I 
109TH CONGRESS 
1ST SESSION 
H. R. 328
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 
JANUARY 25, 2005
Mr. GUTKNECHT (for himself, Mr. EMANUEL, Mrs. EMERSON, Mr. SANDERS, 
Ms. DELAURO, Mrs. NORTHUP, Mr. BURTON of Indiana, Ms. GINNY 
BROWN-WAITE of Florida, Mr. JONES of North Carolina, Mr. BROWN of 
Ohio, Mr. ISTOOK, Mr. KINGSTON, Mr. RAMSTAD, Mr. KING of Iowa, and 
Mr. LANGEVIN) introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committee 
on the Judiciary, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
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 Act of 2005’’.
SEC. 2. FINDINGS. 
Congress finds as follows: 
(1) Americans unjustly pay up to 1000 percent 
more to fill their prescriptions than consumers in 
other countries. 
(2) The United States is the world’s largest 
market for pharmaceuticals yet consumers still pay 
the world’s highest prices. 
(3) An unaffordable drug is neither safe nor ef-
fective. Allowing and structuring the importation of 
prescription drugs ensures access to affordable 
drugs, thus providing a level of safety to American 
consumers they do not currently enjoy. 
(4) According to the Congressional Budget Of-
fice, 
American 
seniors 
alone 
will 
spend 
$1,800,000,000,000 on pharmaceuticals over the 
next 10 years. 
(5) Allowing open pharmaceutical markets 
could 
save 
American 
consumers 
at 
least 
$635,000,000,000 of their own money. 
SEC. 3. PURPOSES. 
The purposes of this Act are as follows: 
(1) To give all Americans immediate relief from 
the outrageously high cost of pharmaceuticals. 
(2) To reverse the perverse economics of the 
American pharmaceutical market.
(3) To allow the importation of prescription 
drugs only if the drugs and facilities where such 
drugs are manufactured are approved by the Food 
and Drug Administration, and to exclude pharma-
ceutical narcotics. 
(4) To require that imported prescription drugs 
be packaged and shipped using counterfeit-resistant 
technologies. 
SEC. 4. AMENDMENTS TO SECTION 804 OF THE FEDERAL 
FOOD, DRUG, AND COSMETIC. 
(a) DEFINITIONS.—Section 804(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384(a)) is 
amended to read as follows: 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) IMPORTER.—The term ‘importer’ means a 
pharmacy, group of pharmacies, pharmacist, or 
wholesaler. 
‘‘(2) PERMITTED
COUNTRY.—The term ‘per-
mitted country’ means a country, union, or economic 
area that is listed in subparagraph (A) of section 
802(b)(1) (as of December 31, 2003), except that 
the Secretary—
‘‘(A) may add a country, union, or eco-
nomic area to such list for purposes of this sec-
tion if the Secretary determines that the coun-
try, union, or economic area has a pharma-
ceutical infrastructure that is substantially 
equivalent or superior to the pharmaceutical in-
frastructure of the United States, taking into 
consideration pharmacist qualifications, phar-
macy storage procedures, the drug distribution 
system, the drug dispensing system, and market 
regulation; and 
‘‘(B) may remove a country, union, or eco-
nomic area from such list for purposes of this 
section if the Secretary determines that the 
country, union, or economic area does not have 
such a pharmaceutical infrastructure. 
‘‘(3) PHARMACIST.—The term ‘pharmacist’ 
means a person licensed by the relevant govern-
mental authority to practice pharmacy, including the 
dispensing and selling of prescription drugs. 
‘‘(4) PHARMACY.—The term ‘pharmacy’ means 
a person that is licensed by the relevant govern-
mental authority to engage in the business of selling 
prescription drugs that employs 1 or more phar-
macists. 
‘‘(5) 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 which 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 sec-
tion 801(d)(1) shall continue to apply. 
‘‘(6) QUALIFYING DRUG.—The term ‘qualifying 
drug’ means a prescription drug that—
‘‘(A) is approved pursuant to an applica-
tion submitted under section 505(b)(1); and 
‘‘(B) is not—
‘‘(i) a drug manufactured through 1 
or more biotechnology processes; 
‘‘(ii) a drug that is required to be re-
frigerated; or
‘‘(iii) a photoreactive drug. 
‘‘(7) QUALIFYING INTERNET PHARMACY.—The 
term ‘qualifying Internet pharmacy’ means a reg-
istered exporter that dispenses qualifying drugs to 
individuals over an Internet website. 
‘‘(8) 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. 
‘‘(9) REGISTERED EXPORTER.—The term ‘reg-
istered exporter’ means a person that is in the busi-
ness of exporting a drug to persons in the United 
States (or that seeks to be in such business), for 
which a registration under this section has been ap-
proved and is in effect. 
‘‘(10) 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.—Section 804(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384(b)) is 
amended to read as follows: 
‘‘(b) REGULATIONS.—Not later than 180 days after 
the date of enactment of the Pharmaceutical Market Ac-
cess Act of 2005, the Secretary, after consultation with 
the United States Trade Representative and the Commis-
sioner of Customs, shall promulgate regulations permit-
ting pharmacists, pharmacies, and wholesalers to import 
qualifying drugs from permitted countries into the United 
States.’’. 
(c) LIMITATION.—Section 804(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384(c)) is 
amended by striking ‘‘prescription drug’’ each place it ap-
pears and inserting ‘‘qualifying drug’’. 
(d) 
INFORMATION
AND
RECORDS.—Section 
804(d)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 384(d)(1)) is amended—
(1) by striking subparagraph (G) and redesig-
nating subparagraphs (H) through (N) as subpara-
graphs (G) through (M), respectively; 
(2) in subparagraph (H) (as so redesignated), 
by striking ‘‘telephone number, and professional li-
cense number (if any)’’ and inserting ‘‘and telephone 
number’’; and
(3) in subparagraph (L) (as so redesignated), 
by striking ‘‘(J) and (L)’’ and inserting ‘‘(I) and 
(K)’’. 
(e) TESTING.—Section 804(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384(e)) is amended 
to read as follows: 
‘‘(e) TESTING.—The regulations under subsection (b) 
shall require that the testing described under subpara-
graphs (I) and (K) of subsection (d)(1) be conducted by 
the importer of the qualifying drug, unless the qualifying 
drug is subject to the requirements under section 505C 
for counterfeit-resistant technologies.’’. 
(f) REGISTRATION OF EXPORTERS; INSPECTIONS.—
Section 804(f) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 384(f)) is amended to read as follows: 
‘‘(f) REGISTRATION OF EXPORTERS; INSPECTIONS.—
‘‘(1) IN GENERAL.—Any person that seeks to 
be a registered exporter (referred to in this sub-
section as the ‘registrant’) shall submit to the Sec-
retary a registration that includes the following: 
‘‘(A) The name of the registrant and iden-
tification of all places of business of the reg-
istrant that relate to qualifying drugs, including 
each warehouse or other facility owned or con-
trolled by, or operated for, the registrant;
‘‘(B) An agreement by the registrant to—
‘‘(i) make its places of business that 
relate to qualifying drugs (including ware-
houses and other facilities owned or con-
trolled by, or operated for, the exporter) 
and records available to the Secretary for 
on-site inspections, without prior notice, 
for the purpose of determining whether the 
registrant is in compliance with this Act’s 
requirements; 
‘‘(ii) export only qualifying drugs; 
‘‘(iii) export only to persons author-
ized to import the drugs; 
‘‘(iv) notify the Secretary of a recall 
or withdrawal of a qualifying drug distrib-
uted in a permitted country to or from 
which the registrant has exported or im-
ported, or intends to export or import, to 
the United States; 
‘‘(v) monitor compliance with registra-
tion conditions and report any noncompli-
ance promptly; 
‘‘(vi) submit a compliance plan show-
ing how the registrant will correct viola-
tions, if any; and
‘‘(vii) promptly notify the Secretary of 
changes in the registration information of 
the registrant. 
‘‘(2) NOTICE OF APPROVAL OR DISAPPROVAL.—
‘‘(A) IN
GENERAL.—Not later than 90 
days after receiving a completed registration 
from a registrant, the Secretary shall—
‘‘(i) notify such registrant of receipt 
of the registration; 
‘‘(ii) assign such registrant a registra-
tion number; and 
‘‘(ii) approve or disapprove the appli-
cation. 
‘‘(B) DISAPPROVAL OF APPLICATION.—
‘‘(i) IN
GENERAL.—The Secretary 
shall disapprove a registration, and notify 
the registrant of such disapproval, if the 
Secretary has reason to believe that such 
registrant is not in compliance with a reg-
istration condition. 
‘‘(ii) SUBSEQUENT
APPROVAL.—The 
Secretary may subsequently approve a reg-
istration that was denied under clause (i) 
if the Secretary finds that the registrant is
in compliance with all registration condi-
tions. 
‘‘(3) LIST.—The Secretary shall—
‘‘(A) maintain an up-to-date list of reg-
istered exporters (including qualifying Internet 
pharmacies that sell qualifying drugs to individ-
uals); 
‘‘(B) make such list available to the public 
on the Internet site of the Food and Drug Ad-
ministration and via a toll-free telephone num-
ber; and 
‘‘(C) update such list promptly after the 
approval of a registration under this subsection. 
‘‘(4) EDUCATION
OF
CONSUMERS.—The Sec-
retary shall carry out activities, by use of the Inter-
net website and toll-free telephone number under 
paragraph (3), that educate consumers with regard 
to the availability of qualifying drugs for import for 
personal use under this section, including informa-
tion on how to verify whether an exporter is reg-
istered. 
‘‘(5) INSPECTION
OF
IMPORTERS
AND
REG-
ISTERED EXPORTERS.—The Secretary shall inspect 
the warehouses, other facilities, and records of im-
porters and registered exporters as often as the Sec-
retary determines necessary to ensure that such im-
porters and registered exporters are in compliance 
with this section.’’. 
(g) SUSPENSION OF IMPORTATION.—Section 804(g) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384(g)) is amended by—
(1) striking ‘‘and the Secretary determines that 
the public is adequately protected from counterfeit 
and violative prescription drugs being imported 
under subsection (b)’’; and 
(2) by adding after the period at the end the 
following: ‘‘The Secretary shall reinstate the impor-
tation by a specific importer upon a determination 
by the Secretary that the violation has been cor-
rected and that the importer has demonstrated that 
further violations will not occur. This subsection 
shall not apply to a prescription drug imported by 
an individual, or to a prescription drug shipped to 
an individual by a qualifying Internet pharmacy.’’. 
(h) WAIVER AUTHORITY FOR INDIVIDUALS.—Section 
804(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 384(j)) is amended to read as follows: 
‘‘(j) IMPORTATION BY INDIVIDUALS.—
‘‘(1) IN GENERAL.—Not later than 180 days 
after the enactment of the Pharmaceutical Market
Access Act of 2005, the Secretary shall by regula-
tion permit an individual to import a drug from a 
permitted country to the United States if the drug 
is—
‘‘(A) a qualifying drug; 
‘‘(B) imported from a licensed pharmacy 
or qualifying Internet pharmacy; 
‘‘(C) for personal use by an individual, or 
family member of the individual, not for resale; 
‘‘(D) in a quantity that does not exceed a 
90-day supply during any 90-day period; and 
‘‘(E) accompanied by a copy of a prescrip-
tion for the drug, which—
‘‘(i) is valid under applicable Federal 
and State laws; and 
‘‘(ii) was issued by a practitioner who 
is authorized to administer prescription 
drugs. 
‘‘(2) DRUGS DISPENSED OUTSIDE THE UNITED 
STATES.—An individual may import a drug from a 
country that is not a permitted country if—
‘‘(A) the drug was dispensed to the indi-
vidual while the individual was in such country, 
and the drug was dispensed in accordance with 
the laws and regulations of such country;
‘‘(B) the individual is entering the United 
States and the drug accompanies the individual 
at the time of entry; 
‘‘(C) the drug is approved for commercial 
distribution in the country in which the drug 
was obtained; 
‘‘(D) the drug does not appear to be adul-
terated; and 
‘‘(E) the quantity of the drug does not ex-
ceed a 14-day supply.’’. 
(i) REPEAL OF CERTAIN PROVISIONS.—Section 804 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384) is amended by striking subsections (l) and (m). 
SEC. 5. REGISTRATION FEES. 
Subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 397f et seq.) is 
amended by adding at the end the following: 
‘‘PART 5—FEES RELATING TO PRESCRIPTION 
DRUG IMPORTATION 
‘‘SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IM-
PORTATION. 
‘‘(a) REGISTRATION FEE.—The Secretary shall es-
tablish a registration fee program under which a reg-
istered exporter under section 804 shall be required to pay
an annual fee to the Secretary in accordance with this sub-
section. 
‘‘(b) COLLECTION.—
‘‘(1) COLLECTION ON INITIAL REGISTRATION.—
A fee under this section shall be payable for the fis-
cal year in which the registered exporter first sub-
mits a registration under section 804 (or reregisters 
under that section if that person has withdrawn its 
registration and subsequently reregisters) in a 
amount of $10,000, due on the date the exporter 
first submits a registration to the Secretary under 
section 804. 
‘‘(2) COLLECTION
IN
SUBSEQUENT
YEARS.—
After the fee is paid for the first fiscal year, the fee 
described under this subsection shall be payable on 
or before October 1 of each year. 
‘‘(3) ONE FEE PER FACILITY.—The fee shall be 
paid only once for each registered exporter for a fis-
cal year in which the fee is payable. 
‘‘(c) FEE AMOUNT.—
‘‘(1) IN
GENERAL.—Subject to subsection 
(b)(1), the amount of the fee shall be determined 
each year by the Secretary and shall be based on the 
anticipated costs to the Secretary of enforcing the
amendments made by the Pharmaceutical Market 
Access Act of 2005 in the subsequent fiscal year. 
‘‘(2) LIMITATION.—
‘‘(A) IN GENERAL.—The aggregate total of 
fees collected under this section shall not exceed 
1 percent of the total price of drugs exported 
annually to the United States by registered ex-
porters under this section. 
‘‘(B) REASONABLE ESTIMATE.—Subject to 
the limitation described in subparagraph (A), a 
fee under this subsection for an exporter shall 
be an amount that is a reasonable estimate by 
the Secretary of the annual share of the ex-
porter of the volume of drugs exported by ex-
porters under this section. 
‘‘(d) USE OF FEES.—The fees collected under this 
section shall be used for the sole purpose of administering 
this section with respect to registered exporters, including 
the costs associated with—
‘‘(1) inspecting the facilities of registered ex-
porters, and of other entities in the chain of custody 
of a qualifying drug; 
‘‘(2) developing, implementing, and maintaining 
a system to determine registered exporters’ compli-
ance with the registration conditions under the
Pharmaceutical Market Access Act of 2005, includ-
ing when shipments of qualifying drugs are offered 
for import into the United States; and 
‘‘(3) inspecting such shipments, as necessary, 
when offered for import into the United States to 
determine if any such shipment should be refused 
admission. 
‘‘(e) ANNUAL FEE SETTING.—The Secretary shall 
establish, 60 days before the beginning of each fiscal year 
beginning after September 30, 2005, for that fiscal year, 
registration fees. 
‘‘(f) EFFECT OF FAILURE TO PAY FEES.—
‘‘(1) DUE DATE.—A fee payable under this sec-
tion shall be paid by the date that is 30 days after 
the date on which the fee is due. 
‘‘(2) FAILURE TO PAY.—If a registered exporter 
subject to a fee under this section fails to pay the 
fee, the Secretary shall not permit the registered ex-
porter to engage in exportation to the United States 
or offering for exportation prescription drugs under 
this Act until all such fees owed by that person are 
paid. 
‘‘(g) REPORTS.—