in the export or import enterprise, or a prin-
cipal officer in such enterprise, and any reg-
istration prepared with the assistance of the 
registrant or such a person, has no legal effect 
under this section. 
‘‘(5) DEFAULT OF BOND.—A bond required to 
be posted by an exporter under paragraph (1)(I)(ii) 
shall be defaulted and paid to the Treasury of the 
United States if, after opportunity for an informal 
hearing, the Secretary determines that the exporter 
has— 
‘‘(A) exported a drug to the United States 
that is not a qualifying drug or that is not in 
compliance with subsection (g)(2)(A), (g)(4), or 
(i); or 
‘‘(B) failed to permit the Secretary to con-
duct an inspection described under subsection 
(d). 
‘‘(c) SOURCES OF QUALIFYING DRUGS.—A registra-
tion condition is that the exporter or importer involved 
agrees that a qualifying drug will under subsection (a) be 
exported or imported into the United States only if there 
is compliance with the following: 
‘‘(1) The drug was manufactured in an estab-
lishment— 
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‘‘(A) required to register under subsection 
(h) or (i) of section 510; and 
‘‘(B)(i) inspected by the Secretary; or 
‘‘(ii) for which the Secretary has elected to 
rely on a satisfactory report of a good manufac-
turing practice inspection of the establishment 
from a permitted country whose regulatory sys-
tem the Secretary recognizes as equivalent 
under a mutual recognition agreement, as pro-
vided for under section 510(i)(3), section 803, 
or part 26 of title 21, Code of Federal Regula-
tions (or any corresponding successor rule or 
regulation). 
‘‘(2) The establishment is located in any coun-
try, and the establishment manufactured the drug 
for distribution in the United States or for distribu-
tion in 1 or more of the permitted countries (without 
regard to whether in addition the drug is manufac-
tured for distribution in a foreign country that is 
not a permitted country). 
‘‘(3) The exporter or importer obtained the 
drug— 
‘‘(A) directly from the establishment; or 
‘‘(B) directly from an entity that, by con-
tract with the exporter or importer— 
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‘‘(i) provides to the exporter or im-
porter a statement (in such form and con-
taining such information as the Secretary 
may require) that, for the chain of custody 
from the establishment, identifies each 
prior sale, purchase, or trade of the drug 
(including the date of the transaction and 
the names and addresses of all parties to 
the transaction); 
‘‘(ii) agrees to permit the Secretary to 
inspect 
such 
statements 
and 
related 
records to determine their accuracy; 
‘‘(iii) agrees, with respect to the quali-
fying drugs involved, to permit the Sec-
retary to inspect warehouses and other fa-
cilities, including records, of the entity for 
purposes of determining whether the facili-
ties are in compliance with any standards 
under this Act that are applicable to facili-
ties of that type in the United States; and 
‘‘(iv) has ensured, through such con-
tractual relationships as may be necessary, 
that the Secretary has the same authority 
regarding other parties in the chain of cus-
tody from the establishment that the Sec-
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retary has under clauses (ii) and (iii) re-
garding such entity. 
‘‘(4)(A) The foreign country from which the im-
porter will import the drug is a permitted country; 
or 
‘‘(B) The foreign country from which the ex-
porter will export the drug is the permitted country 
in which the exporter is located. 
‘‘(5) During any period in which the drug was 
not in the control of the manufacturer of the drug, 
the drug did not enter any country that is not a per-
mitted country. 
‘‘(6) The exporter or importer retains a sample 
of each lot of the drug for testing by the Secretary. 
‘‘(d) INSPECTION OF FACILITIES; MARKING OF SHIP-
MENTS.— 
‘‘(1) INSPECTION OF FACILITIES.—A registra-
tion condition is that, for the purpose of assisting 
the Secretary in determining whether the exporter 
involved is in compliance with all other registration 
conditions— 
‘‘(A) the exporter agrees to permit the Sec-
retary— 
‘‘(i) to conduct onsite inspections, in-
cluding monitoring on a day-to-day basis, 
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of places of business of the exporter that 
relate to qualifying drugs, including each 
warehouse or other facility owned or con-
trolled by, or operated for, the exporter; 
‘‘(ii) to have access, including on a 
day-to-day basis, to— 
‘‘(I) records of the exporter that 
relate to the export of such drugs, in-
cluding financial records; and 
‘‘(II) samples of such drugs; 
‘‘(iii) to carry out the duties described 
in paragraph (3); and 
‘‘(iv) to carry out any other functions 
determined by the Secretary to be nec-
essary regarding the compliance of the ex-
porter; and 
‘‘(B) the Secretary has assigned 1 or more 
employees of the Secretary to carry out the 
functions described in this subsection for the 
Secretary randomly, but not less than 12 times 
annually, on the premises of places of busi-
nesses referred to in subparagraph (A)(i), and 
such an assignment remains in effect on a con-
tinuous basis. 
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‘‘(2) MARKING OF COMPLIANT SHIPMENTS.—A 
registration condition is that the exporter involved 
agrees to affix to each shipping container of quali-
fying drugs exported under subsection (a) such 
markings as the Secretary determines to be nec-
essary to identify the shipment as being in compli-
ance with all registration conditions. Markings under 
the preceding sentence shall— 
‘‘(A) be designed to prevent affixation of 
the markings to any shipping container that is 
not authorized to bear the markings; and 
‘‘(B) include anticounterfeiting or track- 
and-trace technologies, taking into account the 
economic and technical feasibility of those tech-
nologies. 
‘‘(3) CERTAIN DUTIES RELATING TO EXPORT-
ERS.—Duties of the Secretary with respect to an ex-
porter include the following: 
‘‘(A) Inspecting, randomly, but not less 
than 12 times annually, the places of business 
of the exporter at which qualifying drugs are 
stored and from which qualifying drugs are 
shipped. 
‘‘(B) During the inspections under sub-
paragraph (A), verifying the chain of custody of 
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a statistically significant sample of qualifying 
drugs from the establishment in which the drug 
was manufactured to the exporter, which shall 
be accomplished or supplemented by the use of 
anticounterfeiting 
or 
track-and-trace 
tech-
nologies, taking into account the economic and 
technical feasibility of those technologies, except 
that a drug that lacks such technologies from 
the point of manufacture shall not for that rea-
son be excluded from importation by an ex-
porter. 
‘‘(C) Randomly reviewing records of ex-
ports to individuals for the purpose of deter-
mining whether the drugs are being imported 
by the individuals in accordance with the condi-
tions under subsection (i). Such reviews shall be 
conducted in a manner that will result in a sta-
tistically significant determination of compli-
ance with all such conditions. 
‘‘(D) Monitoring the affixing of markings 
under paragraph (2). 
‘‘(E) Inspecting as the Secretary deter-
mines is necessary the warehouses and other fa-
cilities, including records, of other parties in the 
chain of custody of qualifying drugs. 
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‘‘(F) Determining whether the exporter is 
in compliance with all other registration condi-
tions. 
‘‘(4) PRIOR
NOTICE
OF
SHIPMENTS.—A reg-
istration condition is that, not less than 8 hours and 
not more than 5 days in advance of the time of the 
importation of a shipment of qualifying drugs, the 
importer involved agrees to submit to the Secretary 
a notice with respect to the shipment of drugs to be 
imported or offered for import into the United 
States under subsection (a). A notice under the pre-
ceding sentence shall include— 
‘‘(A) the name and complete contact infor-
mation of the person submitting the notice; 
‘‘(B) the name and complete contact infor-
mation of the importer involved; 
‘‘(C) the identity of the drug, including the 
established name of the drug, the quantity of 
the drug, and the lot number assigned by the 
manufacturer; 
‘‘(D) the identity of the manufacturer of 
the drug, including the identity of the establish-
ment at which the drug was manufactured; 
‘‘(E) the country from which the drug is 
shipped; 
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‘‘(F) the name and complete contact infor-
mation for the shipper of the drug; 
‘‘(G) anticipated arrival information, in-
cluding the port of arrival and crossing location 
within that port, and the date and time; 
‘‘(H) a summary of the chain of custody of 
the drug from the establishment in which the 
drug was manufactured to the importer; 
‘‘(I) a declaration as to whether the Sec-
retary has ordered that importation of the drug 
from the permitted country cease under sub-
section (g)(2) (C) or (D); and 
‘‘(J) such other information as the Sec-
retary may require by regulation. 
‘‘(5) MARKING OF COMPLIANT SHIPMENTS.—A 
registration condition is that the importer involved 
agrees, before wholesale distribution (as defined in 
section 503(e)) of a qualifying drug that has been 
imported under subsection (a), to affix to each con-
tainer of such drug such markings or other tech-
nology as the Secretary determines necessary to 
identify the shipment as being in compliance with all 
registration conditions, except that the markings or 
other technology shall not be required on a drug 
that bears comparable, compatible markings or tech-
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nology from the manufacturer of the drug. Markings 
or other technology under the preceding sentence 
shall— 
‘‘(A) be designed to prevent affixation of 
the markings or other technology to any con-
tainer that is not authorized to bear the mark-
ings; and 
‘‘(B) shall include anticounterfeiting or 
track-and-trace technologies, taking into ac-
count the economic and technical feasibility of 
such technologies. 
‘‘(6) CERTAIN DUTIES RELATING TO IMPORT-
ERS.—Duties of the Secretary with respect to an im-
porter include the following: 
‘‘(A) Inspecting, randomly, but not less 
than 12 times annually, the places of business 
of the importer at which a qualifying drug is 
initially received after importation. 
‘‘(B) During the inspections under sub-
paragraph (A), verifying the chain of custody of 
a statistically significant sample of qualifying 
drugs from the establishment in which the drug 
was manufactured to the importer, which shall 
be accomplished or supplemented by the use of 
anticounterfeiting 
or 
track-and-trace 
tech-
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nologies, taking into account the economic and 
technical feasibility of those technologies, except 
that a drug that lacks such technologies from 
the point of manufacture shall not for that rea-
son be excluded from importation by an im-
porter. 
‘‘(C) Reviewing notices under paragraph 
(4). 
‘‘(D) Inspecting as the Secretary deter-
mines is necessary the warehouses and other fa-
cilities, including records of other parties in the 
chain of custody of qualifying drugs. 
‘‘(E) Determining whether the importer is 
in compliance with all other registration condi-
tions. 
‘‘(e) IMPORTER FEES.— 
‘‘(1) REGISTRATION FEE.—A registration con-
dition is that the importer involved pays to the Sec-
retary a fee of $10,000 due on the date on which 
the importer first submits the registration to the 
Secretary under subsection (b). 
‘‘(2) INSPECTION FEE.—A registration condi-
tion is that the importer involved pays a fee to the 
Secretary in accordance with this subsection. Such 
fee shall be paid not later than October 1 and April 
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1 of each fiscal year in the amount provided for 
under paragraph (3). 
‘‘(3) AMOUNT OF INSPECTION FEE.— 
‘‘(A) AGGREGATE TOTAL OF FEES.—Not 
later than 30 days before the start of each fis-
cal year, the Secretary, in consultation with the 
Secretary of Homeland Security and the Sec-
retary of the Treasury, shall establish an aggre-
gate total of fees to be collected under para-
graph (2) for importers for that fiscal year that 
is sufficient, and not more than necessary, to 
pay the costs for that fiscal year of admin-
istering this section with respect to registered 
importers, including the costs associated with— 
‘‘(i) inspecting the facilities of reg-
istered importers, and of other entities in 
the chain of custody of a qualifying drug 
as necessary, under subsection (d)(6); 
‘‘(ii) developing, implementing, and 
operating under such subsection an elec-
tronic system for submission and review of 
the notices required under subsection 
(d)(4) with respect to shipments of quali-
fying drugs under subsection (a) to assess 
compliance with all registration conditions 
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dcolon on DSK2BSOYB1PROD with BILLS
registered importer on April 1 of the sub-
sequent fiscal year so that the limitation 
described in subparagraph (B) is observed. 
‘‘(D) INDIVIDUAL
IMPORTER
FEE.—Sub-
ject to the limitation described in subparagraph 
(B), the fee under paragraph (2) to be paid on 
October 1 and April 1 by an importer shall be 
an amount that is proportional to a reasonable 
estimate by the Secretary of the semiannual 
share of the importer of the volume of quali-
fying drugs imported by importers under sub-
section (a). 
‘‘(4) USE OF FEES.— 
‘‘(A) IN GENERAL.—Subject to appropria-
tions Acts, fees collected by the Secretary under 
paragraphs (1) and (2) shall be credited to the 
appropriation account for salaries and expenses 
of the Food and Drug Administration until ex-
pended (without fiscal year limitation), and the 
Secretary may, in consultation with the Sec-
retary of Homeland Security and the Secretary 
of the Treasury, transfer some proportion of 
such fees to the appropriation account for sala-
ries and expenses of the Bureau of Customs 
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and Border Protection until expended (without 
fiscal year limitation). 
‘‘(B) SOLE
PURPOSE.—Fees collected by 
the Secretary under paragraphs (1) and (2) are 
only available to the Secretary and, if trans-
ferred, to the Secretary of Homeland Security, 
and are for the sole purpose of paying the costs 
referred to in paragraph (3)(A). 
‘‘(5) COLLECTION OF FEES.—In any case where 
the Secretary does not receive payment of a fee as-
sessed under paragraph (1) or (2) within 30 days 
after it is due, such fee shall be treated as a claim 
of the United States Government subject to sub-
chapter II of chapter 37 of title 31, United States 
Code. 
‘‘(f) EXPORTER FEES.— 
‘‘(1) REGISTRATION FEE.—A registration con-
dition is that the exporter involved pays to the Sec-
retary a fee of $10,000 due on the date on which 
the exporter first submits that registration to the 
Secretary under subsection (b). 
‘‘(2) INSPECTION FEE.—A registration condi-
tion is that the exporter involved pays a fee to the 
Secretary in accordance with this subsection. Such 
fee shall be paid not later than October 1 and April 
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1 of each fiscal year in the amount provided for 
under paragraph (3). 
‘‘(3) AMOUNT OF INSPECTION FEE.— 
‘‘(A) AGGREGATE TOTAL OF FEES.—Not 
later than 30 days before the start of each fis-
cal year, the Secretary, in consultation with the 
Secretary of Homeland Security and the Sec-
retary of the Treasury, shall establish an aggre-
gate total of fees to be collected under para-
graph (2) for exporters for that fiscal year that 
is sufficient, and not more than necessary, to 
pay the costs for that fiscal year of admin-
istering this section with respect to registered 
exporters, including the costs associated with— 
‘‘(i) inspecting the facilities of reg-
istered exporters, and of other entities in 
the chain of custody of a qualifying drug 
as necessary, under subsection (d)(3); 
‘‘(ii) developing, implementing, and 
operating under such subsection a system 
to screen marks on shipments of qualifying 
drugs under subsection (a) that indicate 
compliance with all registration conditions, 
when such shipments are offered for im-
port into the United States; and 
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‘‘(iii) screening such markings, and 
inspecting such shipments as necessary, 
when offered for import into the United 
States to determine if such a shipment 
should be refused admission under sub-
section (g)(5). 
‘‘(B) LIMITATION.—Subject to subpara-
graph (C), the aggregate total of fees collected 
under paragraph (2) for a fiscal year shall not 
exceed 2.5 percent of the total price of quali-
fying drugs imported during that fiscal year 
into the United States by registered exporters 
under subsection (a). 
‘‘(C) TOTAL PRICE OF DRUGS.— 
‘‘(i) ESTIMATE.—For the purposes of 
complying with the limitation described in 
subparagraph (B) when establishing under 
subparagraph (A) the aggregate total of 
fees to be collected under paragraph (2) 
for a fiscal year, the Secretary shall esti-
mate the total price of qualifying drugs im-
ported into the United States by registered 
exporters during that fiscal year by adding 
the total price of qualifying drugs exported 
by each registered exporter during the 6- 
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dcolon on DSK2BSOYB1PROD with BILLS
month period from January 1 through 
June 30 of the previous fiscal year, as re-
ported to the Secretary by each registered 
exporter under subsection (b)(1)(I)(iv). 
‘‘(ii) CALCULATION.—Not later than 
March 1 of the fiscal year that follows the 
fiscal year for which the estimate under 
clause (i) is made, the Secretary shall cal-
culate the total price of qualifying drugs 
imported into the United States by reg-
istered exporters during that fiscal year by 
adding the total price of qualifying drugs 
exported by each registered exporter dur-
ing that fiscal year, as reported to the Sec-
retary by each registered exporter under 
subsection (b)(1)(I)(iv). 
‘‘(iii) 
ADJUSTMENT.—If 
the 
total 
price of qualifying drugs imported into the 
United States by registered exporters dur-
ing a fiscal year as calculated under clause 
(ii) is less than the aggregate total of fees 
collected under paragraph (2) for that fis-
cal year, the Secretary shall provide for a 
pro-rata reduction in the fee due from each 
registered exporter on April 1 of the subse-
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quent fiscal year so that the limitation de-
scribed in subparagraph (B) is observed. 
‘‘(D) INDIVIDUAL EXPORTER FEE.—Sub-
ject to the limitation described in subparagraph 
(B), the fee under paragraph (2) to be paid on 
October 1 and April 1 by an exporter shall be 
an amount that is proportional to a reasonable 
estimate by the Secretary of the semiannual 
share of the exporter of the volume of quali-
fying drugs exported by exporters under sub-
section (a). 
‘‘(4) USE OF FEES.— 
‘‘(A) IN GENERAL.—Subject to appropria-
tions Acts, fees collected by the Secretary under 
paragraphs (1) and (2) shall be credited to the 
appropriation account for salaries and expenses 
of the Food and Drug Administration until ex-
pended (without fiscal year limitation), and the 
Secretary may, in consultation with the Sec-
retary of Homeland Security and the Secretary 
of the Treasury, transfer some proportion of 
such fees to the appropriation account for sala-
ries and expenses of the Bureau of Customs 
and Border Protection until expended (without 
fiscal year limitation). 
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‘‘(B) SOLE
PURPOSE.—Fees collected by 
the Secretary under paragraphs (1) and (2) are 
only available to the Secretary and, if trans-
ferred, to the Secretary of Homeland Security, 
and are for the sole purpose of paying the costs 
referred to in paragraph (3)(A). 
‘‘(5) COLLECTION OF FEES.—In any case where 
the Secretary does not receive payment of a fee as-
sessed under paragraph (1) or (2) within 30 days 
after it is due, such fee shall be treated as a claim 
of the United States Government subject to sub-
chapter II of chapter 37 of title 31, United States 
Code. 
‘‘(g) COMPLIANCE WITH SECTION 801(a).— 
‘‘(1) IN GENERAL.—A registration condition is 
that each qualifying drug exported under subsection 
(a) by the registered exporter involved or imported 
under subsection (a) by the registered importer in-
volved is in compliance with the standards referred 
to in section 801(a) regarding admission of the drug 
into the United States, subject to paragraphs (2), 
(3), and (4). 
‘‘(2) SECTION 505; APPROVAL STATUS.— 
‘‘(A) IN GENERAL.—A qualifying drug that 
is imported or offered for import under sub-
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section (a) shall comply with the conditions es-
tablished in the approved application under sec-
tion 505(b) for the U.S. label drug as described 
under this subsection. 
‘‘(B) NOTICE
BY
MANUFACTURER; GEN-
ERAL PROVISIONS.— 
‘‘(i) IN GENERAL.—The person that 
manufactures a qualifying drug that is, or 
will be, introduced for commercial distribu-
tion in a permitted country shall in accord-
ance with this paragraph submit to the 
Secretary a notice that— 
‘‘(I) includes each difference in 
the qualifying drug from a condition 
established in the approved applica-
tion for the U.S. label drug beyond— 
‘‘(aa) the variations provided 
for in the application; and 
‘‘(bb) any difference in label-
ing (except ingredient labeling); 
or 
‘‘(II) states that there is no dif-
ference in the qualifying drug from a 
condition established in the approved 
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application for the U.S. label drug be-
yond— 
‘‘(aa) the variations provided 
for in the application; and 
‘‘(bb) any difference in label-
ing (except ingredient labeling). 
‘‘(ii) INFORMATION
IN
NOTICE.—A 
notice under clause (i)(I) shall include the 
information that the Secretary may require 
under section 506A, any additional infor-
mation the Secretary may require (which 
may include data on bioequivalence if such 
data are not required under section 506A), 
and, with respect to the permitted country 
that approved the qualifying drug for com-
mercial distribution, or with respect to 
which such approval is sought, include the 
following: 
‘‘(I) The date on which the quali-
fying drug with such difference was, 
or will be, introduced for commercial 
distribution in the permitted country. 
‘‘(II) Information demonstrating 
that the person submitting the notice 
has also notified the government of 
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dcolon on DSK2BSOYB1PROD with BILLS
the permitted country in writing that 
the person is submitting to the Sec-
retary a notice under clause (i)(I), 
which notice describes the difference 
in the qualifying drug from a condi-
tion established in the approved appli-
cation for the U.S. label drug. 
‘‘(III) The information that the 
person submitted or will submit to the 
government of the permitted country 
for purposes of obtaining approval for 
commercial distribution of the drug in 
the country which, if in a language 
other than English, shall be accom-
panied by an English translation 
verified to be complete and accurate, 
with the name, address, and a brief 
statement of the qualifications of the 
person that made the translation. 
‘‘(iii) CERTIFICATIONS.—The chief ex-
ecutive officer and the chief medical officer 
of the manufacturer involved shall each 
certify in the notice under clause (i) that— 
‘‘(I) the information provided in 
the notice is complete and true; and 
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‘‘(II) a copy of the notice has 
been provided to the Federal Trade 
Commission and to the State attor-
neys general. 
‘‘(iv) FEE.—If a notice submitted 
under clause (i) includes a difference that 
would, under section 506A, require the 
submission of a supplemental application if 
made as a change to the U.S. label drug, 
the person that submits the notice shall 
pay to the Secretary a fee in the same 
amount as would apply if the person were 
paying 
a 
fee 
pursuant 
to 
section 
736(a)(1)(A)(ii). Subject to appropriations 
Acts, fees collected by the Secretary under 
the preceding sentence are available only to 
the Secretary and are for the sole purpose 
of paying the costs of reviewing notices 
submitted under clause (i). 
‘‘(v) TIMING OF SUBMISSION OF NO-
TICES.— 
‘‘(I) 
PRIOR
APPROVAL
NO-
TICES.—A notice under clause (i) to 
which subparagraph (C) applies shall 
be submitted to the Secretary not 
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later than 120 days before the quali-
fying drug with the difference is intro-
duced for commercial distribution in a 
permitted country, unless the country 
requires that distribution of the quali-
fying drug with the difference begin 
less than 120 days after the country 
requires the difference. 
‘‘(II) 
OTHER
APPROVAL
NO-
TICES.—A notice under clause (i) to 
which subparagraph (D) applies shall 
be submitted to the Secretary not 
later than the day on which the quali-
fying drug with the difference is intro-
duced for commercial distribution in a 
permitted country. 
‘‘(III) OTHER
NOTICES.—A no-
tice under clause (i) to which subpara-
graph (E) applies shall be submitted 
to the Secretary on the date that the 
qualifying drug is first introduced for 
commercial distribution in a permitted 
country and annually thereafter. 
‘‘(vi) REVIEW BY SECRETARY.— 
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‘‘(I) IN GENERAL.—In this para-
graph, the difference in a qualifying 
drug that is submitted in a notice 
under clause (i) from the U.S. label 
drug shall be treated by the Secretary 
as if it were a manufacturing change 
to the U.S. label drug under section 
506A. 
‘‘(II) STANDARD
OF
REVIEW.— 
Except as provided in subclause (III), 
the Secretary shall review and approve 
or disapprove the difference in a no-
tice submitted under clause (i), if re-
quired under section 506A, using the 
safe and effective standard for ap-
proving or disapproving a manufac-
turing change under section 506A. 
‘‘(III) BIOEQUIVALENCE.—If the 
Secretary would approve the dif-
ference in a notice submitted under 
clause (i) using the safe and effective 
standard under section 506A and if 
the Secretary determines that the 
qualifying drug is not bioequivalent to 
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dcolon on DSK2BSOYB1PROD with BILLS
the U.S. label drug, the Secretary 
shall— 
‘‘(aa) include in the labeling 
provided under paragraph (3) a 
prominent 
advisory 
that 
the 
qualifying drug is safe and effec-
tive but is not bioequivalent to 
the U.S. label drug if the Sec-
retary determines that such an 
advisory is necessary for health 
care practitioners and patients to 
use the qualifying drug safely 
and effectively; or 
‘‘(bb) decline to approve the 
difference if the Secretary deter-
mines that the availability of 
both the qualifying drug and the 
U.S. label drug would pose a 
threat to the public health. 
‘‘(IV) REVIEW
BY
THE
SEC-
RETARY.—The Secretary shall review 
and approve or disapprove the dif-
ference in a notice submitted under 
clause (i), if required under section 
506A, not later than 120 days after 
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the date on which the notice is sub-
mitted. 
‘‘(V) ESTABLISHMENT
INSPEC-
TION.—If review of such difference 
would require an inspection of the es-
tablishment in which the qualifying 
drug is manufactured— 
‘‘(aa) such inspection by the 
Secretary shall be authorized; 
and 
‘‘(bb) the Secretary may rely 
on a satisfactory report of a good 
manufacturing practice inspec-
tion of the establishment from a 
permitted country whose regu-
latory system the Secretary rec-
ognizes as equivalent under a 
mutual recognition agreement, as 
provided under section 510(i)(3), 
section 803, or part 26 of title 
21, Code of Federal Regulations 
(or any corresponding successor 
rule or regulation). 
‘‘(vii) PUBLICATION OF INFORMATION 
ON NOTICES.— 
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‘‘(I) IN GENERAL.—Through the 
Internet website of the Food and 
Drug Administration and a toll-free 
telephone number, the Secretary shall 
readily make available to the public a 
list of notices submitted under clause 
(i). 
‘‘(II) CONTENTS.—The list under 
subclause (I) shall include the date on 
which a notice is submitted and 
whether— 
‘‘(aa) a notice is under re-
view; 
‘‘(bb) the Secretary has or-
dered that importation of the 
qualifying drug from a permitted 
country cease; or 
‘‘(cc) the importation of the 
drug is permitted under sub-
section (a). 
‘‘(III) UPDATE.—The Secretary 
shall promptly update the Internet 
website with any changes to the list. 
‘‘(C) NOTICE; DRUG DIFFERENCE REQUIR-
ING PRIOR APPROVAL.—In the case of a notice 
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under subparagraph (B)(i) that includes a dif-
ference that would, under section 506A(c) or 
(d)(3)(B)(i), require the approval of a supple-
mental application before the difference could 
be made to the U.S. label drug the following 
shall occur: 
‘‘(i) Promptly after the notice is sub-
mitted, the Secretary shall notify reg-
istered exporters, registered importers, the 
Federal Trade Commission, and the State 
attorneys general that the notice has been 
submitted with respect to the qualifying 
drug involved. 
‘‘(ii) If the Secretary has not made a 
determination whether such a supple-
mental application regarding the U.S. label 
drug would be approved or disapproved by 
the date on which the qualifying drug in-
volved is to be introduced for commercial 
distribution in a permitted country, the 
Secretary shall— 
‘‘(I) order that the importation of 
the qualifying drug involved from the 
permitted country not begin until the 
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‘‘(iv) If the Secretary determines that 
such a supplemental application regarding 
the U.S. label drug would be approved, the 
Secretary shall— 
‘‘(I) vacate the order under 
clause (ii), if any; 
‘‘(II) consider the difference to 
be a variation provided for in the ap-
proved application for the U.S. label 
drug; 
‘‘(III) permit importation of the 
qualifying drug under subsection (a); 
and 
‘‘(IV) promptly notify registered 
exporters, registered importers, the 
Federal Trade Commission, and the 
State attorneys general of the deter-
mination. 
‘‘(D) NOTICE; DRUG DIFFERENCE NOT RE-
QUIRING PRIOR APPROVAL.—In the case of a 
notice under subparagraph (B)(i) that includes 
a 
difference 
that 
would, 
under 
section 
506A(d)(3)(B)(ii), not require the approval of a 
supplemental application before the difference 
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dcolon on DSK2BSOYB1PROD with BILLS
could be made to the U.S. label drug the fol-
lowing shall occur: 
‘‘(i) During the period in which the 
notice is being reviewed by the Secretary, 
the authority under this subsection to im-
port the qualifying drug involved continues 
in effect. 
‘‘(ii) If the Secretary determines that 
such a supplemental application regarding 
the U.S. label drug would not be approved, 
the Secretary shall— 
‘‘(I) order that the importation of 
the qualifying drug involved from the 
permitted country cease; 
‘‘(II) notify the permitted coun-
try that approved the qualifying drug 
for commercial distribution of the de-
termination; and 
‘‘(III) promptly notify registered 
exporters, registered importers, the 
Federal Trade Commission, and the 
State attorneys general of the deter-
mination. 
‘‘(iii) If the Secretary determines that 
such a supplemental application regarding 
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dcolon on DSK2BSOYB1PROD with BILLS
the U.S. label drug would be approved, the 
difference shall be considered to be a vari-
ation provided for in the approved applica-
tion for the U.S. label drug. 
‘‘(E) NOTICE; DRUG DIFFERENCE NOT RE-
QUIRING APPROVAL; NO DIFFERENCE.—In the 
case of a notice under subparagraph (B)(i) that 
includes a difference for which, under section 
506A(d)(1)(A), 
a 
supplemental 
application 
would not be required for the difference to be 
made to the U.S. label drug, or that states that 
there is no difference, the Secretary— 
‘‘(i) shall consider such difference to 
be a variation provided for in the approved 
application for the U.S. label drug; 
‘‘(ii) may not order that the importa-
tion of the qualifying drug involved cease; 
and 
‘‘(iii) shall promptly notify registered 
exporters and registered importers. 
‘‘(F) DIFFERENCES
IN
ACTIVE
INGRE-
DIENT, ROUTE
OF
ADMINISTRATION, DOSAGE 
FORM, OR STRENGTH.— 
‘‘(i) IN
GENERAL.—A person who 
manufactures a drug approved under sec-
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dcolon on DSK2BSOYB1PROD with BILLS
tion 505(b) shall submit an application 
under section 505(b) for approval of an-
other drug that is manufactured for dis-
tribution in a permitted country by or for 
the person that manufactures the drug ap-
proved under section 505(b) if— 
‘‘(I) there is no qualifying drug 
in commercial distribution in per-
mitted countries whose combined pop-
ulation represents at least 50 percent 
of the total population of all permitted 
countries with the same active ingre-
dient or ingredients, route of adminis-
tration, dosage form, and strength as 
the drug approved under section 
505(b); and 
‘‘(II) each active ingredient of 
the other drug is related to an active 
ingredient of the drug approved under 
section 505(b), as defined in clause 
(v). 
‘‘(ii) APPLICATION
UNDER
SECTION 
505(b).—The application under section 
505(b) required under clause (i) shall— 
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dcolon on DSK2BSOYB1PROD with BILLS
‘‘(I) request approval of the other 
drug for the indication or indications 
for which the drug approved under 
section 505(b) is labeled; 
‘‘(II) include the information that 
the person submitted to the govern-
ment of the permitted country for 
purposes of obtaining approval for 
commercial distribution of the other 
drug in that country, which if in a 
language other than English, shall be 
accompanied by an English trans-
lation verified to be complete and ac-
curate, with the name, address, and a 
brief statement of the qualifications of 
the person that made the translation; 
‘‘(III) include a right of reference 
to the application for the drug ap-
proved under section 505(b); and 
‘‘(IV) include such additional in-
formation as the Secretary may re-
quire. 
‘‘(iii) TIMING OF SUBMISSION OF AP-
PLICATION.—An application under section 
505(b) required under clause (i) shall be 
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dcolon on DSK2BSOYB1PROD with BILLS
submitted to the Secretary not later than 
the day on which the information referred 
to in clause (ii)(II) is submitted to the gov-
ernment of the permitted country. 
‘‘(iv) NOTICE OF DECISION ON APPLI-
CATION.—The Secretary shall promptly no-
tify registered exporters, registered import-
ers, the Federal Trade Commission, and 
the State attorneys general of a determina-
tion to approve or to disapprove an appli-
cation under section 505(b) required under 
clause (i). 
‘‘(v) 
RELATED
ACTIVE
INGREDI-
ENTS.—For purposes of clause (i)(II), 2 
active ingredients are related if they are— 
‘‘(I) the same; or 
‘‘(II) different salts, esters, or 
complexes of the same moiety. 
‘‘(3) SECTION 502; LABELING.— 
‘‘(A) IMPORTATION
BY
REGISTERED
IM-
PORTER.— 
‘‘(i) IN GENERAL.—In the case of a 
qualifying drug that is imported or offered 
for import by a registered importer, such 
drug shall be considered to be in compli-
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ance with section 502 and the labeling re-
quirements under the approved application 
for the U.S. label drug if the qualifying 
drug bears— 
‘‘(I) a copy of the labeling ap-
proved for the U.S. label drug under 
section 505, without regard to wheth-
er the copy bears any trademark in-
volved; 
‘‘(II) the name of the manufac-
turer and location of the manufac-
turer; 
‘‘(III) the lot number assigned by 
the manufacturer; 
‘‘(IV) the name, location, and 
registration number of the importer; 
and 
‘‘(V) the National Drug Code 
number assigned to the qualifying 
drug by the Secretary. 
‘‘(ii) REQUEST FOR COPY OF THE LA-
BELING.—The Secretary shall provide such 
copy to the registered importer involved, 
upon request of the importer. 
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‘‘(iii) REQUESTED
LABELING.—The 
labeling provided by the Secretary under 
clause (ii) shall— 
‘‘(I) 
include 
the 
established 
name, as defined in section 502(e)(3), 
for each active ingredient in the quali-
fying drug; 
‘‘(II) not include the proprietary 
name of the U.S. label drug or any 
active ingredient thereof; 
‘‘(III) if required under para-
graph (2)(B)(vi)(III), a prominent ad-
visory that the qualifying drug is safe 
and effective but not bioequivalent to 
the U.S. label drug; and 
‘‘(IV) if the inactive ingredients 
of the qualifying drug are different 
from the inactive ingredients for the 
U.S. label drug, include— 
‘‘(aa) a prominent notice 
that the ingredients of the quali-
fying drug differ from the ingre-
dients of the U.S. label drug and 
that the qualifying drug must be 
dispensed with an advisory to 
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people with allergies about this 
difference and a list of ingredi-
ents; and 
‘‘(bb) a list of the ingredi-
ents of the qualifying drug as 
would be required under section 
502(e). 
‘‘(B) IMPORTATION BY INDIVIDUAL.— 
‘‘(i) IN GENERAL.—In the case of a 
qualifying drug that is imported or offered 
for import by a registered exporter to an 
individual, such drug shall be considered to 
be in compliance with section 502 and the 
labeling requirements under the approved 
application for the U.S. label drug if the 
packaging and labeling of the qualifying 
drug complies with all applicable regula-
tions promulgated under sections 3 and 4 
of the Poison Prevention Packaging Act of 
1970 (15 U.S.C. 1471 et seq.) and the la-
beling of the qualifying drug includes— 
‘‘(I) directions for use by the 
consumer; 
‘‘(II) the lot number assigned by 
the manufacturer; 
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United States, without regard to 
whether the special labeling bears any 
trademark involved. 
‘‘(ii) PACKAGING.—A qualifying drug 
offered for import to an individual by an 
exporter under this section that is pack-
aged in a unit-of-use container (as those 
items are defined in the United States 
Pharmacopeia and National Formulary) 
shall not be repackaged, provided that— 
‘‘(I) the packaging complies with 
all applicable regulations under sec-
tions 3 and 4 of the Poison Preven-
tion Packaging Act of 1970 (15 
U.S.C. 1471 et seq.); or 
‘‘(II) the consumer consents to 
waive the requirements of such Act, 
after being informed that the pack-
aging does not comply with such Act 
and that the exporter will provide the 
drug in packaging that is compliant at 
no additional cost. 
‘‘(iii) REQUEST FOR COPY OF SPECIAL 
LABELING
AND
INGREDIENT
LIST.—The 
Secretary shall provide to the registered 
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exporter involved a copy of the special la-
beling, the advisory, and the ingredient list 
described under clause (i), upon request of 
the exporter. 
‘‘(iv) REQUESTED LABELING AND IN-
GREDIENT LIST.—The labeling and ingre-
dient list provided by the Secretary under 
clause (iii) shall— 
‘‘(I) 
include 
the 
established 
name, as defined in section 502(e)(3), 
for each active ingredient in the drug; 
and 
‘‘(II) not include the proprietary 
name of the U.S. label drug or any 
active ingredient thereof. 
‘‘(4) SECTION 501; ADULTERATION.—A quali-
fying drug that is imported or offered for import 
under subsection (a) shall be considered to be in 
compliance with section 501 if the drug is in compli-
ance with subsection (c). 
‘‘(5) STANDARDS FOR REFUSING ADMISSION.— 
A drug exported under subsection (a) from a reg-
istered exporter or imported by a registered importer 
may be refused admission into the United States if 
1 or more of the following applies: 
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‘‘(A) The drug is not a qualifying drug. 
‘‘(B) A notice for the drug required under 
paragraph (2)(B) has not been submitted to the 
Secretary. 
‘‘(C) The Secretary has ordered that im-
portation of the drug from the permitted coun-
try cease under paragraph (2) (C) or (D). 
‘‘(D) The drug does not comply with para-
graph (3) or (4). 
‘‘(E) The shipping container appears dam-
aged in a way that may affect the strength, 
quality, or purity of the drug. 
‘‘(F) The Secretary becomes aware that— 
‘‘(i) the drug may be counterfeit; 
‘‘(ii) the drug may have been pre-
pared, packed, or held under insanitary 
conditions; or 
‘‘(iii) the methods used in, or the fa-
cilities or controls used for, the manufac-
turing, processing, packing, or holding of 
the drug do not conform to good manufac-
turing practice. 
‘‘(G) The Secretary has obtained an in-
junction under section 302 that prohibits the 
distribution of the drug in interstate commerce. 
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100 
‘‘(H) The Secretary has under section 
505(e) withdrawn approval of the drug. 
‘‘(I) The manufacturer of the drug has in-
stituted a recall of the drug. 
‘‘(J) If the drug is imported or offered for 
import by a registered importer without submis-
sion of a notice in accordance with subsection 
(d)(4). 
‘‘(K) If the drug is imported or offered for 
import from a registered exporter to an indi-
vidual and 1 or more of the following applies: 
‘‘(i) The shipping container for such 
drug does not bear the markings required 
under subsection (d)(2). 
‘‘(ii) The markings on the shipping 
container appear to be counterfeit. 
‘‘(iii) The shipping container or mark-
ings appear to have been tampered with. 
‘‘(h) EXPORTER LICENSURE IN PERMITTED COUN-
TRY.—A registration condition is that the exporter in-
volved agrees that a qualifying drug will be exported to 
an individual only if the Secretary has verified that— 
‘‘(1) the exporter is authorized under the law of 
the permitted country in which the exporter is lo-
cated to dispense prescription drugs; and 
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101 
‘‘(2) the exporter employs persons that are li-
censed under the law of the permitted country in 
which the exporter is located to dispense prescription 
drugs in sufficient number to dispense safely the 
drugs exported by the exporter to individuals, and 
the exporter assigns to those persons responsibility 
for dispensing such drugs to individuals. 
‘‘(i) INDIVIDUALS; CONDITIONS
FOR
IMPORTA-
TION.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a)(2)(B), the importation of a qualifying drug by 
an individual is in accordance with this subsection if 
the following conditions are met: 
‘‘(A) The drug is accompanied by a copy of 
a prescription for the drug, which prescrip-
tion— 
‘‘(i) is valid under applicable Federal 
and State laws; and 
‘‘(ii) was issued by a practitioner who, 
under the law of a State of which the indi-
vidual is a resident, or in which the indi-
vidual receives care from the practitioner 
who issues the prescription, is authorized 
to administer prescription drugs. 
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102 
‘‘(B) The drug is accompanied by a copy 
of the documentation that was required under 
the law or regulations of the permitted country 
in which the exporter is located, as a condition 
of dispensing the drug to the individual. 
‘‘(C) The copies referred to in subpara-
graphs (A)(i) and (B) are marked in a manner 
sufficient— 
‘‘(i) to indicate that the prescription, 
and the equivalent document in the per-
mitted country in which the exporter is lo-
cated, have been filled; and 
‘‘(ii) to prevent a duplicative filling by 
another pharmacist. 
‘‘(D) The individual has provided to the 
registered exporter a complete list of all drugs 
used by the individual for review by the individ-
uals who dispense the drug. 
‘‘(E) The quantity of the drug does not ex-
ceed a 90-day supply. 
‘‘(F) The drug is not an ineligible subpart 
H drug. For purposes of this section, a pre-
scription drug is an ‘ineligible subpart H drug’ 
if the drug was approved by the Secretary 
under subpart H of part 314 of title 21, Code 
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103 
of Federal Regulations (relating to accelerated 
approval), with restrictions under section 520 of 
such part to assure safe use, and the Secretary 
has published in the Federal Register a notice 
that the Secretary has determined that good 
cause exists to prohibit the drug from being im-
ported pursuant to this subsection. 
‘‘(2) NOTICE REGARDING DRUG REFUSED AD-
MISSION.—If a registered exporter ships a drug to 
an individual pursuant to subsection (a)(2)(B) and 
the drug is refused admission to the United States, 
a written notice shall be sent to the individual and 
to the exporter that informs the individual and the 
exporter of such refusal and the reason for the re-
fusal. 
‘‘(j) MAINTENANCE OF RECORDS AND SAMPLES.— 
‘‘(1) IN GENERAL.—A registration condition is 
that the importer or exporter involved shall— 
‘‘(A) maintain records required under this 
section for not less than 2 years; and 
‘‘(B) maintain samples of each lot of a 
qualifying drug required under this section for 
not more than 2 years. 
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104 
‘‘(2) PLACE OF RECORD MAINTENANCE.—The 
records described under paragraph (1) shall be 
maintained— 
‘‘(A) in the case of an importer, at the 
place of business of the importer at which the 
importer initially receives the qualifying drug 
after importation; or 
‘‘(B) in the case of an exporter, at the fa-
cility from which the exporter ships the quali-
fying drug to the United States. 
‘‘(k) DRUG RECALLS.— 
‘‘(1) MANUFACTURERS.—A person that manu-
factures a qualifying drug imported from a per-
mitted country under this section shall promptly in-
form the Secretary— 
‘‘(A) if the drug is recalled or withdrawn 
from the market in a permitted country; 
‘‘(B) how the drug may be identified, in-
cluding lot number; and 
‘‘(C) the reason for the recall or with-
drawal. 
‘‘(2) SECRETARY.—With respect to each per-
mitted country, the Secretary shall— 
‘‘(A) enter into an agreement with the gov-
ernment of the country to receive information 
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105 
about recalls and withdrawals of qualifying 
drugs in the country; or 
‘‘(B) monitor recalls and withdrawals of 
qualifying drugs in the country using any infor-
mation that is available to the public in any 
media. 
‘‘(3) NOTICE.—The Secretary may notify, as 
appropriate, registered exporters, registered import-
ers, wholesalers, pharmacies, or the public of a recall 
or withdrawal of a qualifying drug in a permitted 
country. 
‘‘(l) DRUG LABELING AND PACKAGING.— 
‘‘(1) IN
GENERAL.—When a qualifying drug 
that is imported into the United States by an im-
porter under subsection (a) is dispensed by a phar-
macist to an individual, the pharmacist shall provide 
that the packaging and labeling of the drug complies 
with all applicable regulations promulgated under 
sections 3 and 4 of the Poison Prevention Packaging 
Act of 1970 (15 U.S.C. 1471 et seq.) and shall in-
clude with any other labeling provided to the indi-
vidual the following: 
‘‘(A) The lot number assigned by the man-
ufacturer. 
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‘‘(B) The name and registration number of 
the importer. 
‘‘(C) 
If 
required 
under 
paragraph 
(2)(B)(vi)(III) of subsection (g), a prominent 
advisory that the drug is safe and effective but 
not bioequivalent to the U.S. label drug. 
‘‘(D) If the inactive ingredients of the drug 
are different from the inactive ingredients for 
the U.S. label drug— 
‘‘(i) a prominent advisory that persons 
with allergies should check the ingredient 
list of the drug because the ingredients of 
the drug differ from the ingredients of the 
U.S. label drug; and 
‘‘(ii) a list of the ingredients of the 
drug as would be required under section 
502(e). 
‘‘(2) PACKAGING.—A qualifying drug that is 
packaged in a unit-of-use container (as those terms 
are defined in the United States Pharmacopeia and 
National Formulary) shall not be repackaged, pro-
vided that— 
‘‘(A) the packaging complies with all appli-
cable regulations under sections 3 and 4 of the 
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107 
Poison Prevention Packaging Act of 1970 (15 
U.S.C. 1471 et seq.); or 
‘‘(B) the consumer consents to waive the 
requirements of such Act, after being informed 
that the packaging does not comply with such 
Act and that the pharmacist will provide the 
drug in packaging that is compliant at no addi-
tional cost. 
‘‘(m) 
CHARITABLE
CONTRIBUTIONS.—Notwith-
standing any other provision of this section, this section 
does not authorize the importation into the United States 
of a qualifying drug donated or otherwise supplied for free 
or at nominal cost by the manufacturer of the drug to 
a charitable or humanitarian organization, including the 
United Nations and affiliates, or to a government of a for-
eign country. 
‘‘(n) UNFAIR AND DISCRIMINATORY ACTS AND PRAC-
TICES.— 
‘‘(1) IN GENERAL.—It is unlawful for a manu-
facturer, directly or indirectly (including by being a 
party to a licensing agreement or other agreement), 
to— 
‘‘(A) discriminate by charging a higher 
price for a prescription drug sold to a registered 
exporter or other person in a permitted country 
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that exports a qualifying drug to the United 
States under this section than the price that is 
charged, inclusive of rebates or other incentives 
to the permitted country or other person, to an-
other person that is in the same country and 
that does not export a qualifying drug into the 
United States under this section; 
‘‘(B) discriminate by charging a higher 
price for a prescription drug sold to a registered 
importer or other person that distributes, sells, 
or uses a qualifying drug imported into the 
United States under this section than the price 
that is charged to another person in the United 
States that does not import a qualifying drug 
under this section, or that does not distribute, 
sell, or use such a drug; 
‘‘(C) discriminate by denying, restricting, 
or delaying supplies of a prescription drug to a 
registered exporter or other person in a per-
mitted country that exports a qualifying drug to 
the United States under this section or to a 
registered importer or other person that distrib-
utes, sells, or uses a qualifying drug imported 
into the United States under this section; 
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109 
‘‘(D) discriminate by publicly, privately, or 
otherwise refusing to do business with a reg-
istered exporter or other person in a permitted 
country that exports a qualifying drug to the 
United States under this section or with a reg-
istered importer or other person that distrib-
utes, sells, or uses a qualifying drug imported 
into the United States under this section; 
‘‘(E) knowingly fail to submit a notice 
under subsection (g)(2)(B)(i), knowingly fail to 
submit such a notice on or before the date spec-
ified in subsection (g)(2)(B)(v) or as otherwise 
required under subsection (e) (3), (4), and (5) 
of section 4 of the Pharmaceutical Market Ac-
cess and Drug Safety Act of 2009, knowingly 
submit such a notice that makes a materially 
false, fictitious, or fraudulent statement, or 
knowingly fail to provide promptly any informa-
tion requested by the Secretary to review such 
a notice; 
‘‘(F) knowingly fail to submit an applica-
tion required under subsection (g)(2)(F), know-
ingly fail to submit such an application on or 
before 
the 
date 
specified 
in 
subsection 
(g)(2)(F)(ii), knowingly submit such an applica-
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110 
tion that makes a materially false, fictitious, or 
fraudulent statement, or knowingly fail to pro-
vide promptly any information requested by the 
Secretary to review such an application; 
‘‘(G) cause there to be a difference (includ-
ing a difference in active ingredient, route of 
administration, dosage form, strength, formula-
tion, manufacturing establishment, manufac-
turing process, or person that manufactures the 
drug) between a prescription drug for distribu-
tion in the United States and the drug for dis-
tribution in a permitted country; 
‘‘(H) refuse to allow an inspection author-
ized under this section of an establishment that 
manufactures a qualifying drug that is, or will 
be, introduced for commercial distribution in a 
permitted country; 
‘‘(I) fail to conform to the methods used 
in, or the facilities used for, the manufacturing, 
processing, packing, or holding of a qualifying 
drug that is, or will be, introduced for commer-
cial distribution in a permitted country to good 
manufacturing practice under this Act; 
‘‘(J) become a party to a licensing agree-
ment or other agreement related to a qualifying 
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111 
drug that fails to provide for compliance with 
all requirements of this section with respect to 
such drug; 
‘‘(K) enter into a contract that restricts, 
prohibits, or delays the importation of a quali-
fying drug under this section; 
‘‘(L) engage in any other action to restrict, 
prohibit, or delay the importation of a quali-
fying drug under this section; or 
‘‘(M) engage in any other action that the 
Federal Trade Commission determines to dis-
criminate against a person that engages or at-
tempts to engage in the importation of a quali-
fying drug under this section. 
‘‘(2) REFERRAL OF POTENTIAL VIOLATIONS.— 
The Secretary shall promptly refer to the Federal 
Trade Commission each potential violation of sub-
paragraph (E), (F), (G), (H), or (I) of paragraph 
(1) that becomes known to the Secretary. 
‘‘(3) AFFIRMATIVE DEFENSE.— 
‘‘(A) DISCRIMINATION.—It shall be an af-
firmative defense to a charge that a manufac-
turer has discriminated under subparagraph 
(A), (B), (C), (D), or (M) of paragraph (1) that 
the higher price charged for a prescription drug 
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112 
sold to a person, the denial, restriction, or delay 
of supplies of a prescription drug to a person, 
the refusal to do business with a person, or 
other discriminatory activity against a person, 
is not based, in whole or in part, on— 
‘‘(i) the person exporting or importing 
a qualifying drug into the United States 
under this section; or 
‘‘(ii) the person distributing, selling, 
or using a qualifying drug imported into 
the United States under this section. 
‘‘(B) DRUG DIFFERENCES.—It shall be an 
affirmative defense to a charge that a manufac-
turer has caused there to be a difference de-
scribed in subparagraph (G) of paragraph (1) 
that— 
‘‘(i) the difference was required by the 
country in which the drug is distributed; 
‘‘(ii) the Secretary has determined 
that the difference was necessary to im-
prove the safety or effectiveness of the 
drug; 
‘‘(iii) the person manufacturing the 
drug for distribution in the United States 
has given notice to the Secretary under 
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113 
subsection (g)(2)(B)(i) that the drug for 
distribution in the United States is not dif-
ferent from a drug for distribution in per-
mitted countries whose combined popu-
lation represents at least 50 percent of the 
total population of all permitted countries; 
or 
‘‘(iv) the difference was not caused, in 
whole or in part, for the purpose of re-
stricting importation of the drug into the 
United States under this section. 
‘‘(4) EFFECT OF SUBSECTION.— 
‘‘(A) SALES IN OTHER COUNTRIES.—This 
subsection applies only to the sale or distribu-
tion of a prescription drug in a country if the 
manufacturer of the drug chooses to sell or dis-
tribute the drug in the country. Nothing in this 
subsection shall be construed to compel the 
manufacturer of a drug to distribute or sell the 
drug in a country. 
‘‘(B) DISCOUNTS TO INSURERS, HEALTH 
PLANS, PHARMACY
BENEFIT
MANAGERS, AND 
COVERED
ENTITIES.—Nothing in this sub-
section shall be construed to— 
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114 
‘‘(i) prevent or restrict a manufac-
turer of a prescription drug from providing 
discounts to an insurer, health plan, phar-
macy benefit manager in the United 
States, or covered entity in the drug dis-
count program under section 340B of the 
Public Health Service Act (42 U.S.C. 
256b) in return for inclusion of the drug 
on a formulary; 
‘‘(ii) require that such discounts be 
made available to other purchasers of the 
prescription drug; or 
‘‘(iii) prevent or restrict any other 
measures taken by an insurer, health plan, 
or pharmacy benefit manager to encourage 
consumption of such prescription drug. 
‘‘(C) 
CHARITABLE
CONTRIBUTIONS.— 
Nothing in this subsection shall be construed 
to— 
‘‘(i) prevent a manufacturer from do-
nating a prescription drug, or supplying a 
prescription drug at nominal cost, to a 
charitable or humanitarian organization, 
including the United Nations and affili-
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115 
ates, or to a government of a foreign coun-
try; or 
‘‘(ii) apply to such donations or sup-
plying of a prescription drug. 
‘‘(5) ENFORCEMENT.— 
‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC-
TICE.—A violation of this subsection shall be 
treated as a violation of a rule defining an un-
fair or deceptive act or practice prescribed 
under section 18(a)(1)(B) of the Federal Trade 
Commission Act (15 U.S.C. 57a(a)(1)(B)). 
‘‘(B) ACTIONS BY THE COMMISSION.—The 
Federal Trade Commission— 
‘‘(i) shall enforce this subsection in 
the same manner, by the same means, and 
with the same jurisdiction, powers, and du-
ties as though all applicable terms and pro-
visions of the Federal Trade Commission 
Act (15 U.S.C. 41 et seq.) were incor-
porated into and made a part of this sec-
tion; and 
‘‘(ii) may seek monetary relief three-
fold the damages sustained, in addition to 
any other remedy available to the Federal 
Trade Commission under the Federal 
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Trade Commission Act (15 U.S.C. 41 et 
seq.). 
‘‘(6) ACTIONS BY STATES.— 
‘‘(A) IN GENERAL.— 
‘‘(i) CIVIL ACTIONS.—In any case in 
which the attorney general of a State has 
reason to believe that an interest of the 
residents of that State have been adversely 
affected by any manufacturer that violates 
paragraph (1), the attorney general of a 
State may bring a civil action on behalf of 
the residents of the State, and persons 
doing business in the State, in a district 
court of the United States of appropriate 
jurisdiction to— 
‘‘(I) enjoin that practice; 
‘‘(II) enforce compliance with 
this subsection; 
‘‘(III) obtain damages, restitu-
tion, or other compensation on behalf 
of residents of the State and persons 
doing business in the State, including 
threefold the damages; or 
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117 
‘‘(IV) obtain such other relief as 
the court may consider to be appro-
priate. 
‘‘(ii) NOTICE.— 
‘‘(I) IN GENERAL.—Before filing 
an action under clause (i), the attor-
ney general of the State involved shall 
provide to the Federal Trade Commis-
sion— 
‘‘(aa) written notice of that 
action; and 
‘‘(bb) a copy of the com-
plaint for that action. 
‘‘(II) 
EXEMPTION.—Subclause 
(I) shall not apply with respect to the 
filing of an action by an attorney gen-
eral of a State under this paragraph, 
if the attorney general determines 
that it is not feasible to provide the 
notice described in that subclause be-
fore filing of the action. In such case, 
the attorney general of a State shall 
provide notice and a copy of the com-
plaint to the Federal Trade Commis-
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118 
sion at the same time as the attorney 
general files the action. 
‘‘(B) INTERVENTION.— 
‘‘(i) IN GENERAL.—On receiving no-
tice under subparagraph (A)(ii), the Fed-
eral Trade Commission shall have the right 
to intervene in the action that is the sub-
ject of the notice. 
‘‘(ii) EFFECT OF INTERVENTION.—If 
the Federal Trade Commission intervenes 
in an action under subparagraph (A), it 
shall have the right— 
‘‘(I) to be heard with respect to 
any matter that arises in that action; 
and 
‘‘(II) to file a petition for appeal. 
‘‘(C) CONSTRUCTION.—For purposes of 
bringing any civil action under subparagraph 
(A), nothing in this subsection shall be con-
strued to prevent an attorney general of a State 
from exercising the powers conferred on the at-
torney general by the laws of that State to— 
‘‘(i) conduct investigations; 
‘‘(ii) administer oaths or affirmations; 
or 
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119 
‘‘(iii) compel the attendance of wit-
nesses or the production of documentary 
and other evidence. 
‘‘(D) ACTIONS BY THE COMMISSION.—In 
any case in which an action is instituted by or 
on behalf of the Federal Trade Commission for 
a violation of paragraph (1), a State may not, 
during the pendency of that action, institute an 
action under subparagraph (A) for the same 
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 
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120 
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 
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 
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121 
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 
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— 
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122 
‘‘(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. 
‘‘(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(b) (21 U.S.C. 333(b), 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 
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123 
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: 
‘‘(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-
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124 
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-
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 
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125 
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 the owner or licensee 
of a patent to enforce such patent, subject to such 
amendment. 
(e) EFFECT OF SECTION 804.— 
(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 
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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 
(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’’) 
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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-
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-
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128 
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 
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-
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129 
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 
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-
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130 
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 
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 
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131 
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 
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 
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132 
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 
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 
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133 
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 
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 
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134 
(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 
(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 
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135 
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. 
(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 
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136 
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 
(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 
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137 
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. 
(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 
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138 
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 
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— 
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(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-
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. 
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140 
(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. 
(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. 303. 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 302, 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 
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141 
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 
‘‘(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 
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142 
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 
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 
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143 
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. 
(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. 304. 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: 
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144 
‘‘(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. 
‘‘(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 
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145 
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 
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.— 
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146 
(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) 
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 
303. 
(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 
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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 
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; 
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148 
(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-
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. 305. 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: 
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149 
‘‘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— 
‘‘(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-
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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: 
‘‘(i) The name of such person. 
‘‘(ii) Each State in which the person 
is authorized by law to dispense prescrip-
tion drugs. 
‘‘(iii) The address and telephone num-
ber of each place of business of the person 
with respect to sales of prescription drugs 
through the Internet, other than a place of 
business that does not mail or ship pre-
scription drugs to purchasers. 
‘‘(iv) The name of each individual who 
serves as a pharmacist for prescription 
drugs that are mailed or shipped pursuant 
to the site, and each State in which the in-
dividual is authorized by law to dispense 
prescription drugs. 
‘‘(v) If the person provides for medical 
consultations through the site for purposes 
of providing prescriptions, the name of 
each individual who provides such con-
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151 
sultations; each State in which the indi-
vidual is licensed or otherwise authorized 
by law to provide such consultations or 
practice medicine; and the type or types of 
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-
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‘‘(iii) a financial institution; 
‘‘(iv) an operator of a terminal at 
which an electronic fund transfer may be 
initiated; 
‘‘(v) a money transmitting business; 
or 
‘‘(vi) a participant in an international, 
national, regional, or local network used to 
effect a credit transaction, electronic fund 
transfer, or money transmitting service. 
‘‘(3) RESTRICTED
TRANSACTION.—The term 
‘restricted transaction’ means a transaction or trans-
mittal, on behalf of an individual who places an un-
lawful drug importation request to any person en-
gaged in the operation of an unregistered foreign 
pharmacy, of— 
‘‘(A) credit, or the proceeds of credit, ex-
tended to or on behalf of the individual for the 
purpose of the unlawful drug importation re-
quest (including credit extended through the 
use of a credit card); 
‘‘(B) an electronic fund transfer or funds 
transmitted by or through a money transmit-
ting business, or the proceeds of an electronic 
fund transfer or money transmitting service, 
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