# 21 CFR § 310.306: Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-310.306

## Section

- **Citation:** 21 CFR § 310.306
- **Heading:** Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications
- **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 D—Records and Reports

## Text

(a) Applicability. Marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application are subject to this section.
(b) Notification of a permanent discontinuance or an interruption in manufacturing. The manufacturer of each product subject to this section must make the notifications required under § 314.81(b)(3)(iii) of this chapter and otherwise comply with § 314.81(b)(3)(iii) of this chapter. If the manufacturer of a product subject to this section fails to provide notification as required under § 314.81(b)(3)(iii), FDA will send a letter to the manufacturer and otherwise follow the procedures set forth under § 314.81(b)(3)(iii)(e).
(c) Drug shortages list. FDA will include on the drug shortages list required by § 314.81(b)(3)(iii)(d) drug products that are subject to this section that it determines to be in shortage. For such drug products, FDA will provide the names of each manufacturer rather than the names of each applicant. With respect to information collected under this paragraph, FDA will observe the confidentiality and disclosure provisions set forth in § 314.81(b)(3)(iii)(d)(2).
[80 FR 38938, July 8, 2015]

## 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-21-310.306. Check the current official text before relying on it. Not legal advice.