that person, but that does not take title to 
such drug and does not have general re-
sponsibility to direct the sale or distribu-
tion of the prescription drug; 
‘‘(viii) for purposes of subsection (d) 
and this subsection, the term ‘wholesale 
distribution’ means the sale, purchase, 
trade, or delivery of a prescription drug be-
tween and within any State, but does not 
include— 
‘‘(I) intracompany sales, pur-
chases, trades, or transfers of any 
prescription drug between members of 
an affiliated group (as that term is 
defined in section 1504 of the Inter-
nal Revenue Code); 
‘‘(II) the purchase or other ac-
quisition by a hospital or other health 
care entity that is a member of a 
group purchasing organization of a 
drug for its own use from the group 
purchasing organization or from other 
hospitals or health care entities that 
are members of such organizations; 
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‘‘(III) the sale, purchase, or 
trade of a drug or an offer to sell, 
purchase, or trade a drug by a chari-
table organization to a nonprofit affil-
iate of the organization to the extent 
otherwise permitted by law; 
‘‘(IV) the sale, purchase, or trade 
of a drug or an offer to sell, purchase, 
or trade a drug among hospitals or 
other health care entities that are 
under common control; 
‘‘(V) the sale, purchase, or trade 
of a drug or an offer to sell, purchase, 
or trade a drug for emergency medical 
reasons; 
‘‘(VI) the sale, purchase, or trade 
of a drug, an offer to sell, purchase, 
or trade a drug, or the dispensing of 
a drug under a prescription executed 
in accordance with subsection (b); 
‘‘(VII) the distribution of drug 
samples by a manufacturer’s rep-
resentative or an authorized dis-
tributor of record’s representative; 
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‘‘(VIII) the sale, purchase, or 
trade of blood or blood components in-
tended for transfusion; 
‘‘(IX) drug returns, when con-
ducted by a dispenser or wholesale 
distributor in accordance with the re-
quirements of subparagraph (D); 
‘‘(X) the sale of minimal quan-
tities of drugs by retail pharmacies to 
licensed practitioners for office use; or 
‘‘(XI) the sale, purchase, or trade 
of prescription drugs when such drugs 
are contained in sealed medical or 
surgical kits that have been assembled 
in a facility registered with the Food 
and Drug Administration as a device 
manufacturer under section 510(c) 
and such drug was purchased by the 
kit assembler directly from the manu-
facturer of such drug; and 
‘‘(ix) the term ‘wholesale distributor’ 
means any person engaged in wholesale 
distribution, except a common carrier. 
‘‘(B) MANUFACTURER
PACKING
LIST.— 
The manufacturer of a prescription drug shall 
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provide to each wholesale distributor or dis-
penser to whom it delivers such drug a packing 
list or comparable document, in paper or elec-
tronic form, that identifies the proprietary and 
established names of the drug, the National 
Drug Code number of the drug, the strength of 
the drug, the container size of the drug, the 
number of containers of the drug, the lot num-
ber or numbers of the drug, the date of the 
transaction, and the names and addresses of 
the manufacturer and the person to whom the 
drug is being delivered. 
‘‘(C) STATEMENT OF DISTRIBUTION HIS-
TORY.—Each person engaged in wholesale dis-
tribution of a prescription drug (except a manu-
facturer that is engaged in the wholesale dis-
tribution of a prescription drug, or a wholesale 
distributor on whose behalf a manufacturer de-
livers a prescription drug directly to a dis-
penser) shall provide to each wholesale dis-
tributor or dispenser to whom such person de-
livers such a drug before, or at the time of, 
each wholesale distribution, one of the fol-
lowing: 
‘‘(i) DIRECT PURCHASE PEDIGREE.— 
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‘‘(I) If the person providing the 
statement is an authorized distributor 
of record for such drug and purchased 
such drug directly from the manufac-
turer, a statement on the invoice, 
whether in paper or electronic form, 
stating that such person is an author-
ized distributor of record for such 
drug; and such person purchased the 
specific unit of the prescription drug 
directly from the manufacturer. 
‘‘(II) If the person providing the 
statement is a member of the affili-
ated group (as that term is defined in 
section 1504 of the Internal Revenue 
Code) of an authorized distributor of 
record that purchased such drug di-
rectly from the manufacturer, and 
such person obtained such drug from 
such authorized distributor of record 
directly or by means of one or more 
transactions involving only members 
of such affiliated group, a statement 
on the invoice, whether in paper or 
electronic form, identifying such au-
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thorized distributor of record; stating 
that such person is a member of the 
affiliated group (as that term is de-
fined in section 1504 of the Internal 
Revenue Code) of such authorized dis-
tributor of record; and stating that 
such authorized distributor of record 
purchased the specific unit of the pre-
scription drug directly from the manu-
facturer. 
‘‘(ii) STANDARD PEDIGREE.—For all 
situations not described in clause (i), a 
statement, whether in paper or electronic 
form, identifying each wholesale distribu-
tion of such drug, back to the authorized 
distributor of record for such drug or a 
member of the affiliated group (as that 
term is defined in section 1504 of the In-
ternal Revenue Code) of such authorized 
distributor of record that provided one of 
the statements described in clause (i), or, 
if there is no such authorized distributor of 
record, back to the manufacturer of such 
drug, and including the following: 
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‘‘(I) The proprietary and estab-
lished names of the drug. 
‘‘(II) The drug’s National Drug 
Code number. 
‘‘(III) Strength. 
‘‘(IV) Container size. 
‘‘(V) Number of containers. 
‘‘(VI) The drug’s lot or control 
number or numbers. 
‘‘(VII) The business name and 
address of all parties to each prior 
transaction involving the drug, start-
ing with the authorized distributor of 
record who provided the original 
statement of distribution history re-
quired under clause (i) or, if there is 
no such authorized distributor of 
record, back to the manufacturer of 
such drug. 
‘‘(VIII) The date of each pre-
vious transaction involving such drug, 
back to the authorized distributor of 
record who provided the original 
statement of distribution history re-
quired under clause (i) or, if there is 
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