(2) the United States is the largest market for 
pharmaceuticals in the world, yet American con-
sumers pay the highest prices for brand pharma-
ceuticals in the world; 
(3) a prescription drug is neither safe nor effec-
tive to an individual who cannot afford it; 
(4) allowing and structuring the importation of 
prescription drugs to ensure access to safe and af-
fordable drugs approved by the Food and Drug Ad-
ministration will provide a level of safety to Amer-
ican consumers that they do not currently enjoy; 
(5) 
Americans 
spend 
more 
than 
$200,000,000,000 on prescription drugs every year; 
(6) the Congressional Budget Office has found 
that the cost of prescription drugs are between 35 
to 55 percent less in other highly-developed coun-
tries than in the United States; and 
(7) promoting competitive market pricing would 
both contribute to health care savings and allow 
greater access to therapy, improving health and sav-
ing lives. 
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SEC. 3. REPEAL OF CERTAIN SECTION REGARDING IMPOR-
TATION OF PRESCRIPTION DRUGS. 
Chapter VIII of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381 et seq.) is amended by striking 
section 804. 
SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER 
OF CERTAIN IMPORT RESTRICTIONS. 
(a) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), 
as amended by section 3, is further amended by inserting 
after section 803 the following: 
‘‘SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF 
PRESCRIPTION DRUGS. 
‘‘(a) IMPORTATION OF PRESCRIPTION DRUGS.— 
‘‘(1) IN GENERAL.—In the case of qualifying 
drugs imported or offered for import into the United 
States from registered exporters or by registered im-
porters— 
‘‘(A) the limitation on importation that is 
established in section 801(d)(1) is waived; and 
‘‘(B) the standards referred to in section 
801(a) regarding admission of the drugs are 
subject to subsection (g) of this section (includ-
ing with respect to qualifying drugs to which 
section 801(d)(1) does not apply). 
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‘‘(2) IMPORTERS.—A qualifying drug may not 
be imported under paragraph (1) unless— 
‘‘(A) the drug is imported by a pharmacy, 
group of pharmacies, or a wholesaler that is a 
registered importer; or 
‘‘(B) the drug is imported by an individual 
for personal use or for the use of a family mem-
ber of the individual (not for resale) from a reg-
istered exporter. 
‘‘(3) RULE
OF
CONSTRUCTION.—This section 
shall apply only with respect to a drug that is im-
ported or offered for import into the United 
States— 
‘‘(A) by a registered importer; or 
‘‘(B) from a registered exporter to an indi-
vidual. 
‘‘(4) DEFINITIONS.— 
‘‘(A) 
REGISTERED
EXPORTER; 
REG-
ISTERED IMPORTER.—For purposes of this sec-
tion: 
‘‘(i) The term ‘registered exporter’ 
means an exporter for which a registration 
under subsection (b) has been approved 
and is in effect. 
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‘‘(ii) The term ‘registered importer’ 
means a pharmacy, group of pharmacies, 
or a wholesaler for which a registration 
under subsection (b) has been approved 
and is in effect. 
‘‘(iii) The term ‘registration condition’ 
means a condition that must exist for a 
registration under subsection (b) to be ap-
proved. 
‘‘(B) QUALIFYING DRUG.—For purposes of 
this section, the term ‘qualifying drug’ means a 
drug for which there is a corresponding U.S. 
label drug. 
‘‘(C) U.S. LABEL DRUG.—For purposes of 
this section, the term ‘U.S. label drug’ means 
a prescription drug that— 
‘‘(i) with respect to a qualifying drug, 
has the same active ingredient or ingredi-
ents, route of administration, dosage form, 
and strength as the qualifying drug; 
‘‘(ii) with respect to the qualifying 
drug, is manufactured by or for the person 
that manufactures the qualifying drug; 
‘‘(iii) 
is 
approved 
under 
section 
505(c); and 
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‘‘(iv) is not— 
‘‘(I) a controlled substance, as 
defined in section 102 of the Con-
trolled Substances Act (21 U.S.C. 
802); 
‘‘(II) a biological product, as de-
fined in section 351 of the Public 
Health Service Act (42 U.S.C. 262), 
including— 
‘‘(aa) a therapeutic DNA 
plasmid product; 
‘‘(bb) a therapeutic synthetic 
peptide product; 
‘‘(cc) a monoclonal antibody 
product for in vivo use; and 
‘‘(dd) a therapeutic recom-
binant DNA-derived product; 
‘‘(III) an infused drug, including 
a peritoneal dialysis solution; 
‘‘(IV) an injected drug; 
‘‘(V) a drug that is inhaled dur-
ing surgery; 
‘‘(VI) a drug that is the listed 
drug referred to in 2 or more abbre-
viated new drug applications under 
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which the drug is commercially mar-
keted; or 
‘‘(VII) a sterile opthlamic drug 
intended for topical use on or in the 
eye. 
‘‘(D) OTHER DEFINITIONS.—For purposes 
of this section: 
‘‘(i)(I) The term ‘exporter’ means a 
person that is in the business of exporting 
a drug to individuals in the United States 
from Canada or from a permitted country 
designated by the Secretary under sub-
clause (II), or that, pursuant to submitting 
a registration under subsection (b), seeks 
to be in such business. 
‘‘(II) The Secretary shall designate a 
permitted country under subparagraph (E) 
(other than Canada) as a country from 
which an exporter may export a drug to in-
dividuals in the United States if the Sec-
retary determines that— 
‘‘(aa) the country has statutory 
or regulatory standards that are 
equivalent to the standards in the 
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United States and Canada with re-
spect to— 
‘‘(AA) the training of phar-
macists; 
‘‘(BB) the practice of phar-
macy; and 
‘‘(CC) the protection of the 
privacy of personal medical infor-
mation; and 
‘‘(bb) the importation of drugs to 
individuals in the United States from 
the country will not adversely affect 
public health. 
‘‘(ii) The term ‘importer’ means a 
pharmacy, a group of pharmacies, or a 
wholesaler that is in the business of im-
porting a drug into the United States or 
that, pursuant to submitting a registration 
under subsection (b), seeks to be in such 
business. 
‘‘(iii) The term ‘pharmacist’ means a 
person licensed by a State to practice 
pharmacy, including the dispensing and 
selling of prescription drugs. 
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and remove drugs found not to 
be safe or effective; and 
‘‘(ee) that require the label-
ing and promotion of drugs to be 
in accordance with the approval 
of the drug. 
‘‘(II) The valid marketing au-
thorization system in the country is 
equivalent to the systems in the coun-
tries described in clauses (i) through 
(vi). 
‘‘(III) The importation of drugs 
to the United States from the country 
will not adversely affect public health. 
‘‘(b) REGISTRATION OF IMPORTERS AND EXPORT-
ERS.— 
‘‘(1) REGISTRATION
OF
IMPORTERS
AND
EX-
PORTERS.—A registration condition is that the im-
porter or exporter involved (referred to in this sub-
section as a ‘registrant’) submits to the Secretary a 
registration containing the following: 
‘‘(A)(i) In the case of an exporter, the 
name of the exporter and an identification of all 
places of business of the exporter that relate to 
qualifying drugs, including each warehouse or 
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other facility owned or controlled by, or oper-
ated for, the exporter. 
‘‘(ii) In the case of an importer, the name 
of the importer and an identification of the 
places of business of the importer at which the 
importer initially receives a qualifying drug 
after importation (which shall not exceed 3 
places of business except by permission of the 
Secretary). 
‘‘(B) Such information as the Secretary 
determines to be necessary to demonstrate that 
the registrant is in compliance with registration 
conditions under— 
‘‘(i) in the case of an importer, sub-
sections (c), (d), (e), (g), and (j) (relating 
to the sources of imported qualifying 
drugs; the inspection of facilities of the im-
porter; the payment of fees; compliance 
with the standards referred to in section 
801(a); and maintenance of records and 
samples); or 
‘‘(ii) in the case of an exporter, sub-
sections (c), (d), (f), (g), (h), (i), and (j) 
(relating to the sources of exported quali-
fying drugs; the inspection of facilities of 
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the exporter and the marking of compliant 
shipments; the payment of fees; and com-
pliance with the standards referred to in 
section 801(a); being licensed as a phar-
macist; conditions for individual importa-
tion; and maintenance of records and sam-
ples). 
‘‘(C) An agreement by the registrant that 
the registrant will not under subsection (a) im-
port or export any drug that is not a qualifying 
drug. 
‘‘(D) An agreement by the registrant to— 
‘‘(i) notify the Secretary of a recall or 
withdrawal of a qualifying drug distributed 
in a permitted country that the registrant 
has exported or imported, or intends to ex-
port or import, to the United States under 
subsection (a); 
‘‘(ii) provide for the return to the reg-
istrant of such drug; and 
‘‘(iii) cease, or not begin, the expor-
tation or importation of such drug unless 
the Secretary has notified the registrant 
that exportation or importation of such 
drug may proceed. 
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‘‘(E) An agreement by the registrant to 
ensure and monitor compliance with each reg-
istration condition, to promptly correct any 
noncompliance with such a condition, and to 
promptly report to the Secretary any such non-
compliance. 
‘‘(F) A plan describing the manner in 
which the registrant will comply with the agree-
ment under subparagraph (E). 
‘‘(G) An agreement by the registrant to 
enforce a contract under subsection (c)(3)(B) 
against a party in the chain of custody of a 
qualifying drug with respect to the authority of 
the Secretary under clauses (ii) and (iii) of that 
subsection. 
‘‘(H) An agreement by the registrant to 
notify the Secretary not more than 30 days be-
fore the registrant intends to make the change, 
of— 
‘‘(i) any change that the registrant in-
tends to make regarding information pro-
vided under subparagraph (A) or (B); and 
‘‘(ii) any change that the registrant 
intends to make in the compliance plan 
under subparagraph (F). 
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‘‘(I) In the case of an exporter: 
‘‘(i) An agreement by the exporter 
that a qualifying drug will not under sub-
section (a) be exported to any individual 
not authorized pursuant to subsection 
(a)(2)(B) to be an importer of such drug. 
‘‘(ii) An agreement to post a bond, 
payable to the Treasury of the United 
States that is equal in value to the lesser 
of— 
‘‘(I) the value of drugs exported 
by the exporter to the United States 
in a typical 4-week period over the 
course of a year under this section; or 
‘‘(II) $1,000,000. 
‘‘(iii) An agreement by the exporter to 
comply with applicable provisions of Cana-
dian law, or the law of the permitted coun-
try 
designated 
under 
subsection 
(a)(4)(D)(i)(II) in which the exporter is lo-
cated, that protect the privacy of personal 
information with respect to each individual 
importing a prescription drug from the ex-
porter under subsection (a)(2)(B). 
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‘‘(iv) An agreement by the exporter to 
report to the Secretary— 
‘‘(I) not later than August 1 of 
each fiscal year, the total price and 
the total volume of drugs exported to 
the United States by the exporter dur-
ing the 6-month period from January 
1 through June 30 of that year; and 
‘‘(II) not later than January 1 of 
each fiscal year, the total price and 
the total volume of drugs exported to 
the United States by the exporter dur-
ing the previous fiscal year. 
‘‘(J) In the case of an importer, an agree-
ment by the importer to report to the Sec-
retary— 
‘‘(i) not later than August 1 of each 
fiscal year, the total price and the total 
volume of drugs imported to the United 
States by the importer during the 6-month 
period from January 1 through June 30 of 
that fiscal year; and 
‘‘(ii) not later than January 1 of each 
fiscal year, the total price and the total 
volume of drugs imported to the United 
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istration is approved if the Secretary deter-
mines that the registrant is in compliance with 
such conditions. 
‘‘(B) CHANGES IN REGISTRATION INFOR-
MATION.—Not later than 30 days after receiv-
ing a notice under paragraph (1)(H) from a 
registrant, the Secretary shall determine wheth-
er the change involved affects the approval of 
the registration of the registrant under para-
graph (1), and shall inform the registrant of 
the determination. 
‘‘(3) PUBLICATION OF CONTACT INFORMATION 
FOR REGISTERED EXPORTERS.—Through the Inter-
net website of the Food and Drug Administration 
and a toll-free telephone number, the Secretary shall 
make readily available to the public a list of reg-
istered exporters, including contact information for 
the exporters. Promptly after the approval of a reg-
istration submitted under paragraph (1), the Sec-
retary shall update the Internet website and the in-
formation provided through the toll-free telephone 
number accordingly. 
‘‘(4) SUSPENSION AND TERMINATION.— 
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‘‘(A) SUSPENSION.—With respect to the 
effectiveness of a registration submitted under 
paragraph (1): 
‘‘(i) Subject to clause (ii), the Sec-
retary may suspend the registration if the 
Secretary determines, after notice and op-
portunity for a hearing, that the registrant 
has failed to maintain substantial compli-
ance with a registration condition. 
‘‘(ii) If the Secretary determines that, 
under color of the registration, the ex-
porter has exported a drug or the importer 
has imported a drug that is not a quali-
fying drug, or a drug that does not comply 
with subsection (g)(2)(A) or (g)(4), or has 
exported a qualifying drug to an individual 
in violation of subsection (i)(2)(F), the 
Secretary shall immediately suspend the 
registration. A suspension under the pre-
ceding sentence is not subject to the provi-
sion by the Secretary of prior notice, and 
the Secretary shall provide to the reg-
istrant an opportunity for a hearing not 
later than 10 days after the date on which 
the registration is suspended. 
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‘‘(iii) The Secretary may reinstate the 
registration, whether suspended under 
clause (i) or (ii), if the Secretary deter-
mines that the registrant has demonstrated 
that further violations of registration con-
ditions will not occur. 
‘‘(B) TERMINATION.—The Secretary, after 
notice and opportunity for a hearing, may ter-
minate the registration under paragraph (1) of 
a registrant if the Secretary determines that 
the registrant has engaged in a pattern or prac-
tice of violating 1 or more registration condi-
tions, or if on 1 or more occasions the Secretary 
has under subparagraph (A)(ii) suspended the 
registration of the registrant. The Secretary 
may make the termination permanent, or for a 
fixed period of not less than 1 year. During the 
period in which the registration is terminated, 
any registration submitted under paragraph (1) 
by the registrant, or a person that is a partner 
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. 
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‘‘(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— 
‘‘(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-
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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— 
‘‘(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 
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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-
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 
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‘‘(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, 
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; 
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‘‘(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. 
‘‘(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-
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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 
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-
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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 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. 
‘‘(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 
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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; 
‘‘(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; 
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‘‘(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-
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-
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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-
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-
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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 
1 of each fiscal year in the amount provided for 
under paragraph (3). 
‘‘(3) AMOUNT OF INSPECTION FEE.— 
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‘‘(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 
when such shipments are offered for im-
port into the United States; and 
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‘‘(iii) inspecting such shipments as 
necessary, when offered for import into the 
United States to determine if such a ship-
ment should be refused admission under 
subsection (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 importers 
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 
importers during that fiscal year by adding 
the total price of qualifying drugs imported 
by each registered importer during the 6- 
month period from January 1 through 
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June 30 of the previous fiscal year, as re-
ported to the Secretary by each registered 
importer under subsection (b)(1)(J). 
‘‘(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 importers during that fiscal year by 
adding the total price of qualifying drugs 
imported by each registered importer dur-
ing that fiscal year, as reported to the Sec-
retary by each registered importer under 
subsection (b)(1)(J). 
‘‘(iii) 
ADJUSTMENT.—If 
the 
total 
price of qualifying drugs imported into the 
United States by registered importers 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 importer on April 1 of the sub-
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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 
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. 
‘‘(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 
1 of each fiscal year in the amount provided for 
under paragraph (3). 
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‘‘(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 
‘‘(iii) screening such markings, and 
inspecting such shipments as necessary, 
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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- 
month period from January 1 through 
June 30 of the previous fiscal year, as re-
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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-
quent fiscal year so that the limitation de-
scribed in subparagraph (B) is observed. 
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‘‘(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). 
‘‘(B) SOLE
PURPOSE.—Fees collected by 
the Secretary under paragraphs (1) and (2) are 
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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-
section (a) shall comply with the conditions es-
tablished in the approved application under sec-
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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 
application for the U.S. label drug be-
yond— 
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‘‘(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 
the permitted country in writing that 
the person is submitting to the Sec-
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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 
‘‘(II) a copy of the notice has 
been provided to the Federal Trade 
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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 
later than 120 days before the quali-
fying drug with the difference is intro-
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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.— 
‘‘(I) IN GENERAL.—In this para-
graph, the difference in a qualifying 
drug that is submitted in a notice 
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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 
the U.S. label drug, the Secretary 
shall— 
‘‘(aa) include in the labeling 
provided under paragraph (3) a 
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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 
the date on which the notice is sub-
mitted. 
‘‘(V) ESTABLISHMENT
INSPEC-
TION.—If review of such difference 
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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.— 
‘‘(I) IN GENERAL.—Through the 
Internet website of the Food and 
Drug Administration and a toll-free 
telephone number, the Secretary shall 
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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 
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 
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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 
Secretary completes review of the no-
tice; and 
‘‘(II) promptly notify registered 
exporters, registered importers, the 
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Federal Trade Commission, and the 
State attorneys general of the order. 
‘‘(iii) 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, or provide 
that an order under clause (ii), if any, 
remains in effect; 
‘‘(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. 
‘‘(iv) If the Secretary determines that 
such a supplemental application regarding 
the U.S. label drug would be approved, the 
Secretary shall— 
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‘‘(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 
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-
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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 
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. 
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‘‘(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-
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 
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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— 
‘‘(I) request approval of the other 
drug for the indication or indications 
for which the drug approved under 
section 505(b) is labeled; 
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‘‘(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 
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. 
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‘‘(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-
ance with section 502 and the labeling re-
quirements under the approved application 
for the U.S. label drug if the qualifying 
drug bears— 
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‘‘(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. 
‘‘(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), 
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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 
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 
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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; 
‘‘(III) the name and registration 
number of the exporter; 
‘‘(IV) if required under para-
graph (2)(B)(vi)(III), a prominent ad-
visory that the drug is safe and effec-
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tive but not bioequivalent to the U.S. 
label drug; 
‘‘(V) if the inactive ingredients of 
the drug are different from the inac-
tive ingredients for the U.S. label 
drug— 
‘‘(aa) a prominent advisory 
that persons with an allergy 
should check the ingredient list 
of the drug because the ingredi-
ents of the drug differ from the 
ingredients of the U.S. label 
drug; and 
‘‘(bb) a list of the ingredi-
ents of the drug as would be re-
quired under section 502(e); and 
‘‘(VI) a copy of any special label-
ing that would be required by the Sec-
retary had the U.S. label drug been 
dispensed by a pharmacist in the 
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 
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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 
exporter involved a copy of the special la-
beling, the advisory, and the ingredient list 
described under clause (i), upon request of 
the exporter. 
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‘‘(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: 
‘‘(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. 
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‘‘(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. 
‘‘(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. 
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‘‘(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 
‘‘(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 
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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. 
‘‘(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. 
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‘‘(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 
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 
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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. 
‘‘(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 
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‘‘(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 
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. 
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‘‘(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. 
‘‘(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. 
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‘‘(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 
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 
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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 
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 
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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; 
‘‘(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-
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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-
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 
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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 
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; 
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‘‘(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 
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— 
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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— 
‘‘(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 
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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-
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 
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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 
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 
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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 
‘‘(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— 
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‘‘(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-
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 
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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 
‘‘(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 
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