---
kind: "section"
citation: "21 U.S.C. § 356f"
title: "21"
title_heading: "Food and Drugs"
number: "356f"
heading: "Hospital repackaging of drugs in shortage"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/356f"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §356f. Hospital repackaging of drugs in shortage

- (a) **Definitions—** In this section:
  - (1) **Drug—** The term “[drug](/usc/21/321.md?p=g-1)” excludes any controlled substance (as such term is defined in [section 802 of this title](/usc/21/802.md)).
  - (2) **Health system—** 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](/usc/21/321.md?p=g-1) order information for their patients.
  - (3) **Repackage—** For the purposes of this section only, the term “repackage”, with respect to a [drug](/usc/21/321.md?p=g-1), means to divide the volume of a [drug](/usc/21/321.md?p=g-1) into smaller amounts in order to—
    - (A) extend the supply of a [drug](/usc/21/321.md?p=g-1) in response to the placement of the [drug](/usc/21/321.md?p=g-1) on a [drug](/usc/21/321.md?p=g-1) shortage list under [section 356e of this title](/usc/21/356e.md); and
    - (B) facilitate access to the [drug](/usc/21/321.md?p=g-1) 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](/usc/21/360.md) solely because it repackages a [drug](/usc/21/321.md?p=g-1) and transfers it to another hospital within the same health system in accordance with the conditions in [subsection (c)](#c)—
  - (1) during any period in which the [drug](/usc/21/321.md?p=g-1) is listed on the [drug](/usc/21/321.md?p=g-1) shortage list under [section 356e of this title](/usc/21/356e.md); or
  - (2) during the 60-day period following any period described in [paragraph (1)](#b-1).
- (c) **Conditions—** [Subsection (b)](#b) shall only apply to a hospital, with respect to the repackaging of a [drug](/usc/21/321.md?p=g-1) for transfer to another hospital within the same health system, if the following conditions are met:
  - (1) **Drug for intrasystem use only—** In no case may a [drug](/usc/21/321.md?p=g-1) 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.
  - (2) **Compliance with State rules—** Repackaging of a [drug](/usc/21/321.md?p=g-1) under this section shall be done in compliance with applicable [State](/usc/21/321.md?p=a-1) requirements of each [State](/usc/21/321.md?p=a-1) in which the [drug](/usc/21/321.md?p=g-1) is repackaged and received.
- (d) **Termination—** This section shall not apply on or after the date on which the [Secretary](/usc/21/321.md?p=d) issues final guidance that clarifies the policy of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration regarding hospital pharmacies repackaging and safely transferring repackaged [drugs](/usc/21/321.md?p=g-1) to other hospitals within the same health system during a [drug](/usc/21/321.md?p=g-1) shortage.

## Source credit

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