21 U.S.C. § 356i — Prompt reports of marketing status

(a) Notification of withdrawal. The holder of an application approved under section 355(c) or (j), or under section 262(a) or (k) of title 42, must notify the Secretary in writing 180 days before withdrawing the approved drug from sale — or if 180 days isn't practicable, as soon as practicable but no later than the withdrawal date. The notice must include: the National Drug Code; the drug's identity by established name (or proper name, for a biological product) and proprietary name, if any; the application number; the drug's strength; the date it's expected to no longer be available for sale; and the reason for withdrawal. (b) Notification of drug not available for sale. The same categories of holders must notify the Secretary in writing within 180 calendar days of a drug's approval if it won't be available for sale within 180 days of that approval. The notice must include: the drug's identity by established (or proper) name and proprietary name, if any; the application number; the drug's strength; the expected sale-availability date, if known; and the reason for not marketing it. (c) Additional one-time report. Within 180 days of December 29, 2022, all holders of applications approved under section 262(a) or (k) of title 42 had to review the information in the list published under section 262(k)(9)(A) of title 42, and submit written notice either stating that all their non-discontinued listed biological products are available for sale, or — for any that are discontinued or never available — providing the subsection (a) or (b) information for each. (d) Failure to meet requirements. If a holder fails to submit the required information under subsection (a), (b), or (c), the Secretary may: move that holder's drugs from the active to the discontinued section of the list published under section 355(j)(7)(A) — except that drugs withdrawn for reasons of safety or effectiveness must instead be removed from the list entirely, under section 355(j)(7)(C); and identify the holder's biological products as discontinued in the list published under section 262(k)(9)(A) of title 42 — except that products whose license was revoked or suspended for safety, purity, or potency reasons must instead be removed from that list under section 262(k)(9)(B). (e) Updates. The Secretary must update the section 355(j)(7)(A) list based on information from subsections (a), (b), and (c), moving unavailable drugs from active to discontinued — except drugs withdrawn for safety or effectiveness reasons, which are removed from the list entirely. The Secretary must similarly update the section 262(k)(9)(A) list for biological products, with products whose license was revoked or suspended for safety, purity, or potency reasons removed from the list entirely. The Secretary must make monthly updates based on subsection (a) and (b) information, and update the lists based on subsection (c) information as soon as practicable. (f) Limitation on use of notices. A notice submitted under this section may not be made public by the Secretary, and may only be used for the subsection (e) updates.