146 
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-
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 
VerDate Aug 31 2005 
03:43 Aug 07, 2008
Jkt 069200
PO 00000
Frm 00146
Fmt 6652
Sfmt 6201
E:\BILLS\H6800.IH
H6800
erowe on PROD1PC71 with BILLS
147 
or offered for import into the United States and has a 
declared value equal to or greater than $10,000.’’. 
(2) PROCEDURES.—Procedures for carrying out 
section 805 of the Federal Food, Drug, and Cos-
metic Act, as added by this subsection, shall be es-
tablished not later than 90 days after the date of the 
enactment of this Act. 
(3) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect on the date that 
is 90 days after the date of enactment of this Act. 
(d) CIVIL ACTIONS REGARDING PROPERTY.— 
(1) 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 sub-
section: 
‘‘(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— 
‘‘(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 
VerDate Aug 31 2005 
03:43 Aug 07, 2008
Jkt 069200
PO 00000
Frm 00147
Fmt 6652
Sfmt 6201
E:\BILLS\H6800.IH
H6800
erowe on PROD1PC71 with BILLS
148 
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.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by this subsection shall take effect on the day that 
is 90 days after the date of enactment of this Act. 
(e) WHOLESALE DISTRIBUTION OF DRUGS; STATE-
MENTS
REGARDING
PRIOR
SALE, 
PURCHASE, 
OR 
TRADE.— 
(1) 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— 
(A) in paragraph (1)— 
(i) by striking ‘‘and who is not the 
manufacturer or an authorized distributor 
of record of such drug’’; 
(ii) by striking ‘‘to an authorized dis-
tributor of record or’’; and 
(iii) by striking subparagraph (B) and 
inserting the following: 
VerDate Aug 31 2005 
03:43 Aug 07, 2008
Jkt 069200
PO 00000
Frm 00148
Fmt 6652
Sfmt 6201
E:\BILLS\H6800.IH
H6800
erowe on PROD1PC71 with BILLS
149 
‘‘(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 
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 
VerDate Aug 31 2005 
03:43 Aug 07, 2008
Jkt 069200
PO 00000
Frm 00149
Fmt 6652
Sfmt 6201
E:\BILLS\H6800.IH
H6800
erowe on PROD1PC71 with BILLS
150 
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).’’; 
(B) 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 sec-
tion 804.’’; and 
(C) in paragraph (3), by striking ‘‘and 
subsection (d)—’’ in the matter preceding sub-
paragraph (A) and all that follows through ‘‘the 
term ‘wholesale distribution’ means’’ in sub-
paragraph (B) and inserting the following: ‘‘and 
subsection (d), the term ‘wholesale distribution’ 
means’’. 
(2) 
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: 
‘‘(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 
VerDate Aug 31 2005 
03:43 Aug 07, 2008
Jkt 069200
PO 00000
Frm 00150
Fmt 6652
Sfmt 6201
E:\BILLS\H6800.IH
H6800
erowe on PROD1PC71 with BILLS