Title 21 — Food and DrugsRelease 119-73

§356f Hospital repackaging of drugs in shortage

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

Last updated Apr 6, 2026|Official source

Summary

Hospitals may split up a drug that is on the official drug shortage list and send the smaller amounts to other hospitals in the same health system without having to register as a drug establishment under federal law. That permission only lasts while the drug is on the shortage list and for 60 days after it is removed. The hospitals must not sell or give the repackaged drug to anyone outside their health system, and they must follow the state rules where the drug is repackaged and received. The rule stops applying once the Secretary issues final FDA guidance on this practice. Definitions: "drug" — excludes controlled substances; "health system" — group of hospitals owned by the same entity that share drug order databases; "repackage" — divide a drug into smaller amounts to stretch supply during a shortage and make it easier to share within the health system.

Full Legal Text

Title 21, §356f

Food and Drugs — Source: USLM XML via OLRC

(a)In this section:

(1)The term “drug” excludes any controlled substance (as such term is defined in section 802 of this title).

(2)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)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)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)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)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)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)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

Apr 6, 2026

Release point: 119-73