I 
108TH CONGRESS 
1ST SESSION H. R. 2497
To permit commercial importation of prescription drugs from Canada, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 17, 2003
Mr. SANDERS
(for himself, Mr. BROWN
of Ohio, Mr. OLVER, Mrs. 
NAPOLITANO, Mr. SERRANO, Ms. LEE, Ms. CORRINE BROWN of Florida, 
Mr. MURTHA, Mr. HOLDEN, Mr. PALLONE, Mr. PAUL, Mr. LANTOS, Mr. 
FILNER, Mr. FROST, Ms. BALDWIN, Mr. FRANK of Massachusetts, Mr. 
CONYERS, Mr. HINCHEY, Mr. TIERNEY, Mr. ABERCROMBIE, Mr. WYNN, 
Ms. SLAUGHTER, Mr. NADLER, Ms. NORTON, Mr. COSTELLO, Mr. 
OWENS, Mr. CROWLEY, Mr. KLECZKA, Mr. KUCINICH, Mr. CASE, Mr. 
DEFAZIO, Ms. WOOLSEY, and Mr. DAVIS of Illinois) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce 
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. SHORT TITLE. 
This Act may be cited as the ‘‘Prescription Drug Par-
ity for Americans Act’’.
SEC. 2. 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; or 
‘‘(E) a drug that is inhaled during surgery.
‘‘(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-
‘‘(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 im-
porter—
‘‘(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-
retary the name and place of business of the establish-
ment. 
‘‘(g) SUSPENSION OF IMPORTATION.—The Secretary 
shall require that importations of a specific prescription 
drug or importations by a specific importer under sub-
section (b) be immediately suspended on discovery of a 
pattern of importation of the prescription drugs or by the 
importer that is counterfeit or in violation of any require-
ment under this section, until an investigation is com-
pleted and the Secretary determines that the public is ade-
quately protected from counterfeit and violative prescrip-
tion drugs being imported under subsection (b). 
‘‘(h) APPROVED LABELING.—The manufacturer of a 
prescription drug shall provide an importer written au-
thorization for the importer to use, at no cost, the ap-
proved labeling for the prescription drug. 
‘‘(i) PROHIBITION OF DISCRIMINATION.—
‘‘(1) IN GENERAL.—It shall be unlawful for a 
manufacturer of a prescription drug to discriminate
against, or cause any other person to discriminate 
against, a pharmacist or wholesaler that purchases 
or offers to purchase a prescription drug from the 
manufacturer or from any person that distributes a 
prescription drug manufactured by the drug manu-
facturer. 
‘‘(2) DISCRIMINATION.—For the purposes of 
paragraph (1), a manufacturer of a prescription 
drug shall be considered to discriminate against a 
pharmacist or wholesaler if the manufacturer enters 
into a contract for sale of a prescription drug, places 
a limit on supply, or employs any other measure, 
that has the effect of—
‘‘(A) providing pharmacists or wholesalers 
access to prescription drugs on terms or condi-
tions that are less favorable than the terms or 
conditions provided to a foreign purchaser 
(other than a charitable or humanitarian orga-
nization) of the prescription drug; or 
‘‘(B) restricting the access of pharmacists 
or wholesalers to a prescription drug that is 
permitted to be imported into the United States 
under this section. 
‘‘(j) 
CHARITABLE
CONTRIBUTIONS.—Notwith-
standing any other provision of this section, section
801(d)(1) continues to apply to a prescription drug that 
is donated or otherwise supplied at no charge by the man-
ufacturer of the drug to a charitable or humanitarian or-
ganization (including the United Nations and affiliates) 
or to a government of a foreign country. 
‘‘(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 
804(a)’’ and inserting ‘‘prescription drug under sec-
tion 804(b)’’.
Æ