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

(a) Definitions. In this section: "Drug^*" excludes any controlled substance as defined in section 802. "Health system" means a group of hospitals owned and operated by the same entity that share access to databases with drug order information for their patients. "Repackage," for purposes of this section only, means dividing a drug's volume into smaller amounts in order to (A) extend the drug's supply in response to its being placed on the drug shortage list under section 356e, and (B) let hospitals in the same health system access the drug.

(b) Exclusion from registration. Despite any other provision of this chapter, a hospital isn't considered an "establishment" requiring registration under section 360 solely because it repackages a drug and transfers it to another hospital in the same health system, if it follows subsection (c)'s conditions — during any period the drug is on the section 356e shortage list, or during the 60 days following such a period.

(c) Conditions. Subsection (b) only applies to a hospital's repackaging and transfer of a drug within its health system if: (1) the repackaged drug is never sold or otherwise distributed to anyone outside the health system; and (2) the repackaging complies with the applicable requirements of each state where the drug is repackaged and received.

(d) Termination. This section stops applying once the Secretary^* issues final guidance clarifying FDA policy on hospital pharmacies repackaging and safely transferring repackaged drugs to other hospitals in the same health system during a drug shortage.