Title: Drug Diversion and Counterfeit Crackdown Act of 2017
Policy area: Health

Summary:
Drug Diversion and Counterfeit Crackdown Act of 2017
This bill makes it illegal except in cases of a drug shortage to import into the United States prescription drugs manufactured outside the United States and intended by the manufacturer or labeled to be marketed outside the United States.
The bill establishes a penalty for knowingly dispensing or selling a counterfeit drug.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2376 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                H. R. 2376

   To amend the Federal Food, Drug, and Cosmetic Act to protect and 
   strengthen the drug supply chain in the United States by closing 
several statutory gaps in the penalty provisions of such Act that apply 
                 to drug diversion and counterfeiting.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 4, 2017

 Mr. Lance (for himself, Mrs. Dingell, Mr. Burgess, and Mr. Gene Green 
  of Texas) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to protect and 
   strengthen the drug supply chain in the United States by closing 
several statutory gaps in the penalty provisions of such Act that apply 
                 to drug diversion and counterfeiting.

    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 ``Drug Diversion and Counterfeit 
Crackdown Act of 2017''.

SEC. 2. SENSE OF CONGRESS.

    It is the sense of the Congress that--
            (1) there should not be differing penalties under the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
        for illegally diverting drugs into the United States that 
        arbitrarily turn on the location where the drugs were initially 
        manufactured;
            (2) such disparity should be addressed by providing the 
        same penalties for diverting drugs made outside the United 
        States and intended for a foreign market as the penalties that 
        exist for diverting drugs made inside the United States and 
        intended for a foreign market;
            (3) there should not be unequal treatment of counterfeiting 
        and diversion, enabling criminal enterprises to exploit 
        statutory loopholes and jeopardize patient and consumer safety 
        without fear of significant penalties; and
            (4) such unequal treatment should be addressed by 
        increasing the penalties for counterfeiting to match the 
        penalties for diversion.

SEC. 3. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.

    (a) Diverted Drugs.--Paragraph (1) of section 801(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
            (1) by striking ``(d)(1) Except as'' and inserting 
        ``(d)(1)(A) Except as''; and
            (2) by adding at the end the following:
    ``(B) Except as authorized by the Secretary in the case of a drug 
that appears on the drug shortage list in effect under section 506E, no 
drug that would be subject to section 503(b), and which is manufactured 
outside the United States and intended by the manufacturer or labeled 
to be marketed outside the United States, may be imported into the 
United States for sale or commercial use.''.
    (b) Counterfeit Drugs.--Subsection (b) of section 303 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 
adding at the end the following:
    ``(8) Notwithstanding subsection (a), any person who violates 
section 301(i)(3) by knowingly selling or dispensing, or holding for 
sale or dispensing, a counterfeit drug shall be imprisoned for not more 
than 10 years or fined in accordance with title 18, United States Code, 
or both.''.
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