I 
108TH CONGRESS 
1ST SESSION H. R. 3297
To amend the Federal Food, Drug, and Cosmetic Act to establish recall 
authority regarding drugs, to increase criminal penalties for the sale 
or trade of prescription drugs knowingly caused to be adulterated or 
misbranded, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 15, 2003
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 
establish recall authority regarding drugs, to increase 
criminal penalties for the sale or trade of prescription 
drugs knowingly caused to be adulterated or misbranded, 
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 the ‘‘Counterfeit Drug En-
forcement Act’’.
SEC. 2. 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. 3. SALE OR TRADE OF PRESCRIPTION DRUGS KNOW-
INGLY CAUSED TO BE ADULTERATED OR MIS-
BRANDED; KNOWING PURCHASE OR TRADE. 
(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 paragraph: 
‘‘(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.’’. 
(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 section 303(a)(3) 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 becoming aware of the infor-
mation.’’. 
(c) INCREASED FUNDING FOR INSPECTIONS, EXAMI-
NATIONS, AND INVESTIGATIONS.—For the purpose of in-
creasing the capacity of the Food and Drug Administra-
tion to conduct inspections, examinations, and investiga-
tions under the Federal Food, Drug, and Cosmetic Act 
with respect to violations described in section 303(a)(3) 
of such Act, there is authorized to be appropriated 
$60,000,000 for each of the fiscal years 2004 through 
2008, in addition to other authorizations of appropriations 
that are available for such purpose. 
SEC. 4. OTHER CRIMINAL PENALTIES; CLARIFICATION RE-
GARDING FINES. 
Section 303 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 333) is amended—
(1) in subsection (a)—