I 
108TH CONGRESS 
1ST SESSION H. R. 2769
To permit commercial importation of prescription drugs from Canada, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 17, 2003
Mrs. EMERSON 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. SHORT TITLE. 
This Act may be cited as the ‘‘Save Our Seniors Act 
of 2003’’. 
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; 
‘‘(E) a drug that is inhaled during surgery; 
or 
‘‘(F) a drug that 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 section 
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.—
‘‘(1) IMPORTATION FROM CANADA.—The Sec-
retary shall promulgate regulations permitting phar-
macists and wholesalers to import prescription drugs 
from Canada into the United States. 
‘‘(2) IMPORTATION FROM EUROPEAN UNION.—
Not sooner than 3 years after the date of the enact-
ment of the Save Our Seniors Act of 2003, if the 
Secretary finds that drugs imported from Canada 
into the United States under this section have 
proved safe and effective, the Secretary may expand
the application of regulations promulgated under 
this section to permit pharmacists and wholesalers 
to import prescription drugs from any member of 
the European Union into the United States. 
‘‘(c) LIMITATION.—The regulations under subsection 
(b)—
‘‘(1) shall require that safeguards be in place to 
ensure 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) shall require that an importer of a pre-
scription drug under the regulations comply with 
subsections (d)(1) and (e); 
‘‘(3) may require the incorporation of—
‘‘(A) overt optically variable counterfeit re-
sistant packaging technologies that—
‘‘(i) are visible to the naked eye; 
‘‘(ii) are similar to the technologies 
used by the Bureau of Engraving and 
Printing to secure United States currency;
‘‘(iii) are manufactured and distrib-
uted in a highly secure, tightly controlled 
environment; and 
‘‘(iv) incorporate any additional visible 
and non-visible security features deter-
mined to be appropriate by the Secretary; 
or 
‘‘(B) technologies that are determined by 
the Secretary to have a function of security 
equivalent to such optically variable counterfeit 
resistant packaging technologies; and 
‘‘(4) may contain any additional provisions de-
termined by the Secretary to be appropriate as a 
safeguard 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 manufacturer or the original 
source of the prescription 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, 
documentation 
demonstrating
that the prescription drug was received by the 
recipient from the manufacturer and subse-
quently shipped by the recipient to the im-
porter. 
‘‘(ii) In the case of any subsequent ship-
ment, documentation identifying each prior 
sale, purchase, or trade of the prescription drug 
(including the date of the transaction and the 
names and addresses of all parties to the trans-
action). 
‘‘(iii) Documentation of the quantity of 
each lot of the prescription drug received by the 
first foreign recipient demonstrating that the 
quantity being imported into the United States 
is not more than the quantity that was received 
by the first foreign recipient. 
‘‘(iv)(I) In the case of an initial imported 
shipment from the recipient involved, docu-
mentation demonstrating that each batch of the 
prescription drug in the shipment was statis-
tically sampled and tested for authenticity and 
degradation. 
‘‘(II) In the case of any subsequent ship-
ment, documentation demonstrating that a sta-
tistically valid sample of the shipment was test-
ed for authenticity and degradation. 
‘‘(K) Certification from the importer 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 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 (or within any member of the 
European Union with respect to which the Secretary pro-
mulgates regulations under subsection (b)(2)) engaged in 
the distribution of a prescription drug that is imported 
or offered for importation into the United States shall reg-
ister with the Secretary the name and place of business 
of the establishment. 
‘‘(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) OPEN MARKET ACCESS.—
‘‘(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) APPLICATION.—For the purposes of para-
graph (1), a manufacturer of a prescription drug 
shall be considered to discriminate against a phar-
macist 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.—The Congress declares 
that in the enforcement against individuals of the 
prohibition of importation of prescription drugs and 
devices, 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, with a valid 
prescription, not for resale, in quantities that 
do not exceed a 90-day supply;
‘‘(B) is imported from Canada, or from 
any member of the European Union with re-
spect to which the Secretary promulgates regu-
lations under subsection (b)(2), from a seller 
registered with the Secretary; 
‘‘(C) is a prescription drug approved by 
the Secretary under chapter V; 
‘‘(D) is in the form of a final finished dos-
age that was manufactured in an establishment 
registered under section 510; and 
‘‘(E) 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 
to evaluate the effect of importations 
under the regulations under sub-
section (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 the Congress a report describing the 
findings 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 the Congress a 
report describing the findings of the study 
under subparagraph (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’’; and 
(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)’’.
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