amended by section 2(b)) is amended by adding at the 
end the following: 
‘‘(ii) The sale of a prescription drug, or the ownership 
or operation of an Internet pharmacy, in violation of sec-
tion 511. 
‘‘(jj) The representation by advertisement, sales pres-
entation, direct communication (including telephone, fac-
simile, or electronic mail), or otherwise by an Internet 
pharmacy, that a prescription drug may be obtained from 
the Internet pharmacy without a prescription, in violation 
of section 511. 
‘‘(kk) The acceptance of an advertisement from an 
Internet pharmacy by the provider of an interactive com-
puter service, unless the provider has on file a copy of 
the license issued to the Internet pharmacy under section 
511.’’. 
(c) LINKS TO ILLEGAL INTERNET PHARMACIES.— 
Section 302 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 332) is amended by adding at the end the fol-
lowing: 
‘‘(c) (1) In the case of a violation of section 511 relat-
ing to an illegal Internet pharmacy, the district courts of 
the United States and the United States courts of the ter-
ritories shall have jurisdiction to order a provider of an 
interactive computer service to remove, or disable access
to, a website violating that section that resides on a com-
puter server that the provider controls or operates. 
‘‘(2) Relief under paragraph (1)— 
‘‘(A) shall be available only after provision to 
the provider of notice and an opportunity to appear; 
‘‘(B) shall not impose any obligation on the 
provider to monitor its service or to affirmatively 
seek facts indicating activity violating section 511; 
and 
‘‘(C) shall specify the provider to which the re-
lief applies.’’. 
(d) REGULATIONS.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall promulgate in-
terim final regulations that are consistent with the 
Verified Internet Pharmacy Sites certification pro-
gram developed by the National Association of 
Boards of Pharmacy to carry out the amendments 
made by this section. 
(2) EFFECTIVE DATE.—The requirement of li-
censure under section 511 of the Federal Food, 
Drug, and Cosmetic Act (as added by this section) 
shall take effect on the date determined by the Sec-
retary of Health and Human Services but in no
event later than 90 days after the effective date of 
the interim final regulations under paragraph (1). 
(e) RETURN TO SENDER.—Section 801 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 381) is 
amended by adding at the end the following: 
‘‘(p) UNLICENSED INTERNET PHARMACY.—If an 
Internet pharmacy is not licensed by the Secretary in ac-
cordance with section 511, any shipment of a prescription 
drug from such an Internet pharmacy to an individual 
shall be refused admission into the United States and the 
Secretary shall return the prescription drug, other than 
a prescription drug that is required to be destroyed, to 
the Internet pharmacy at the expense of the Internet phar-
macy. 
‘‘(q) LICENSED INTERNET PHARMACY.—If a ship-
ment of a prescription drug from an Internet pharmacy 
licensed by the Secretary in accordance with section 511 
to an individual is refused admission into the United 
States, the Secretary shall— 
‘‘(1) return the prescription drug, other than a 
prescription drug that is required to be destroyed, to 
the Internet pharmacy at the expense of the Internet 
pharmacy; and 
‘‘(2) provide the individual and the Internet 
pharmacy with a written notice that informs the in-
dividual and the Internet pharmacy of the refusal 
and of the reason for the refusal.’’. 
SEC. 5. ADMINISTRATIVE DETENTION AND TEMPORARY 
HOLD. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by adding after section 815 (as 
added by section 9) the following: 
‘‘SEC. 816. ADMINISTRATIVE DETENTION. 
‘‘(a) ADMINISTRATIVE DETENTION
OF PRESCRIP-
TION DRUGS.— 
‘‘(1) DETENTION AUTHORITY.— 
‘‘(A) IN GENERAL.—An officer or qualified 
employee of the Food and Drug Administration 
may order the detention, in accordance with 
this subsection, of any prescription drug that is 
found during an inspection, examination, or in-
vestigation under this Act conducted by the of-
ficer or qualified employee, if the officer or 
qualified employee has credible evidence or in-
formation indicating that the prescription drug 
presents a risk to the public health. 
‘‘(B) APPROVAL.—A prescription drug 
may be detained under subparagraph (A) only 
if the Secretary or an official designated by the 
Secretary approves the order of detention.
‘‘(2) PERIOD OF DETENTION.—A prescription 
drug may be detained under paragraph (1) for a 
reasonable period, not to exceed 20 days, unless a 
greater period, not to exceed 30 days, is necessary, 
to enable the Secretary to commence an action 
under this subsection or section 302. 
‘‘(3) SECURITY OF DETAINED ARTICLE.— 
‘‘(A) IN GENERAL.—An order under para-
graph (1) with respect to a prescription drug— 
‘‘(i) may require that the prescription 
drug be labeled or marked as detained; and 
‘‘(ii) shall require that the prescrip-
tion drug be removed to a secure facility, 
as appropriate. 
‘‘(B) NO TRANSFER.—A prescription drug 
subject to an order under paragraph (1) shall 
not be transferred by any person from the place 
at which the prescription drug is ordered de-
tained or from the place to which the prescrip-
tion drug is removed, until released by the Sec-
retary or until the expiration of the detention 
period applicable under the order, whichever oc-
curs first. 
‘‘(C) EFFECT OF PARAGRAPH.—This para-
graph does not authorize the delivery of a pre-
scription drug pursuant to the execution of a 
bond while the prescription drug is subject to 
an order under paragraph (1). 
‘‘(D) EFFECT OF BONDING PROVISION.— 
Section 801(b) does not authorize the delivery 
of a prescription drug pursuant to the execution 
of a bond while the prescription drug is subject 
to an order under paragraph (1). 
‘‘(4) APPEAL OF DETENTION ORDER.— 
‘‘(A) IN GENERAL.—With respect to a pre-
scription drug detained under paragraph (1), 
any person that would be entitled to be a claim-
ant for the prescription drug if the prescription 
drug were seized under paragraph (1) may ap-
peal the order of detention to the Secretary. 
‘‘(B) ACTION
BY
THE
SECRETARY.—Not 
later than 5 days after an appeal is filed, the 
Secretary, after providing opportunity for an in-
formal hearing, shall confirm or terminate the 
order, and confirmation by the Secretary shall 
be considered to be a final agency action for 
purposes of section 702 of title 5, United States 
Code. 
‘‘(C) FAILURE TO ACT.—If, during the 5- 
day period specified in subparagraph (B), the
Secretary fails to provide an opportunity for 
hearing or to confirm or terminate the order, 
the order shall be deemed to be terminated. 
‘‘(D) EFFECT
OF
COMMENCEMENT
OF 
COURT ACTION.—The process under this para-
graph for the appeal of an order under para-
graph (1) with respect to a prescription drug 
terminates if the Secretary commences an ac-
tion under subsection (a) or section 302 regard-
ing the prescription drug. 
‘‘(b) 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.’’. 
(b) TEMPORARY HOLD AT PORT OF ENTRY.—Sec-
tion 801 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 381) (as amended by section 4(e)) is amended 
by adding at the end the following: 
‘‘(r) TEMPORARY HOLD AT PORT OF ENTRY.— 
‘‘(1) IN GENERAL.—If an officer or qualified 
employee of the Food and Drug Administration has 
credible evidence or information indicating that a 
prescription drug presents a risk to the public 
health, and the officer or qualified employee is un-
able to inspect, examine, or investigate the prescrip-
tion drug upon the prescription drug’s being offered 
for import at a port of entry into the United States, 
the officer or qualified employee shall request the 
Secretary of the Treasury to hold the prescription 
drug at the port of entry for a reasonable period of 
time, not to exceed 24 hours, for the purpose of ena-
bling the Secretary to inspect, examine, or inves-
tigate the prescription drug as appropriate. 
‘‘(2) APPROVAL.— 
‘‘(A) IN GENERAL.—An officer or qualified 
employee of the Food and Drug Administration 
may make a request under paragraph (1) only 
if the Secretary or an official designated by the 
Secretary approves the request. 
‘‘(B) DESIGNEES.—An official may not be 
designated under subparagraph (A) unless the 
official is the director of the district under this 
Act in which the prescription drug is located, or 
is an official senior to that director. 
‘‘(3) NOTIFICATION.—With respect to a pre-
scription drug for which a request under paragraph 
(1) is made, the Secretary, promptly after the re-
quest is made, shall notify the State in which the 
port of entry involved is located that the request has
been made, and as applicable, that the prescription 
drug, is being held under this subsection. 
‘‘(4) REMOVAL.—A prescription drug held 
under paragraph (1) shall be removed to a secure fa-
cility, as appropriate. 
‘‘(5) NO
TRANSFER.—During the period in 
which a prescription drug is held under this sub-
section, the prescription drug shall not be trans-
ferred by any person from the port of entry into the 
United States for the prescription drug or from the 
secure facility to which the prescription drug has 
been removed. 
‘‘(6) EFFECT OF BONDING PROVISION.—Sub-
section (b) does not authorize the delivery of a pre-
scription drug held under this subsection pursuant 
to the execution of a bond while the prescription 
drug is held under this subsection. 
‘‘(7) 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.’’. 
(c) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as
amended by section 4(b)) is amended by adding at the 
end the following: 
‘‘(ll) The transfer of a prescription drug in violation 
of an order under section 816, or the removal or alteration 
of any mark or label required by the order to identify the 
prescription drug as detained.’’. 
SEC. 6. SUSPENSION. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by adding after section 816 (as 
added by section 5) the following: 
‘‘SEC. 817. SUSPENSION OF IMPORTATION. 
‘‘(a) PRESCRIPTION DRUG.—If the Secretary deter-
mines that the importation of a particular prescription 
drug or particular dosage form of a prescription drug into 
the United States presents a risk to the public health, the 
Secretary may immediately order the suspension of the 
importation of the particular prescription drug or par-
ticular dosage form of the prescription drug. 
‘‘(b) SUSPENSION.—If the Secretary determines that 
a drug importation facility, pharmacy, Internet pharmacy, 
or wholesaler is engaged in a pattern of importing or offer-
ing for importation a prescription drug into the United 
States in violation of any of the requirements of this Act, 
the Secretary may immediately order the suspension of 
that person from engaging in the importation or offering
for importation of prescription drugs into the United 
States. 
‘‘(c) CANADA OR PERMITTED COUNTRY.—If the Sec-
retary determines that there is a pattern of prescription 
drugs being imported or offered for importation into the 
United States from Canada or a permitted country in vio-
lation of any of the requirements of this Act, the Secretary 
may immediately order the suspension of the importation 
or offering for importation into the United States of pre-
scription drugs from Canada or that permitted country, 
as appropriate. 
‘‘(d) APPEAL OF SUSPENSION ORDER.— 
‘‘(1) IN GENERAL.— 
‘‘(A) PRESCRIPTION DRUGS.—With respect 
to the importation of a prescription drug, the 
importation of which is suspended under sub-
section (a), any person that would be entitled to 
be a claimant for the prescription drug may ap-
peal the suspension order to the Secretary. 
‘‘(B) SUSPENDED PERSONS.—With respect 
to a drug importation facility, pharmacy, Inter-
net pharmacy, or wholesaler subject to a sus-
pension order under subsection (b) or (c), the 
drug importation facility, pharmacy, Internet
pharmacy or wholesaler may appeal the suspen-
sion order to the Secretary. 
‘‘(2) ACTION BY THE SECRETARY.—Not later 
than 30 days after an appeal is filed, the Secretary, 
after providing opportunity for an informal hearing, 
shall confirm or terminate the order. 
‘‘(3) FAILURE TO ACT.—If, during the 30-day 
period specified in paragraph (2), the Secretary fails 
to provide an opportunity for a hearing or to con-
firm or terminate the order, the order shall be 
deemed to be terminated. 
‘‘(e) NO JUDICIAL REVIEW.—An order under this 
section shall not be subject to judicial review. 
‘‘(f) 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.’’. 
(b) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as 
amended by section 5(c)) is amended by adding at the end 
the following: 
‘‘(mm) The importation or offering for importation 
of a prescription drug in violation of an order under sec-
tion 817.’’.
SEC. 7. DEBARMENT FOR REPEATED OR SERIOUS PRE-
SCRIPTION 
DRUG 
IMPORTATION 
VIOLA-
TIONS. 
(a) DEBARMENT AUTHORITY.— 
(1) 
PERMISSIVE
DEBARMENT.—Section 
306(b)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 335a(b)(1)) is amended— 
(A) in subparagraph (B), by striking ‘‘or’’ 
at the end; 
(B) in subparagraph (C), by striking the 
period at the end and inserting ‘‘, or’’; and 
(C) by adding at the end the following: 
‘‘(D) a person from importing a prescrip-
tion drug or offering a prescription drug for im-
portation into the United States.’’. 
(2) 
AMENDMENT
REGARDING
DEBARMENT 
GROUNDS.—Section 306(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is 
amended— 
(A) by redesignating paragraph (4) as 
paragraph (5); and 
(B) by inserting after paragraph (3) the 
following: 
‘‘(4) PERSONS
SUBJECT
TO
PERMISSIVE
DE-
BARMENT; PRESCRIPTION DRUG IMPORTATION.—
‘‘(A) IN GENERAL.—A person is subject to 
debarment under paragraph (1)(D) if— 
‘‘(i) the person has been convicted of 
a felony for conduct relating to the impor-
tation into the United States of any pre-
scription drug; or 
‘‘(ii) the person has engaged in a pat-
tern of importing or offering for import a 
prescription drug that presents a risk to 
the public health. 
‘‘(B) EFFECT
OF
PARAGRAPH.—Nothing 
in this paragraph applies to a prescription drug 
imported by an individual under section 812 or 
to a commercial transaction conducted between 
an Internet pharmacy and an individual.’’. 
(b) CONFORMING AMENDMENTS.—Section 306 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a) 
is amended— 
(1) in subsection (b), by striking the subsection 
heading and inserting the following: 
‘‘(b) PERMISSIVE DEBARMENT; CERTAIN DRUG AP-
PLICATIONS; IMPORTS.—’’; 
(2) in subsection (c)(2)(A)(iii), by striking 
‘‘paragraph (2) or (3) of subsection (b)’’ and insert-
ing ‘‘paragraph (2), (3), or (4) of subsection (b)’’; 
and 
(3) in subsection (d)(3)— 
(A) in subparagraph (A)(i), by striking ‘‘or 
paragraph (2)(A) or (3) of subsection (b)’’ and 
inserting ‘‘paragraph (2)(A), (3), or (4) of sub-
section (b)’’; 
(B) in clauses (i) and (ii) of subparagraph 
(B), by striking ‘‘or subsection (b)(3)’’ and in-
serting ‘‘paragraph (3) or (4) of subsection 
(b)’’; and 
(C) in subparagraph (B)(ii), by striking 
‘‘or the food importation process, as the case 
may be’’ and inserting ‘‘, or the food or pre-
scription drug importation process, as the case 
may be’’. 
(c) EFFECTIVE DATE.—Section 306(l)(2) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) 
is amended— 
(1) in the first sentence, by striking ‘‘and sub-
section 
(b)(3)(A)’’ 
and 
inserting 
‘‘subsection 
(b)(3)(A), and subsection (b)(4)(A)’’; and 
(2) in the second sentence, by inserting ‘‘, sub-
section (b)(4)(B),’’ after ‘‘subsection (b)(3)(B)’’.
(d) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as 
amended by section 6(b)) is amended by adding at the 
end the following: 
‘‘(nn) The importing or offering for importation into 
the United States of a prescription drug by, with the as-
sistance of, or at the direction of a person debarred under 
section 306(b)(4).’’. 
(e) IMPORTATION BY DEBARRED PERSONS.—Section 
801 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381) (as amended by section 5(b)) is amended by 
adding at the end the following: 
‘‘(s) IMPORTATION
OF PRESCRIPTION DRUGS
BY 
DEBARRED PERSONS.— 
‘‘(1) IN GENERAL.—If a prescription drug is 
imported or offered for importation into the United 
States, and the importer, owner, or consignee of the 
prescription drug is a person that has been debarred 
under section 306(b)(4), the prescription drug— 
‘‘(A) shall be held at the port of entry for 
the prescription drug; and 
‘‘(B) may not be delivered to the person. 
‘‘(2) 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. 
‘‘(3) REMOVAL.—A prescription drug held 
under this subsection shall be removed to a secure 
facility, as appropriate. 
‘‘(4) 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 prescription drug or from the secure facility 
to which the prescription drug has been removed. 
‘‘(5) PERMISSIBLE DELIVERY.—A prescription 
drug held under this subsection may be delivered to 
a person that is not a debarred person under section 
306(b)(4) if the person affirmatively establishes, at 
the expense of the person, that the prescription drug 
complies with the requirements of this Act, as deter-
mined by the Secretary.’’. 
SEC. 8. REGISTRATION OF PRESCRIPTION DRUG IMPORTA-
TION FACILITIES. 
(a) REGISTRATION OF CERTAIN IMPORTERS.—The 
Federal Food, Drug, and Cosmetic Act is amended by 
adding after section 813 (as added by section 2) the fol-
lowing: