I 
109TH CONGRESS 
1ST SESSION 
H. R. 700
To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
importation of prescription drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 9, 2005
Mrs. EMERSON (for herself, Mr. BROWN of Ohio, Mrs. NORTHUP, Mr. BERRY, 
Mr. WAMP, Mr. ALLEN, Mr. MOORE of Kansas, and Mr. SANDERS) intro-
duced the following bill; which was referred to the Committee on Energy 
and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to the importation of 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. 
This Act may be cited as the ‘‘Pharmaceutical Mar-
ket Access and Drug Safety Act of 2005’’. 
SEC. 2. FINDINGS. 
Congress finds that—
(1) Americans unjustly pay up to 5 times more 
to fill their prescriptions than consumers in other 
countries; 
(2) the United States is the largest market for 
pharmaceuticals in the world, yet American con-
sumers pay the highest prices for brand pharma-
ceuticals in the world; 
(3) a prescription drug is neither safe nor effec-
tive to an individual who cannot afford it; 
(4) allowing and structuring the importation of 
prescription drugs to ensure access to safe and af-
fordable drugs approved by the Food and Drug Ad-
ministration will provide a level of safety to Amer-
ican consumers that they do not currently enjoy; 
(5) 
American 
seniors 
alone 
will 
spend 
$1,800,000,000,000 on pharmaceuticals over the 
next 10 years; and 
(6) allowing open pharmaceutical markets could 
save American consumers at least $38,000,000,000 
each year. 
SEC. 3. REPEAL OF CERTAIN SECTION REGARDING IMPOR-
TATION OF PRESCRIPTION DRUGS. 
Chapter VIII of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381 et seq.) is amended by striking 
section 804.
SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER 
OF CERTAIN IMPORT RESTRICTIONS. 
(a) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), 
as amended by section 3, is further amended by inserting 
after section 803 the following: 
‘‘SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF 
PRESCRIPTION DRUGS. 
‘‘(a) IMPORTATION OF PRESCRIPTION DRUGS.— 
‘‘(1) IN GENERAL.—In the case of qualifying 
drugs imported or offered for import into the United 
States from registered exporters or by registered im-
porters— 
‘‘(A) the limitation on importation that is 
established in section 801(d)(1) is waived; and 
‘‘(B) the standards referred to in section 
801(a) regarding admission of the drugs are 
subject to subsection (g) of this section (includ-
ing with respect to qualifying drugs to which 
section 801(d)(1) does not apply). 
‘‘(2) IMPORTERS.—A qualifying drug may not 
be imported under paragraph (1) unless— 
‘‘(A) the drug is imported by a pharmacy, 
group of pharmacies, or a wholesaler that is a 
registered importer; or
‘‘(B) the drug is imported by an individual 
for personal use or for the use of a family mem-
ber of the individual (not for resale) from a reg-
istered exporter. 
‘‘(3) RULE
OF
CONSTRUCTION.—This section 
shall apply only with respect to a drug that is im-
ported or offered for import into the United 
States— 
‘‘(A) by a registered importer; or 
‘‘(B) from a registered exporter to an indi-
vidual. 
‘‘(4) DEFINITIONS.— 
‘‘(A) 
REGISTERED
EXPORTER; 
REG-
ISTERED IMPORTER.—For purposes of this sec-
tion: 
‘‘(i) The term ‘registered exporter’ 
means an exporter for which a registration 
under subsection (b) has been approved 
and is in effect. 
‘‘(ii) The term ‘registered importer’ 
means a pharmacy, group of pharmacies, 
or a wholesaler for which a registration 
under subsection (b) has been approved 
and is in effect.
‘‘(iii) The term ‘registration condition’ 
means a condition that must exist for a 
registration under subsection (b) to be ap-
proved. 
‘‘(B) QUALIFYING DRUG.—For purposes of 
this section, the term ‘qualifying drug’ means a 
drug for which there is a corresponding U.S. 
label drug. 
‘‘(C) U.S. LABEL DRUG.—For purposes of 
this section, the term ‘U.S. label drug’ means 
a prescription drug that— 
‘‘(i) with respect to a qualifying drug, 
has the same active ingredient or ingredi-
ents, route of administration, dosage form, 
and strength as the qualifying drug; 
‘‘(ii) with respect to the qualifying 
drug, is manufactured by or for the person 
that manufactures the qualifying drug; 
‘‘(iii) 
is 
approved 
under 
section 
505(c); and 
‘‘(iv) is not—
‘‘(I) a controlled substance, as 
defined in section 102 of the Con-
trolled Substances Act (21 U.S.C. 
802);
‘‘(II) a biological product, as de-
fined in section 351 of the Public 
Health Service Act (42 U.S.C. 262), 
including—
‘‘(aa) a therapeutic DNA 
plasmid product; 
‘‘(bb) a therapeutic synthetic 
peptide product; 
‘‘(cc) a monoclonal antibody 
product for in vivo use; and 
‘‘(dd) a therapeutic recom-
binant DNA-derived product; 
‘‘(III) an infused drug, including 
a peritoneal dialysis solution; 
‘‘(IV) an injected drug; 
‘‘(V) a drug that is inhaled dur-
ing surgery; or 
‘‘(VI) a drug that is the listed 
drug referred to in 2 or more abbre-
viated new drug applications under 
which the drug is commercially mar-
keted. 
‘‘(D) OTHER DEFINITIONS.—For purposes 
of this section:
‘‘(i)(I) The term ‘exporter’ means a 
person that is in the business of exporting 
a drug to individuals in the United States 
from Canada or from a permitted country 
designated by the Secretary under sub-
clause (II), or that, pursuant to submitting 
a registration under subsection (b), seeks 
to be in such business. 
‘‘(II) The Secretary shall designate a 
permitted country under subparagraph (E) 
(other than Canada) as a country from 
which an exporter may export a drug to in-
dividuals in the United States if the Sec-
retary determines that—
(aa) the country has statutory or 
regulatory standards that are equiva-
lent to the standards in the United 
States and Canada with respect to—
‘‘(AA) the training of phar-
macists; 
‘‘(BB) the practice of phar-
macy; and 
‘‘(CC) the protection of the 
privacy of personal medical infor-
mation; and
‘‘(bb) the importation of drugs to 
individuals in the United States from 
the country will not adversely affect 
public health. 
‘‘(ii) The term ‘importer’ means a 
pharmacy, a group of pharmacies, or a 
wholesaler that is in the business of im-
porting a drug into the United States or 
that, pursuant to submitting a registration 
under subsection (b), seeks to be in such 
business. 
‘‘(iii) The term ‘pharmacist’ means a 
person licensed by a State to practice 
pharmacy, including the dispensing and 
selling of prescription drugs. 
‘‘(iv) The term ‘pharmacy’ means a 
person that— 
‘‘(I) is licensed by a State to en-
gage in the business of selling pre-
scription drugs at retail; and 
‘‘(II) employs 1 or more phar-
macists. 
‘‘(v) The term ‘prescription drug’ 
means a drug that is described in section 
503(b)(1).
‘‘(vi) The term ‘wholesaler’— 
‘‘(I) means a person licensed as a 
wholesaler or distributor of prescrip-
tion drugs in the United States under 
section 503(e)(2)(A); and 
‘‘(II) does not include a person 
authorized to import drugs under sec-
tion 801(d)(1). 
‘‘(E) PERMITTED
COUNTRY.—The term 
‘permitted country’ means— 
‘‘(i) Australia; 
‘‘(ii) Canada; 
‘‘(iii) a member country of the Euro-
pean Union, but does not include a mem-
ber country with respect to which—
‘‘(I) the country’s Annex to the 
Treaty of Accession to the European 
Union 2003 includes a transitional 
measure for the regulation of human 
pharmaceutial products that has not 
expired; or 
‘‘(II) the Secretary determines 
that the requirements described in 
subclauses (I) and (II) of clause (vii) 
will not be met by the date on which
such transitional measure for the reg-
ulation of human pharmaceutial prod-
ucts expires; 
‘‘(iv) Japan; 
‘‘(v) New Zealand; 
‘‘(vi) Switzerland; and 
‘‘(vii) a country in which the Sec-
retary determines the following require-
ments are met: 
‘‘(I) The country has statutory or 
regulatory requirements— 
‘‘(aa) that require the review 
of drugs for safety and effective-
ness by an entity of the govern-
ment of the country; 
‘‘(bb) that authorize the ap-
proval of only those drugs that 
have been determined to be safe 
and effective by experts employed 
by or acting on behalf of such en-
tity and qualified by scientific 
training and experience to evalu-
ate the safety and effectiveness of 
drugs on the basis of adequate 
and well-controlled investigations,
including clinical investigations, 
conducted by experts qualified by 
scientific training and experience 
to evaluate the safety and effec-
tiveness of drugs; 
‘‘(cc) that require the meth-
ods used in, and the facilities and 
controls used for the manufac-
ture, processing, and packing of 
drugs in the country to be ade-
quate to preserve their identity, 
quality, purity, and strength; 
‘‘(dd) for the reporting of 
adverse reactions to drugs and 
procedures to withdraw approval 
and remove drugs found not to 
be safe or effective; and 
‘‘(ee) that require the label-
ing and promotion of drugs to be 
in accordance with the approval 
of the drug. 
‘‘(II) The valid marketing au-
thorization system in the country is 
equivalent to the systems in the coun-
tries described in clauses (i) through 
(vi). 
‘‘(III) The importation of drugs 
to the United States from the country 
will not adversely affect public health. 
‘‘(b) REGISTRATION OF IMPORTERS AND EXPORT-
ERS.— 
‘‘(1) REGISTRATION
OF
IMPORTERS
AND
EX-
PORTERS.—A registration condition is that the im-
porter or exporter involved (referred to in this sub-
section as a ‘registrant’) submits to the Secretary a 
registration containing the following: 
‘‘(A)(i) In the case of an exporter, the 
name of the exporter and an identification of all 
places of business of the exporter that relate to 
qualifying drugs, including each warehouse or 
other facility owned or controlled by, or oper-
ated for, the exporter. 
‘‘(ii) In the case of an importer, the name 
of the importer and an identification of the 
places of business of the importer at which the 
importer initially receives a qualifying drug 
after importation (which shall not exceed 3 
places of business except by permission of the 
Secretary).
‘‘(B) Such information as the Secretary 
determines to be necessary to demonstrate that 
the registrant is in compliance with registration 
conditions under— 
‘‘(i) in the case of an importer, sub-
sections (c), (d), (e), (g), and (j) (relating 
to the sources of imported qualifying 
drugs; the inspection of facilities of the im-
porter; the payment of fees; compliance 
with the standards referred to in section 
801(a); and maintenance of records and 
samples); or 
‘‘(ii) in the case of an exporter, sub-
sections (c), (d), (f), (g), (h), (i), and (j) 
(relating to the sources of exported quali-
fying drugs; the inspection of facilities of 
the exporter and the marking of compliant 
shipments; the payment of fees; and com-
pliance with the standards referred to in 
section 801(a); being licensed as a phar-
macist; conditions for individual importa-
tion; and maintenance of records and sam-
ples). 
‘‘(C) An agreement by the registrant that 
the registrant will not under subsection (a) im-
port or export any drug that is not a qualifying 
drug. 
‘‘(D) An agreement by the registrant to— 
‘‘(i) notify the Secretary of a recall or 
withdrawal of a qualifying drug distributed 
in a permitted country that the registrant 
has exported or imported, or intends to ex-
port or import, to the United States under 
subsection (a); 
‘‘(ii) provide for the return to the reg-
istrant of such drug; and 
‘‘(iii) cease, or not begin, the expor-
tation or importation of such drug unless 
the Secretary has notified the registrant 
that exportation or importation of such 
drug may proceed. 
‘‘(E) An agreement by the registrant to 
ensure and monitor compliance with each reg-
istration condition, to promptly correct any 
noncompliance with such a condition, and to 
promptly report to the Secretary any such non-
compliance. 
‘‘(F) A plan describing the manner in 
which the registrant will comply with the agree-
ment under subparagraph (E).
‘‘(G) An agreement by the registrant to 
enforce a contract under subsection (c)(3)(B) 
against a party in the chain of custody of a 
qualifying drug with respect to the authority of 
the Secretary under clauses (ii) and (iii) of that 
subsection. 
‘‘(H) An agreement by the registrant to 
notify the Secretary not more than 30 days be-
fore the registrant intends to make the change, 
of— 
‘‘(i) any change that the registrant in-
tends to make regarding information pro-
vided under subparagraph (A) or (B); and 
‘‘(ii) any change that the registrant 
intends to make in the compliance plan 
under subparagraph (F). 
‘‘(I) In the case of an exporter— 
‘‘(i) An agreement by the exporter 
that a qualifying drug will not under sub-
section (a) be exported to any individual 
not authorized pursuant to subsection 
(a)(2)(B) to be an importer of such drug. 
‘‘(ii) An agreement to post a bond, 
payable to the Treasury of the United
States that is equal in value to the lesser 
of— 
‘‘(I) the value of drugs exported 
by the exporter to the United States 
in a typical 4-week period over the 
course of a year under this section; or 
‘‘(II) $1,000,000; 
‘‘(iii) An agreement by the exporter to 
comply with applicable provisions of Cana-
dian law, or the law of the permitted coun-
try 
designated 
under 
subsection 
(a)(4)(D)(i)(II) in which the exporter is lo-
cated, that protect the privacy of personal 
information with respect to each individual 
importing a prescription drug from the ex-
porter under subsection (a)(2)(B). 
‘‘(iv) An agreement by the exporter to 
report to the Secretary— 
‘‘(I) not later than August 1 of 
each fiscal year, the total price and 
the total volume of drugs exported to 
the United States by the exporter dur-
ing the 6-month period from January 
1 through June 30 of that year; and
‘‘(II) not later than January 1 of 
each fiscal year, the total price and 
the total volume of drugs exported to 
the United States by the exporter dur-
ing the previous fiscal year. 
‘‘(J) In the case of an importer, an agree-
ment by the importer to report to the Sec-
retary— 
‘‘(i) not later than August 1 of each 
fiscal year, the total price and the total 
volume of drugs imported to the United 
States by the importer during the 6-month 
period from January 1 through June 30 of 
that fiscal year; and 
‘‘(ii) not later than January 1 of each 
fiscal year, the total price and the total 
volume of drugs imported to the United 
States by the importer during the previous 
fiscal year. 
‘‘(K) Such other provisions as the Sec-
retary may require by regulation to protect the 
public health while permitting— 
‘‘(i) the importation by pharmacies, 
groups of pharmacies, and wholesalers as
registered importers of qualifying drugs 
under subsection (a); and 
‘‘(ii) importation by individuals of 
qualifying drugs under subsection (a). 
‘‘(2) APPROVAL OR DISAPPROVAL OF REGISTRA-
TION.— 
‘‘(A) IN
GENERAL.—Not later than 90 
days after the date on which a registrant sub-
mits to the Secretary a registration under para-
graph (1), the Secretary shall notify the reg-
istrant whether the registration is approved or 
is disapproved. The Secretary shall disapprove 
a registration if there is reason to believe that 
the registrant is not in compliance with one or 
more registration conditions, and shall notify 
the registrant of such reason. In the case of a 
disapproved registration, the Secretary shall 
subsequently notify the registrant that the reg-
istration is approved if the Secretary deter-
mines that the registrant is in compliance with 
such conditions. 
‘‘(B) CHANGES IN REGISTRATION INFOR-
MATION.—Not later than 30 days after receiv-
ing a notice under paragraph (1)(H) from a 
registrant, the Secretary shall determine wheth-
er the change involved affects the approval of 
the registration of the registrant under para-
graph (1), and shall inform the registrant of 
the determination. 
‘‘(3) PUBLICATION OF CONTACT INFORMATION 
FOR REGISTERED EXPORTERS.—Through the Inter-
net website of the Food and Drug Administration 
and a toll-free telephone number, the Secretary shall 
make readily available to the public a list of reg-
istered exporters, including contact information for 
the exporters. Promptly after the approval of a reg-
istration submitted under paragraph (1), the Sec-
retary shall update the Internet website and the in-
formation provided through the toll-free telephone 
number accordingly. 
‘‘(4) SUSPENSION AND TERMINATION.— 
‘‘(A) SUSPENSION.—With respect to the 
effectiveness of a registration submitted under 
paragraph (1): 
‘‘(i) Subject to clause (ii), the Sec-
retary may suspend the registration if the 
Secretary determines, after notice and op-
portunity for a hearing, that the registrant 
has failed to maintain substantial compli-
ance with a registration condition.