. Check the current official text before relying on it. Not legal advice.