I 
113TH CONGRESS 
2D SESSION 
H. R. 5874 
To amend the Federal Food, Drug, and Cosmetic Act to increase criminal 
penalties for the sale or trade of prescription drugs knowingly caused 
to be adulterated or misbranded, to establish recall authority regarding 
drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 11, 2014 
Mr. ISRAEL 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 
increase criminal penalties for the sale or trade of pre-
scription drugs knowingly caused to be adulterated or 
misbranded, to establish recall authority regarding drugs, 
and for other purposes. 
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 ‘‘Tim Fagan’s Law’’ or the 
‘‘Counterfeit Drug Enforcement Act of 2014’’. 
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SEC. 2. SALE OR TRADE OF PRESCRIPTION DRUGS KNOW-
INGLY CAUSED TO BE ADULTERATED OR MIS-
BRANDED; 
MISREPRESENTATION 
AS 
AP-
PROVED DRUGS. 
(a) CRIMINAL PENALTY.—Section 303(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)) 
is amended by adding at the end the following paragraphs: 
‘‘(3) Notwithstanding paragraph (1) or (2), in the 
case of a person who violates subsection (a), (b), or (c) 
of section 301 with respect to a drug that is subject to 
section 503(b)(1)(B), if the person knowingly caused the 
drug to be adulterated or misbranded and sells or trades 
the drug, or the person purchases or trades for the drug 
knowing or having reason to know that the drug was 
knowingly caused to be adulterated or misbranded, the 
person shall be fined in accordance with title 18, United 
States Code, or imprisoned for any term of years or for 
life, or both. 
‘‘(4) Notwithstanding paragraph (1) or (2), in the 
case of a person who violates section 301(d) with respect 
to a drug, if the person caused the drug to be misrepre-
sented as a drug that is subject to section 503(b)(1)(B) 
and for which an approved application is in effect under 
section 505 and the person sells or trades the drug, or 
the person purchases or trades for the drug knowing or 
having reason to know that the drug was knowingly 
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caused to be so misrepresented, the person shall be fined 
in accordance with title 18, United States Code, or impris-
oned for any term of years or for life, or both.’’. 
(b) NOTIFICATION OF FOOD AND DRUG ADMINIS-
TRATION BY MANUFACTURERS.—Section 505(k) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(k)) 
is amended by adding at the end the following paragraph: 
‘‘(6) A manufacturer of a drug that receives or other-
wise becomes aware of information that reasonably sug-
gests that a violation described in paragraph (3) or (4) 
of section 303(a) may have occurred with respect to the 
drug shall report such information to the Secretary not 
later than 48 hours after first receiving or otherwise be-
coming aware of the information.’’. 
SEC. 3. USE OF TECHNOLOGIES FOR PREVENTING COUN-
TERFEITING OF DRUGS. 
Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is amended by adding at the end the 
following: 
‘‘(dd) If it is a drug and it is not manufactured in 
accordance with any regulations of the Secretary requiring 
the use of technologies that the Secretary has determined 
are technically feasible and will assist in preventing viola-
tions of this Act to which paragraphs (3) and (4) of sec-
tion 303(a) apply (relating to the knowing adulteration or 
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misbranding of drugs and the knowing misrepresentation 
of drugs).’’. 
SEC. 4. COUNTERFEIT DRUGS; INCREASED FUNDING FOR 
INSPECTIONS, EXAMINATIONS, AND INVES-
TIGATIONS. 
For the purpose of increasing the capacity of the 
Food and Drug Administration to conduct inspections, ex-
aminations, and investigations under the Federal Food, 
Drug, and Cosmetic Act with respect to violations de-
scribed in paragraphs (3) and (4) of section 303(a) of such 
Act, there is authorized to be appropriated $60,000,000 
for each of the fiscal years 2015 through 2018, in addition 
to other authorizations of appropriations that are available 
for such purpose. 
SEC. 5. PUBLIC EDUCATION REGARDING COUNTERFEIT 
DRUGS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall carry out a program to educate the 
public and health care professionals on counterfeit drugs, 
including techniques to identify drugs as counterfeit. 
(b) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out subsection (a), there is authorized 
to be appropriated $5,000,000 for each of the fiscal years 
2015 through 2018, in addition to other authorizations 
of appropriations that are available for such purpose. 
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