PRIA, Government Policy, Made Personal

Summary

The Secretary of Health and Human Services must keep and update a list of drugs that are in short supply in the United States. For each drug, the list must show the drug’s name and National Drug Code, the makers, the reason for the shortage (one of: problems meeting manufacturing quality rules, regulatory delays, lack of an active ingredient, lack of an inactive ingredient, stopped production, shipping delays, or a sudden rise in demand), and how long the shortage is expected to last. The Secretary must make the list public but may withhold parts that are trade secrets or other confidential business information or when sharing them would harm public health (for example by causing hoarding). Starting no later than 180 days after March 27, 2020, and every 90 days after that, the Secretary must send a report about 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)Establishment

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)Contents

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)Public availability

(1)In general

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

(2)Trade secrets and confidential information

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

(3)Public health exception

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)Interagency notification

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