104
as amended by section 3, is further amended by adding 
at the end the following section: 
‘‘SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED AD-
MISSION. 
‘‘(a) IN GENERAL.—The Secretary of Homeland Se-
curity shall deliver to the Secretary a shipment of drugs 
that is imported or offered for import into the United 
States if— 
‘‘(1) the shipment has a declared value of less 
than $10,000; and 
‘‘(2)(A) the shipping container for such drugs 
does not bear the markings required under section 
804(d)(2); or 
‘‘(B) the Secretary has requested delivery of 
such shipment of drugs. 
‘‘(b) NO BOND OR EXPORT.—Section 801(b) does 
not authorize the delivery to the owner or consignee of 
drugs delivered to the Secretary under subsection (a) pur-
suant to the execution of a bond, and such drugs may not 
be exported. 
‘‘(c) DESTRUCTION OF VIOLATIVE SHIPMENT.—The 
Secretary shall destroy a shipment of drugs delivered by 
the Secretary of Homeland Security to the Secretary 
under subsection (a) if—
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‘‘(1) in the case of drugs that are imported or 
offered for import from a registered exporter under 
section 804, the drugs are in violation of any stand-
ard described in section 804(g)(5); or 
‘‘(2) in the case of drugs that are not imported 
or offered for import from a registered exporter 
under section 804, the drugs are in violation of a 
standard referred to in section 801(a) or 801(d)(1). 
‘‘(d) CERTAIN PROCEDURES.— 
‘‘(1) IN GENERAL.—The delivery and destruc-
tion of drugs under this section may be carried out 
without notice to the importer, owner, or consignee 
of the drugs except as required by section 801(g) or 
section 804(i)(2). The issuance of receipts for the 
drugs, and recordkeeping activities regarding the 
drugs, may be carried out on a summary basis. 
‘‘(2) OBJECTIVE OF PROCEDURES.—Procedures 
promulgated under paragraph (1) shall be designed 
toward the objective of ensuring that, with respect to 
efficiently utilizing Federal resources available for 
carrying out this section, a substantial majority of 
shipments of drugs subject to described in sub-
section (c) are identified and destroyed. 
‘‘(e) EVIDENCE EXCEPTION.—Drugs may not be de-
stroyed under subsection (c) to the extent that the Attor-
106
ney General of the United States determines that the 
drugs should be preserved as evidence or potential evi-
dence with respect to an offense against the United States. 
‘‘(f) RULE OF CONSTRUCTION.—This section may 
not be construed as having any legal effect on applicable 
law with respect to a shipment of drugs that is imported 
or offered for import into the United States and has a 
declared value equal to or greater than $10,000.’’. 
(b) PROCEDURES.—Procedures for carrying out sec-
tion 805 of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (a), shall be established not later 
than 90 days after the date of the enactment of this Act. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on the date that is 90 days 
after the date of enactment of this Act. 
SEC. 6. CIVIL ACTIONS REGARDING PROPERTY. 
(a) IN GENERAL.—Section 303 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 
adding at the end the following subsection: 
‘‘(g)(1) If a person is alienating or disposing of prop-
erty, or intends to alienate or dispose of property, that 
is obtained as a result of or is traceable to a drug imported 
in violation of section 801(a) or 801(d), the Attorney Gen-
eral may commence a civil action in any Federal court—
107
‘‘(A) to enjoin such alienation or disposition of 
property; or 
‘‘(B) for a restraining order to— 
‘‘(i) prohibit any person from withdrawing, 
transferring, removing, dissipating, or disposing 
of any such property or property of equivalent 
value; and 
‘‘(ii) appoint a temporary receiver to ad-
minister such restraining order. 
‘‘(2) Proceedings under paragraph (1) shall be car-
ried out in the same manner as applies under section 1345 
of title 18, United States Code.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall take effect on the day that is 90 days 
after the date of enactment of this Act. 
SEC. 7. WHOLESALE DISTRIBUTION OF DRUGS; STATE-
MENTS REGARDING PRIOR SALE, PURCHASE, 
OR TRADE. 
(a) STRIKING OF EXEMPTIONS; APPLICABILITY TO 
REGISTERED EXPORTERS.—Section 503(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) is 
amended— 
(1) in paragraph (1)—
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(A) by striking ‘‘and who is not the manu-
facturer or an authorized distributor of record 
of such drug’’; 
(B) by striking ‘‘to an authorized dis-
tributor of record or’’; and 
(C) by striking subparagraph (B) and in-
serting the following: 
‘‘(B) The fact that a drug subject to subsection (b) 
is exported from the United States does not with respect 
to such drug exempt any person that is engaged in the 
business of the wholesale distribution of the drug from 
providing the statement described in subparagraph (A) to 
the person that receives the drug pursuant to the export 
of the drug. 
‘‘(C)(i) The Secretary shall by regulation establish re-
quirements that supersede subparagraph (A) (referred to 
in this subparagraph as ‘alternative requirements’) to 
identify the chain of custody of a drug subject to sub-
section (b) from the manufacturer of the drug throughout 
the wholesale distribution of the drug to a pharmacist who 
intends to sell the drug at retail if the Secretary deter-
mines that the alternative requirements, which may in-
clude standardized anti-counterfeiting or track-and-trace 
technologies, will identify such chain of custody or the 
identity of the discrete package of the drug from which
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the drug is dispensed with equal or greater certainty to 
the requirements of subparagraph (A), and that the alter-
native requirements are economically and technically fea-
sible. 
‘‘(ii) When the Secretary promulgates a final rule to 
establish such alternative requirements, the final rule in 
addition shall, with respect to the registration condition 
established in clause (i) of section 804(c)(3)(B), establish 
a condition equivalent to the alternative requirements, and 
such equivalent condition may be met in lieu of the reg-
istration condition established in such clause (i).’’; 
(2) in paragraph (2)(A), by adding at the end 
the following: ‘‘The preceding sentence may not be 
construed as having any applicability with respect to 
a registered exporter under section 804.’’; and 
(3) in paragraph (3), by striking ‘‘and sub-
section (d)—’’ in the matter preceding subparagraph 
(A) and all that follows through ‘‘the term ‘whole-
sale distribution’ means’’ in subparagraph (B) and 
inserting the following: ‘‘and subsection (d), the 
term ‘wholesale distribution’ means’’. 
(b) CONFORMING AMENDMENT.—Section 503(d) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(d)) is amended by adding at the end the following:
110
‘‘(4) Each manufacturer of a drug subject to sub-
section (b) shall maintain at its corporate offices a current 
list of the authorized distributors of record of such drug. 
‘‘(5) For purposes of this subsection, the term ‘au-
thorized distributors of record’ means those distributors 
with whom a manufacturer has established an ongoing re-
lationship to distribute such manufacturer’s products.’’. 
(c) EFFECTIVE DATE.— 
(1) IN GENERAL.—The amendments made by 
paragraphs (1) and (3) of subsection (a) and by sub-
section (b) shall take effect on January 1, 2010. 
(2) DRUGS IMPORTED BY REGISTERED IMPORT-
ERS
UNDER
SECTION
804.—Notwithstanding para-
graph (1), the amendments made by paragraphs (1) 
and (3) of subsection (a) and by subsection (b) shall 
take effect on the date that is 90 days after the date 
of enactment of this Act with respect to qualifying 
drugs imported under section 804 of the Federal 
Food, Drug, and Cosmetic Act, as added by section 
4. 
(3) HIGH-RISK DRUGS.— 
(A) IN GENERAL.—Notwithstanding para-
graph (1), the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Sec-
retary’’) may apply the amendments made by
111
paragraphs (1) and (3) of subsection (a) and by 
subsection (b) before January 1, 2010, with re-
spect to a prescription drug if the Secretary— 
(i) determines that the drug is at high 
risk for being counterfeited; and 
(ii) publishes the determination and 
the basis for the determination in the Fed-
eral Register. 
(B) PEDIGREE NOT REQUIRED.—Notwith-
standing a determination under subparagraph 
(A) with respect to a prescription drug, the 
amendments described in such subparagraph 
shall not apply with respect to a wholesale dis-
tribution of such drug if the drug is distributed 
by the manufacturer of the drug to a person 
that distributes the drug to a retail pharmacy 
for distribution to the consumer or patient, with 
no other intervening transactions. 
(C) 
LIMITATION.—The 
Secretary 
may 
make the determination under subparagraph 
(A) with respect to not more than 50 drugs be-
fore January 1, 2010. 
(4) EFFECT
WITH
RESPECT
TO
REGISTERED 
EXPORTERS.—The amendment made by subsection
112
(a)(2) shall take effect on the date that is 90 days 
after the date of enactment of this Act. 
(5) ALTERNATIVE REQUIREMENTS.—The Sec-
retary shall issue regulations to establish the alter-
native requirements, referred to in the amendment 
made by subsection (a)(1), that take effect not later 
than—
(A) January 1, 2008, with respect to a 
prescription drug determined under paragraph 
(3)(A) to be at high risk for being counter-
feited; and 
(B) January 1, 2010, with respect to all 
other prescription drugs. 
(6) INTERMEDIATE REQUIREMENTS.—With re-
spect to the prescription drugs described under para-
graph (5)(B), the Secretary shall by regulation re-
quire the use of standardized anti-counterfeiting or 
track-and-trace technologies on such prescription 
drugs at the case and pallet level effective not later 
than January 1, 2008. 
SEC. 8. INTERNET SALES OF PRESCRIPTION DRUGS. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 503A the following:
113
‘‘SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS. 
‘‘(a) REQUIREMENTS REGARDING INFORMATION ON 
INTERNET SITE.— 
‘‘(1) IN GENERAL.—A person may not dispense 
a prescription drug pursuant to a sale of the drug 
by such person if— 
‘‘(A) the purchaser of the drug submitted 
the purchase order for the drug, or conducted 
any other part of the sales transaction for the 
drug, through an Internet site; 
‘‘(B) the person dispenses the drug to the 
purchaser by mailing or shipping the drug to 
the purchaser; and 
‘‘(C) such site, or any other Internet site 
used by such person for purposes of sales of a 
prescription drug, fails to meet each of the re-
quirements specified in paragraph (2), other 
than a site or pages on a site that— 
‘‘(i) are not intended to be accessed 
by purchasers or prospective purchasers; or 
‘‘(ii) provide an Internet information 
location tool within the meaning of section 
231(e)(5) of the Communications Act of 
1934 (47 U.S.C. 231(e)(5)). 
‘‘(2) REQUIREMENTS.—With respect to an 
Internet site, the requirements referred to in sub-
114
paragraph (C) of paragraph (1) for a person to 
whom such paragraph applies are as follows: 
‘‘(A) Each page of the site shall include ei-
ther the following information or a link to a 
page that provides the following information: 
‘‘(i) The name of such person. 
‘‘(ii) Each State in which the person 
is authorized by law to dispense prescrip-
tion drugs. 
‘‘(iii) The address and telephone num-
ber of each place of business of the person 
with respect to sales of prescription drugs 
through the Internet, other than a place of 
business that does not mail or ship pre-
scription drugs to purchasers. 
‘‘(iv) The name of each individual who 
serves as a pharmacist for prescription 
drugs that are mailed or shipped pursuant 
to the site, and each State in which the in-
dividual is authorized by law to dispense 
prescription drugs. 
‘‘(v) If the person provides for medical 
consultations through the site for purposes 
of providing prescriptions, the name of 
each individual who provides such con-