‘‘(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 
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 
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. 
‘‘(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). 
‘‘(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). 
‘‘(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 
States by the importer during the previous 
fiscal year. 
‘‘(K) Such other provisions as the Sec-
retary may require by regulation to protect the 
public health while permitting— 
‘‘(i) the importation by pharmacies, 
groups of pharmacies, and wholesalers as 
registered importers of qualifying drugs 
under subsection (a); and 
‘‘(ii) importation by individuals of 
qualifying drugs under subsection (a). 
‘‘(2) APPROVAL OR DISAPPROVAL OF REGISTRA-
TION.—
‘‘(A) IN
GENERAL.—Not later than 90 
days after the date on which a registrant sub-
mits to the Secretary a registration under para-
graph (1), the Secretary shall notify the reg-
istrant whether the registration is approved or 
is disapproved. The Secretary shall disapprove 
a registration if there is reason to believe that 
the registrant is not in compliance with one or 
more registration conditions, and shall notify 
the registrant of such reason. In the case of a 
disapproved registration, the Secretary shall 
subsequently notify the registrant that the reg-
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.— 
‘‘(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