[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4538 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 4538

To amend title III of the Public Health Service Act to limit the orphan 
 drug exclusion under the drug discount program under section 340B of 
                              such title.


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                    IN THE HOUSE OF REPRESENTATIVES

                           September 26, 2019

Mr. Welch (for himself and Mr. McKinley) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend title III of the Public Health Service Act to limit the orphan 
 drug exclusion under the drug discount program under section 340B of 
                              such title.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Closing Loopholes for Orphan Drugs 
Act''.

SEC. 2. LIMITING THE ORPHAN DRUG EXCLUSION UNDER 340B DRUG DISCOUNT 
              PROGRAM.

    (a) In General.--Section 340B(e) of the Public Health Service Act 
(42 U.S.C. 256b(e)) is amended by inserting before the period at the 
end the following: ``when transferred, prescribed, sold, or otherwise 
used for the rare condition or disease for which such drug is so 
designated''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply with respect to covered outpatient drugs purchased on or after 
the date of the enactment of this Act.
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