Hospital repackaging of drugs in shortage

21 U.S.C. § 356f

• Title: 21 — Food and Drugs
• Chapter: SUBCHAPTER V—DRUGS AND DEVICES
• Part: A

Text

(a) Definitions
In this section:
The term "drug" excludes any controlled substance (as such term is defined in section 802 of this title).
The term "health system" means a collection of hospitals that are owned and operated by the same entity and that share access to databases with drug order information for their patients.
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:
In no case may a drug that has been repackaged in accordance with this section be sold or otherwise distributed by the health system or a hospital within the system to an entity or individual that is not a hospital within such health system.
Repackaging of a drug under this section shall be done in compliance with applicable State requirements of each State in which the drug is repackaged and received.
(d) Termination
This section shall not apply on or after the date on which the Secretary issues final guidance that clarifies the policy of the Food and Drug Administration regarding hospital pharmacies repackaging and safely transferring repackaged drugs to other hospitals within the same health system during a drug shortage.

History

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