# 21 CFR § 16.5: Inapplicability and limited applicability

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-16.5

## Section

- **Citation:** 21 CFR § 16.5
- **Heading:** Inapplicability and limited applicability
- **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 16—REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION > Subpart A—General Provisions

## Text

(a) This part does not apply to the following:
(1) Informal presentation of views before reporting a criminal violation under section 305 of the act and section 5 of the Federal Import Milk Act and § 1210.31.
(2) A hearing on a refusal of admission of a food, drug, device, or cosmetic under section 801(a) of the act and § 1.94, or of an electronic product under section 360(a) of the Public Health Service Act and § 1005.20.
(3) Factory inspections, recalls (except mandatory recalls of medical devices intended for human use), regulatory letters, and similar compliance activities related to law enforcement.
(4) A hearing on an order for relabeling, diversion, or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264) and §§ 101.17(h) and 115.50 of this chapter.
(5) A hearing on an order for diversion or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264), and § 118.12 of this chapter.
(b) If a regulation provides a person with an opportunity for hearing and specifies some procedures for the hearing but not a comprehensive set of procedures, the procedures in this part apply to the extent that they are supplementary and not in conflict with the other procedures specified for the hearing. Thus, the procedures in subpart A of part 108 relating to emergency permit control are supplemented by the nonconflicting procedures in this part, e.g., the right to counsel, public notice of the hearing, reconsideration and stay, and judicial review.
[44 FR 22367, Apr. 13, 1979, as amended at 57 FR 58403, Dec. 10, 1992; 65 FR 76110, Dec. 5, 2000; 74 FR 33095, July 9, 2009; 89 FR 83781, Oct. 18, 2024]

## Nearby sections

- [21 CFR § 16.1 § 16.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.1.md)
- [21 CFR § 16.5 § 16.5 Inapplicability and limited applicability.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.5.md)
- [21 CFR § 16.22 § 16.22 Initiation of regulatory hearing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.22.md)
- [21 CFR § 16.24 § 16.24 Regulatory hearing required by the act or a regulation.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.24.md)
- [21 CFR § 16.26 § 16.26 Denial of hearing and summary decision.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.26.md)
- [21 CFR § 16.40 § 16.40 Commissioner.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.40.md)
- [21 CFR § 16.42 § 16.42 Presiding officer.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.42.md)
- [21 CFR § 16.44 § 16.44 Communication to presiding officer and Commissioner.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.44.md)
- [21 CFR § 16.60 § 16.60 Hearing procedure.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.60.md)
- [21 CFR § 16.62 § 16.62 Right to counsel.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.62.md)
- [21 CFR § 16.80 § 16.80 Administrative record of a regulatory hearing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.80.md)
- [21 CFR § 16.85 § 16.85 Examination of administrative record.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.85.md)
- [21 CFR § 16.95 § 16.95 Administrative decision and record for decision.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.95.md)
- [21 CFR § 16.119 § 16.119 Reconsideration and stay of action.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.119.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-16.5. Check the current official text before relying on it. Not legal advice.