I 
115TH CONGRESS 
1ST SESSION H. R. 2376 
To amend the Federal Food, Drug, and Cosmetic Act to protect and strength-
en 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 Com-
mittee 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 diver-
sion and counterfeiting. 
Be it enacted by the Senate and House of Representa-
tives 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— 
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(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 manufac-
tured; 
(2) such disparity should be addressed by pro-
viding 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 enter-
prises to exploit statutory loopholes and jeopardize 
patient and consumer safety without fear of signifi-
cant 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— 
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(1) by striking ‘‘(d)(1) Except as’’ and insert-
ing ‘‘(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 la-
beled 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 fol-
lowing: 
‘‘(8) Notwithstanding subsection (a), any person who 
violates section 301(i)(3) by knowingly selling or dis-
pensing, 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.’’. 
Æ 
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