GroundRules
21 CFR 230.72: Change in ownership of a granted certification.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER C—DRUGS: GENERAL
- PART 230—CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES
- Subpart B—Certification of Designated Medical Gases
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON