21 CFR 230.72 - Change in ownership of a granted certification.

Regulations last checked for updates: Jan 11, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart B [§ 230.50 - § 230.150]

§ 230.72 - Change in ownership of a granted certification.

An applicant may transfer ownership of its certification. At the time of transfer the new and former owners are required to submit information to FDA as follows:

(a) The former owner must submit a letter or other document that states that all rights to the certification have been transferred to the new owner.

(b) The new owner must submit a supplement under § 230.70 signed by the new owner describing any changes in the conditions in the granted certification and a letter or other document containing the date that the change in ownership is effective.

authority: 21 U.S.C. 321,331,351,352,353,355,355a,355f,356,356a,356b,356c,356e,360b,360cc,360ddd,360ddd-1,371,374,379e,379k,381

source: 89 FR 51777, June 18, 2024, unless otherwise noted.

cite as: 21 CFR 230.72