107 
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-
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
108 
‘‘(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— 
‘‘(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:
109 
‘‘(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-
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
110 
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 
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
111 
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-
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.
112 
‘‘(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 
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.
113 
‘‘(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 
may— 
‘‘(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
114 
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 
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
115 
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 
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
116 
‘‘(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 
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
117 
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 
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
118 
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— 
‘‘(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.
119 
‘‘(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-
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
120 
‘‘(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. 
‘‘(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
121 
‘‘(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 
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
122 
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; 
‘‘(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
123 
‘‘(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. 
‘‘(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.—
124 
‘‘(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— 
‘‘(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
125 
‘‘(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), 
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