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

National Drug Code; identity of the drug by established name (or, in the case of a biological product, the proper name) and by proprietary name, if any; new drug application number, abbreviated application number, or biologics license application number; strength of the drug; date on which the drug is expected to no longer be available for sale; and reason for withdrawal of the drug. identity of the drug by established name (or, in the case of a biological product, the proper name) and by proprietary name, if any; new drug application number, abbreviated application number, or biologics license application number; strength of the drug; date on which the drug will be available for sale, if known; and reason for not marketing the drug after approval. stating that all of the application holder’s biological products in the list published under such section 262(k)(9)(A) of title 42 that are not listed as discontinued are available for sale; or including the information required pursuant to subsection (a) or (b), as applicable, for each of the application holder’s biological products that are in the list published under such section 262(k)(9)(A) of title 42 and not listed as discontinued, but have been discontinued from sale or never have been available for sale. move the application holder’s drugs from the active section of the list published under section 355(j)(7)(A) of this title to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with section 355(j)(7)(C) of this title drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness; and identify the application holder’s biological products as discontinued in the list published under section 262(k)(9)(A) of title 42 , except that the Secretary shall remove from the list in accordance with section 262(k)(9)(B) of such title biological products for which the license has been revoked or suspended for reasons of safety, purity, or potency. The Secretary shall update the list published under section 355(j)(7)(A) of this title based on the information provided under subsections (a), (b), and (c) by moving drugs that are not available for sale from the active section to the discontinued section of the list, except that drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness shall be removed from the list in accordance with section 355(j)(7)(C) of this title . The Secretary shall update the list published under section 262(k)(9)(A) of title 42 based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that biological products for which the license has been revoked or suspended for safety, purity, or potency reasons shall be removed from the list in accordance with section 262(k)(9)(B) of title 42 . The Secretary shall make monthly updates to the lists referred to in the preceding sentences based on the information provided pursuant to subsections (a) and (b), and shall update such lists based on the information provided under subsection (c) as soon as practicable. Any notice submitted under this section shall not be made public by the Secretary and shall be used solely for the purpose of the updates described in subsection (e).