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 
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; 
‘‘(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. 
‘‘(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— 
‘‘(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), 
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 
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-
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) 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 
of the drug, upon request of the exporter. 
‘‘(iii) REQUESTED LABELING AND IN-
GREDIENT LIST.—The labeling and ingre-
dient list 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 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. 
‘‘(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. 
‘‘(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) LICENSING
AS PHARMACIST.—A registration 
condition is that the exporter involved agrees that a quali-
fying 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 
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. 
‘‘(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 
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 less 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 
‘‘(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. 
‘‘(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.—When a qualifying drug that 
is imported into the United States by an importer under 
subsection (a) is dispensed by a pharmacist to an indi-
vidual, the pharmacist shall provide that the packaging 
and labeling of the drug complies with all applicable regu-
lations promulgated under sections 3 and 4 of the Poison 
Prevention Packaging Act of 1970 (15 U.S.C. 1471 et 
seq.) and include with any other labeling provided to the 
individual the following: 
‘‘(1) The lot number assigned by the manufac-
turer. 
‘‘(2) The name and registration number of the 
importer.