174 
(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: 
‘‘(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.
175 
‘‘(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 
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
176 
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 
with whom a manufacturer has established an ongoing re-
lationship to distribute such manufacturer’s products.’’. 
(3) EFFECTIVE DATE.— 
(A) IN GENERAL.—The amendments made 
by subparagraphs (A) and (C) of paragraph (1) 
and by paragraph (2) shall take effect on Janu-
ary 1, 2011.
177 
(B) DRUGS IMPORTED BY REGISTERED IM-
PORTERS
UNDER
SECTION
804.—Notwith-
standing subparagraph (A), the amendments 
made by subparagraphs (A) and (C) of para-
graph (1) and by paragraph (2) shall take ef-
fect on the date that is 90 days after the date 
of enactment of this Act with respect to quali-
fying drugs imported under section 804 of the 
Federal Food, Drug, and Cosmetic Act, as 
added by this section. 
(C) HIGH-RISK DRUGS.— 
(i) IN
GENERAL.—Notwithstanding 
subparagraph (A), the Secretary of Health 
and Human Services (referred to in this 
section as the ‘‘Secretary’’) may apply the 
amendments made by subparagraphs (A) 
and (C) of paragraph (1) and by para-
graph (2) before January 1, 2011, with re-
spect to a prescription drug if the Sec-
retary— 
(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 Federal Register.
178 
(ii) PEDIGREE NOT REQUIRED.—Not-
withstanding a determination under clause 
(i) with respect to a prescription drug, the 
amendments described in such clause shall 
not apply with respect to a wholesale dis-
tribution of such drug if the drug is dis-
tributed by the manufacturer of the drug 
to a person that distributes the drug to a 
retail pharmacy for distribution to the con-
sumer or patient, with no other intervening 
transactions. 
(iii) LIMITATION.—The Secretary may 
make the determination under clause (i) 
with respect to not more than 50 drugs be-
fore January 1, 2011. 
(D) EFFECT
WITH
RESPECT
TO
REG-
ISTERED EXPORTERS.—The amendment made 
by paragraph (1)(B) shall take effect on the 
date that is 90 days after the date of enactment 
of this Act. 
(E) ALTERNATIVE
REQUIREMENTS.—The 
Secretary shall issue regulations to establish the 
alternative requirements, referred to in the 
amendment made by paragraph (1)(A), that 
take effect not later than—
179 
(i) January 1, 2009, with respect to a 
prescription drug determined under sub-
paragraph (C)(i) to be at high risk for 
being counterfeited; and 
(ii) January 1, 2011, with respect to 
all other prescription drugs. 
(F) 
INTERMEDIATE
REQUIREMENTS.— 
With respect to the prescription drugs described 
under subparagraph (E)(ii), the Secretary shall 
by regulation require the use of standardized 
anti-counterfeiting 
or 
track-and-trace 
tech-
nologies on such prescription drugs at the case 
and pallet level effective not later than January 
1, 2010. 
(f) INTERNET SALES OF PRESCRIPTION DRUGS.— 
(1) IN GENERAL.—Chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 
seq.) is amended by inserting after section 503A the 
following: 
‘‘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—