‘‘(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 
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 
involved is in compliance with all other registration 
conditions— 
‘‘(A) the exporter agrees to permit the Sec-
retary— 
‘‘(i) to conduct onsite inspections, in-
cluding monitoring on a day-to-day basis, 
of places of business of the exporter that 
relate to qualifying drugs, including each 
warehouse or other facility owned or con-
trolled by, or operated for, the exporter; 
‘‘(ii) to have access, including on a 
day-to-day basis, to— 
‘‘(I) records of the exporter that 
relate to the export of such drugs, in-
cluding financial records; and 
‘‘(II) samples of such drugs;
‘‘(iii) to carry out the duties described 
in paragraph (3); and 
‘‘(iv) to carry out any other functions 
determined by the Secretary to be nec-
essary regarding the compliance of the ex-
porter; and 
‘‘(B) the Secretary has assigned 1 or more 
employees of the Secretary to carry out the 
functions described in this subsection for the 
Secretary randomly, but not less than 12 times 
annually, on the premises of places of busi-
nesses referred to in subparagraph (A)(i), and 
such an assignment remains in effect on a con-
tinuous basis. 
‘‘(2) MARKING OF COMPLIANT SHIPMENTS.—A 
registration condition is that the exporter involved 
agrees to affix to each shipping container of quali-
fying drugs exported under subsection (a) such 
markings as the Secretary determines to be nec-
essary to identify the shipment as being in compli-
ance with all registration conditions. Markings under 
the preceding sentence shall— 
‘‘(A) be designed to prevent affixation of 
the markings to any shipping container that is 
not authorized to bear the markings; and
‘‘(B) include anticounterfeiting or track-
and-trace technologies, taking into account the 
economic and technical feasibility of those tech-
nologies. 
‘‘(3) CERTAIN DUTIES RELATING TO EXPORT-
ERS.—Duties of the Secretary with respect to an ex-
porter include the following: 
‘‘(A) Inspecting, randomly, but not less 
than 12 times annually, the places of business 
of the exporter at which qualifying drugs are 
stored and from which qualifying drugs are 
shipped. 
‘‘(B) During the inspections under sub-
paragraph (A), verifying the chain of custody of 
a statistically significant sample of qualifying 
drugs from the establishment in which the drug 
was manufactured to the exporter, which shall 
be accomplished or supplemented by the use of 
anticounterfeiting 
or 
track-and-trace 
tech-
nologies, taking into account the economic and 
technical feasibility of those technologies, except 
that a drug that lacks such technologies from 
the point of manufacture shall not for that rea-
son be excluded from importation by an ex-
porter.
‘‘(C) Randomly reviewing records of ex-
ports to individuals for the purpose of deter-
mining whether the drugs are being imported 
by the individuals in accordance with the condi-
tions under subsection (i). Such reviews shall be 
conducted in a manner that will result in a sta-
tistically significant determination of compli-
ance with all such conditions. 
‘‘(D) Monitoring the affixing of markings 
under paragraph (2). 
‘‘(E) Inspecting as the Secretary deter-
mines is necessary the warehouses and other fa-
cilities, including records, of other parties in the 
chain of custody of qualifying drugs. 
‘‘(F) Determining whether the exporter is 
in compliance with all other registration condi-
tions. 
‘‘(4) PRIOR
NOTICE
OF
SHIPMENTS.—A reg-
istration condition is that, not less than 8 hours and 
not more than 5 days in advance of the time of the 
importation of a shipment of qualifying drugs, the 
importer involved agrees to submit to the Secretary 
a notice with respect to the shipment of drugs to be 
imported or offered for import into the United
States under subsection (a). A notice under the pre-
ceding sentence shall include— 
‘‘(A) the name and complete contact infor-
mation of the person submitting the notice; 
‘‘(B) the name and complete contact infor-
mation of the importer involved; 
‘‘(C) the identity of the drug, including the 
established name of the drug, the quantity of 
the drug, and the lot number assigned by the 
manufacturer; 
‘‘(D) the identity of the manufacturer of 
the drug, including the identity of the establish-
ment at which the drug was manufactured; 
‘‘(E) the country from which the drug is 
shipped; 
‘‘(F) the name and complete contact infor-
mation for the shipper of the drug; 
‘‘(G) anticipated arrival information, in-
cluding the port of arrival and crossing location 
within that port, and the date and time; 
‘‘(H) a summary of the chain of custody of 
the drug from the establishment in which the 
drug was manufactured to the importer; 
‘‘(I) a declaration as to whether the Sec-
retary has ordered that importation of the drug
from the permitted country cease under sub-
section (g)(2)(C) or (D); and 
‘‘(J) such other information as the Sec-
retary may require by regulation. 
‘‘(5) MARKING OF COMPLIANT SHIPMENTS.—A 
registration condition is that the importer involved 
agrees, before wholesale distribution (as defined in 
section 503(e)) of a qualifying drug that has been 
imported under subsection (a), to affix to each con-
tainer of such drug such markings or other tech-
nology as the Secretary determines necessary to 
identify the shipment as being in compliance with all 
registration conditions, except that the markings or 
other technology shall not be required on a drug 
that bears comparable, compatible markings or tech-
nology from the manufacturer of the drug. Markings 
or other technology under the preceding sentence 
shall— 
‘‘(A) be designed to prevent affixation of 
the markings or other technology to any con-
tainer that is not authorized to bear the mark-
ings; and 
‘‘(B) shall include anticounterfeiting or 
track-and-trace technologies, taking into ac-
count the economic and technical feasibility of 
such technologies. 
‘‘(6) CERTAIN DUTIES RELATING TO IMPORT-
ERS.—Duties of the Secretary with respect to an im-
porter include the following: 
‘‘(A) Inspecting, randomly, but not less 
than 12 times annually, the places of business 
of the importer at which a qualifying drug is 
initially received after importation. 
‘‘(B) During the inspections under sub-
paragraph (A), verifying the chain of custody of 
a statistically significant sample of qualifying 
drugs from the establishment in which the drug 
was manufactured to the importer, which shall 
be accomplished or supplemented by the use of 
anticounterfeiting 
or 
track-and-trace 
tech-
nologies, taking into account the economic and 
technical feasibility of those technologies, except 
that a drug that lacks such technologies from 
the point of manufacture shall not for that rea-
son be excluded from importation by an im-
porter. 
‘‘(C) Reviewing notices under paragraph 
(4).
‘‘(D) Inspecting as the Secretary deter-
mines is necessary the warehouses and other fa-
cilities, including records of other parties in the 
chain of custody of qualifying drugs. 
‘‘(E) Determining whether the importer is 
in compliance with all other registration condi-
tions. 
‘‘(e) IMPORTER FEES.— 
‘‘(1) REGISTRATION FEE.—A registration con-
dition is that the importer involved pays to the Sec-
retary a fee of $10,000 due on the date on which 
the importer first submits the registration to the 
Secretary under subsection (b). 
‘‘(2) INSPECTION FEE.—A registration condi-
tion is that the importer involved pays a fee to the 
Secretary in accordance with this subsection. Such 
fee shall be paid not later than October 1 and April 
1 of each fiscal year in the amount provided for 
under paragraph (3). 
‘‘(3) AMOUNT OF INSPECTION FEE.— 
‘‘(A) AGGREGATE TOTAL OF FEES.—Not 
later than 30 days before the start of each fis-
cal year, the Secretary, in consultation with the 
Secretary of Homeland Security and the Sec-
retary of the Treasury, shall establish an aggre-
gate total of fees to be collected under para-
graph (2) for importers for that fiscal year that 
is sufficient, and not more than necessary, to 
pay the costs for that fiscal year of admin-
istering this section with respect to registered 
importers, including the costs associated with— 
‘‘(i) inspecting the facilities of reg-
istered importers, and of other entities in 
the chain of custody of a qualifying drug 
as necessary, under subsection (d)(6); 
‘‘(ii) developing, implementing, and 
operating under such subsection an elec-
tronic system for submission and review of 
the notices required under subsection 
(d)(4) with respect to shipments of quali-
fying drugs under subsection (a) to assess 
compliance with all registration conditions 
when such shipments are offered for im-
port into the United States; and 
‘‘(iii) inspecting such shipments as 
necessary, when offered for import into the 
United States to determine if such a ship-
ment should be refused admission under 
subsection (g)(5).
‘‘(B) LIMITATION.—Subject to subpara-
graph (C), the aggregate total of fees collected 
under paragraph (2) for a fiscal year shall not 
exceed 1 percent of the total price of qualifying 
drugs imported during that fiscal year into the 
United States by registered importers under 
subsection (a). 
‘‘(C) TOTAL PRICE OF DRUGS.— 
‘‘(i) ESTIMATE.—For the purposes of 
complying with the limitation described in 
subparagraph (B) when establishing under 
subparagraph (A) the aggregate total of 
fees to be collected under paragraph (2) 
for a fiscal year, the Secretary shall esti-
mate the total price of qualifying drugs im-
ported into the United States by registered 
importers during that fiscal year by adding 
the total price of qualifying drugs imported 
by each registered importer during the 6-
month period from January 1 through 
June 30 of the previous fiscal year, as re-
ported to the Secretary by each registered 
importer under subsection (b)(1)(J). 
‘‘(ii) CALCULATION.—Not later than 
March 1 of the fiscal year that follows the
fiscal year for which the estimate under 
clause (i) is made, the Secretary shall cal-
culate the total price of qualifying drugs 
imported into the United States by reg-
istered importers during that fiscal year by 
adding the total price of qualifying drugs 
imported by each registered importer dur-
ing that fiscal year, as reported to the Sec-
retary by each registered importer under 
subsection (b)(1)(J). 
‘‘(iii) 
ADJUSTMENT.—If 
the 
total 
price of qualifying drugs imported into the 
United States by registered importers dur-
ing a fiscal year as calculated under clause 
(ii) is less than the aggregate total of fees 
collected under paragraph (2) for that fis-
cal year, the Secretary shall provide for a 
pro-rata reduction in the fee due from each 
registered importer on April 1 of the sub-
sequent fiscal year so that the limitation 
described in subparagraph (B) is observed. 
‘‘(D) INDIVIDUAL
IMPORTER
FEE.—Sub-
ject to the limitation described in subparagraph 
(B), the fee under paragraph (2) to be paid on 
October 1 and April 1 by an importer shall be
an amount that is proportional to a reasonable 
estimate by the Secretary of the semiannual 
share of the importer of the volume of quali-
fying drugs imported by importers under sub-
section (a). 
‘‘(4) USE OF FEES.— 
‘‘(A) IN GENERAL.—Subject to appropria-
tions Acts, fees collected by the Secretary under 
paragraphs (1) and (2) shall be credited to the 
appropriation account for salaries and expenses 
of the Food and Drug Administration until ex-
pended (without fiscal year limitation), and the 
Secretary may, in consultation with the Sec-
retary of Homeland Security and the Secretary 
of the Treasury, transfer some proportion of 
such fees to the appropriation account for sala-
ries and expenses of the Bureau of Customs 
and Border Protection until expended (without 
fiscal year limitation). 
‘‘(B) SOLE
PURPOSE.—Fees collected by 
the Secretary under paragraphs (1) and (2) are 
only available to the Secretary and, if trans-
ferred, to the Secretary of Homeland Security, 
and are for the sole purpose of paying the costs 
referred to in paragraph (3)(A).
‘‘(5) COLLECTION OF FEES.—In any case where 
the Secretary does not receive payment of a fee as-
sessed under paragraph (1) or (2) within 30 days 
after it is due, such fee shall be treated as a claim 
of the United States Government subject to sub-
chapter II of chapter 37 of title 31, United States 
Code. 
‘‘(f) EXPORTER FEES.— 
‘‘(1) REGISTRATION FEE.—A registration con-
dition is that the exporter involved pays to the Sec-
retary a fee of $10,000 due on the date on which 
the exporter first submits that registration to the 
Secretary under subsection (b). 
‘‘(2) INSPECTION FEE.—A registration condi-
tion is that the exporter involved pays a fee to the 
Secretary in accordance with this subsection. Such 
fee shall be paid not later than October 1 and April 
1 of each fiscal year in the amount provided for 
under paragraph (3). 
‘‘(3) AMOUNT OF INSPECTION FEE.— 
‘‘(A) AGGREGATE TOTAL OF FEES.—Not 
later than 30 days before the start of each fis-
cal year, the Secretary, in consultation with the 
Secretary of Homeland Security and the Sec-
retary of the Treasury, shall establish an aggre-