§356e — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary must keep a current list of drugs that are in shortage in the United States. For each drug the list must show the drug name and National Drug Code, the makers, why it is short (for example: manufacturing problems, ingredient shortages, stopped production, shipping delays, regulatory delay, or higher demand), and how long the shortage is expected to last. The list is public unless sharing it would harm public health (for example by causing hoarding). This does not change protections in 18 U.S.C. 1905 or 5 U.S.C. 552(b)(4). Not later than 180 days after March 27, 2020, and every 90 days after that, the Secretary must send a report on the current shortage list to the Administrator of the Centers for Medicare & Medicaid Services.

Title 21, §356e

Food and Drugs — Source: USLM XML via OLRC

(a)The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States.

(b)For each drug on such list, the Secretary shall include the following information:

(1)The name of the drug in shortage, including the National Drug Code number for such drug.

(2)The name of each manufacturer of such drug.

(3)The reason for the shortage, as determined by the Secretary, selecting from the following categories:

(A)Requirements related to complying with good manufacturing practices.

(B)Regulatory delay.

(C)Shortage of an active ingredient.

(D)Shortage of an inactive ingredient component.

(E)Discontinuance of the manufacture of the drug.

(F)Delay in shipping of the drug.

(G)Demand increase for the drug.

(4)The estimated duration of the shortage as determined by the Secretary.

(c)(1)Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available.

(2)Nothing in this section alters or amends section 1905 of title 18 or section 552(b)(4) of title 5.

(3)The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or section 356c(c) of this title if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of drug products to patients).

(d)Not later than 180 days after March 27, 2020, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the current drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2020—Subsec. (d). Pub. L. 116–136 added subsec. (d). 2016—Subsec. (b)(3)(E). Pub. L. 114–255, which directed substitution of “discontinuance” for “discontinuation”, was executed by substituting “Discontinuance” for “Discontinuation” to reflect the probable intent of Congress.

Statutory Notes and Related Subsidiaries

Effective Date

of 2020 AmendmentAmendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.

§356e Drug Shortage List