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. 
‘‘(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. 
‘‘(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-
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 
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 
‘‘(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 sufficient 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