# 21 CFR § 315.1: Scope

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-315.1

## Section

- **Citation:** 21 CFR § 315.1
- **Heading:** Scope
- **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 D—DRUGS FOR HUMAN USE > PART 315—DIAGNOSTIC RADIOPHARMACEUTICALS

## Text

The regulations in this part apply to radiopharmaceuticals intended for in vivo administration for diagnostic and monitoring use. They do not apply to radiopharmaceuticals intended for therapeutic purposes. In situations where a particular radiopharmaceutical is proposed for both diagnostic and therapeutic uses, the radiopharmaceutical must be evaluated taking into account each intended use.

## Nearby sections

- [21 CFR § 315.1 § 315.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.1.md)
- [21 CFR § 315.2 § 315.2 Definition.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.2.md)
- [21 CFR § 315.3 § 315.3 General factors relevant to safety and effectiveness.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.3.md)
- [21 CFR § 315.4 § 315.4 Indications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.4.md)
- [21 CFR § 315.5 § 315.5 Evaluation of effectiveness.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.5.md)
- [21 CFR § 315.6 § 315.6 Evaluation of safety.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.6.md)
- [21 CFR § 317.2 § 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health.](https://www.frixlaw.com/law-library/statutes/ecfr-21-317.2.md)
- [21 CFR § 329.100 § 329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-329.100.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-315.1. Check the current official text before relying on it. Not legal advice.