§207.65. How can a waiver of the electronic submission requirement be obtained? — Inbound Citations

(e) ? The information described in paragraphs (c) and (d) of this section must be submitted electronically unless FDA grants a waiver under § 207.65.

(1) Except as provided in § 207.65, all information submitted under this part must be transmitted to FDA in electronic format by using our electronic drug registration and listing system, in a form that we can process, review, and archive. We may periodically issue guidance on how to provide registration and listing information in electronic format (specifying for example method of transmission, media, file formats, preparation, and organization of files).

(iv) (a) Within 30 calendar days of the withdrawal of an approved drug from sale, applicants who are manufacturers, repackers, or relabelers subject to part 207 of this chapter must submit the following information about the drug, in accordance with the applicable requirements described in §§ 207.61 and 207.65:

(1) The National Drug Code (NDC);

(2) The identity of the drug by established name and by proprietary name, if any;

(3) The new drug application number or abbreviated application number;

(4) The date on which the drug is expected to be no longer in commercial distribution. FDA requests that the reason for withdrawal of the drug from sale be included with the information.

(b) Within 30 calendar days of the withdrawal of an approved drug from sale, applicants who are not subject to part 207 of this chapter must submit the information listed in paragraphs (b)(3)(iv)(a)(1) through (4) of this section. The information must be submitted either electronically or in writing to the Drug Registration and Listing Office, Food and Drug Administration, Center for Drug Evaluation and Research.

(c) Reporting under paragraph (b)(3)(iv)(a) of this section constitutes compliance with the requirements of § 207.57 of this chapter to update drug listing information with respect to the withdrawal from sale.

(f) A holder of a biologics license application (BLA) must report to FDA, in accordance with the requirements of §§ 207.61 and 207.65, the withdrawal from sale of an approved biological product. The information must be submitted to FDA within 30 working days of the biological product's withdrawal from sale. The following information must be submitted: The holder's name; product name; BLA number; the National Drug Code; and the date on which the product is expected to be no longer in commercial distribution. The reason for the withdrawal of the biological product is requested but not required to be submitted.