I 
109TH CONGRESS 
1ST SESSION 
H. R. 753 
To amend the Federal Food, Drug, and Cosmetic Act to protect the public 
health from the unsafe importation of prescription drugs and from coun-
terfeit prescription drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 10, 2005 
Mr. BRADLEY of New Hampshire 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 
protect the public health from the unsafe importation 
of prescription drugs and from counterfeit prescription 
drugs, 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; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Safe Importation of Medical Products and Other Rx 
Therapies Act of 2005’’ or the ‘‘Safe IMPORT Act of 
2005’’.
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Importation. 
Sec. 3. Protection against adulterated prescription drugs. 
Sec. 4. Internet pharmacies. 
Sec. 5. Administrative detention and temporary hold. 
Sec. 6. Suspension. 
Sec. 7. Debarment for repeated or serious prescription drug importation viola-
tions. 
Sec. 8. Registration of prescription drug importation facilities. 
Sec. 9. Maintenance and inspection of records for prescription drugs. 
Sec. 10. Advance notice of imported prescription drug shipments. 
Sec. 11. Authority to mark prescription drugs refused admission into the 
United States. 
Sec. 12. Prohibition of port shopping. 
Sec. 13. Authority to commission other Federal and State officials to conduct 
inspections. 
Sec. 14. User fees relating to prescription drug importation. 
Sec. 15. Anticounterfeiting provisions. 
Sec. 16. Conforming amendments. 
SEC. 2. IMPORTATION. 
(a) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 
is amended— 
(1) by inserting after the chapter heading the 
following: 
‘‘Subchapter A—General Provisions’’; and 
(2) by adding at the end the following: 
‘‘Subchapter B—Importation of Prescription 
Drugs 
‘‘SEC. 811. DEFINITIONS. 
‘‘In this subchapter: 
‘‘(1) DRUG IMPORTATION FACILITY.—The term 
‘drug importation facility’ means a person, other
than an individual importing a prescription drug 
under section 812, located outside the United States 
(other than a transporter) that engages in the dis-
tribution or dispensing of a prescription drug that is 
imported or offered for importation into the United 
States. 
‘‘(2) INTERNET PHARMACY.—The term ‘Inter-
net pharmacy’ means a person, other than an indi-
vidual importing a prescription drug under section 
812, that offers to dispense in the United States a 
prescription drug through an Internet website in 
interstate commerce, regardless of whether the phys-
ical location of the principal place of business of the 
Internet pharmacy is in the United States or in an-
other country. 
‘‘(3) PHARMACY.—The term ‘pharmacy’ means 
a person, other than an individual importing a pre-
scription drug under section 812, licensed by a State 
to dispense prescription drugs or to provide pharma-
ceutical care. 
‘‘(4) PERMITTED COUNTRY.— 
‘‘(A) IN GENERAL.—The term ‘permitted 
country’ means a country that— 
‘‘(i) was a member of the European 
Union as of December 31, 2003; and
‘‘(ii) is designated by the Secretary as 
a permitted country under subparagraph 
(B). 
‘‘(B) REPORT.—Three years after the date 
of enactment of this subchapter, the Secretary 
shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and 
to the Committee on Energy and Commerce of 
the House of Representatives a report that in-
cludes— 
‘‘(i) a list of countries under subpara-
graph (A)(i) designated by the Secretary 
from which a prescription drug shall be 
permitted to be imported into the United 
States under this subchapter, and the basis 
for the Secretary’s determination that the 
importation of a prescription drug from 
such countries would not present an in-
creased risk to the public health; 
‘‘(ii) a list of countries under subpara-
graph (A)(i) from which a prescription 
drug shall not be permitted to be imported 
into the United States under this sub-
chapter, and the basis for Secretary’s de-
termination that the importation of a pre-
scription drug from such countries would 
present an increased risk to the public 
health; 
‘‘(iii) for countries identified in clause 
(i), any additional measures that could be 
taken to ensure that there will be no in-
creased risk to the public health; and 
‘‘(iv) for countries identified in clause 
(ii), any additional measures that could be 
taken to avoid, reduce, or mitigate such in-
creased risk to the public health. 
‘‘(C) 
DETERMINATION.—The 
Secretary 
may determine whether to designate a per-
mitted country at any time after submission of 
the report under subparagraph (B). 
‘‘(5) PRESCRIPTION DRUG.— 
‘‘(A) IN GENERAL.—The term ‘prescription 
drug’ means a drug described in section 503(b) 
that is approved by the Secretary under section 
505. 
‘‘(B) EXCLUSIONS.—The term ‘prescrip-
tion drug’ does not include— 
‘‘(i) a controlled substance (as defined 
in section 102 of the Controlled Sub-
stances Act (21 U.S.C. 802));
‘‘(ii) a biological product (as defined 
in section 351 of the Public Health Service 
Act (42 U.S.C. 262)); 
‘‘(iii) an infused drug (including a 
peritoneal dialysis solution); 
‘‘(iv) an intravenously injected drug; 
‘‘(v) a drug that is inhaled during sur-
gery; 
‘‘(vi) a parenteral drug; 
‘‘(vii) a drug manufactured through 1 
or more biotechnology processes, includ-
ing— 
‘‘(I) a therapeutic DNA plasmid 
product; 
‘‘(II) 
a 
therapeutic 
synthetic 
peptide product of not more than 40 
amino acids; 
‘‘(III) a monoclonal antibody 
product for in vivo use; and 
‘‘(IV) a therapeutic recombinant 
DNA-derived product; 
‘‘(viii) a drug required to be refrig-
erated at any time during manufacturing, 
packing, processing, or holding; or 
‘‘(ix) a photoreactive drug.
‘‘(6) TREATING PROVIDER.—The term ‘treating 
provider’ means a licensed health care provider 
that— 
‘‘(A)(i) performs a documented patient 
evaluation (including a patient history and 
physical examination) of an individual to estab-
lish the diagnosis for which a prescription drug 
is prescribed; 
‘‘(ii) discusses with the individual the 
treatment options of the individual and the 
risks and benefits of treatment; and 
‘‘(iii) maintains contemporaneous medical 
records concerning the individual; or 
‘‘(B) provides care to an individual as part 
of an on-call or cross-coverage arrangement 
with a health care provider described in sub-
paragraph (A). 
‘‘(7) WHOLESALER.— 
‘‘(A) IN GENERAL.—The term ‘wholesaler’ 
means a person licensed as a wholesaler or dis-
tributor of prescription drugs in the United 
States as described in section 503(e)(2). 
‘‘(B) EXCLUSION.—The term ‘wholesaler’ 
does not include—
‘‘(i) a person authorized to import 
drugs under section 801(d)(1); or 
‘‘(ii) an individual importing a pre-
scription drug under section 812. 
‘‘SEC. 812. PERSONAL IMPORTATION. 
‘‘(a) IN GENERAL.—An individual may import a pre-
scription drug from Canada or a permitted country into 
the United States for personal use (not for resale), subject 
to subsections (b) and (c). 
‘‘(b) IMPORTATION.—An individual may import a 
prescription drug if— 
‘‘(1) the prescription drug is purchased from a 
licensed pharmacy in Canada or a licensed pharmacy 
in a permitted country and dispensed in compliance 
with the applicable laws of Canada or the permitted 
country regarding the practice of pharmacy; 
‘‘(2) the prescription drug is imported for per-
sonal use (not for resale) by the individual; 
‘‘(3) the prescription drug is imported from 
Canada or a permitted country into the United 
States; 
‘‘(4) the prescription drug is imported by the 
individual on the person of the individual;
‘‘(5) the quantity of the prescription drug im-
ported does not exceed a 90-day supply during any 
90-day period; and 
‘‘(6) the prescription drug is accompanied by— 
‘‘(A) a copy of a prescription valid in a 
State and cosigned by a prescribing physician 
in Canada or the permitted country; or 
‘‘(B) if the prescription drug is available in 
Canada or the permitted country without a pre-
scription, a copy of the valid prescription signed 
by a pharmacist licensed in Canada or the per-
mitted country. 
‘‘(c) COMPASSIONATE USE.—The Secretary may per-
mit an individual to import an up to a 90-day supply of 
a drug that is not approved by the Secretary under section 
505 if the importation is for continuation of personal use 
by the individual for treatment, begun in a foreign coun-
try, of a serious medical condition. 
‘‘SEC. 813. PHARMACY AND WHOLESALER IMPORTATION OF 
PRESCRIPTION DRUGS. 
‘‘(a) IN GENERAL.— 
‘‘(1) IMPORTATION.—A drug importation facil-
ity, pharmacy, Internet pharmacy, or wholesaler may 
import a prescription drug from Canada or a per-
mitted country into the United States for dispensing
in the United States in accordance with this sub-
chapter. 
‘‘(2) LIMITATION
TO
CERTAIN
PORTS.—The 
Secretary may limit the ports of entry in the United 
States through which a prescription drug may be 
imported under this section to a reasonable number 
of ports designated by the Secretary. 
‘‘(b) REQUIREMENTS.—Each prescription drug im-
ported under this subchapter shall— 
‘‘(1) be approved under section 505; 
‘‘(2) comply with sections 501 and 502; 
‘‘(3) be in a container that bears a label stat-
ing, in prominent and conspicuous type— 
‘‘(A) the lot number of the prescription 
drug; 
‘‘(B) the name, address and phone number 
of the drug importation facility; 
‘‘(C) the following: ‘This drug has been im-
ported from lllll.’, with the name of the 
permitted country from which the prescription 
drug is imported in the blank space; and 
‘‘(D) a unique identifier code provided by 
the Secretary that modifies the national drug 
code of the prescription drug to indicate that 
the drug has been imported; and
‘‘(4) comply with any other applicable require-
ment of this Act. 
‘‘(c) APPROVED LABELING.— 
‘‘(1) IN GENERAL.—A drug importation facility 
that offers for importation a prescription drug under 
this subchapter shall submit to the Secretary an ap-
plication for approval that demonstrates that the la-
beling of the prescription drug to be imported into 
the United States complies with the requirements of 
sections 502 and 503. 
‘‘(2) PROCEDURE.—Not later than 60 days 
after receipt of a completed application under para-
graph (1), the Secretary shall— 
‘‘(A) approve or deny the application con-
sistent with the requirements of sections 502 
and 503; and 
‘‘(B) notify the applicant of the decision of 
the Secretary and, if the application is denied, 
the reason for the denial. 
‘‘(3) LISTS.— 
‘‘(A) APPLICATIONS.—The Secretary shall 
maintain an updated list of applications pend-
ing, applications approved, and applications de-
nied under this subsection.
‘‘(B) PORTS.—The Secretary shall main-
tain an updated list of ports through which a 
prescription drug may be imported under this 
section and make the list available to the public 
on an Internet website. 
‘‘(d) PROHIBITION OF IMPORTATION OF A PRESCRIP-
TION DRUG THAT ENTERS OTHER COUNTRIES.— 
‘‘(1) IN GENERAL.—A drug importation facility, 
pharmacy, Internet pharmacy, or wholesaler shall 
not import a prescription drug if, during any period 
in which the prescription drug was not in the control 
of the manufacturer, the prescription drug entered a 
country other than— 
‘‘(A) Canada; or 
‘‘(B) subject to paragraph (2), a country 
that was a member of the European Union as 
of December 31, 2003. 
‘‘(2) LIMITATION.—The Secretary may exclude 
1 or more of the countries under subparagraph (B) 
of paragraph (1) from the application of that sub-
paragraph if the Secretary determines that allowing 
a prescription drug to be imported into the United 
States after having entered that country outside con-
trol of a manufacturer would present a risk to the 
public health.
‘‘(e) PROHIBITION OF COMMINGLING.— 
‘‘(1) IN GENERAL.—A drug importation facility, 
pharmacy, Internet pharmacy, or wholesaler shall 
not commingle a prescription drug imported into the 
United States under this subchapter with a prescrip-
tion drug that is not imported from Canada or a 
permitted country. 
‘‘(2) LABEL.—A pharmacy or Internet phar-
macy that dispenses a prescription drug imported 
from Canada or a permitted country shall affix on 
each dispensed container of the prescription drug 
the label required under subsection (b)(3) unless 
such a label is already affixed to the container. 
‘‘(f) DRUG RECALLS.—On receipt of notification 
from the manufacturer of a prescription drug imported 
from Canada or a permitted country under this section 
that the prescription drug has been recalled or withdrawn 
from the market in Canada or a permitted country, a drug 
importation facility shall promptly provide the Secretary 
and any person to whom the prescription drug was distrib-
uted a notice that the drug has been recalled or withdrawn 
from the market and that includes— 
‘‘(1) information (including the lot number) 
that identifies the prescription drug; and
‘‘(2) a statement of the reason for the recall or 
withdrawal. 
‘‘(g) 
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 or a nominal 
charge by the manufacturer of the prescription drug to 
a charitable or humanitarian organization (including the 
United Nations and affiliates) or to a government of a 
foreign country. 
‘‘(h) JURISDICTION.—The district courts of the 
United States shall have jurisdiction in an action brought 
by the United States against a person importing or offer-
ing for importation a prescription drug in violation of the 
requirements of this section. 
‘‘(i) EFFECT OF SECTION.—Nothing in this section 
limits the authority of the Secretary relating to the impor-
tation of prescription drugs (including the interdiction of 
prescription drugs that are unapproved, adulterated, or 
misbranded), other than with respect to section 801(d)(1) 
as provided in subsection (g).’’. 
(b) REGULATIONS.— 
(1) PERSONAL IMPORTATION.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services may promulgate
regulations to carry out section 812 of the Fed-
eral Food, Drug, and Cosmetic Act (as added 
by this section). 
(B) EFFECTIVE DATE.—Section 812 of the 
Federal Food, Drug, and Cosmetic Act shall 
take effect on the date of enactment of this Act, 
without regard to whether the Secretary of 
Health and Human Services has promulgated 
regulations under paragraph (1). 
(2) PHARMACY
AND
WHOLESALER
IMPORTA-
TION OF PRESCRIPTION DRUGS.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services shall promulgate 
interim final regulations to carry out section 
813 of the Federal Food, Drug, and Cosmetic 
Act (as added by this section). 
(B) EFFECTIVE DATE.—Section 813 of the 
Federal Food, Drug, and Cosmetic Act shall 
take effect on the date that is 1 year after the 
date of enactment of this Act, without regard to 
whether the Secretary of Health and Human 
Services has promulgated regulations under 
paragraph (1).
(c) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(hh) Dispensing or offering to dispense a prescrip-
tion drug imported into the United States in violation of 
the requirements of section 813.’’. 
SEC. 3. PROTECTION AGAINST ADULTERATED PRESCRIP-
TION DRUGS. 
Section 801(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(h)) is amended— 
(1) in paragraph (2)— 
(A) by inserting ‘‘and prescription drugs’’ 
after ‘‘related to foods’’; 
(B) by inserting ‘‘and of prescription 
drugs’’ after ‘‘adulteration of food,’’; and 
(C) by inserting ‘‘and prescription drugs’’ 
after ‘‘importation of food’’; and 
(2) in paragraph (3), by inserting ‘‘and for en-
suring the safety of imported prescription drugs’’ 
after ‘‘food safety’’. 
SEC. 4. INTERNET PHARMACIES. 
(a) INTERNET PHARMACIES.—Chapter V of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 
seq.) is amended by inserting after section 510 the fol-
lowing:
‘‘SEC. 511. INTERNET PHARMACIES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ADVERTISING
SERVICE
PROVIDER.—The 
term ‘advertising service provider’ means an adver-
tising company that contracts with a provider of an 
interactive computer service (as defined in section 
230(f) of the Communications Act of 1934 (47 
U.S.C. 230(f)) to provide advertising on the Inter-
net. 
‘‘(2) DESIGNATED PAYMENT SYSTEM.— 
‘‘(A) IN GENERAL.—The term ‘designated 
payment system’ means a system used by a per-
son to effect a credit transaction, electronic 
transfer, or money transmitting service de-
scribed in subparagraph (B) that the Federal 
functional regulators determine, by regulation 
or order, could be used in connection with, or 
to facilitate, a restricted transaction. 
‘‘(B) PERSONS DESCRIBED.—A person re-
ferred to in subparagraph (A) is— 
‘‘(i) a creditor; 
‘‘(ii) a credit card issuer; 
‘‘(iii) a financial institution; 
‘‘(iv) an operator of a terminal at 
which an electronic fund transfer may be 
initiated;
‘‘(v) a money transmitting business; 
or 
‘‘(vi) (I) an international, national, re-
gional, or local network used to effect a 
credit transaction, electronic fund transfer, 
or money transmitting service; or 
‘‘(II) any participant in a network de-
scribed in subclause (I). 
‘‘(3) FEDERAL FUNCTIONAL REGULATOR.—The 
term ‘Federal functional regulator’ has the meaning 
given the term in section 509 of the Gramm-Leach- 
Bliley Act (15 U.S.C. 6809). 
‘‘(4) PRESCRIPTION
DRUG.—The term ‘pre-
scription drug’ means a drug described in section 
503(b) that is approved by the Secretary under sec-
tion 505. 
‘‘(5) INTERNET PHARMACY.—The term ‘Inter-
net pharmacy’ means a person that dispenses or of-
fers to dispense a prescription drug through an 
Internet website in interstate commerce in the 
United States regardless of whether the physical lo-
cation of the principal place of business of the Inter-
net pharmacy is in the United States or in another 
country.
‘‘(6) RESTRICTED
TRANSACTION.—The term 
‘restricted transaction’ means a transaction or trans-
mittal, on behalf of a individual who places an un-
lawful Internet pharmacy request to any person en-
gaged in the operation of an unlicensed Internet 
pharmacy, of— 
‘‘(A) credit, or the proceeds of credit, ex-
tended to or on behalf of the individual who 
placed the unlawful Internet request (including 
credit extended through the use of a credit 
card); 
‘‘(B) an electronic fund transfer or funds 
transmitted by or through a money transmit-
ting business, or the proceeds of an electronic 
fund transfer or money transmitting service, 
from or on behalf of the individual who placed 
the unlawful Internet request; 
‘‘(C) a check, draft, or similar instrument 
which is drawn by or on behalf of the individual 
who placed the unlawful Internet request and is 
drawn on or payable at or through any financial 
institution; or 
‘‘(D) the proceeds of any other form of fi-
nancial transaction (identified by the Federal 
functional regulators by regulation) that in-
volves a financial institution as a payor or fi-
nancial intermediary on behalf of or for the 
benefit of the individual who placed the unlaw-
ful Internet request. 
‘‘(7) UNLAWFUL
INTERNET
PHARMACY
RE-
QUEST.—The term ‘unlawful Internet pharmacy re-
quest’ means the request, or transmittal of a re-
quest, made to an unlicensed Internet pharmacy for 
a prescription drug by mail (including a private car-
rier), facsimile, phone, or electronic mail, or by a 
means that involves the use, in whole or in part, of 
the Internet. 
‘‘(8) OTHER DEFINITIONS.— 
‘‘(A) CREDIT; CREDITOR; CREDIT CARD.— 
The terms ‘credit’, ‘creditor’, and ‘credit card’ 
have the meanings given the terms in section 
103 of the Truth in Lending Act (15 U.S.C. 
1602). 
‘‘(B) ELECTRONIC FUND TRANSFER.—The 
term ‘electronic fund transfer’— 
‘‘(i) has the meaning given the term 
in section 903 of the Electronic Fund 
Transfer Act (15 U.S.C. 1693a); and 
‘‘(ii) includes any fund transfer cov-
ered under Article 4A of the Uniform
Commercial Code, as in effect in any 
State. 
‘‘(C) FINANCIAL INSTITUTION.—The term 
‘financial institution’— 
‘‘(i) has the meaning given the term 
in section 903 of the Electronic Transfer 
Fund Act (15 U.S.C. 1693a); and 
‘‘(ii) includes a financial institution 
(as defined in section 509 of the Gramm- 
Leach-Bliley Act (15 U.S.C. 6809)). 
‘‘(D) MONEY
TRANSMITTING
BUSINESS; 
MONEY
TRANSMITTING
SERVICE.—The terms 
‘money transmitting business’ and ‘money 
transmitting service’ have the meaning given 
the terms in section 5330(d) of title 31, United 
States Code. 
‘‘(b) IN GENERAL.—An Internet pharmacy may only 
dispense or offer to dispense a prescription drug to a per-
son in the United States in accordance with this section. 
‘‘(c) LICENSING OF INTERNET PHARMACIES.— 
‘‘(1) IN GENERAL.—To be licensed under this 
section an Internet pharmacy shall— 
‘‘(A) have its principal place of business in 
the United States, Canada, or a permitted 
country; and
‘‘(B) be licensed by the Secretary in ac-
cordance with this section prior to dispensing a 
prescription drug to an individual. 
‘‘(2) CONDITIONS FOR LICENSING.— 
‘‘(A) APPLICATION
REQUIREMENTS.—An 
Internet pharmacy shall submit to the Sec-
retary an application that includes— 
‘‘(i) (I) in the case of an Internet 
pharmacy located in the United States, 
verification that, in each State in which 
the Internet pharmacy engages in dis-
pensing or offering to dispense prescription 
drugs, the Internet pharmacy, and all em-
ployees and agents of the Internet phar-
macy, is in compliance with applicable 
Federal and State laws regarding— 
‘‘(aa) the practice of pharmacy, 
including licensing laws and inspec-
tion requirements; and 
‘‘(bb) the manufacturing and dis-
tribution of controlled substances, in-
cluding with respect to mailing or 
shipping controlled substances to con-
sumers; or
‘‘(II) in the case of an Inter-
net pharmacy located in Canada 
or 
a 
permitted 
country, 
verification that— 
‘‘(aa) all employees and 
agents of the Internet phar-
macy are in compliance with 
applicable laws of Canada or 
the permitted country re-
garding the practice of phar-
macy, 
including 
licensing 
laws and inspection require-
ments; and 
‘‘(bb) 
the 
Internet 
pharmacy is in compliance 
with applicable Federal and 
State laws regarding the 
practice of pharmacy, in-
cluding licensing laws and 
inspection requirements; 
‘‘(ii) verification that the person that 
owns the Internet pharmacy has not had a 
license for an Internet pharmacy termi-
nated by the Secretary, and that no other 
Internet pharmacy owned by the person
has had a license under this subsection 
that has been terminated by the Secretary; 
‘‘(iii) verification from the person that 
owns the Internet pharmacy that the per-
son will permit inspection of the facilities 
and business practices of the Internet 
pharmacy by the Secretary to the extent 
necessary to determine whether the Inter-
net pharmacy is in compliance with this 
subsection; and 
‘‘(iv) in the case of an agreement be-
tween a patient and an Internet pharmacy 
that releases the Internet pharmacy, and 
any employee or agent of the Internet 
pharmacy, from liability for damages aris-
ing out of the negligence of the Internet 
pharmacy, an assurance that such a limita-
tion of liability shall be null and void. 
‘‘(B) IDENTIFICATION
REQUIREMENTS.— 
An Internet pharmacy shall provide to any per-
son that accesses the Internet pharmacy 
website, on each page of the website of the 
Internet pharmacy or by a link to a separate 
page, the following information: