§ 356f. Hospital repackaging of drugs in shortage

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 title X § 1007 · 126 Stat. 993

   Enacted · 21 U.S.C. § 356f

   (June 25, 1938, ch. 675, § 506F, as added Pub. L. 112–144, title X, § 1007, July 9, 2012, 126 Stat. 1106.)

   Source evidence

   Code source credit
   (June 25, 1938, ch. 675, § 506F, as added Pub. L. 112–144, title X, § 1007, July 9, 2012, 126 Stat. 1106.)

   Enacted provision · exact public law section
   SEC. 1007. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.   Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 506E, as added by section 1004 of this Act, the following: “SEC. 506F. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE. “(a) Definitions.— In this section: “(1) Drug.— The term ‘drug’ excludes any controlled substance (as such term is defined in section 102 of the Controlled Substances Act). “(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. “(3) Repackage.— 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 506E; and “(B) facilitate access to the drug by hospitals within the same health system. “(b) Exclusion From Registration.— Notwithstanding any other provision of this Act, a hospital shall not be considered an establishment for which registration is required under section 510 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 506E; or “(2) during the 60-day period following any period described in paragraph (1). “(c) Conditions.— 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. “(2) Compliance with state rules.— 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) Termination.— 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.” .

1 of 1 references resolved to an enrolled provision