153 
‘‘(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.’’. 
(B) 
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
154 
drug that is, or may be, imported or offered for 
import into the United States under section 
804,’’. 
(C) 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. 
(4) EXHAUSTION.— 
(A) IN GENERAL.—Section 271 of title 35, 
United States Code, is amended— 
(i) by redesignating subsections (h) 
and (i) as (i) and (j), respectively; and 
(ii) 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.’’. 
(B) RULE OF CONSTRUCTION.—Nothing in 
the amendment made by paragraph (1) shall be 
construed to affect the ability of a patent owner 
or licensee to enforce their patent, subject to 
such amendment.
155 
(5) EFFECT OF SECTION 804.— 
(A) IN GENERAL.—Section 804 of the Fed-
eral Food, Drug, and Cosmetic Act, as added 
by subsection (a), shall permit the importation 
of qualifying drugs (as defined in such section 
804) into the United States without regard to 
the status of the issuance of implementing reg-
ulations— 
(i) from exporters registered under 
such section 804 on the date that is 90 
days after the date of enactment of this 
Act; and 
(ii) from permitted countries, as de-
fined in such section 804, by importers 
registered under such section 804 on the 
date that is 1 year after the date of enact-
ment of this Act. 
(B) REVIEW OF REGISTRATION BY CER-
TAIN EXPORTERS.— 
(i) REVIEW PRIORITY.—In the review 
of registrations submitted under subsection 
(b) of such section 804, registrations sub-
mitted by entities in Canada that are sig-
nificant exporters of prescription drugs to 
individuals in the United States as of the
156 
date of enactment of this Act will have pri-
ority during the 90 day period that begins 
on such date of enactment. 
(ii) PERIOD
FOR
REVIEW.—During 
such 90-day period, the reference in sub-
section (b)(2)(A) of such section 804 to 90 
days (relating to approval or disapproval of 
registrations) is, as applied to such enti-
ties, deemed to be 30 days. 
(iii) LIMITATION.—That an exporter 
in Canada exports, or has exported, pre-
scription 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. 
(iv) FIRST YEAR LIMIT ON NUMBER 
OF EXPORTERS.—During the 1-year period 
beginning on the date of enactment of this 
Act, the Secretary of Health and Human 
Services (referred to in this section as the 
‘‘Secretary’’) may limit the number of reg-
istered exporters under such section 804 to 
not less than 50, so long as the Secretary
157 
gives priority to those exporters with dem-
onstrated ability to process a high volume 
of shipments of drugs to individuals in the 
United States. 
(v) SECOND YEAR LIMIT ON NUMBER 
OF EXPORTERS.—During the 1-year period 
beginning on the date that is 1 year after 
the date of enactment of this Act, the Sec-
retary 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 exporters with dem-
onstrated ability to process a high volume 
of shipments of drugs to individuals in the 
United States. 
(vi) FURTHER LIMIT ON NUMBER OF 
EXPORTERS.—The Secretary shall report 
to Congress to request the authority to im-
pose a limitation on the number of reg-
istered exporters under such section 804 
during any period beginning on a date that 
is not less than 2 years after the date of 
enactment of this Act if the Secretary de-
termines that—
158 
(I) a limitation on the number of 
registered exporters is necessary for 
the effective and efficient enforcement 
of the requirements of such section 
804 with respect to such exporters; 
and 
(II) such limitation will not re-
strict the ability of individuals to im-
port prescription drugs for personal 
use from registered exporters under 
such section 804. 
(C) LIMITS ON NUMBER OF IMPORTERS.— 
(i) FIRST YEAR LIMIT ON NUMBER OF 
IMPORTERS.—During the 1-year period be-
ginning on the date that is 1 year after the 
date of enactment of this Act, the Sec-
retary may limit the number of registered 
importers under such section 804 to not 
less than 100 (of which at least a signifi-
cant number shall be groups of phar-
macies, 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
159 
to process a high volume of shipments of 
drugs imported into the United States. 
(ii) SECOND YEAR LIMIT ON NUMBER 
OF IMPORTERS.—During the 1-year period 
beginning on the date that is 2 years after 
the date of enactment of this Act, the Sec-
retary may limit the number of registered 
importers under such section 804 to not 
less than 200 (of which at least a signifi-
cant number shall be groups of phar-
macies, 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 volume of shipments of 
drugs to individuals in the United States. 
(iii) FURTHER LIMIT ON NUMBER OF 
IMPORTERS.—The Secretary shall report to 
Congress to request the authority to im-
pose a limitation on the number of reg-
istered importers under such section 804 
during any period beginning on a date that 
is not less than 3 years after the date of 
enactment of this Act if the Secretary de-
termines that—
160 
(I) a limitation on the number of 
registered importers is necessary for 
the effective and efficient enforcement 
of the requirements of such section 
804 with respect to such importers; 
and 
(II) such limitation will not re-
strict the ability of individuals to pur-
chase qualifying drugs imported under 
such section 804 or savings available 
to individuals by purchasing such 
qualifying drugs. 
(D) NOTICES
FOR
DRUGS
FOR
IMPORT 
FROM CANADA.—The notice with respect to a 
qualifying drug introduced for commercial dis-
tribution in 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 sub-
mitted to the Secretary not later than 30 days 
after the date of enactment of this Act if— 
(i) 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
161 
month period most recently completed be-
fore the date of enactment of this Act; or 
(ii) the notice is a notice under sub-
section (g)(2)(B)(i)(II) of such section 
804. 
(E) NOTICE
FOR
DRUGS
FOR
IMPORT 
FROM OTHER COUNTRIES.—The notice with re-
spect to a qualifying drug introduced for com-
mercial distribution 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 sub-
mitted to the Secretary not later than 180 days 
after the date of enactment of this Act if— 
(i) the U.S. label drug for the quali-
fying 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 com-
pleted on the date that is 120 days after 
the date of enactment of this Act; or 
(ii) the notice is a notice under sub-
section (g)(2)(B)(i)(II) of such section 
804.
162 
(F) NOTICE FOR OTHER DRUGS FOR IM-
PORT.— 
(i) 
GUIDANCE
ON
SUBMISSION 
DATES.—The Secretary shall by guidance 
establish a series of submission dates for 
the notices under subsection (g)(2)(B)(i) of 
such section 804 with respect to qualifying 
drugs introduced for commercial distribu-
tion as of the date of enactment of this Act 
and that are not required to be submitted 
under subparagraph (D) or (E). 
(ii) CONSISTENT AND EFFICIENT USE 
OF RESOURCES.—The Secretary shall es-
tablish the dates described under clause (i) 
so that such notices described under such 
clause are submitted and reviewed at a 
rate that allows consistent and efficient 
use of the resources and staff available to 
the Secretary for such reviews. Review of 
all such notices shall be completed not 
later than 5 years after the date of enact-
ment of this Act. 
(iii) PRIORITY
FOR
DRUGS
WITH 
HIGHER SALES.—The Secretary shall es-
tablish the dates described under clause (i)
163 
so that the Secretary reviews the notices 
described under such clause with respect to 
qualifying drugs with higher dollar volume 
of sales in the United States before the no-
tices with respect to drugs with lower sales 
in the United States. 
(G) NOTICES
FOR
DRUGS
APPROVED 
AFTER EFFECTIVE DATE.—The notice required 
under subsection (g)(2)(B)(i) of such section 
804 for a qualifying drug first introduced for 
commercial distribution in a permitted country 
(as defined in such section 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 section 804, 
without regard to subparagraph (D), (E), or 
(F). 
(H) REPORT.—Beginning with fiscal year 
2007, not later than 90 days after the end of 
each fiscal year during which the Secretary re-
views a notice referred to in subparagraph (D), 
(E), or (F), the Secretary shall submit a report 
to Congress concerning the progress of the 
Food and Drug Administration in reviewing the
164 
notices referred to in subparagraphs (D), (E), 
and (F). 
(I) USER FEES.— 
(i) EXPORTERS.—When establishing 
an aggregate total of fees to be collected 
from exporters under subsection (f)(2) of 
such section 804, the Secretary shall, 
under subsection (f)(3)(C)(i) of such sec-
tion 804, estimate the total price of drugs 
imported under subsection (a) of such sec-
tion 804 into the United States by reg-
istered exporters during fiscal year 2007 to 
be $1,000,000,000. 
(ii) IMPORTERS.—When establishing 
an aggregate total of fees to be collected 
from importers under subsection (e)(2) of 
such section 804, the Secretary shall, 
under subsection (e)(3)(C)(i) of such sec-
tion 804, estimate the total price of drugs 
imported under subsection (a) of such sec-
tion 804 into the United States by reg-
istered importers during— 
(I) fiscal year 2007 to be 
$1,000,000,000; and
165 
(II) fiscal year 2008 to be 
$10,000,000,000. 
(iii) FISCAL
YEAR
2008
ADJUST-
MENT.— 
(I) REPORTS.—Not later than 
February 20, 2008, registered import-
ers 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, 2007, through 
January 31, 2008. 
(II) 
REESTIMATE.—Notwith-
standing subsection (e)(3)(C)(ii) of 
such section 804 or clause (ii), the 
Secretary shall reestimate the total 
price of qualifying drugs imported 
under subsection (a) of such section 
804 into the United States by reg-
istered importers during fiscal year 
2008. Such reestimate shall be equal 
to— 
(aa) the total price of quali-
fying drugs imported by each im-
166 
porter as reported under sub-
clause (I); multiplied by 
(bb) 3. 
(III) ADJUSTMENT.—The Sec-
retary shall adjust the fee due on 
April 1, 2008, from each importer so 
that the aggregate total of fees col-
lected under paragraph (5)(B) for fis-
cal year 2008 does not exceed the 
total price of qualifying drugs im-
ported under subsection (a) of such 
section 804 into the United States by 
registered importers during fiscal year 
2008 as reestimated under subclause 
(II). 
(iv) ANNUAL REPORT.— 
(I) FOOD
AND
DRUG
ADMINIS-
TRATION.—Beginning with fiscal year 
2007, not later than 180 days after 
the end of each fiscal year during 
which fees are collected under sub-
section (e), (f), or (g)(2)(B)(iv) of 
such section 804, the Secretary shall 
prepare and submit to the House of 
Representatives and the Senate a re-
167 
port on the implementation of the au-
thority for such fees during such fis-
cal year and the use, by the Food and 
Drug Administration, of the fees col-
lected for the fiscal year for which the 
report is made and credited to the 
Food and Drug Administration. 
(II) CUSTOMS AND BORDER CON-
TROL.—Beginning with fiscal year 
2007, not later than 180 days after 
the end of each fiscal year during 
which fees are collected under sub-
section (e) or (f) of such section 804, 
the Secretary of Homeland Security, 
in consultation with the Secretary of 
the Treasury, shall prepare and sub-
mit 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, trans-
ferred by the Secretary to the Bureau 
of Customs and Border Protection for 
the fiscal year for which the report is 
made. 
(6) IMPLEMENTATION OF SECTION 804.—
168 
(A) INTERIM RULE.—The Secretary may 
promulgate an interim rule for implementing 
section 804 of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a) of this 
section. 
(B) NO
NOTICE
OF
PROPOSED
RULE-
MAKING.—The interim rule described under 
subparagraph (A) may be developed and pro-
mulgated by the Secretary without providing 
general notice of proposed rulemaking. 
(C) FINAL RULE.—Not later than 1 year 
after the date on which the Secretary promul-
gates an interim rule under subparagraph (A), 
the Secretary shall, in accordance with proce-
dures under section 553 of title 5, United 
States Code, promulgate a final rule for imple-
menting such section 804, which may incor-
porate by reference provisions of the interim 
rule provided for under subparagraph (A), to 
the extent that such provisions are not modi-
fied. 
(7) CONSUMER
EDUCATION.—The Secretary 
shall carry out activities that educate consumers— 
(A) with regard to the availability of quali-
fying drugs for import for personal use from an
169 
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 section, including infor-
mation on how to verify whether an exporter is 
registered and approved by use of the Internet 
website of the Food and Drug Administration 
and the toll-free telephone number required by 
this Act; 
(B) that drugs that consumers attempt to 
import from an exporter that is not registered 
with and approved by the Food and Drug Ad-
ministration can be seized by the United States 
Customs Service and destroyed, and that such 
drugs may be counterfeit, unapproved, unsafe, 
or ineffective; and 
(C) with regard to the availability at do-
mestic retail pharmacies of qualifying drugs im-
ported under such section 804 by domestic 
wholesalers and pharmacies registered with and 
approved by the Food and Drug Administra-
tion. 
(8) EFFECT ON ADMINISTRATION PRACTICES.— 
Notwithstanding any provision of this Act (and the 
amendments made by this Act), nothing in this Act
170 
(or the amendments made by this Act) shall be con-
strued to change, limit, or restrict the practices of 
the Food and Drug Administration or the Bureau of 
Customs and Border Protection in effect on January 
1, 2004, with respect to the importation of prescrip-
tion drugs into the United States by an individual, 
on the person of such individual, for personal use. 
(c) DISPOSITION OF CERTAIN DRUGS DENIED AD-
MISSION INTO UNITED STATES.— 
(1) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et 
seq.), as amended by this section, is further amend-
ed 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
171 
‘‘(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
172 
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.’’. 
(2) PROCEDURES.—Procedures for carrying out 
section 805 of the Federal Food, Drug, and Cos-
metic Act, as added by this subsection, shall be es-
tablished not later than 90 days after the date of the 
enactment of this Act.
173 
(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) CIVIL ACTIONS REGARDING PROPERTY.— 
(1) IN GENERAL.—Section 303 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is 
amended by adding at the end the following sub-
section: 
‘‘(g)(1) If a person is alienating or disposing of prop-
erty, or intends to alienate or dispose of property, that 
is obtained as a result of or is traceable to a drug imported 
in violation of section 801(a) or 801(d), the Attorney Gen-
eral may commence a civil action in any Federal court— 
‘‘(A) to enjoin such alienation or disposition of 
property; or 
‘‘(B) for a restraining order to— 
‘‘(i) prohibit any person from withdrawing, 
transferring, removing, dissipating, or disposing 
of any such property or property of equivalent 
value; and 
‘‘(ii) appoint a temporary receiver to ad-
minister such restraining order. 
‘‘(2) Proceedings under paragraph (1) shall be car-
ried out in the same manner as applies under section 1345 
of title 18, United States Code.’’.