# 21 CFR § 1301.16: Amendments to and withdrawal of applications

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.16

## Section

- **Citation:** 21 CFR § 1301.16
- **Heading:** Amendments to and withdrawal of 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 II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE > PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES > Registration

## Text

(a) An application may be amended or withdrawn without permission of the Administrator at any time before the date on which the applicant receives an order to show cause pursuant to § 1301.37. An application may be amended or withdrawn with permission of the Administrator at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest.
(b) After an application has been accepted for filing, the request by the applicant that it be returned or the failure of the applicant to respond to official correspondence regarding the application, when sent by registered or certified mail, return receipt requested, shall be deemed to be a withdrawal of the application.
[62 FR 13949, Mar. 24, 1997]

## Nearby sections

- [21 CFR § 1301.01 § 1301.01 Scope of this part 1301.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.01.md)
- [21 CFR § 1301.02 § 1301.02 Definitions. Link](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.02.md)
- [21 CFR § 1301.03 § 1301.03 Information; special instructions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.03.md)
- [21 CFR § 1301.11 § 1301.11 Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.11.md)
- [21 CFR § 1301.12 § 1301.12 Separate registrations for separate locations.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.12.md)
- [21 CFR § 1301.13 § 1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.13.md)
- [21 CFR § 1301.14 § 1301.14 Filing of application; acceptance for filing; defective applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.14.md)
- [21 CFR § 1301.15 § 1301.15 Additional information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.15.md)
- [21 CFR § 1301.16 § 1301.16 Amendments to and withdrawal of applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.16.md)
- [21 CFR § 1301.17 § 1301.17 Special procedures for certain applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.17.md)
- [21 CFR § 1301.18 § 1301.18 Research protocols.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.18.md)
- [21 CFR § 1301.19 § 1301.19 Special requirements for online pharmacies.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.19.md)
- [21 CFR § 1301.20 § 1301.20 Registration for emergency medical services agencies.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.20.md)
- [21 CFR § 1301.21 § 1301.21 Exemption from fees.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.21.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-1301.16. Check the current official text before relying on it. Not legal advice.