21 USC 356f - Hospital repackaging of drugs in shortage

U.S Code last checked for updates: Jan 19, 2025

§ 356f.

Hospital repackaging of drugs in shortage

(a)

Definitions

In this section:

(1)

Drug

(2)

Health system

(3)

Repackage

For the purposes of this section only, the term “repackage”, with respect to a drug, means to divide the volume of a drug into smaller amounts in order to—

(A)

extend the supply of a drug in response to the placement of the drug on a drug shortage list under section 356e of this title; and

(B)

facilitate access to the drug by hospitals within the same health system.

(b)

Exclusion from registration

Notwithstanding any other provision of this chapter, a hospital shall not be considered an establishment for which registration is required under section 360 of this title solely because it repackages a drug and transfers it to another hospital within the same health system in accordance with the conditions in subsection (c)—

(1)

during any period in which the drug is listed on the drug shortage list under section 356e of this title; or

(2)

during the 60-day period following any period described in paragraph (1).

(c)

Conditions

Subsection (b) shall only apply to a hospital, with respect to the repackaging of a drug for transfer to another hospital within the same health system, if the following conditions are met:

(1)

Drug for intrasystem use only

(2)

Compliance with State rules

(d)

Termination

(June 25, 1938, ch. 675, § 506F, as added Pub. L. 112–144, title X, § 1007, July 9, 2012, 126 Stat. 1106.)

cite as: 21 USC 356f