violation against any defendant named in the 
complaint in that action. 
‘‘(E) VENUE.—Any action brought under 
subparagraph (A) may be brought in the dis-
trict court of the United States that meets ap-
plicable requirements relating to venue under 
section 1391 of title 28, United States Code. 
‘‘(F) SERVICE OF PROCESS.—In an action 
brought under subparagraph (A), process may 
be served in any district in which the defend-
ant— 
‘‘(i) is an inhabitant; or 
‘‘(ii) may be found. 
‘‘(G) MEASUREMENT
OF
DAMAGES.—In 
any action under this paragraph to enforce a 
cause of action under this subsection in which 
there has been a determination that a defend-
ant has violated a provision of this subsection, 
damages may be proved and assessed in the ag-
gregate by statistical or sampling methods, by 
the computation of illegal overcharges or by 
such other reasonable system of estimating ag-
gregate damages as the court in its discretion 
may permit without the necessity of separately 
proving the individual claim of, or amount of 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00086
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
damage to, persons on whose behalf the suit 
was brought. 
‘‘(H) EXCLUSION
ON
DUPLICATIVE
RE-
LIEF.—The district court shall exclude from the 
amount of monetary relief awarded in an action 
under this paragraph brought by the attorney 
general of a State any amount of monetary re-
lief which duplicates amounts which have been 
awarded for the same injury. 
‘‘(7) EFFECT ON ANTITRUST LAWS.—Nothing 
in this subsection shall be construed to modify, im-
pair, or supersede the operation of the antitrust 
laws. For the purpose of this subsection, the term 
‘antitrust laws’ has the meaning given it in the first 
section of the Clayton Act, except that it includes 
section 5 of the Federal Trade Commission Act to 
the extent that such section 5 applies to unfair 
methods of competition. 
‘‘(8) MANUFACTURER.—In this subsection, the 
term ‘manufacturer’ means any entity, including any 
affiliate or licensee of that entity, that is engaged 
in— 
‘‘(A) the production, preparation, propaga-
tion, compounding, conversion, or processing of 
a prescription drug, either directly or indirectly 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00087
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
by extraction from substances of natural origin, 
or independently by means of chemical syn-
thesis, or by a combination of extraction and 
chemical synthesis; or 
‘‘(B) the packaging, repackaging, labeling, 
relabeling, or distribution of a prescription 
drug.’’. 
(b) PROHIBITED ACTS.—The Federal Food, Drug, 
and Cosmetic Act is amended— 
(1) in section 301 (21 U.S.C. 331), by striking 
paragraph (aa) and inserting the following: 
‘‘(aa)(1) The sale or trade by a pharmacist, or by 
a business organization of which the pharmacist is a part, 
of a qualifying drug that under section 804(a)(2)(A) was 
imported by the pharmacist, other than— 
‘‘(A) a sale at retail made pursuant to dis-
pensing the drug to a customer of the pharmacist or 
organization; or 
‘‘(B) a sale or trade of the drug to a pharmacy 
or a wholesaler registered to import drugs under sec-
tion 804. 
‘‘(2) The sale or trade by an individual of a qualifying 
drug that under section 804(a)(2)(B) was imported by the 
individual. 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00088
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
‘‘(3) The making of a materially false, fictitious, or 
fraudulent statement or representation, or a material 
omission, in a notice under clause (i) of section 
804(g)(2)(B) or in an application required under section 
804(g)(2)(F), or the failure to submit such a notice or 
application. 
‘‘(4) The importation of a drug in violation of a reg-
istration condition or other requirement under section 
804, the falsification of any record required to be main-
tained, or provided to the Secretary, under such section, 
or the violation of any registration condition or other re-
quirement under such section.’’; and 
(2) in section 303(a) (21 U.S.C. 333(a)), by 
striking paragraph (6) and inserting the following: 
‘‘(6) Notwithstanding subsection (a), any person that 
knowingly violates section 301(i) (2) or (3) or section 
301(aa)(4) shall be imprisoned not more than 10 years, 
or fined in accordance with title 18, United States Code, 
or both.’’. 
(c) AMENDMENT OF CERTAIN PROVISIONS.— 
(1) IN GENERAL.—Section 801 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381) is 
amended by striking subsection (g) and inserting the 
following: 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00089
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
‘‘(g) With respect to a prescription drug that is im-
ported or offered for import into the United States by an 
individual who is not in the business of such importation, 
that is not shipped by a registered exporter under section 
804, and that is refused admission under subsection (a), 
the Secretary shall notify the individual that— 
‘‘(1) the drug has been refused admission be-
cause the drug was not a lawful import under sec-
tion 804; 
‘‘(2) the drug is not otherwise subject to a 
waiver of the requirements of subsection (a); 
‘‘(3) the individual may under section 804 law-
fully import certain prescription drugs from export-
ers registered with the Secretary under section 804; 
and 
‘‘(4) the individual can find information about 
such importation, including a list of registered ex-
porters, on the Internet website of the Food and 
Drug Administration or through a toll-free telephone 
number required under section 804.’’. 
(2) ESTABLISHMENT
REGISTRATION.—Section 
510(i) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360(i)) is amended in paragraph (1) by 
inserting after ‘‘import into the United States’’ the 
following: ‘‘, including a drug that is, or may be, im-
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00090
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
ported or offered for import into the United States 
under section 804,’’. 
(3) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect on the date that 
is 90 days after the date of enactment of this Act. 
(d) EXHAUSTION.— 
(1) IN
GENERAL.—Section 271 of title 35, 
United States Code, is amended— 
(A) by redesignating subsections (h) and 
(i) as (i) and (j), respectively; and 
(B) by inserting after subsection (g) the 
following: 
‘‘(h) It shall not be an act of infringement to use, 
offer to sell, or sell within the United States or to import 
into the United States any patented invention under sec-
tion 804 of the Federal Food, Drug, and Cosmetic Act 
that was first sold abroad by or under authority of the 
owner or licensee of such patent.’’. 
(2) RULE OF CONSTRUCTION.—Nothing in the 
amendment made by paragraph (1) shall be con-
strued to affect the ability of a patent owner or li-
censee to enforce their patent, subject to such 
amendment. 
(e) EFFECT OF SECTION 804.— 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00091
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
(1) IN GENERAL.—Section 804 of the Federal 
Food, Drug, and Cosmetic Act, as added by sub-
section (a), shall permit the importation of quali-
fying drugs (as defined in such section 804) into the 
United States without regard to the status of the 
issuance of implementing regulations— 
(A) from exporters registered under such 
section 804 on the date that is 90 days after 
the date of enactment of this Act; and 
(B) from permitted countries, as defined in 
such section 804, by importers registered under 
such section 804 on the date that is 1 year 
after the date of enactment of this Act. 
(2) REVIEW OF REGISTRATION BY CERTAIN EX-
PORTERS.— 
(A) REVIEW PRIORITY.—In the review of 
registrations submitted under subsection (b) of 
such section 804, registrations submitted by en-
tities in Canada that are significant exporters 
of prescription drugs to individuals in the 
United States as of the date of enactment of 
this Act will have priority during the 90-day pe-
riod that begins on such date of enactment. 
(B) PERIOD FOR REVIEW.—During such 
90-day period, the reference in subsection 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00092
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
(b)(2)(A) of such section 804 to 90 days (relat-
ing to approval or disapproval of registrations) 
is, as applied to such entities, deemed to be 30 
days. 
(C) LIMITATION.—That an exporter in 
Canada exports, or has exported, prescription 
drugs to individuals in the United States on or 
before the date that is 90 days after the date 
of enactment of this Act shall not serve as a 
basis, in whole or in part, for disapproving a 
registration under such section 804 from the 
exporter. 
(D) FIRST
YEAR
LIMIT
ON
NUMBER
OF 
EXPORTERS.—During the 1-year period begin-
ning on the date of enactment of this Act, the 
Secretary of Health and Human Services (re-
ferred to in this section as the ‘‘Secretary’’) 
may limit the number of registered exporters 
under such section 804 to not less than 50, so 
long as the Secretary gives priority to those ex-
porters with demonstrated ability to process a 
high volume of shipments of drugs to individ-
uals in the United States. 
(E) SECOND YEAR LIMIT ON NUMBER OF 
EXPORTERS.—During the 1-year period begin-
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00093
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
ning on the date that is 1 year after the date 
of enactment of this Act, the Secretary may 
limit the number of registered exporters under 
such section 804 to not less than 100, so long 
as the Secretary gives priority to those export-
ers with demonstrated ability to process a high 
volume of shipments of drugs to individuals in 
the United States. 
(F) FURTHER LIMIT ON NUMBER OF EX-
PORTERS.—During any 1-year period beginning 
on a date that is 2 or more years after the date 
of enactment of this Act, the Secretary may 
limit the number of registered exporters under 
such section 804 to not less than 25 more than 
the number of such exporters during the pre-
vious 1-year period, so long as the Secretary 
gives priority to those exporters with dem-
onstrated ability to process a high volume of 
shipments of drugs to individuals in the United 
States. 
(3) LIMITS ON NUMBER OF IMPORTERS.— 
(A) FIRST YEAR LIMIT ON NUMBER OF IM-
PORTERS.—During the 1-year period beginning 
on the date that is 1 year after the date of en-
actment of this Act, the Secretary may limit the 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00094
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
number of registered importers under such sec-
tion 804 to not less than 100 (of which at least 
a significant number shall be groups of phar-
macies, to the extent feasible given the applica-
tions submitted by such groups), so long as the 
Secretary gives priority to those importers with 
demonstrated ability to process a high volume 
of shipments of drugs imported into the United 
States. 
(B) SECOND YEAR LIMIT ON NUMBER OF 
IMPORTERS.—During the 1-year period begin-
ning on the date that is 2 years after the date 
of enactment of this Act, the Secretary may 
limit the number of registered importers under 
such section 804 to not less than 200 (of which 
at least a significant number shall be groups of 
pharmacies, to the extent feasible given the ap-
plications submitted by such groups), so long as 
the Secretary gives priority to those importers 
with demonstrated ability to process a high vol-
ume of shipments of drugs into the United 
States. 
(C) FURTHER LIMIT ON NUMBER OF IM-
PORTERS.—During any 1-year period beginning 
on a date that is 3 or more years after the date 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00095
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
of enactment of this Act, the Secretary may 
limit the number of registered importers under 
such section 804 to not less than 50 more (of 
which at least a significant number shall be 
groups of pharmacies, to the extent feasible 
given the applications submitted by such 
groups) than the number of such importers 
during the previous 1-year period, so long as 
the Secretary gives priority to those importers 
with demonstrated ability to process a high vol-
ume of shipments of drugs to the United 
States. 
(4) NOTICES FOR DRUGS FOR IMPORT FROM 
CANADA.—The notice with respect to a qualifying 
drug introduced for commercial distribution in Can-
ada as of the date of enactment of this Act that is 
required under subsection (g)(2)(B)(i) of such sec-
tion 804 shall be submitted to the Secretary not 
later than 30 days after the date of enactment of 
this Act if— 
(A) the U.S. label drug (as defined in such 
section 804) for the qualifying drug is 1 of the 
100 prescription drugs with the highest dollar 
volume of sales in the United States based on 
the 12-calendar-month period most recently 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00096
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
completed before the date of enactment of this 
Act; or 
(B) the notice is a notice under subsection 
(g)(2)(B)(i)(II) of such section 804. 
(5) NOTICE
FOR
DRUGS
FOR
IMPORT
FROM 
OTHER COUNTRIES.—The notice with respect to a 
qualifying drug introduced for commercial distribu-
tion in a permitted country other than Canada as of 
the date of enactment of this Act that is required 
under subsection (g)(2)(B)(i) of such section 804 
shall be submitted to the Secretary not later than 
180 days after the date of enactment of this Act 
if— 
(A) the U.S. label drug for the qualifying 
drug is 1 of the 100 prescription drugs with the 
highest dollar volume of sales in the United 
States based on the 12-calendar-month period 
that is first completed on the date that is 120 
days after the date of enactment of this Act; or 
(B) the notice is a notice under subsection 
(g)(2)(B)(i)(II) of such section 804. 
(6) NOTICE FOR OTHER DRUGS FOR IMPORT.— 
(A) GUIDANCE ON SUBMISSION DATES.— 
The Secretary shall by guidance establish a se-
ries of submission dates for the notices under 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00097
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
subsection (g)(2)(B)(i) of such section 804 with 
respect to qualifying drugs introduced for com-
mercial distribution as of the date of enactment 
of this Act and that are not required to be sub-
mitted under paragraph (4) or (5). 
(B) CONSISTENT AND EFFICIENT USE OF 
RESOURCES.—The Secretary shall establish the 
dates described under subparagraph (A) so that 
such notices described under subparagraph (A) 
are submitted and reviewed at a rate that al-
lows consistent and efficient use of the re-
sources and staff available to the Secretary for 
such reviews. The Secretary may condition the 
requirement to submit such a notice, and the 
review of such a notice, on the submission by a 
registered exporter or a registered importer to 
the Secretary of a notice that such exporter or 
importer intends to import such qualifying drug 
to the United States under such section 804. 
(C) PRIORITY FOR DRUGS WITH HIGHER 
SALES.—The Secretary shall establish the dates 
described under subparagraph (A) so that the 
Secretary reviews the notices described under 
such subparagraph with respect to qualifying 
drugs with higher dollar volume of sales in the 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00098
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
United States before the notices with respect to 
drugs with lower sales in the United States. 
(7) NOTICES FOR DRUGS APPROVED AFTER EF-
FECTIVE
DATE.—The notice required under sub-
section (g)(2)(B)(i) of such section 804 for a quali-
fying drug first introduced for commercial distribu-
tion in a permitted country (as defined in such sec-
tion 804) after the date of enactment of this Act 
shall be submitted to and reviewed by the Secretary 
as provided under subsection (g)(2)(B) of such sec-
tion 804, without regard to paragraph (4), (5), or 
(6). 
(8) REPORT.—Beginning with the first full fis-
cal year after the date of enactment of this Act, not 
later than 90 days after the end of each fiscal year 
during which the Secretary reviews a notice referred 
to in paragraph (4), (5), or (6), the Secretary shall 
submit a report to Congress concerning the progress 
of the Food and Drug Administration in reviewing 
the notices referred to in paragraphs (4), (5), and 
(6). 
(9) USER FEES.— 
(A) EXPORTERS.—When establishing an 
aggregate total of fees to be collected from ex-
porters under subsection (f)(2) of such section 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00099
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
100 
804, the Secretary shall, under subsection 
(f)(3)(C)(i) of such section 804, estimate the 
total price of drugs imported under subsection 
(a) of such section 804 into the United States 
by registered exporters during the first fiscal 
year in which this Act takes effect to be an 
amount equal to the amount which bears the 
same ratio to $1,000,000,000 as the number of 
days in such fiscal year during which this Act 
is effective bears to 365. 
(B) IMPORTERS.—When establishing an 
aggregate total of fees to be collected from im-
porters under subsection (e)(2) of such section 
804, the Secretary shall, under subsection 
(e)(3)(C)(i) of such section 804, estimate the 
total price of drugs imported under subsection 
(a) of such section 804 into the United States 
by registered importers during— 
(i) the first fiscal year in which this 
Act takes effect to be an amount equal to 
the amount which bears the same ratio to 
$1,000,000,000 as the number of days in 
such fiscal year during which this Act is 
effective bears to 365; and 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00100
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
101 
(ii) the second fiscal year in which 
this Act is in effect to be $3,000,000,000. 
(C) SECOND YEAR ADJUSTMENT.— 
(i) REPORTS.—Not later than Feb-
ruary 20 of the second fiscal year in which 
this Act is in effect, registered importers 
shall report to the Secretary the total price 
and the total volume of drugs imported to 
the United States by the importer during 
the 4-month period from October 1 
through January 31 of such fiscal year. 
(ii) 
REESTIMATE.—Notwithstanding 
subsection (e)(3)(C)(ii) of such section 804 
or subparagraph (B), the Secretary shall 
reestimate the total price of qualifying 
drugs imported under subsection (a) of 
such section 804 into the United States by 
registered importers during the second fis-
cal year in which this Act is in effect. Such 
reestimate shall be equal to— 
(I) the total price of qualifying 
drugs imported by each importer as 
reported under clause (i); multiplied 
by 
(II) 3. 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00101
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
102 
(iii) ADJUSTMENT.—The Secretary 
shall adjust the fee due on April 1 of the 
second fiscal year in which this Act is in 
effect, from each importer so that the ag-
gregate total of fees collected under sub-
section (e)(2) for such fiscal year does not 
exceed the total price of qualifying drugs 
imported under subsection (a) of such sec-
tion 804 into the United States by reg-
istered importers during such fiscal year as 
reestimated under clause (ii). 
(D) FAILURE
TO
PAY
FEES.—Notwith-
standing any other provision of this section, the 
Secretary may prohibit a registered importer or 
exporter that is required to pay user fees under 
subsection (e) or (f) of such section 804 and 
that fails to pay such fees within 30 days after 
the date on which it is due, from importing or 
offering for importation a qualifying drug under 
such section 804 until such fee is paid. 
(E) ANNUAL REPORT.— 
(i) FOOD
AND
DRUG
ADMINISTRA-
TION.—Not later than 180 days after the 
end of each fiscal year during which fees 
are collected under subsection (e), (f), or 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00102
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
103 
(g)(2)(B)(iv) of such section 804, the Sec-
retary shall prepare and submit to the 
House of Representatives and the Senate a 
report on the implementation of the au-
thority for such fees during such fiscal 
year and the use, by the Food and Drug 
Administration, of the fees collected for the 
fiscal year for which the report is made 
and credited to the Food and Drug Admin-
istration. 
(ii) CUSTOMS
AND
BORDER
CON-
TROL.—Not later than 180 days after the 
end of each fiscal year during which fees 
are collected under subsection (e) or (f) of 
such section 804, the Secretary of Home-
land Security, in consultation with the Sec-
retary of the Treasury, shall prepare and 
submit to the House of Representatives 
and the Senate a report on the use, by the 
Bureau of Customs and Border Protection, 
of the fees, if any, transferred by the Sec-
retary to the Bureau of Customs and Bor-
der Protection for the fiscal year for which 
the report is made. 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00103
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
104 
(10) SPECIAL RULE REGARDING IMPORTATION 
BY INDIVIDUALS.— 
(A) IN
GENERAL.—Notwithstanding any 
provision of this Act (or an amendment made 
by this Act), the Secretary shall expedite the 
designation of any additional countries from 
which an individual may import a qualifying 
drug into the United States under such section 
804 if any action implemented by the Govern-
ment of Canada has the effect of limiting or 
prohibiting the importation of qualifying drugs 
into the United States from Canada. 
(B) TIMING
AND
CRITERIA.—The Sec-
retary shall designate such additional countries 
under subparagraph (A)— 
(i) not later than 6 months after the 
date of the action by the Government of 
Canada described under such subpara-
graph; and 
(ii) using the criteria described under 
subsection (a)(4)(D)(i)(II) of such section 
804. 
(f) IMPLEMENTATION OF SECTION 804.— 
(1) INTERIM RULE.—The Secretary may pro-
mulgate an interim rule for implementing section 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00104
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
105 
804 of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (a) of this section. 
(2) NO NOTICE OF PROPOSED RULEMAKING.— 
The interim rule described under paragraph (1) may 
be developed and promulgated by the Secretary with-
out providing general notice of proposed rulemaking. 
(3) FINAL RULE.—Not later than 1 year after 
the date on which the Secretary promulgates an in-
terim rule under paragraph (1), the Secretary shall, 
in accordance with procedures under section 553 of 
title 5, United States Code, promulgate a final rule 
for implementing such section 804, which may incor-
porate by reference provisions of the interim rule 
provided for under paragraph (1), to the extent that 
such provisions are not modified. 
(g) CONSUMER EDUCATION.—The Secretary shall 
carry out activities that educate consumers— 
(1) with regard to the availability of qualifying 
drugs for import for personal use from an exporter 
registered with and approved by the Food and Drug 
Administration under section 804 of the Federal 
Food, Drug, and Cosmetic Act, as added by this sec-
tion, including information on how to verify whether 
an exporter is registered and approved by use of the 
Internet website of the Food and Drug Administra-
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00105
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
106 
tion and the toll-free telephone number required by 
this Act; 
(2) that drugs that consumers attempt to im-
port from an exporter that is not registered with and 
approved by the Food and Drug Administration can 
be seized by the United States Customs Service and 
destroyed, and that such drugs may be counterfeit, 
unapproved, unsafe, or ineffective; 
(3) with regard to the suspension and termi-
nation of any registration of a registered importer or 
exporter under such section 804; and 
(4) with regard to the availability at domestic 
retail pharmacies of qualifying drugs imported under 
such section 804 by domestic wholesalers and phar-
macies registered with and approved by the Food 
and Drug Administration. 
(h) EFFECT ON ADMINISTRATION PRACTICES.—Not-
withstanding any provision of this Act (and the amend-
ments made by this Act), the practices and policies of the 
Food and Drug Administration and Bureau of Customs 
and Border Protection, in effect on January 1, 2004, with 
respect to the importation of prescription drugs into the 
United States by an individual, on the person of such indi-
vidual, for personal use, shall remain in effect. 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00106
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
107 
(i) REPORT
TO CONGRESS.—The Federal Trade 
Commission shall, on an annual basis, submit to Congress 
a report that describes any action taken during the period 
for which the report is being prepared to enforce the provi-
sions of section 804(n) of the Federal Food, Drug, and 
Cosmetic Act (as added by this Act), including any pend-
ing investigations or civil actions under such section. 
SEC. 5. DISPOSITION OF CERTAIN DRUGS DENIED ADMIS-
SION INTO UNITED STATES. 
(a) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), 
as amended by section 4, is further amended by adding 
at the end the following section: 
‘‘SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED AD-
MISSION. 
‘‘(a) IN GENERAL.—The Secretary of Homeland Se-
curity shall deliver to the Secretary a shipment of drugs 
that is imported or offered for import into the United 
States if— 
‘‘(1) the shipment has a declared value of less 
than $10,000; and 
‘‘(2)(A) the shipping container for such drugs 
does not bear the markings required under section 
804(d)(2); or 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00107
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
108 
‘‘(B) the Secretary has requested delivery of 
such shipment of drugs. 
‘‘(b) NO BOND OR EXPORT.—Section 801(b) does 
not authorize the delivery to the owner or consignee of 
drugs delivered to the Secretary under subsection (a) pur-
suant to the execution of a bond, and such drugs may not 
be exported. 
‘‘(c) DESTRUCTION OF VIOLATIVE SHIPMENT.—The 
Secretary shall destroy a shipment of drugs delivered by 
the Secretary of Homeland Security to the Secretary 
under subsection (a) if— 
‘‘(1) in the case of drugs that are imported or 
offered for import from a registered exporter under 
section 804, the drugs are in violation of any stand-
ard described in section 804(g)(5); or 
‘‘(2) in the case of drugs that are not imported 
or offered for import from a registered exporter 
under section 804, the drugs are in violation of a 
standard referred to in section 801(a) or 801(d)(1). 
‘‘(d) CERTAIN PROCEDURES.— 
‘‘(1) IN GENERAL.—The delivery and destruc-
tion of drugs under this section may be carried out 
without notice to the importer, owner, or consignee 
of the drugs except as required by section 801(g) or 
section 804(i)(2). The issuance of receipts for the 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00108
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
109 
drugs, and recordkeeping activities regarding the 
drugs, may be carried out on a summary basis. 
‘‘(2) OBJECTIVE OF PROCEDURES.—Procedures 
promulgated under paragraph (1) shall be designed 
toward the objective of ensuring that, with respect to 
efficiently utilizing Federal resources available for 
carrying out this section, a substantial majority of 
shipments of drugs subject to described in sub-
section (c) are identified and destroyed. 
‘‘(e) EVIDENCE EXCEPTION.—Drugs may not be de-
stroyed under subsection (c) to the extent that the Attor-
ney General of the United States determines that the 
drugs should be preserved as evidence or potential evi-
dence with respect to an offense against the United States. 
‘‘(f) RULE OF CONSTRUCTION.—This section may 
not be construed as having any legal effect on applicable 
law with respect to a shipment of drugs that is imported 
or offered for import into the United States and has a 
declared value equal to or greater than $10,000.’’. 
(b) PROCEDURES.—Procedures for carrying out sec-
tion 805 of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (a), shall be established not later 
than 90 days after the date of the enactment of this Act. 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00109
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
110 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on the date that is 90 days 
after the date of enactment of this Act. 
SEC. 6. WHOLESALE DISTRIBUTION OF DRUGS; STATE-
MENTS REGARDING PRIOR SALE, PURCHASE, 
OR TRADE. 
(a) STRIKING OF EXEMPTIONS; APPLICABILITY TO 
REGISTERED EXPORTERS.—Section 503(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) is 
amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘and who is not the manu-
facturer or an authorized distributor of record 
of such drug’’; 
(B) by striking ‘‘to an authorized dis-
tributor of record or’’; and 
(C) by striking subparagraph (B) and in-
serting the following: 
‘‘(B) The fact that a drug subject to subsection (b) 
is exported from the United States does not with respect 
to such drug exempt any person that is engaged in the 
business of the wholesale distribution of the drug from 
providing the statement described in subparagraph (A) to 
the person that receives the drug pursuant to the export 
of the drug. 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00110
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
111 
‘‘(C)(i) The Secretary shall by regulation establish re-
quirements that supersede subparagraph (A) (referred to 
in this subparagraph as ‘alternative requirements’) to 
identify the chain of custody of a drug subject to sub-
section (b) from the manufacturer of the drug throughout 
the wholesale distribution of the drug to a pharmacist who 
intends to sell the drug at retail if the Secretary deter-
mines that the alternative requirements, which may in-
clude standardized anti-counterfeiting or track-and-trace 
technologies, will identify such chain of custody or the 
identity of the discrete package of the drug from which 
the drug is dispensed with equal or greater certainty to 
the requirements of subparagraph (A), and that the alter-
native requirements are economically and technically fea-
sible. 
‘‘(ii) When the Secretary promulgates a final rule to 
establish such alternative requirements, the final rule in 
addition shall, with respect to the registration condition 
established in clause (i) of section 804(c)(3)(B), establish 
a condition equivalent to the alternative requirements, and 
such equivalent condition may be met in lieu of the reg-
istration condition established in such clause (i).’’; 
(2) in paragraph (2)(A), by adding at the end 
the following: ‘‘The preceding sentence may not be 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00111
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
112 
construed as having any applicability with respect to 
a registered exporter under section 804.’’; and 
(3) in paragraph (3), by striking ‘‘and sub-
section (d)—’’ in the matter preceding subparagraph 
(A) and all that follows through ‘‘the term ‘whole-
sale distribution’ means’’ in subparagraph (B) and 
inserting the following: ‘‘and subsection (d), the 
term ‘wholesale distribution’ means’’. 
(b) CONFORMING AMENDMENT.—Section 503(d) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(d)) is amended by adding at the end the following: 
‘‘(4) Each manufacturer of a drug subject to sub-
section (b) shall maintain at its corporate offices a current 
list of the authorized distributors of record of such drug. 
‘‘(5) For purposes of this subsection, the term ‘au-
thorized distributors of record’ means those distributors 
with whom a manufacturer has established an ongoing re-
lationship to distribute such manufacturer’s products.’’. 
(c) EFFECTIVE DATE.— 
(1) IN GENERAL.—The amendments made by 
paragraphs (1) and (3) of subsection (a) and by sub-
section (b) shall take effect on January 1, 2012. 
(2) DRUGS IMPORTED BY REGISTERED IMPORT-
ERS UNDER SECTION 804.—Notwithstanding para-
graph (1), the amendments made by paragraphs (1) 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00112
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
113 
and (3) of subsection (a) and by subsection (b) shall 
take effect on the date that is 90 days after the date 
of enactment of this Act with respect to qualifying 
drugs imported under section 804 of the Federal 
Food, Drug, and Cosmetic Act, as added by section 
4. 
(3) EFFECT
WITH
RESPECT
TO
REGISTERED 
EXPORTERS.—The amendment made by subsection 
(a)(2) shall take effect on the date that is 90 days 
after the date of enactment of this Act. 
(4) ALTERNATIVE REQUIREMENTS.—The Sec-
retary shall issue regulations to establish the alter-
native requirements, referred to in the amendment 
made by subsection (a)(1), that take effect not later 
than January 1, 2012. 
(5) INTERMEDIATE REQUIREMENTS.—The Sec-
retary shall by regulation require the use of stand-
ardized anti-counterfeiting or track-and-trace tech-
nologies on prescription drugs at the case and pallet 
level effective not later than 1 year after the date of 
enactment of this Act. 
(6) ADDITIONAL REQUIREMENTS.— 
(A) IN
GENERAL.—Notwithstanding any 
other provision of this section, the Secretary 
shall, not later than 18 months after the date 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00113
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
114 
of enactment of this Act, require that the pack-
aging of any prescription drug incorporates— 
(i) a standardized numerical identifier 
unique to each package of such drug, ap-
plied at the point of manufacturing and re-
packaging (in which case the numerical 
identifier shall be linked to the numerical 
identifier applied at the point of manufac-
turing); and 
(ii)(I) overt optically variable counter-
feit-resistant technologies that— 
(aa) are visible to the naked eye, 
providing for visual identification of 
product authenticity without the need 
for readers, microscopes, lighting de-
vices, or scanners; 
(bb) are similar to that used by 
the Bureau of Engraving and Printing 
to secure United States currency; 
(cc) are manufactured and dis-
tributed in a highly secure, tightly 
controlled environment; and 
(dd) incorporate additional layers 
of nonvisible convert security features 
up to and including forensic capa-
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00114
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
115 
bility, as described in subparagraph 
(B); or 
(II) technologies that have a function 
of security comparable to that described in 
subclause (I), as determined by the Sec-
retary. 
(B) STANDARDS
FOR
PACKAGING.—For 
the purpose of making it more difficult to coun-
terfeit the packaging of drugs subject to this 
paragraph, the manufacturers of such drugs 
shall incorporate the technologies described in 
subparagraph (A) into at least 1 additional ele-
ment of the physical packaging of the drugs, in-
cluding blister packs, shrink wrap, package la-
bels, package seals, bottles, and boxes. 
SEC. 7. INTERNET SALES OF PRESCRIPTION DRUGS. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 503B the following: 
‘‘SEC. 503C. INTERNET SALES OF PRESCRIPTION DRUGS. 
‘‘(a) REQUIREMENTS REGARDING INFORMATION ON 
INTERNET SITE.— 
‘‘(1) IN GENERAL.—A person may not dispense 
a prescription drug pursuant to a sale of the drug 
by such person if— 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00115
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
116 
‘‘(A) 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; 
‘‘(B) the person dispenses the drug to the 
purchaser by mailing or shipping the drug to 
the purchaser; and 
‘‘(C) such site, or any other Internet site 
used by such person for purposes of sales of a 
prescription drug, fails to meet each of the re-
quirements specified in paragraph (2), other 
than a site or pages on a site that— 
‘‘(i) are not intended to be accessed 
by purchasers or prospective purchasers; or 
‘‘(ii) provide an Internet information 
location tool within the meaning of section 
231(e)(5) of the Communications Act of 
1934 (47 U.S.C. 231(e)(5)). 
‘‘(2) REQUIREMENTS.—With respect to an 
Internet site, the requirements referred to in sub-
paragraph (C) of paragraph (1) for a person to 
whom such paragraph applies are as follows: 
‘‘(A) Each page of the site shall include ei-
ther the following information or a link to a 
page that provides the following information: 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00116
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
118 
health professions for which the individual 
holds such licenses or other authorizations. 
‘‘(B) A link to which paragraph (1) applies 
shall be displayed in a clear and prominent 
place and manner, and shall include in the cap-
tion for the link the words ‘licensing and con-
tact information’. 
‘‘(b) INTERNET
SALES
WITHOUT
APPROPRIATE 
MEDICAL RELATIONSHIPS.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), a person may not dispense a prescription 
drug, or sell such a drug, if— 
‘‘(A) for purposes of such dispensing or 
sale, the purchaser communicated with the per-
son through the Internet; 
‘‘(B) the patient for whom the drug was 
dispensed or purchased did not, when such 
communications began, have a prescription for 
the drug that is valid in the United States; 
‘‘(C) pursuant to such communications, the 
person provided for the involvement of a practi-
tioner, or an individual represented by the per-
son as a practitioner, and the practitioner or 
such individual issued a prescription for the 
drug that was purchased; 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00118
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
119 
‘‘(D) the person knew, or had reason to 
know, that the practitioner or the individual re-
ferred to in subparagraph (C) did not, when 
issuing the prescription, have a qualifying med-
ical relationship with the patient; and 
‘‘(E) the person received payment for the 
dispensing or sale of the drug. 
For purposes of subparagraph (E), payment is re-
ceived if money or other valuable consideration is re-
ceived. 
‘‘(2) EXCEPTIONS.—Paragraph (1) does not 
apply to— 
‘‘(A) the dispensing or selling of a pre-
scription drug pursuant to telemedicine prac-
tices sponsored by— 
‘‘(i) a hospital that has in effect a 
provider agreement under title XVIII of 
the Social Security Act (relating to the 
Medicare program); or 
‘‘(ii) a group practice that has not 
fewer than 100 physicians who have in ef-
fect provider agreements under such title; 
or 
‘‘(B) the dispensing or selling of a pre-
scription drug pursuant to practices that pro-
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00119
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
120 
mote the public health, as determined by the 
Secretary by regulation. 
‘‘(3) QUALIFYING MEDICAL RELATIONSHIP.— 
‘‘(A) 
IN
GENERAL.—With 
respect 
to 
issuing a prescription for a drug for a patient, 
a practitioner has a qualifying medical relation-
ship with the patient for purposes of this sec-
tion if— 
‘‘(i) at least one in-person medical 
evaluation of the patient has been con-
ducted by the practitioner; or 
‘‘(ii) the practitioner conducts a med-
ical evaluation of the patient as a covering 
practitioner. 
‘‘(B) IN-PERSON MEDICAL EVALUATION.— 
A medical evaluation by a practitioner is an in- 
person medical evaluation for purposes of this 
section if the practitioner is in the physical 
presence of the patient as part of conducting 
the evaluation, without regard to whether por-
tions of the evaluation are conducted by other 
health professionals. 
‘‘(C) COVERING PRACTITIONER.—With re-
spect to a patient, a practitioner is a covering 
practitioner for purposes of this section if the 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00120
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
121 
practitioner conducts a medical evaluation of 
the patient at the request of a practitioner who 
has conducted at least one in-person medical 
evaluation of the patient and is temporarily un-
available to conduct the evaluation of the pa-
tient. A practitioner is a covering practitioner 
without regard to whether the practitioner has 
conducted any in-person medical evaluation of 
the patient involved. 
‘‘(4) RULES OF CONSTRUCTION.— 
‘‘(A) 
INDIVIDUALS
REPRESENTED
AS 
PRACTITIONERS.—A person who is not a practi-
tioner (as defined in subsection (e)(1)) lacks 
legal capacity under this section to have a 
qualifying medical relationship with any patient. 
‘‘(B) STANDARD
PRACTICE
OF
PHAR-
MACY.—Paragraph (1) may not be construed as 
prohibiting any conduct that is a standard prac-
tice in the practice of pharmacy. 
‘‘(C) 
APPLICABILITY
OF
REQUIRE-
MENTS.—Paragraph (3) may not be construed 
as having any applicability beyond this section, 
and does not affect any State law, or interpre-
tation of State law, concerning the practice of 
medicine. 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00121
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
122 
‘‘(c) ACTIONS BY STATES.— 
‘‘(1) IN GENERAL.—Whenever an attorney gen-
eral of any State has reason to believe that the in-
terests of the residents of that State have been or 
are being threatened or adversely affected because 
any person has engaged or is engaging in a pattern 
or practice that violates section 301(l), the State 
may bring a civil action on behalf of its residents in 
an appropriate district court of the United States to 
enjoin such practice, to enforce compliance with such 
section (including a nationwide injunction), to obtain 
damages, restitution, or other compensation on be-
half of residents of such State, to obtain reasonable 
attorneys fees and costs if the State prevails in the 
civil action, or to obtain such further and other relief 
as the court may deem appropriate. 
‘‘(2) NOTICE.—The State shall serve prior writ-
ten notice of any civil action under paragraph (1) or 
(5)(B) upon the Secretary and provide the Secretary 
with a copy of its complaint, except that if it is not 
feasible for the State to provide such prior notice, 
the State shall serve such notice immediately upon 
instituting such action. Upon receiving a notice re-
specting a civil action, the Secretary shall have the 
right— 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00122
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
123 
‘‘(A) to intervene in such action; 
‘‘(B) upon so intervening, to be heard on 
all matters arising therein; and 
‘‘(C) to file petitions for appeal. 
‘‘(3) CONSTRUCTION.—For purposes of bring-
ing any civil action under paragraph (1), nothing in 
this chapter shall prevent an attorney general of a 
State from exercising the powers conferred on the 
attorney general by the laws of such State to con-
duct investigations or to administer oaths or affir-
mations or to compel the attendance of witnesses or 
the production of documentary and other evidence. 
‘‘(4) VENUE; SERVICE OF PROCESS.—Any civil 
action brought under paragraph (1) in a district 
court of the United States may be brought in the 
district in which the defendant is found, is an inhab-
itant, or transacts business or wherever venue is 
proper under section 1391 of title 28, United States 
Code. Process in such an action may be served in 
any district in which the defendant is an inhabitant 
or in which the defendant may be found. 
‘‘(5) ACTIONS BY OTHER STATE OFFICIALS.— 
‘‘(A) Nothing contained in this section 
shall prohibit an authorized State official from 
proceeding in State court on the basis of an al-
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00123
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
124 
leged violation of any civil or criminal statute of 
such State. 
‘‘(B) In addition to actions brought by an 
attorney general of a State under paragraph 
(1), such an action may be brought by officers 
of such State who are authorized by the State 
to bring actions in such State on behalf of its 
residents. 
‘‘(d) EFFECT OF SECTION.—This section shall not 
apply to a person that is a registered exporter under sec-
tion 804. 
‘‘(e) GENERAL DEFINITIONS.—For purposes of this 
section: 
‘‘(1) The term ‘practitioner’ means a practi-
tioner referred to in section 503(b)(1) with respect 
to issuing a written or oral prescription. 
‘‘(2) The term ‘prescription drug’ means a drug 
that is described in section 503(b)(1). 
‘‘(3) The term ‘qualifying medical relationship’, 
with respect to a practitioner and a patient, has the 
meaning indicated for such term in subsection (b). 
‘‘(f) INTERNET-RELATED DEFINITIONS.— 
‘‘(1) IN GENERAL.—For purposes of this sec-
tion: 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00124
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
125 
‘‘(A) The term ‘Internet’ means collectively 
the myriad of computer and telecommunications 
facilities, including equipment and operating 
software, which comprise the interconnected 
world-wide network of networks that employ the 
transmission control protocol/internet protocol, 
or any predecessor or successor protocols to 
such protocol, to communicate information of 
all kinds by wire or radio. 
‘‘(B) The term ‘link’, with respect to the 
Internet, means one or more letters, words, 
numbers, symbols, or graphic items that appear 
on a page of an Internet site for the purpose 
of serving, when activated, as a method for exe-
cuting an electronic command— 
‘‘(i) to move from viewing one portion 
of a page on such site to another portion 
of the page; 
‘‘(ii) to move from viewing one page 
on such site to another page on such site; 
or 
‘‘(iii) to move from viewing a page on 
one Internet site to a page on another 
Internet site. 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00125
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
126 
‘‘(C) The term ‘page’, with respect to the 
Internet, means a document or other file 
accessed at an Internet site. 
‘‘(D)(i) The terms ‘site’ and ‘address’, with 
respect to the Internet, mean a specific location 
on the Internet that is determined by Internet 
Protocol numbers. Such term includes the do-
main name, if any. 
‘‘(ii) The term ‘domain name’ means a 
method of representing an Internet address 
without direct reference to the Internet Protocol 
numbers for the address, including methods 
that use designations such as ‘.com’, ‘.edu’, 
‘.gov’, ‘.net’, or ‘.org’. 
‘‘(iii) The term ‘Internet Protocol num-
bers’ includes any successor protocol for deter-
mining a specific location on the Internet. 
‘‘(2) AUTHORITY
OF
SECRETARY.—The Sec-
retary may by regulation modify any definition 
under paragraph (1) to take into account changes in 
technology. 
‘‘(g) INTERACTIVE COMPUTER SERVICE; ADVER-
TISING.—No provider of an interactive computer service, 
as defined in section 230(f)(2) of the Communications Act 
of 1934 (47 U.S.C. 230(f)(2)), or of advertising services 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00126
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
127 
shall be liable under this section for dispensing or selling 
prescription drugs in violation of this section on account 
of another person’s selling or dispensing such drugs, pro-
vided that the provider of the interactive computer service 
or of advertising services does not own or exercise cor-
porate control over such person.’’. 
(b) INCLUSION AS PROHIBITED ACT.—Section 301 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331) is amended by inserting after paragraph (k) the fol-
lowing: 
‘‘(l) The dispensing or selling of a prescription drug 
in violation of section 503C.’’. 
(c) INTERNET SALES
OF PRESCRIPTION DRUGS; 
CONSIDERATION BY SECRETARY OF PRACTICES AND PRO-
CEDURES
FOR CERTIFICATION
OF LEGITIMATE BUSI-
NESSES.—In carrying out section 503C of the Federal 
Food, Drug, and Cosmetic Act (as added by subsection 
(a) of this section), the Secretary of Health and Human 
Services shall take into consideration the practices and 
procedures of public or private entities that certify that 
businesses selling prescription drugs through Internet 
sites are legitimate businesses, including practices and 
procedures regarding disclosure formats and verification 
programs. 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00127
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS
128 
(d) REPORTS REGARDING INTERNET-RELATED VIO-
LATIONS OF FEDERAL AND STATE LAWS ON DISPENSING 
OF DRUGS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this subsection as 
the ‘‘Secretary’’) shall, pursuant to the submission 
of an application meeting the criteria of the Sec-
retary, make an award of a grant or contract to the 
National Clearinghouse on Internet Prescribing (op-
erated by the Federation of State Medical Boards) 
for the purpose of— 
(A) identifying Internet sites that appear 
to be in violation of Federal or State laws con-
cerning the dispensing of drugs; 
(B) reporting such sites to State medical 
licensing boards and State pharmacy licensing 
boards, and to the Attorney General and the 
Secretary, for further investigation; and 
(C) submitting, for each fiscal year for 
which the award under this subsection is made, 
a report to the Secretary describing investiga-
tions undertaken with respect to violations de-
scribed in subparagraph (A). 
(2) AUTHORIZATION OF APPROPRIATIONS.—For 
the purpose of carrying out paragraph (1), there is 
VerDate Nov 24 2008 
02:36 Mar 06, 2009
Jkt 079200
PO 00000
Frm 00128
Fmt 6652
Sfmt 6201
E:\BILLS\H1298.IH
H1298
jbell on PROD1PC69 with BILLS