21 USC 356e - Drug shortage list

U.S Code last checked for updates: Nov 22, 2024

§ 356e.

Drug shortage list

(a)

Establishment

(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

(2)

Trade secrets and confidential information

(3)

Public health exception

(d)

Interagency notification

(June 25, 1938, ch. 675, § 506E, as added Pub. L. 112–144, title X, § 1004, July 9, 2012, 126 Stat. 1104; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(G), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 116–136, div. A, title III, § 3112(c), Mar. 27, 2020, 134 Stat. 362.)

cite as: 21 USC 356e