Change in ownership of an index file.

21 C.F.R. § 516.163
in effectEffective: 2024-07-01
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(a) A holder may transfer ownership of a drug's index file to another person. (1) The former owner shall submit in writing to FDA a statement that all rights in the index file have been transferred, giving the name and address of the new owner and the date of the transfer. The former owner shall also certify that a complete copy of the following, to the extent that they exist at the time of the transfer of ownership, has been provided to the new owner: (i) The request for determination of eligibility; (ii) The request for addition to the index; (iii) Any modifications to the index listing; (iv) Any records and reports under § 516.165; and (v) All correspondence with FDA relevant to the indexed drug and its index listing. (2) The new owner shall submit the following information in writing to FDA: (i) The date that the change in ownership is effective; (ii) A statement that the new owner has a complete copy of all documents listed in paragraph (a)(1) of this section to the extent that they exist at the time of the transfer of ownership; (iii) A statement that the new owner understands and accepts the responsibilities of a holder of an indexed drug; (iv) The name and address of a new primary contact person or permanent-resident U.S. agent; and (v) A list of labeling changes associated with the change of ownership (e.g., a new trade name) as draft labeling, with complete final printed labeling to be submitted in the indexed drug annual report in accordance with §§ 516.161 and 516.165. (b) Upon receiving the necessary information to support a change of ownership of a drug's index file, FDA will update its publicly-available listing in accordance with § 516.157.

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