An email from the FDA explained that on March 17, 2023 the FDA added information to the Purple Book Database of Licensed Biological Products (here) to include information on new reporting requirements established by the Section 3201 of the Consolidated Appropriations Act of 2023. According to the Purple Book Q&A #8:
“Section 506I(c) of the FD&C Act requires that all BLA sponsors review information published in the Purple Book and submit a one-time written report to FDA indicating that:
1. the BLA sponsor’s product(s) in the Purple Book that have a status of “Rx” are available for sale; or
2. one or more of the BLA sponsor’s products in the Purple Book that have a status of “Rx” have been withdrawn from sale or have never been available for sale.
Section 506I(c) of the FD&C Act requires that this one-time marketing status report be submitted to the FDA within 180 days of enactment (i.e., by Tuesday, June 27, 2023).”
Q&A #9 explains how and what to submit in the report and provides the report’s suggested format. Sponsors are advised to prominently display the following on the submission: “MARKETING STATUS REPORT / ONE-TIME UPDATE.”
So please take note of this update to the Purple Book as the June date approaches and get your report into the FDA on time.