tion drug, and each person that processes, packages, 
distributes, receives, holds, or transports the pre-
scription drug shall, at the request of an officer or 
employee duly designated by the Secretary, permit 
the officer or employee, upon presentation of appro-
priate credentials and a written notice to such phar-
macy or person, at reasonable times, within reason-
able limits and in a reasonable manner, to have ac-
cess to and copy all records relating to the prescrip-
tion drug that are needed to enable the Secretary to 
determine whether the prescription drug presents a 
risk to the public health. 
‘‘(2) APPLICABILITY.—Paragraph (1) applies to 
all records maintained by or on behalf of the drug 
importation facility, pharmacy, Internet pharmacy, 
or wholesaler or such other person in any format 
(including paper and electronic formats) and at any 
location. 
‘‘(c) PROTECTION OF SENSITIVE INFORMATION.— 
The Secretary shall take appropriate measures to ensure 
that there are in effect effective procedures to prevent the 
unauthorized disclosure of any trade secret or confidential 
information that is obtained by the Secretary under this 
section or any commercial or financial information that 
is privileged or confidential.
‘‘(d) EFFECT OF SECTION.—Nothing in this section 
applies to a prescription drug imported by an individual 
under section 812 or to a commercial transaction con-
ducted between an Internet pharmacy and an individual.’’. 
SEC. 10. ADVANCE NOTICE OF IMPORTED PRESCRIPTION 
DRUG SHIPMENTS. 
(a) IN GENERAL.—Section 801 of the Federal Food, 
Drug, and Cosmetic Act (as amended by section 8(b)) is 
amended by adding at the end the following: 
‘‘(u) ADVANCE NOTICE OF IMPORTED PRESCRIPTION 
DRUG SHIPMENTS.— 
‘‘(1) IN GENERAL.—For purposes of enabling 
the Secretary to inspect at ports of entry a prescrip-
tion drug that is being imported or offered for im-
portation into the United States, the person import-
ing or offering for importation the prescription drug 
shall, in advance, provide to the Secretary a notice 
that includes— 
‘‘(A) the established name (as defined by 
section 502(e)), dosage form, and quantity of 
the prescription drug; 
‘‘(B) the name of the shipper of the pre-
scription drug; 
‘‘(C) the name of the country from which 
the prescription drug originates;
‘‘(D) the country from which the prescrip-
tion drug is shipped; 
‘‘(E) the name of the port of entry of the 
prescription drug; 
‘‘(F) documentation from the drug impor-
tation facility located in Canada or a permitted 
country specifying— 
‘‘(i) the original source of the pre-
scription drug; and 
‘‘(ii) the quantity of each lot of the 
prescription drug originally received by the 
facility from that source; 
‘‘(G) the lot or control number assigned to 
the prescription drug by the manufacturer of 
the prescription drug; 
‘‘(H) the name, address, telephone num-
ber, and professional license number of the 
drug importation facility located in Canada or 
a permitted country; and 
‘‘(I) certification from the drug importa-
tion facility located in a foreign country or from 
the manufacturer of the prescription drug that 
the prescription drug—
‘‘(i) is approved for marketing in the 
United States and is not adulterated or 
misbranded; and 
‘‘(ii) meets all labeling requirements 
under this Act. 
‘‘(2) REFUSAL OF ADMISSION.—A prescription 
drug imported or offered for importation without 
submission of a notice under paragraph (1) shall be 
refused admission into the United States. 
‘‘(3) PERIOD OF ADVANCE NOTICE.—The pe-
riod in which the notice under paragraph (1) is re-
quired to be made in advance of the time of the im-
portation of a prescription drug or the offering of a 
prescription drug for importation shall be not less 
than 24 hours and not more than 5 days. 
‘‘(4) FAILURE TO PROVIDE NOTICE.— 
‘‘(A) IN GENERAL.—If a prescription drug 
is being imported or offered for importation 
into the United States and notice is not pro-
vided in advance in accordance with paragraph 
(1), the prescription drug shall be held at the 
port of entry for the prescription drug, and may 
not be delivered to the importer, owner, or con-
signee of the prescription drug, until the notice 
is submitted to the Secretary and the Secretary
examines the notice and determines that the no-
tice is in accordance with the requirements 
under paragraph (1). 
‘‘(5) EFFECT OF BONDING PROVISION.—Sub-
section (b) does not authorize the delivery of a pre-
scription drug pursuant to the execution of a bond 
while the prescription drug is held under this sub-
section. 
‘‘(6) REMOVAL.—A prescription drug held 
under this subsection shall be removed to a secure 
facility, as appropriate. 
‘‘(7) NO TRANSFER.—During a period in which 
a prescription drug is held under this subsection, the 
prescription drug shall not be transferred by any 
person from the port of entry into the United States 
for the article or from the secure facility to which 
the prescription drug has been removed. 
‘‘(8) EFFECT OF SUBSECTION.— 
‘‘(A) AUTHORITY.—This subsection does 
not limit the authority of the Secretary to ob-
tain information under any other provision of 
this Act. 
‘‘(B) IMPORTATION
BY
INDIVIDUALS.— 
Nothing in this subsection applies to a prescrip-
tion drug imported by an individual under sec-
tion 812 or to a commercial transaction con-
ducted between an Internet pharmacy and an 
individual.’’. 
(b) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as 
amended by section 8(c)) is amended by adding at the end 
the following: 
‘‘(pp) The failure to submit prior notice of the impor-
tation of a prescription drug in violation of section 
801(s).’’. 
SEC. 11. AUTHORITY TO MARK PRESCRIPTION DRUGS RE-
FUSED 
ADMISSION 
INTO 
THE 
UNITED 
STATES. 
(a) IN GENERAL.—Section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381) (as amended by 
section 10(a)) is amended by adding at the end the fol-
lowing: 
‘‘(v) PRESCRIPTION DRUGS REFUSED ADMISSION.— 
‘‘(1) IN GENERAL.—If a prescription drug has 
been refused admission under subsection (a), other 
than such a prescription drug that is required to be 
destroyed, the Secretary may require the owner or 
consignee of the prescription drug to affix to the 
container of the prescription drug a label that clear-
ly and conspicuously bears the statement: ‘UNITED 
STATES: REFUSED ENTRY’. 
‘‘(2) EXPENSES.—All expenses in connection 
with affixing a label under paragraph (1)— 
‘‘(A) shall be paid by the owner or con-
signee of the prescription drug; and 
‘‘(B) in default of such payment, shall con-
stitute a lien against future importations made 
by the owner or consignee. 
‘‘(3) 
EFFECTIVE
PERIOD.—A 
requirement 
under paragraph (1) with respect to a prescription 
drug remains in effect until the Secretary deter-
mines that the prescription drug has been brought 
into compliance with this Act. 
‘‘(4) EFFECT OF SUBSECTION.—Nothing in this 
subsection applies to a prescription drug imported 
by an individual under section 812 or to a commer-
cial transaction conducted between an Internet phar-
macy and an individual.’’. 
(b) MISBRANDED PRESCRIPTION DRUGS.—Section 
502 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352) is amended by adding at the end the fol-
lowing: 
‘‘(w) If—
‘‘(1) it is a prescription drug refused admission 
into the United States that fails to bear a label re-
quired by the Secretary under section 801(v); 
‘‘(2) the Secretary finds that the prescription 
drug presents a risk to the public health; and 
‘‘(3) on or after notifying the owner or con-
signee of the prescription drug that the label is re-
quired under section 801(v), the Secretary informs 
the owner or consignee that the prescription drug 
presents such a risk.’’. 
(c) RULE OF CONSTRUCTION.—With respect to a 
prescription drug that is imported or offered for importa-
tion into the United States, nothing in this section limits 
the authority of the Secretary of Health and Human Serv-
ices or the Secretary of the Treasury to require the mark-
ing of prescription drugs refused admission under any 
other provision of law. 
SEC. 12. PROHIBITION OF PORT SHOPPING. 
Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) (as amended by section 11(b)) is 
amended by adding at the end the following: 
‘‘(x) PORT SHOPPING.— 
‘‘(1) IN GENERAL.—If—
‘‘(A) it is a prescription drug imported or 
offered for importation into the United States; 
and 
‘‘(B) the prescription drug has previously 
been refused admission under section 801(a); 
unless the person reoffering the prescription drug af-
firmatively establishes, at the expense of the owner 
or consignee of the prescription drug, that the pre-
scription drug complies with the applicable require-
ments of this Act, as determined by the Secretary. 
‘‘(2) EFFECT OF PARAGRAPH.—Nothing in this 
paragraph applies to importation of a prescription 
drug under section 812 or to a commercial trans-
action conducted between an Internet pharmacy and 
an individual.’’. 
SEC. 13. AUTHORITY TO COMMISSION OTHER FEDERAL 
AND STATE OFFICIALS TO CONDUCT INSPEC-
TIONS. 
Section 702(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 372(a)) is amended— 
(1) by redesignating paragraphs (3) and (4) as 
paragraphs (5) and (6), respectively; and 
(2) inserting after paragraph (2) the following: 
‘‘(3) (A) The Secretary, pursuant to a memo-
randum of understanding between the Secretary and
the head of another Federal agency, may conduct 
examinations and investigations for the purposes of 
enforcing compliance with the amendments made by 
the Safe IMPORT Act of 2005 through the officers 
and employees of the other agency. 
‘‘(B) A memorandum of understanding under 
subparagraph (A) shall include— 
‘‘(i) provisions to ensure adequate training 
of officers and employees to conduct the exami-
nations and investigations; and 
‘‘(ii) provisions regarding reimbursement 
that may, in the discretion of the head of the 
other agency, require reimbursement, in whole 
or in part, from the Secretary for the examina-
tions or investigations performed under this 
paragraph by the officers or employees of the 
other agency. 
‘‘(C) A memorandum of understanding under 
subparagraph (A) shall be effective only with respect 
to examinations or inspections at facilities or other 
locations that are jointly regulated by the Secretary 
and the other agency. 
‘‘(D) Not later than 60 days after the end of 
each fiscal year in which the head of a Federal agen-
cy carries out 1 or more examinations or inspections
under a memorandum of understanding under sub-
paragraph (A), the Secretary and the agency head 
shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and to 
the Committee on Energy and Commerce of the 
House of Representatives, a report that discloses, 
for that year— 
‘‘(i) the number of officers or employees 
that carried out 1 or more programs, projects, 
or activities under the memorandum of under-
standing; 
‘‘(ii) the number of additional articles that 
were inspected or examined as a result of the 
memorandum of understanding; and 
‘‘(iii) the number of additional examina-
tions or investigations that were carried out 
pursuant to the memorandum of understanding. 
‘‘(4) (A) The Secretary may enter into a con-
tract with a State to use the State Board of Phar-
macy personnel of the State to conduct examinations 
and inspection for the purpose of carrying out the 
amendments made by the Safe IMPORT Act of 
2005. 
‘‘(B) A contract entered into under subpara-
graph (A) shall—
‘‘(i) ensure adequate training of officers 
and employees to conduct the examinations and 
investigations; and 
‘‘(ii) be effective only with respect to ex-
aminations or inspections of drug importation 
facilities, pharmacies, Internet pharmacies, and 
wholesalers located in the State.’’. 
SEC. 14. USER FEES RELATING TO PRESCRIPTION DRUG 
IMPORTATION. 
Subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 397f et seq.) is 
amended by adding at the end the following: 
‘‘PART 5—FEES RELATING TO PRESCRIPTION 
DRUG IMPORTATION 
‘‘SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IM-
PORTATION. 
‘‘(a) REGISTRATION FEE.—The Secretary shall es-
tablish a user fee program under which a drug importation 
facility, pharmacy, Internet pharmacy, or wholesaler reg-
istering with the Secretary under section 814 shall be re-
quired to pay a fee to the Secretary. 
‘‘(b) COLLECTION.— 
‘‘(1) COLLECTION ON INITIAL REGISTRATION.— 
A fee under this section shall be payable for the fis-
cal year in which the drug importation facility, phar-
macy, Internet pharmacy, or wholesaler first reg-
isters under section 814 (or reregisters under that 
section if that person has withdrawn its registration 
and subsequently reregisters). 
‘‘(2) COLLECTION
IN
SUBSEQUENT
YEARS.— 
After the fee is paid for that fiscal year, the fee shall 
be payable on or before October 1 of each year. 
‘‘(3) ONE FEE PER FACILITY.—The fee shall be 
paid only once for each drug importation facility, 
pharmacy, Internet pharmacy, or wholesaler reg-
istered for a fiscal year in which the fee is payable. 
‘‘(c) FEE AMOUNT.—The amount of the fee shall be 
determined each year by the Secretary and shall be based 
on the anticipated costs to the Secretary of enforcing the 
amendments made by the Safe IMPORT Act of 2005 in 
the subsequent fiscal year. 
‘‘(d) USE OF FEES.—The fees collected under this 
section shall be used, without further appropriation, to en-
force the amendments made by the Safe IMPORT Act of 
2005. 
‘‘(e) ANNUAL FEE SETTING.—The Secretary shall 
establish, 60 days before the beginning of each fiscal year 
beginning after September 30, 2005, for that fiscal year, 
registration fees. 
‘‘(f) EFFECT OF FAILURE TO PAY FEES.—
‘‘(1) DUE DATE.—A fee payable under this sec-
tion shall be paid by the date that is 30 days after 
the date on which the fee is due. 
‘‘(2) FAILURE TO PAY.—If a registered drug 
importation facility, pharmacy, Internet pharmacy, 
or wholesaler subject to a fee under this section fails 
to pay the fee, the Secretary shall not permit the 
drug importation facility pharmacy, Internet phar-
macy, or wholesaler to engage in importation or of-
fering for importation prescription drugs under this 
Act until all such fees owed by that person are paid. 
‘‘(g) REPORTS.— 
‘‘(1) FEE ESTABLISHMENT.—Not later than 60 
days before each fiscal year, the Secretary shall— 
‘‘(A) publish user fees under this section 
for that fiscal year; 
‘‘(B) hold a meeting at which the public 
may comment on the recommendations; and 
‘‘(C) provide for a period of 30 days for 
the public to provide written comments on the 
recommendations. 
‘‘(2) PERFORMANCE AND FISCAL REPORT.—Be-
ginning with fiscal year 2006, not later than 60 days 
after the end of each fiscal year during which fees 
are collected under this section, the Secretary shall
submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives a report that describes— 
‘‘(A) implementation of the user fee au-
thority during the fiscal year; and 
‘‘(B) the use by the Secretary of the fees 
collected during the fiscal year for which the re-
port is made.’’. 
SEC. 15. ANTICOUNTERFEITING PROVISIONS. 
(a) REQUIRED RECORDS.—Section 503(e) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) 
is amended by striking paragraph (1) and inserting the 
following: 
‘‘(1) A distributor of record that is engaged in 
the wholesale distribution of a drug subject to sub-
section (b), shall— 
‘‘(A) before each wholesale distribution of the 
drug— 
‘‘(i) with respect to each wholesale dis-
tribution of a drug subject to subsection (b), 
provide the person that receives the drug a 
statement that identifies the immediately pre-
vious distributor of record from which the drug 
was purchased; and
‘‘(ii) with respect to a drug subject to sub-
section (b) that is imported to the United 
States, provide the person that receives the 
drug a statement (in such form and containing 
such information as the Secretary may require) 
identifying each prior sale, purchase, or trade of 
the drug (including the date of transmission 
and the names and addresses of all parties to 
the transaction); and 
‘‘(B) create, maintain for 2 years, and make 
available to the Secretary for inspection at reason-
able time, records that— 
‘‘(i) with respect to each wholesale dis-
tribution of a drug subject to subsection (b), 
identifies— 
‘‘(I) the immediately previous dis-
tributor of record from which the drug was 
purchased; and 
‘‘(II) the immediately subsequent dis-
tributor of record to which the drug was 
sold or otherwise transferred; and 
‘‘(ii) with respect to a drug subject to sub-
section (b) that is imported to the United 
States, identifies—
‘‘(I) each previous distributor of 
record from which the drug was purchased 
or otherwise transferred; and 
‘‘(II) each subsequent distributor of 
record to which the drug was sold or other-
wise transferred, to the extent feasible.’’. 
(b) 
ELECTRONIC
TRACK
AND
TRACE
TECH-
NOLOGY.—Not later than December 31, 2007, the Sec-
retary of Health and Human Services shall require the 
adoption and use of electronic track and trace technology 
for a prescription drug at the case and pallet level that 
will identify each sale, purchase, or trade of that case or 
pallet (including the date of transmission and the names 
and addresses of all parties to the transaction) . 
(c) DISTRIBUTORS OF RECORD.—Section 503(e) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(e)) is amended by striking paragraph (3) and insert-
ing the following: 
‘‘(3) For the purposes of this subsection and sub-
section (d)— 
‘‘(A) the term ‘distributor of record’— 
‘‘(i) means a person that takes title to or 
possession of a drug subject to subsection (b) 
from manufacture to retail sale;
‘‘(ii) includes a person that manufacturers, 
processes, packs, distributes, receives, holds, 
imports, or offers for importation a drug sub-
ject to subsection (b); and 
‘‘(iii) does not include a transporter; 
‘‘(B) the term ‘transporter’ means the United 
States Postal Service, or equivalent governmental 
service of a foreign country, or a private carrier en-
gaged in the business of transporting packages for 
hire; and 
‘‘(C) the term ‘wholesale distribution’ means 
the distribution of a drug subject to subsection (b) 
to other than the consumer or patient but not in-
cluding an intracompany sale or distribution of a 
drug described in subsection (c)(3)(B).’’. 
(d) 
ANTICOUNTERFEITING
PROGRAMS.—Section 
503(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(e)) is amended by adding at the end the fol-
lowing: 
‘‘(4) The Secretary shall— 
‘‘(A) establish a network to be known as the 
‘Counterfeit Alert Network’ for the purpose of pro-
viding prompt notification to health professionals 
and the public of counterfeit drugs subject to sub-
section (b);
‘‘(B) (i) develop and publish an Internet acces-
sible-reference document to facilitate the positive 
identification by health professionals and regulatory 
agency personnel of prescription drugs marketed in 
the United States and Canada; and 
‘‘(ii) update the materials described under 
clause (i) quarterly and when a new permitted coun-
try is designated by the Secretary; 
‘‘(C) develop and publish educational materials 
to help health professionals and consumers identify 
and report cases of counterfeit drugs subject to sub-
section (b); 
‘‘(D) develop and publish secure business prac-
tice guidelines for the sale and distribution of such 
drugs in cooperation with members of a drug supply 
chain; and 
‘‘(E) in cooperation with the National Associa-
tion of Boards of Pharmacy, develop and publish re-
vised model rules for licensure of drug wholesalers 
for adoption by the States.’’. 
SEC. 16. CONFORMING AMENDMENTS. 
(a) Section 1006 of the Controlled Substances Import 
and Export Act (21 U.S.C. 956) is repealed. 
(b) The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended—
(1) in section 301(aa)— 
(A) by striking ‘‘section 804’’ and insert-
ing ‘‘subchapter B of chapter VIII’’; and 
(B) by striking ‘‘such section’’ each place 
it appears and inserting ‘‘that subchapter’’; 
(2) in section 801(d)(1), by striking ‘‘section 
804’’ and inserting ‘‘subchapter B’’; and 
(3) by striking section 804. 
Æ