I 
108TH CONGRESS 
1ST SESSION H. R. 2717
To amend the Federal Food, Drug, and Cosmetic Act to establish a program 
to provide for the voluntary certification of Internet and mail-order 
pharmacies, to amend such Act to authorize, subject to certain conditions, 
the importation by individuals of prescription drugs from Canada for 
personal use, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 14, 2003
Mr. BROWN of Ohio (for himself, Mr. STARK, and Mr. HINCHEY) 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 a program to provide for the voluntary certifi-
cation of Internet and mail-order pharmacies, to amend 
such Act to authorize, subject to certain conditions, the 
importation by individuals of prescription drugs from 
Canada for personal use, 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 ‘‘Affordable Medicine 
Safety and Access Act’’. 
TITLE I—INTERNET AND MAIL-
ORDER PHARMACIES 
SEC. 
101. 
VOLUNTARY 
CERTIFICATIONS 
REGARDING 
INTERNET AND MAIL-ORDER PHARMACIES. 
(a) IN GENERAL.—Chapter 5 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 503A the following section: 
‘‘SEC. 503B. VOLUNTARY CERTIFICATIONS REGARDING 
INTERNET AND MAIL-ORDER PHARMACIES. 
‘‘(a) IN
GENERAL.—The Secretary, directly or 
through contract with one or more public or nonprofit pri-
vate entities, shall establish a program under which Inter-
net and mail-order pharmacies, on a voluntary basis, are 
certified by the Secretary as meeting the requirements of 
this section for certification. 
‘‘(b) SEAL.—The Secretary shall provide for a seal 
that Internet and mail-order pharmacies certified under 
subsection (a) are authorized to display for purposes of 
indicating to the public the fact of such certification. 
‘‘(c) CONDITIONS FOR CERTIFICATION.—As a condi-
tion of certifying an Internet or mail-order pharmacy 
under subsection (a), the Secretary shall require the fol-
lowing with respect to such pharmacy:
‘‘(1) Verification that, in each State in which 
the pharmacy engages in pharmaceutical activities, 
the pharmacy, and all the employees and agents of 
the pharmacy, are in compliance with applicable 
laws regarding—
‘‘(A) the practice of pharmacy, including 
licensing laws; and 
‘‘(B) the manufacturing and distribution of 
controlled substances, including with respect to 
mailing or shipping such substances to con-
sumers. 
‘‘(2) Controls to ensure that a prescription drug 
is dispensed by the pharmacy only pursuant to a 
valid prescription, including circumstance in which 
the drug is shipped or mailed from a country under 
whose laws the drug is not a prescription drug. 
‘‘(3) The prominent display of contact informa-
tion for the pharmacy, including a telephone num-
ber, an electronic mail address, a mailing address, 
and (if different from the mailing address) the ad-
dress for the physical location of the principal place 
of business of the pharmacy. 
‘‘(4) The prominent display of complete and ac-
curate information concerning the ownership and
management of the pharmacy, including addresses 
and contact information. 
‘‘(5) A certification from the person who owns 
or manages the pharmacy that a certification under 
subsection (a) for the pharmacy has not previously 
been terminated by the Secretary, and that no other 
Internet or mail-order pharmacy owned or managed 
by such person has received a certification under 
subsection (a) that has been terminated by the Sec-
retary. 
‘‘(6) An agreement by the pharmacy that, upon 
certification under subsection (a), the facilities and 
business practices of the pharmacy will be subject to 
inspection by the Secretary to the extent appropriate 
to determine whether the pharmacy is in compliance 
with conditions under this subsection. 
‘‘(7) Meaningful and accessible opportunities 
for a consumer to consult with a licensed pharmacist 
regarding a drug prior to the time at which the 
pharmacy dispenses the drug to the consumer. 
‘‘(8) Controls to ensure that, prior to dis-
pensing a drug to a consumer, a prospective review 
of the use of the drug by the consumer is completed, 
based on accurate information about the consumer
and the medication profiles of the consumer and 
other pertinent medical information. 
‘‘(9) Effective, accessible systems for commu-
nication with consumers, including systems for con-
sumer reporting of adverse drug reactions and er-
rors, systems by which consumers can effectively 
track and report problems with unfulfilled orders, 
systems for the investigation and redress of con-
sumer complaints, and systems facilitating effective 
communication between the pharmacy and con-
sumers concerning drug recalls. 
‘‘(10) Controls to ensure the protection of pa-
tient privacy and confidentiality, including but not 
limited to the prevention of unauthorized internal 
and external use of personally-identifiable patient in-
formation. 
‘‘(11) An agreement by the pharmacy that the 
pharmacy will notify the Secretary within 10 days 
concerning any change in information submitted 
under this subsection as a condition of certification 
under subsection (a). 
‘‘(12) Such additional criteria as the Secretary 
determines, after notice and opportunity for com-
ment, to be appropriate for the sound operation of 
certified pharmacies or the protection of consumers.
‘‘(d) ANNUAL APPLICATION; DURATION OF CERTIFI-
CATION.—
‘‘(1) IN GENERAL.—The Secretary may certify 
an Internet or mail-order pharmacy under sub-
section (a) only if the pharmacy submits to the Sec-
retary an application for such certification that dem-
onstrates compliance with the conditions under sub-
section (c) and is in such form, and is made in such 
manner, as the Secretary may require. The Sec-
retary shall establish an application form for pur-
poses of the preceding sentence, including an elec-
tronic application form. 
‘‘(2) 
DURATION
OF
CERTIFICATION; 
RE-
NEWAL.—
‘‘(A) IN GENERAL.—A certification under 
subsection (a) is effective for the one-year pe-
riod beginning on the date on which the appli-
cation under paragraph (1) for such certifi-
cation is approved by the Secretary. The Sec-
retary may renew the certification, pursuant to 
the submission of an additional application 
under paragraph (1), and the number of renew-
als of the certification is not limited. The Sec-
retary may establish an abbreviated process for 
such renewal applications.
‘‘(B) RENEWAL EVALUATION.—Before re-
newing a certification under subsection (a), the 
Secretary shall conduct an evaluation to deter-
mine whether the pharmacy involved is in com-
pliance with the conditions under subsection 
(c). The evaluation, at the Secretary’s discre-
tion and as applicable, may include testing of 
the Internet site of the pharmacy or other sys-
tems through which the pharmacy commu-
nicates with consumers, and may include phys-
ical inspection of the records and premises of 
the pharmacy pursuant to subsection (c)(6). 
‘‘(e) FEES.—The Secretary may impose a fee on the 
submission of an application under subsection (d). Any 
such fee is due upon the submission of the application. 
To the extent provided in appropriations Acts, such fees 
are available to the Secretary for carrying out this section. 
‘‘(f) INFORMATION CAMPAIGN.—The Secretary shall 
carry out activities to inform the public of the program 
under subsection (a), including information on the signifi-
cance of the seal under subsection (b) when displayed by 
an Internet or mail-order pharmacy, and including infor-
mation on the benefits of doing business with a pharmacy 
certified under subsection (a) as compared to a pharmacy 
that is not so certified.
‘‘(g) TERMINATION OF CERTIFICATION.—The Sec-
retary, upon the own initiative of the Secretary or a peti-
tion by an interested person, may terminate a certification 
under subsection (a), after notice to the Internet or mail-
order pharmacy involved and an opportunity for a hearing. 
‘‘(h) CONTRACT FOR OPERATION OF PROGRAM.—
‘‘(1) DETERMINATION REGARDING USE OF CON-
TRACT
AUTHORITY.—The Secretary may award a 
contract under subsection (a) for the operation of 
the program under such subsection only if the Sec-
retary determines that the administration by the 
contractor of such program would be as protective or 
more protective of the public than direct administra-
tion of the program by the Secretary. 
‘‘(2) CERTAIN
REQUIREMENTS.—With respect 
to a contract under subsection (a): 
‘‘(A) The duration of the contract may not 
exceed two years. 
‘‘(B) The Secretary may renew the con-
tract, subject to compliance with subparagraph 
(A). 
‘‘(C) The Secretary shall annually review 
performance under the contract.
‘‘(D) The contract shall specify that the 
Secretary may terminate the contract for unsat-
isfactory performance under the contract. 
‘‘(i) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘Internet pharmacy’ means a 
pharmacy that, by shipping, mailing, or transporting 
a prescription drug, dispenses such drug pursuant to 
a sale of the drug by the pharmacy in circumstances 
in which the purchaser of the drug submitted the 
purchase order for the drug, or conducted any other 
part of the sales transaction for the drug, through 
an Internet site. 
‘‘(2) The term ‘mail-order pharmacy’ means a 
pharmacy that, by shipping, mailing, or transporting 
a prescription drug, dispenses such drug pursuant to 
a sale of the drug by the pharmacy in circumstances 
in which the purchaser of the drug submitted the 
purchase order for the drug, or conducted any other 
part of the sales transaction for the drug, through 
the mail or through any telecommunications means 
other than an Internet site. 
‘‘(3)(A) Subject to subparagraph (B), the term 
‘pharmacy’ means an organization licensed by a 
State to practice pharmacy, including the dispensing 
and selling of prescription drugs.
‘‘(B) The Secretary shall consider an organiza-
tion as meeting the definition established in sub-
paragraph (A) if the Secretary determines that the 
organization would qualify for licensure in at least 
one of the States but for a policy of such State that 
denies licensure as a pharmacy on the basis that the 
organization dispenses prescription drugs from loca-
tions in Canada or dispenses prescription drugs ob-
tained by such organization from an entity in Can-
ada. 
‘‘(4) The term ‘prescription drug’ means a drug 
subject to section 503(b).’’. 
(b) UNAUTHORIZED
DISPLAY
OF
SEAL; FALSE 
CLAIMS.—Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at 
the end the following: 
‘‘(hh) The display by an Internet or mail-order phar-
macy of the seal under section 503B without a certifi-
cation in effect under such section for the pharmacy, or 
the making by such a pharmacy of a false claim that such 
a certification is in effect for the pharmacy.’’.
TITLE II—PERSONAL IMPORTA-
TION 
OF 
PRESCRIPTION 
DRUGS FROM CANADA 
Subtitle A—Waiver Requirement 
SEC. 201. WAIVER REQUIREMENT FOR PERSONAL IMPOR-
TATION OF PRESCRIPTION DRUGS FROM 
CANADA. 
Chapter VIII of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381 et seq.) is amended by adding 
at the end the following section: 
‘‘WAIVER REQUIREMENT FOR PERSONAL IMPORTATION 
OF PRESCRIPTION DRUGS FROM CANADA 
‘‘SEC. 805. With respect to the importation by indi-
viduals of prescription drugs from Canada, the Secretary 
shall in accordance with this section establish by regula-
tion a waiver of prohibitions under this Act that apply to 
the importation of drugs. Such a waiver shall permit an 
individual to import into the United States any prescrip-
tion drug that—
‘‘(1) is imported from Canada for personal use 
by the individual (not for resale); 
‘‘(2) is approved by the Secretary under section 
505, is manufactured in an establishment registered 
with the Secretary under section 510, and is not a
controlled substance in schedule I, II, or III under 
section 202(c) of the Controlled Substances Act; 
‘‘(3) is imported from a Canadian pharmacy 
that has submitted to the Secretary a registration 
that identifies the pharmacy and provides docu-
mentation that the pharmacy is licensed in Canada; 
‘‘(4) is imported in a quantity that does not 
(for that instance of importation) exceed a 90-day 
supply; 
‘‘(5) at the time of importation, is accompanied 
by a copy of a valid prescription for the drug for the 
individual, issued in the United States by a practi-
tioner in accordance with section 503(b), or is ac-
companied by documentation that verifies the 
issuance of such a prescription for the individual; 
‘‘(6) is in the form of a final finished dosage; 
and 
‘‘(7) is imported under such other conditions as 
the Secretary determines to be necessary to ensure 
public safety.’’. 
Subtitle B—Studies 
SEC. 211. STUDY REGARDING IN-PERSON PERSONAL IM-
PORTATION FROM CANADA. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this subtitle as the ‘‘Sec-
retary’’), acting through the Commissioner of Food and 
Drugs, shall conduct a study for the purpose of developing 
recommendations regarding any legislative or administra-
tive changes that may be necessary to provide reasonable 
assurance concerning the safety and effectiveness of pre-
scription drugs that are purchased in-person at a licensed 
pharmacy in Canada and imported from Canada into the 
United States for personal use by individuals who are not 
in the business of importing such drugs (referred to in 
this section with respect to such drugs as ‘‘in-person per-
sonal importation’’). Not later than 18 months after the 
date of the enactment of this Act, the Secretary shall sub-
mit to the Congress a report describing the findings of 
such study. 
(b) CERTAIN REQUIREMENTS.—The activities of the 
Secretary in carrying out the study under subsection (a) 
shall include the following: 
(1) With respect to prescription drugs that are 
commonly purchased from Canadian pharmacies for 
in-person personal importation, the purchase of a 
representative sample of such drugs at randomly-se-
lected Canadian pharmacies that are representative 
of Canadian pharmacies from which prescription 
drugs are purchased for personal importation.
(2) Determining, for purposes of laws and regu-
lations administered by the Food and Drug Adminis-
tration, the safety and effectiveness of the prescrip-
tion drugs that are purchased under paragraph (1). 
(3) Making a comparison of laws and regula-
tions referred to in paragraph (2) with the Canadian 
system for the regulation of the safety and effective-
ness of prescription drugs. 
(c) ADVISORY BOARD.—The Secretary shall establish 
an advisory board for the purpose of providing advice to 
the Secretary regarding the design of the study under sub-
section (a) and regarding the development of recommenda-
tions in the study. The membership of the advisory board 
shall include representatives of the Directorate of Border 
and Transportation Security (Department of Homeland 
Security); the comparable agency or agencies of the Cana-
dian government; health officials of State and local gov-
ernments; pharmacists in the United States; and physi-
cians and patients in the United States. 
SEC. 212. STUDY REGARDING INTERNET AND MAIL-ORDER 
PHARMACIES CLAIMING CANADIAN SOURCES 
FOR PRESCRIPTION DRUGS. 
With respect to prescription drugs that are commonly 
prescribed in the United States, the Secretary, acting
through the Commissioner of Food and Drugs, shall con-
duct a study through which the Secretary—
(1) makes purchases of such drugs from Inter-
net pharmacies and mail-order pharmacies that 
make sales to consumers in the United States and 
claim such drugs are obtained from Canadian phar-
macies or wholesalers, which purchases are a rep-
resentative sample of such drugs purchased from 
such pharmacies; and 
(2) determines whether the drugs purchased 
under paragraph (1) are approved for commercial 
distribution in Canada and are obtained from Cana-
dian pharmacies or wholesalers. 
The Secretary shall seek the cooperation of the Govern-
ment of Canada in making the determination under para-
graph (2). Not later than 18 months after the date of the 
enactment of this Act, the Secretary shall submit to the 
Congress a report describing the findings of such study.
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