I
107TH CONGRESS
2D SESSION
H. R. 4614
To permit commercial importation of prescription drugs from Canada, and
for other purposes.
IN THE HOUSE OF REPRESENTATIVES
APRIL 25, 2002
Mr. SANDERS introduced the following bill; which was referred to the
Committee on Energy and Commerce
A BILL
To permit commercial importation of prescription drugs from
Canada, 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. 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:
‘‘(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
‘‘(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
period of time as the Secretary determines to be nec-
essary.
‘‘(e) TESTING.—The regulations under subsection (b)
shall require—
‘‘(1) that testing described in subparagraphs
(J) and (L) of subsection (d)(1) be conducted by the
importer or by the manufacturer of the prescription
drug at a qualified laboratory;
‘‘(2) if the tests are conducted by the
importer—
‘‘(A) that information needed to—
‘‘(i) authenticate the prescription drug
being tested; and
‘‘(ii) confirm that the labeling of the
prescription drug complies with labeling re-
quirements under this Act;
be supplied by the manufacturer of the pre-
scription drug to the pharmacist or wholesaler;
and
‘‘(B) that the information supplied under
subparagraph (A) be kept in strict confidence
and used only for purposes of testing or other-
wise complying with this Act; and
‘‘(3) may include such additional provisions as
the Secretary determines to be appropriate to pro-
vide for the protection of trade secrets and commer-
cial or financial information that is privileged or
confidential.
‘‘(f) REGISTRATION OF FOREIGN SELLERS.—Any es-
tablishment within Canada engaged in the distribution of
a prescription drug that is imported or offered for impor-
tation into the United States shall register with the Sec-
‘‘(k) WAIVER AUTHORITY FOR IMPORTATION BY IN-
DIVIDUALS.—
‘‘(1) DECLARATIONS.—Congress declares that
in the enforcement against individuals of the prohi-
bition of importation of prescription drugs and de-
vices, the Secretary should—
‘‘(A) focus enforcement on cases in which
the importation by an individual poses a signifi-
cant threat to public health; and
‘‘(B) exercise discretion to permit individ-
uals to make such importations in cir-
cumstances in which—
‘‘(i) the importation is clearly for per-
sonal use; and
‘‘(ii) the prescription drug or device
imported does not appear to present an
unreasonable risk to the individual.
‘‘(2) WAIVER AUTHORITY.—
‘‘(A) IN
GENERAL.—The Secretary may
grant to individuals, by regulation or on a case-
by-case basis, a waiver of the prohibition of im-
portation of a prescription drug or device or
class of prescription drugs or devices, under
such conditions as the Secretary determines to
be appropriate.
‘‘(B) GUIDANCE ON CASE-BY-CASE WAIV-
ERS.—The Secretary shall publish, and update
as necessary, guidance that accurately describes
circumstances in which the Secretary will con-
sistently grant waivers on a case-by-case basis
under subparagraph (A), so that individuals
may know with the greatest practicable degree
of certainty whether a particular importation
for personal use will be permitted.
‘‘(3) DRUGS
IMPORTED
FROM
CANADA.—In
particular, the Secretary shall by regulation grant
individuals a waiver to permit individuals to import
into the United States a prescription drug that—
‘‘(A) is imported from a licensed pharmacy
for personal use by an individual, not for resale,
in quantities that do not exceed a 90-day sup-
ply;
‘‘(B) is accompanied by a copy of a valid
prescription;
‘‘(C) is imported from Canada, from a sell-
er registered with the Secretary;
‘‘(D) is a prescription drug approved by
the Secretary under chapter V;
‘‘(E) is in the form of a final finished dos-
age that was manufactured in an establishment
registered under section 510; and
‘‘(F) is imported under such other condi-
tions as the Secretary determines to be nec-
essary to ensure public safety.
‘‘(l) STUDIES; REPORTS.—
‘‘(1) BY THE INSTITUTE OF MEDICINE OF THE
NATIONAL ACADEMY OF SCIENCES.—
‘‘(A) STUDY.—
‘‘(i) IN
GENERAL.—The Secretary
shall request that the Institute of Medicine
of the National Academy of Sciences con-
duct a study of—
‘‘(I) importations of prescription
drugs made under the regulations
under subsection (b); and
‘‘(II) 
information 
and 
docu-
mentation submitted under subsection
(d).
‘‘(ii) REQUIREMENTS.—In conducting
the study, the Institute of Medicine shall—
‘‘(I) evaluate the compliance of
importers with the regulations under
subsection (b);
‘‘(II) compare the number of
shipments 
under 
the 
regulations
under subsection (b) during the study
period that are determined to be
counterfeit, misbranded, or adulter-
ated, and compare that number with
the number of shipments made during
the study period within the United
States that are determined to be
counterfeit, misbranded, or adulter-
ated; and
‘‘(III) consult with the Secretary,
the United States Trade Representa-
tive, and the Commissioner of Patents
and Trademarks to evaluate the effect
of importations under the regulations
under subsection (b) on trade and
patent rights under Federal law.
‘‘(B) REPORT.—Not later than 2 years
after the effective date of the regulations under
subsection (b), the Institute of Medicine shall
submit to Congress a report describing the find-
ings of the study under subparagraph (A).
‘‘(2) BY THE COMPTROLLER GENERAL.—
‘‘(A) STUDY.—The Comptroller General of
the United States shall conduct a study to de-
termine the effect of this section on the price of
prescription drugs sold to consumers at retail.
‘‘(B) REPORT.—Not later than 18 months
after the effective date of the regulations under
subsection (b), the Comptroller General of the
United States shall submit to Congress a report
describing the findings of the study under sub-
paragraph (A).
‘‘(m) CONSTRUCTION.—Nothing in this section limits
the authority of the Secretary relating to the importation
of prescription drugs, other than with respect to section
801(d)(1) as provided in this section.
‘‘(n) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated such sums as are nec-
essary to carry out this section.’’.
(b) 
CONFORMING
AMENDMENTS.—The 
Federal
Food, Drug, and Cosmetic Act is amended—
(1) in section 301(aa) (21 U.S.C. 331(aa)), by
striking ‘‘covered product in violation of section
804’’ and inserting ‘‘prescription drug in violation of
section 804’’;
(2) in section 303(a)(6) (21 U.S.C. 333(a)(6),
by striking ‘‘covered product pursuant to section