21 U.S. Code § 356f - Hospital repackaging of drugs in shortage
In this section:
The term “drug” excludes any controlled substance (as such term is defined in section 802 of this title).
(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.
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) 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
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.
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.
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