21 CFR 230.72
§ 230.72 Change in ownership of a granted certification.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 230.72, § 230.72 Change in ownership of a granted certification, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86139
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.