Title 21 — Food and DrugsRelease 119-73not60

§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 Apr 5, 2026|Official source

Summary

Hospitals can split a drug that is in short supply and send part of it to another hospital in the same health system without being treated as a drug establishment that must register, but only if certain rules are followed. Key words: "drug" here does not include controlled substances; "health system" means hospitals owned by the same organization that share patient drug-order data; "repackage" means dividing a drug into smaller amounts to stretch supply during a shortage and to help hospitals in the same system. The no-registration rule only applies while the drug is on the official drug shortage list and for 60 days after it is removed. Repackaged drug may not be sold or given to anyone outside the same health system. Repackaging must follow the state laws where the drug is handled and where it is received. The rule stops applying once the FDA issues final guidance explaining its policy.

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 5, 2026

Release point: 119-73not60