# 21 CFR § 310.4: Biologics; products subject to license control

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-310.4

## Section

- **Citation:** 21 CFR § 310.4
- **Heading:** Biologics; products subject to license control
- **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 310—NEW DRUGS > Subpart A—General Provisions

## Text

(a) If a drug has an approved license under section 351 of the Public Health Service Act (42 U.S.C. 262 et seq.) or under the animal virus, serum, and toxin law of March 4, 1913 (21 U.S.C. 151 et seq.), it is not required to have an approved application under section 505 of the act.
(b) To obtain marketing approval for radioactive biological products for human use, as defined in § 600.3(ee) of this chapter, manufacturers must comply with the provisions of § 601.2(a) of this chapter.
[64 FR 56448, Oct. 20, 1999, as amended at 70 FR 14981, Mar. 24, 2005]

## Nearby sections

- [21 CFR § 310.3 § 310.3 Definitions and interpretations.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.3.md)
- [21 CFR § 310.4 § 310.4 Biologics; products subject to license control.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.4.md)
- [21 CFR § 310.6 § 310.6 Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.6.md)
- [21 CFR § 310.100 § 310.100 New drug status opinions; statement of policy.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.100.md)
- [21 CFR § 310.103 § 310.103 New drug substances intended for hypersensitivity testing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.103.md)
- [21 CFR § 310.200 § 310.200 Prescription-exemption procedure.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.200.md)
- [21 CFR § 310.201 § 310.201 Exemption for certain drugs limited by new-drug applications to prescription sale.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.201.md)
- [21 CFR § 310.305 § 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.305.md)
- [21 CFR § 310.306 § 310.306 Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.306.md)
- [21 CFR § 310.501 § 310.501 Patient package inserts for oral contraceptives.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.501.md)
- [21 CFR § 310.502 § 310.502 Certain drugs accorded new drug status through rulemaking procedures.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.502.md)
- [21 CFR § 310.503 § 310.503 Requirements regarding certain radioactive drugs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.503.md)
- [21 CFR § 310.509 § 310.509 Parenteral drug products in plastic containers.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.509.md)
- [21 CFR § 310.515 § 310.515 Patient package inserts for estrogens.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.515.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-310.4. Check the current official text before relying on it. Not legal advice.