I 
109TH CONGRESS 
1ST SESSION H. R. 2345 
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 modify requirements for maintaining 
records of the chain-of-custody of prescription drugs, to establish recall 
authority regarding drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 12, 2005 
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 modify requirements for maintaining 
records of the chain-of-custody of prescription drugs, 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 2005’’.
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 section 301(a), 301(b), or 
301(c) 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 
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: 
‘‘(3) 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: 
‘‘(x) 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
misbranding of drugs and the knowing misrepresentation 
of drugs).’’. 
SEC. 4. WHOLESALE DISTRIBUTION OF DRUGS; STATE-
MENTS REGARDING PRIOR SALE, PURCHASE, 
OR TRADE. 
(a) STRIKING
OF EXEMPTIONS
FOR AUTHORIZED 
DISTRIBUTORS OF RECORD.—Section 503(e) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) 
is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘and who is not the manu-
facturer or an authorized distributor of record 
of such drug’’; 
(B) by striking ‘‘to an authorized dis-
tributor of record or’’; and 
(C) by striking subparagraph (B) and in-
serting the following: 
‘‘(B) The Secretary shall by regulation establish re-
quirements that supersede subparagraph (A) (referred to 
in this subparagraph as ‘alternative requirements’) to 
identify the chain of custody of a drug subject to sub-
section (b) from the manufacturer of the drug throughout 
the wholesale distribution of the drug to a pharmacist who 
intends to sell the drug at retail if the Secretary deter-
mines that—
‘‘(i) the alternative requirements (which may in-
clude standardized anticounterfeiting or track-and- 
trace technologies) will identify such chain of cus-
tody, or the identity of the discrete package of the 
drug from which the drug is dispensed, with equal 
or greater certainty than the requirements of sub-
paragraph (A); and 
‘‘(ii) the alternative requirements are tech-
nically feasible.’’; and 
(2) in paragraph (3), by striking ‘‘and sub-
section (d)--’’ in the matter preceding subparagraph 
(A) and all that follows through ‘‘the term ‘whole-
sale distribution’ means’’ in subparagraph (B) and 
inserting the following: ‘‘and subsection (d), the 
term ‘wholesale distribution’ means’’. 
(b) CONFORMING AMENDMENT.—Section 503(d) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(d)) is amended by adding at the end the following: 
‘‘(4) Each manufacturer of a drug subject to sub-
section (b) shall maintain at its corporate offices a current 
list of the authorized distributors of record of such drug. 
‘‘(5) For purposes of this subsection, the term ‘au-
thorized distributors of record’ means any distributor that 
a manufacturer designates as an authorized distributor of
record and whose name the manufacturer makes publicly 
available.’’. 
(c) FINAL RULE.—The Secretary shall ensure that, 
not later than 90 days after the date of the enactment 
of this Act, there is in effect a final rule to implement 
section 503(e) of the Federal Food, Drug, and Cosmetic 
Act, including the amendments made by this section. 
SEC. 5. 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 2006 through 2010, in addition 
to other authorizations of appropriations that are available 
for such purpose. 
SEC. 6. 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 
2006 through 2010, in addition to other authorizations 
of appropriations that are available for such purpose. 
SEC. 7. RECALL AUTHORITY REGARDING DRUGS. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 506C the following section: 
‘‘SEC. 506D. RECALL AUTHORITY. 
‘‘(a) ORDER TO CEASE DISTRIBUTION OF DRUG; NO-
TIFICATION OF HEALTH PROFESSIONALS.— 
‘‘(1) IN GENERAL.—If the Secretary finds that 
there is a reasonable probability that a drug in-
tended for human use would cause serious, adverse 
health consequences or death, the Secretary shall 
issue an order requiring the appropriate person (in-
cluding the manufacturers, importers, distributors, 
or retailers of the drug)— 
‘‘(A) to immediately cease distribution of 
the drug; and 
‘‘(B) to immediately notify health profes-
sionals of the order and to instruct such profes-
sionals to cease administering or prescribing the 
drug.
‘‘(2) INFORMAL
HEARING.—An order under 
paragraph (1) shall provide the person subject to the 
order with an opportunity for an informal hearing, 
to be held not later than 10 days after the date of 
the issuance of the order, on the actions required by 
the order and on whether the order should be 
amended to require a recall of the drug involved. If, 
after providing an opportunity for such a hearing, 
the Secretary determines that inadequate grounds 
exist to support the actions required by the order, 
the Secretary shall vacate the order. 
‘‘(b) ORDER TO RECALL DRUG.— 
‘‘(1) IN GENERAL.—If, after providing an op-
portunity for an informal hearing under subsection 
(a)(2), the Secretary determines that the order 
should be amended to include a recall of the drug 
with respect to which the order was issued, the Sec-
retary shall, except as provided in paragraphs (2) 
and (3), amend the order to require a recall. The 
Secretary shall specify a timetable in which the drug 
recall will occur and shall require periodic reports to 
the Secretary describing the progress of the recall. 
‘‘(2) CERTAIN
ACTIONS.—An amended order 
under paragraph (1)—
‘‘(A) shall not include recall of a drug from 
individuals; and 
‘‘(B) shall provide for notice to individuals 
subject to the risks associated with the use of 
the drug. 
‘‘(3) 
ASSISTANCE
OF
HEALTH
PROFES-
SIONALS.—In providing the notice required by para-
graph (2)(B), the Secretary may use the assistance 
of health professionals who administered the drug 
involved to individuals or prescribed the drug for in-
dividuals. If a significant number of such individuals 
cannot be identified, the Secretary shall notify such 
individuals pursuant to section 705(b).’’. 
SEC. 8. AUTHORITY TO ISSUE SUBPOENAS WITH RESPECT 
TO PREVENTING THREATS TO THE PUBLIC 
HEALTH. 
Section 303 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 333(a)) is amended by adding at the end 
the following subsection: 
‘‘(g) The Secretary and the Attorney General shall 
develop and implement a procedure through which the 
Chief Counsel in the Food and Drug Administration is au-
thorized to issue subpoenas regarding investigations under 
this Act of acts or omissions that may constitute a threat 
to the public health, including investigations of alleged vio-
lations to which paragraph (3) or (4) of subsection (a) 
apply and alleged violations with respect to which the Sec-
retary is considering the use of authorities under section 
304.’’. 
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