‘‘(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