§ 356i. Prompt reports of marketing status

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   FDA Reauthorization Act of 2017

   Pub. L. 115–52 title VIII § 804 · 131 Stat. 1005

   Enacted · 21 U.S.C. § 356i

   June 25, 1938, ch. 675, § 506I, as added Pub. L. 115–52, title VIII, § 804, Aug. 18, 2017, 131 Stat. 1071

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 506I, as added Pub. L. 115–52, title VIII, § 804, Aug. 18, 2017, 131 Stat. 1071

   Enacted provision · exact public law section
   SEC. 804. ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED COMPETITION.   Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506H, as added by section 803, the following: “SEC. 506I. PROMPT REPORTS OF MARKETING STATUS. “(a) Notification of Withdrawal.— The holder of an application approved under subsection (c) or (j) of section 505 shall notify the Secretary in writing 180 days prior to withdrawing the approved drug from sale, or if 180 days is not practicable as soon as practicable but not later than the date of withdrawal. The holder shall include with such notice the— “(1) National Drug Code; “(2) identity of the drug by established name and by proprietary name, if any; “(3) new drug application number or abbreviated application number; “(4) strength of the drug; “(5) date on which the drug is expected to no longer be available for sale; and “(6) reason for withdrawal of the drug. “(b) Notification of Drug Not Available for Sale.— The holder of an application approved under subsection (c) or (j) shall notify the Secretary in writing within 180 calendar days of the date of approval of the drug if the drug will not be available for sale within 180 calendar days of such date of approval. The holder shall include with such notice the— “(1) identity of the drug by established name and by proprietary name, if any; “(2) new drug application number or abbreviated application number; “(3) strength of the drug; “(4) date on which the drug will be available for sale, if known; and “(5) reason for not marketing the drug after approval. “(c) Additional One-time Report.— Within 180 days of the date of enactment of this section, all holders of applications approved under subsection (c) or (j) of section 505 shall review the information in the list published under subsection 505(j)(7)(A) and shall notify the Secretary in writing that— “(1) all of the application holder’s drugs in the active section of the list published under subsection 505(j)(7)(A) are available for sale; or “(2) one or more of the application holder’s drugs in the active section of the list published under subsection 505(j)(7)(A) have been withdrawn from sale or have never been available for sale, and include with such notice the information required pursuant to subsection (a) or (b), as applicable. “(d) Failure to Meet Requirements.— If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may move the application holder’s drugs from the active section of the list published under subsection 505(j)(7)(A) to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with subsection 505(j)(7)(C) drugs the Secretary determines have been withdrawn from sale for reasons of safety of effectiveness. “(e) Updates.— The Secretary shall update the list published under subsection 505(j)(7)(A) 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 subsection 505(j)(7)(C). The Secretary shall make monthly updates to the list based on the information provided pursuant to subsections (a) and (b), and shall update the list based on the information provided under subsection (c) as soon as practicable. “(f) Limitation on Use of Notices.— 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).” .

2. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3201(a)(1)(A) · 136 Stat. 4459

   Substituted · 21 U.S.C. § 356i(a)

   Pub. L. 117–328, § 3201(a)(1)(A), substituted “The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42” for “The holder of an application approved under subsection (c) or (j) of section 355 of this title” in introductory provisions

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 117–328, § 3201(a)(1)(A), substituted “The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42” for “The holder of an application approved under subsection (c) or (j) of section 355 of this title” in introductory provisions.

   Enacted provision · exact public law section
   (A) in the matter preceding paragraph (1), by striking “The holder of an application approved under subsection (c) or (j) of section 505” and inserting “The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act”;

3. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3201(a)(1)(B) · 136 Stat. 4459

   Substituted · 21 U.S.C. § 356i(a)(2)

   Pub. L. 117–328, § 3201(a)(1)(B), substituted “established name (or, in the case of a biological product, the proper name)” for “established name”

   Source evidence

   Code amendment note
   Subsec. (a)(2). Pub. L. 117–328, § 3201(a)(1)(B), substituted “established name (or, in the case of a biological product, the proper name)” for “established name”.

   Enacted provision · exact public law section
   (B) in paragraph (2), by striking “established name” and inserting “established name (or, in the case of a biological product, the proper name)”; and

4. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3201(a)(1)(C) · 136 Stat. 4459

   Substituted · 21 U.S.C. § 356i(a)(3)

   Pub. L. 117–328, § 3201(a)(1)(C), substituted “, abbreviated application number, or biologics license application number” for “or abbreviated application number”

   Source evidence

   Code amendment note
   Subsec. (a)(3). Pub. L. 117–328, § 3201(a)(1)(C), substituted “, abbreviated application number, or biologics license application number” for “or abbreviated application number”.

   Enacted provision · exact public law section
   (C) in paragraph (3), by striking “or abbreviated application number” and inserting “, abbreviated application number, or biologics license application number”; and

5. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3201(a)(2)(A) · 136 Stat. 4459

   Substituted · 21 U.S.C. § 356i(b)

   Pub. L. 117–328, § 3201(a)(2)(A), substituted “The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42” for “The holder of an application approved under subsection (c) or (j)” in introductory provisions

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 117–328, § 3201(a)(2)(A), substituted “The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42” for “The holder of an application approved under subsection (c) or (j)” in introductory provisions.

   Enacted provision · exact public law section
   (A) in the matter preceding paragraph (1), by striking “The holder of an application approved under subsection (c) or (j)” and inserting “The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act”;

6. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3201(a)(2)(B) · 136 Stat. 4459

   Substituted · 21 U.S.C. § 356i(b)(1)

   Pub. L. 117–328, § 3201(a)(2)(B), substituted “established name (or, in the case of a biological product, the proper name)” for “established name”

   Source evidence

   Code amendment note
   Subsec. (b)(1). Pub. L. 117–328, § 3201(a)(2)(B), substituted “established name (or, in the case of a biological product, the proper name)” for “established name”.

   Enacted provision · exact public law section
   (B) in paragraph (1), by striking “established name” and inserting “established name (or, in the case of a biological product, the proper name)”; and

7. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3201(a)(2)(C) · 136 Stat. 4459

   Substituted · 21 U.S.C. § 356i(b)(2)

   Pub. L. 117–328, § 3201(a)(2)(C), substituted “, abbreviated application number, or biologics license application number” for “or abbreviated application number”

   Source evidence

   Code amendment note
   Subsec. (b)(2). Pub. L. 117–328, § 3201(a)(2)(C), substituted “, abbreviated application number, or biologics license application number” for “or abbreviated application number”.

   Enacted provision · exact public law section
   (C) in paragraph (2), by striking “or abbreviated application number” and inserting “, abbreviated application number, or biologics license application number”.

8. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3201(b) · 136 Stat. 4459

   Amended · 21 U.S.C. § 356i(c)

   Pub. L. 117–328, § 3201(b), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to an additional one-time report to be done within 180 days of Aug. 18, 2017

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 117–328, § 3201(b), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to an additional one-time report to be done within 180 days of Aug. 18, 2017.

   Enacted provision · exact public law section
   (b) Additional One-Time Report.— Subsection (c) of section 506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended to read as follows: “(c) Additional One-Time Report.— Within 180 days of the date of enactment of the Food and Drug Omnibus Reform Act of 2022, all holders of applications approved under subsection (a) or (k) of section 351 of the Public Health Service Act shall review the information in the list published under section 351(k)(9)(A) of the Public Health Service Act and shall submit a written notice to the Secretary— “(1) stating that all of the application holder’s biological products in the list published under such section 351(k)(9)(A) that are not listed as discontinued are available for sale; or “(2) 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 351(k)(9)(A) and not listed as discontinued, but have been discontinued from sale or never have been available for sale.” .

9. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3201(c)(1) · 136 Stat. 4459

   1. Added · 21 U.S.C. § 356i(d)

      Pub. L. 117–328, § 3201(c)(1), added subsec. (d)

   2. Struck · 21 U.S.C. § 356i(d)

      Pub. L. 117–328, § 3201(c)(1), struck out former subsec. (d). Prior to amendment, text read as follows: “If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may move the application holder’s drugs from the active section of the list published under subsection 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 subsection 355(j)(7)(C) of this title drugs the Secretary determines have been withdrawn from sale for reasons of safety of effectiveness.”

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 117–328, § 3201(c)(1), added subsec. (d) and struck out former subsec. (d). Prior to amendment, text read as follows: “If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may move the application holder’s drugs from the active section of the list published under subsection 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 subsection 355(j)(7)(C) of this title drugs the Secretary determines have been withdrawn from sale for reasons of safety of effectiveness.”

   Enacted provision · exact public law section
   (1) by striking subsection (d) and inserting the following: “(d) Failure To Meet Requirements.— If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may— “(1) Determinations. move the application holder’s drugs from the active section of the list published under section 505(j)(7)(A) to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with section 505(j)(7)(C) drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness; and “(2) identify the application holder’s biological products as discontinued in the list published under section 351(k)(9)(A) of the Public Health Service Act, except that the Secretary shall remove from the list in accordance with section 351(k)(9)(B) of such Act biological products for which the license has been revoked or suspended for reasons of safety, purity, or potency.” ; and

10. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3201(d) · 136 Stat. 4459

    1. Substituted · 21 U.S.C. § 356i(e)

       Pub. L. 117–328, § 3201(d), substituted “section 355(j)(7)(A) of this title” for “subsection 355(j)(7)(A) of this title”

    2. Substituted · 21 U.S.C. § 356i(e)

       Pub. L. 117–328, § 3201(d), substituted “section 355(j)(7)(C) of this title” for “subsection 355(j)(7)(C) of this title”

    Source evidence

    Code amendment note
    Subsec. (e). Pub. L. 117–328, § 3201(d), substituted “section 355(j)(7)(A) of this title” for “subsection 355(j)(7)(A) of this title” and “section 355(j)(7)(C) of this title” for “subsection 355(j)(7)(C) of this title”.

    Enacted provision · exact public law section
    (d) Technical Corrections.— Section 506I(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i(e)) is amended— (1) by striking “subsection 505(j)(7)(A)” and inserting “section 505(j)(7)(A)”; and (2) by striking “subsection 505(j)(7)(C)” and inserting “section 505(j)(7)(C)”.

11. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3201(c)(2) · 136 Stat. 4459

    1. Inserted · 21 U.S.C. § 356i(e)

       Pub. L. 117–328, § 3201(c)(2), inserted “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.” before “The Secretary shall make monthly updates”

    2. Substituted · 21 U.S.C. § 356i(e)

       Pub. L. 117–328, § 3201(c)(2), substituted “monthly updates to the lists referred to in the preceding sentences” for “monthly updates to the list”

    3. Substituted · 21 U.S.C. § 356i(e)

       Pub. L. 117–328, § 3201(c)(2), substituted “and shall update such lists based on” for “and shall update the list based on”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–328, § 3201(c)(2), inserted “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.” before “The Secretary shall make monthly updates” and substituted “monthly updates to the lists referred to in the preceding sentences” for “monthly updates to the list” and “and shall update such lists based on” for “and shall update the list based on”.

    Enacted provision · exact public law section
    (2) in subsection (e)— (A) Update. by inserting after the first sentence the following: “The Secretary shall update the list published under section 351(k)(9)(A) of the Public Health Service Act 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 351(k)(9)(B) of the Public Health Service Act.”; (B) by striking “monthly updates to the list” and inserting “monthly updates to the lists referred to in the preceding sentences”; and (C) by striking “and shall update the list based on” and inserting “and shall update such lists based on”.

15 of 15 references resolved to an enrolled provision