---
kind: "section"
citation: "21 C.F.R. § 314.72"
title: "21"
number: "314.72"
heading: "Change in ownership of an application."
url: "https://uscodex.org/cfr/21/314.72"
---

# §314.72. Change in ownership of an application.

- (a) An applicant may transfer ownership of its application. At the time of transfer the new and former owners are required to submit information to the Food and Drug Administration as follows:
  - (1) The former owner shall submit a letter or other document that states that all rights to the application have been transferred to the new owner.
  - (2) The new owner shall submit an application form signed by the new owner and a letter or other document containing the following:
    - (i) The new owner's commitment to agreements, promises, and conditions made by the former owner and contained in the application;
    - (ii) The date that the change in ownership is effective; and
    - (iii) Either a statement that the new owner has a complete copy of the approved application, including supplements and records that are required to be kept under [§ 314.81](/cfr/21/314.81.md), or a request for a copy of the application from FDA's files. FDA will provide a copy of the application to the new owner under the fee schedule in [§ 20.45](/cfr/21/20.45.md) of FDA's public information regulations.
- (b) The new owner shall advise FDA about any change in the conditions in the approved application under [§ 314.70](/cfr/21/314.70.md), except the new owner may advise FDA in the next annual report about a change in the drug product's label or labeling to change the product's brand or the name of its manufacturer, packer, or distributor.

## Notes

### Amendments

[50 FR 7493, Feb. 22, 1985; 50 FR 14212, Apr. 11, 1985, as amended at 50 FR 21238, May 23, 1985; 67 FR 9586, Mar. 4, 2002; 68 FR 25287, May 12, 2003]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1.

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

### Amendments

[50 FR 7493, Feb. 22, 1985; 50 FR 14212, Apr. 11, 1985, as amended at 50 FR 21238, May 23, 1985; 67 FR 9586, Mar. 4, 2002; 68 FR 25287, May 12, 2003]