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)facilitate access to the drug by hospitals within the same health system.
(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
(2)during the 60-day period following any period described in paragraph (1).
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.
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.
The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.
The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013
An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.