21 USC 356i - Prompt reports of marketing status

United States Code

USC most recently checked for updates: Mar 22, 2023

§ 356h. Competitive generic therapies

§ 356j. Discontinuance or interruption in the production of medical devices

U.S. Code
Notes

§ 356i.

Prompt reports of marketing status

(a)

Notification of withdrawal

The holder of an application approved under subsection (c) or (j) of section 355 of this title 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) 1

 So in original. Probably means subsection (c) or (j) of section 355 of this title.

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 August 18, 2017, all holders of applications approved under subsection (c) or (j) of section 355 of this title shall review the information in the list published under subsection 2

 So in original. Probably should be “section”.

355(j)(7)(A) of this title 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 ² 355(j)(7)(A) of this title 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holder’s drugs in the active section of the list published under subsection ² 355(j)(7)(A) of this title have been withdrawn from sale or have never been available for sale, and include with such notice the information required pursuant to subsection (a) or (b), as applicable.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 ² 355(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 ² 355(j)(7)(C) of this title drugs the Secretary determines have been withdrawn from sale for reasons of safety of 3

 So in original. Probably should be “or”.

effectiveness.

(e)

Updates

The Secretary shall update the list published under subsection ² 355(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 subsection ² 355(j)(7)(C) of this title. 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).

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

cite as: 21 USC 356i