I
108TH CONGRESS
2D SESSION
H. R. 3710
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
importation of prescription drugs.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 20, 2004
Mr. WEXLER 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 with
respect to the importation of prescription drugs.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. IMPORTATION OF PRESCRIPTION DRUGS.
(a) IN GENERAL.—Chapter VIII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.)
is amended by striking section 804 and inserting the fol-
lowing:
‘‘SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS.
‘‘(a) DEFINITIONS.—In this section:
‘‘(1) IMPORTER.—The term ‘importer’ means a
pharmacist or wholesaler.
‘‘(2) PHARMACIST.—The term ‘pharmacist’
means a person licensed by a State to practice phar-
macy, including the dispensing and selling of pre-
scription drugs.
‘‘(3) PRESCRIPTION
DRUG.—The term ‘pre-
scription drug’ means a drug subject to section
503(b), other than—
‘‘(A) a controlled substance (as defined in
section 102 of the Controlled Substances Act
(21 U.S.C. 802));
‘‘(B) a biological product (as defined in
section 351 of the Public Health Service Act
(42 U.S.C. 262));
‘‘(C) an infused drug (including a peri-
toneal dialysis solution);
‘‘(D) an intravenously injected drug;
‘‘(E) a drug that is inhaled during surgery;
or
‘‘(F) a drug which is a parenteral drug,
the importation of which pursuant to subsection
(b) is determined by the Secretary to pose a
threat to the public health, in which case sec-
tion 801(d)(1) shall continue to apply.
‘‘(4) QUALIFYING
LABORATORY.—The term
‘qualifying laboratory’ means a laboratory in the
United States that has been approved by the Sec-
retary for the purposes of this section.
‘‘(5) WHOLESALER.—
‘‘(A) IN GENERAL.—The term ‘wholesaler’
means a person licensed as a wholesaler or dis-
tributor of prescription drugs in the United
States under section 503(e)(2)(A).
‘‘(B) EXCLUSION.—The term ‘wholesaler’
does not include a person authorized to import
drugs under section 801(d)(1).
‘‘(b) REGULATIONS.—The Secretary, after consulta-
tion with the United States Trade Representative and the
Commissioner of Customs, shall promulgate regulations
permitting pharmacists and wholesalers to import pre-
scription drugs from Canada into the United States.
‘‘(c) LIMITATION.—The regulations under subsection
(b) shall—
‘‘(1) require that safeguards be in place to en-
sure that each prescription drug imported under the
regulations complies with section 505 (including
with respect to being safe and effective for the in-
tended use of the prescription drug), with sections
501 and 502, and with other applicable require-
ments of this Act;
‘‘(2) require that an importer of a prescription
drug under the regulations comply with subsections
(d)(1) and (e); and
‘‘(3) contain any additional provisions deter-
mined by the Secretary to be appropriate as a safe-
guard to protect the public health or as a means to
facilitate the importation of prescription drugs.
‘‘(d) INFORMATION AND RECORDS.—
‘‘(1) IN GENERAL.—The regulations under sub-
section (b) shall require an importer of a prescrip-
tion drug under subsection (b) to submit to the Sec-
retary the following information and documentation:
‘‘(A) The name and quantity of the active
ingredient of the prescription drug.
‘‘(B) A description of the dosage form of
the prescription drug.
‘‘(C) The date on which the prescription
drug is shipped.
‘‘(D) The quantity of the prescription drug
that is shipped.
‘‘(E) The point of origin and destination of
the prescription drug.
‘‘(F) The price paid by the importer for
the prescription drug.
‘‘(G) Documentation from the foreign sell-
er specifying—
‘‘(i) the original source of the pre-
scription drug; and
‘‘(ii) the quantity of each lot of the
prescription drug originally received by the
seller from that source.
‘‘(H) The lot or control number assigned
to the prescription drug by the manufacturer of
the prescription drug.
‘‘(I) The name, address, telephone number,
and professional license number (if any) of the
importer.
‘‘(J)(i) In the case of a prescription drug
that is shipped directly from the first foreign
recipient of the prescription drug from the
manufacturer:
‘‘(I) 
Documentation 
demonstrating
that the prescription drug was received by
the recipient from the manufacturer and
subsequently shipped by the first foreign
recipient to the importer.
‘‘(II) Documentation of the quantity
of each lot of the prescription drug re-
ceived by the first foreign recipient dem-
onstrating that the quantity being im-
ported into the United States is not more
than the quantity that was received by the
first foreign recipient.
‘‘(III)(aa) In the case of an initial im-
ported 
shipment, 
documentation 
dem-
onstrating that each batch of the prescrip-
tion drug in the shipment was statistically
sampled and tested for authenticity and
degradation.
‘‘(bb) In the case of any subsequent
shipment, documentation demonstrating
that a statistically valid sample of the ship-
ment was tested for authenticity and deg-
radation.
‘‘(ii) In the case of a prescription drug
that is not shipped directly from the first for-
eign recipient of the prescription drug from the
manufacturer, 
documentation 
demonstrating
that each batch in each shipment offered for
importation into the United States was statis-
tically sampled and tested for authenticity and
degradation.
‘‘(K) Certification from the importer or
manufacturer of the prescription drug that the
prescription drug—
‘‘(i) is approved for marketing in the
United States and is not adulterated or
misbranded; and
‘‘(ii) meets all labeling requirements
under this Act.
‘‘(L) Laboratory records, including com-
plete data derived from all tests necessary to
ensure that the prescription drug is in compli-
ance with established specifications and stand-
ards.
‘‘(M) Documentation demonstrating that
the testing required by subparagraphs (J) and
(L) was conducted at a qualifying laboratory.
‘‘(N) Any other information that the Sec-
retary determines is necessary to ensure the
protection of the public health.
‘‘(2) MAINTENANCE BY THE SECRETARY.—The
Secretary shall maintain information and docu-
mentation submitted under paragraph (1) for such