Title 21, Food and DrugsRelease 119-110

§356f Hospital Repackaging of Drugs in Shortage

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part A — Drugs and Devices › § 356f

Last updated Sep 22, 2026|Official source

Summary

Hospitals can split a drug into smaller doses and send it to another hospital in the same hospital system during a drug shortage without having to register as a drug establishment under section 360, as long as the drug is on the shortage list under section 356e or within 60 days after it is removed from that list. Definitions: "drug" does not include controlled substances (see section 802); "health system" means hospitals owned by the same entity that share drug-order databases; "repackage" means dividing a drug into smaller amounts to stretch supply and help hospitals in the same system. The repackaged drug cannot be sold or sent outside that hospital system, and the repackaging must follow state rules where it is done or received. This allowance ends when the Secretary issues final guidance clarifying the FDA policy on these transfers.

Full Legal Text

Title 21, §356f

Food and Drugs, Source: USLM XML via OLRC

(a)Definitions

In this section: (1) Drug

(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 order information for their patients.

(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

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.

(2)Compliance with State rules

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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 356f

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110