21 U.S.C. § 356f: Hospital repackaging of drugs in shortage

The term “drug” excludes any controlled substance (as such term is defined in section 802 of this title ). 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. 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 facilitate access to the drug by hospitals within the same health system. during any period in which the drug is listed on the drug shortage list under section 356e of this title ; or during the 60-day period following any period described in paragraph (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. 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. 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.