‘‘(4) comply with any other applicable require-
ment of this Act. 
‘‘(c) APPROVED LABELING.—
‘‘(1) IN GENERAL.—A drug importation facility 
that offers for importation a prescription drug under 
this subchapter shall submit to the Secretary an ap-
plication for approval that demonstrates that the la-
beling of the prescription drug to be imported into 
the United States complies with the requirements of 
sections 502 and 503. 
‘‘(2) PROCEDURE.—Not later than 60 days 
after receipt of a completed application under para-
graph (1), the Secretary shall—
‘‘(A) approve or deny the application con-
sistent with the requirements of sections 502 
and 503; and 
‘‘(B) notify the applicant of the decision of 
the Secretary and, if the application is denied, 
the reason for the denial. 
‘‘(3) LISTS.—
‘‘(A) APPLICATIONS.—The Secretary shall 
maintain an updated list of applications pend-
ing, applications approved, and applications de-
nied under this subsection.
‘‘(B) PORTS.—The Secretary shall main-
tain an updated list of ports through which a 
prescription drug may be imported under this 
section and make the list available to the public 
on an Internet website. 
‘‘(d) PROHIBITION OF IMPORTATION OF A PRESCRIP-
TION DRUG THAT ENTERS OTHER COUNTRIES.—
‘‘(1) IN GENERAL.—A drug importation facility, 
pharmacy, Internet pharmacy, or wholesaler shall 
not import a prescription drug if, during any period 
in which the prescription drug was not in the control 
of the manufacturer, the prescription drug entered a 
country other than—
‘‘(A) Canada; or 
‘‘(B) subject to paragraph (2), a country 
that was a member of the European Union as 
of December 31, 2003. 
‘‘(2) LIMITATION.—The Secretary may exclude 
1 or more of the countries under subparagraph (B) 
of paragraph (1) from the application of that sub-
paragraph if the Secretary determines that allowing 
a prescription drug to be imported into the United 
States after having entered that country outside con-
trol of a manufacturer would present a risk to the 
public health.
‘‘(e) PROHIBITION OF COMMINGLING.—
‘‘(1) IN GENERAL.—A drug importation facility, 
pharmacy, Internet pharmacy, or wholesaler shall 
not commingle a prescription drug imported into the 
United States under this subchapter with a prescrip-
tion drug that is not imported from Canada or a 
permitted country. 
‘‘(2) LABEL.—A pharmacy or Internet phar-
macy that dispenses a prescription drug imported 
from Canada or a permitted country shall affix on 
each dispensed container of the prescription drug 
the label required under subsection (b)(3) unless 
such a label is already affixed to the container. 
‘‘(f) DRUG RECALLS.—On receipt of notification 
from the manufacturer of a prescription drug imported 
from Canada or a permitted country under this section 
that the prescription drug has been recalled or withdrawn 
from the market in Canada or a permitted country, a drug 
importation facility shall promptly provide the Secretary 
and any person to whom the prescription drug was distrib-
uted a notice that the drug has been recalled or withdrawn 
from the market and that includes—
‘‘(1) information (including the lot number) 
that identifies the prescription drug; and