‘‘(6) WHOLESALE
DISTRIBUTOR
LICENSES.— 
Notwithstanding section 581(9)(A), until the effec-
tive date of the wholesale distributor licensing regu-
lations under section 583, the term ‘licensed’ or ‘au-
thorized’, as it relates to a wholesale distributor with 
respect to prescription drugs, shall mean a wholesale 
distributor with a valid license under State law. 
‘‘(7) THIRD-PARTY
LOGISTICS
PROVIDER
LI-
CENSES.—Until the effective date of the third-party 
logistics provider licensing regulations under section 
584, a third-party logistics provider shall be consid-
ered ‘licensed’ under section 581(9)(B) unless the 
Secretary has made a finding that the third-party lo-
gistics provider does not utilize good handling and 
distribution practices and publishes notice thereof. 
‘‘(8) LABEL CHANGES.—Changes made to pack-
age labels solely to incorporate the product identifier 
may be submitted to the Secretary in the annual re-
port of an establishment, in accordance with section 
314.70(d) of chapter 21, Code of Federal Regula-
tions (or any successor regulation). 
‘‘(9) PRODUCT IDENTIFIERS.—With respect to 
any requirement relating to product identifiers under 
this subchapter— 
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‘‘(A) unless the Secretary allows, through 
guidance, the use of other technologies for data 
instead of or in addition to the technologies de-
scribed in clauses (i) and (ii), the applicable 
data— 
‘‘(i) shall be included in a 2-dimen-
sional data matrix barcode when affixed to, 
or imprinted upon, a package; and 
‘‘(ii) shall be included in a linear or 2- 
dimensional data matrix barcode when af-
fixed to, or imprinted upon, a homo-
geneous case; and 
‘‘(B) verification of the product identifier 
may occur by using human-readable or ma-
chine-readable methods. 
‘‘(b) MANUFACTURER REQUIREMENTS.— 
‘‘(1) PRODUCT TRACING.— 
‘‘(A) IN
GENERAL.—Beginning not later 
than January 1, 2015, a manufacturer shall— 
‘‘(i) prior to, or at the time of, each 
transaction in which such manufacturer 
transfers ownership of a product, provide 
the subsequent owner with transaction his-
tory, transaction information, and a trans-
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action statement, in a single document in 
an paper or electronic format; and 
‘‘(ii) capture the transaction informa-
tion (including lot level information), 
transaction history, and transaction state-
ment for each transaction and maintain 
such information, history, and statement 
for not less than 6 years after the date of 
the transaction. 
‘‘(B) REQUESTS
FOR
INFORMATION.— 
Upon a request by the Secretary or other ap-
propriate Federal or State official, in the event 
of a recall or for the purpose of investigating a 
suspect product or an illegitimate product, a 
manufacturer shall, not later than 1 business 
day, and not to exceed 48 hours, after receiving 
the request, or in other such reasonable time as 
determined by the Secretary, based on the cir-
cumstances of the request, provide the applica-
ble transaction information, transaction history, 
and transaction statement for the product. 
‘‘(C) ELECTRONIC FORMAT.— 
‘‘(i) IN
GENERAL.—Beginning not 
later than 4 years after the date of enact-
ment of the Drug Supply Chain Security 
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Act, except as provided under clause (ii), a 
manufacturer shall provide the transaction 
information, 
transaction 
history, 
and 
transaction statement required under sub-
paragraph (A)(i) in electronic format. 
‘‘(ii) EXCEPTION.—A manufacturer 
may continue to provide the transaction in-
formation, transaction history, and trans-
action statement required under subpara-
graph (A)(i) in a paper format to a li-
censed health care practitioner authorized 
to prescribe medication under State law or 
other licensed individual under the super-
vision or direction of such a practitioner 
who dispenses product in the usual course 
of professional practice. 
‘‘(2) PRODUCT IDENTIFIER.— 
‘‘(A) IN
GENERAL.—Beginning not later 
than 4 years after the date of enactment of the 
Drug Supply Chain Security Act, a manufac-
turer shall affix or imprint a product identifier 
to each package and homogenous case of a 
product intended to be introduced in a trans-
action into commerce. Such manufacturer shall 
maintain the product identifier information for 
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such product for not less than 6 years after the 
date of the transaction. 
‘‘(B) EXCEPTION.—A package that is re-
quired to have a standardized numerical identi-
fier is not required to have a unique device 
identifier. 
‘‘(3) AUTHORIZED
TRADING
PARTNERS.—Be-
ginning not later than January 1, 2015, the trading 
partners of a manufacturer may be only authorized 
trading partners. 
‘‘(4) VERIFICATION.—Beginning not later than 
January 1, 2015, a manufacturer shall have systems 
in place to enable the manufacturer to comply with 
the following requirements: 
‘‘(A) SUSPECT PRODUCT.— 
‘‘(i) IN
GENERAL.—Upon making a 
determination that a product in the posses-
sion or control of the manufacturer is a 
suspect product, or upon receiving a re-
quest for verification from the Secretary 
that has made a determination that a 
product within the possession or control of 
a manufacturer is a suspect product, a 
manufacturer shall— 
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‘‘(I) quarantine such product 
within the possession or control of the 
manufacturer from product intended 
for distribution until such product is 
cleared or dispositioned; and 
‘‘(II) promptly conduct an inves-
tigation in coordination with trading 
partners, as applicable, to determine 
whether the product is an illegitimate 
product, which shall include validating 
any applicable transaction history and 
transaction information in the posses-
sion of the manufacturer and other-
wise investigating to determine wheth-
er the product is an illegitimate prod-
uct, and, beginning 4 years after the 
date of enactment of the Drug Supply 
Chain Security Act, verifying the 
product at the package level, including 
the standardized numerical identifier. 
‘‘(ii) 
CLEARED
PRODUCT.—If 
the 
manufacturer makes the determination 
that a suspect product is not an illegit-
imate product, the manufacturer shall 
promptly notify the Secretary, if applica-
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PWALKER on DSK7TPTVN1PROD with BILLS
ble, of such determination and such prod-
uct may be further distributed. 
‘‘(iii) 
RECORDS.—A 
manufacturer 
shall keep records of the investigation of a 
suspect product for not less than 6 years 
after the conclusion of the investigation. 
‘‘(B) ILLEGITIMATE PRODUCT.— 
‘‘(i) IN GENERAL.—Upon determining 
that a product in the possession or control 
of a manufacturer is an illegitimate prod-
uct, the manufacturer shall, in a manner 
consistent with the systems and processes 
of such manufacturer— 
‘‘(I) quarantine such product 
within the possession or control of the 
manufacturer from product intended 
for distribution until such product is 
dispositioned; 
‘‘(II) disposition the illegitimate 
product within the possession or con-
trol of the manufacturer; 
‘‘(III) take reasonable and appro-
priate steps to assist a trading part-
ner to disposition an illegitimate prod-
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PWALKER on DSK7TPTVN1PROD with BILLS
uct not in the possession or control of 
the manufacturer; and 
‘‘(IV) retain a sample of the 
product for further physical examina-
tion or laboratory analysis of the 
product by the manufacturer or Sec-
retary (or other appropriate Federal 
or State official) upon request by the 
Secretary (or other appropriate Fed-
eral or State official), as necessary 
and appropriate. 
‘‘(ii) MAKING A NOTIFICATION.— 
‘‘(I) ILLEGITIMATE
PRODUCT.— 
Upon determining that a product in 
the possession or control of the manu-
facturer is an illegitimate product, the 
manufacturer shall notify the Sec-
retary and all immediate trading part-
ners that the manufacturer has reason 
to believe may have received such ille-
gitimate product of such determina-
tion not later than 24 hours after 
making such determination. 
‘‘(II) HIGH
RISK
OF
ILLEGIT-
IMACY.—A manufacturer shall notify 
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the Secretary and immediate trading 
partners that the manufacturer has 
reason to believe may have in the 
trading partner’s possession a product 
manufactured by, or purported to be a 
product manufactured by, the manu-
facturer not later than 24 hours after 
determining or being notified by the 
Secretary or a trading partner that 
there is a high risk that such product 
is an illegitimate product. For pur-
poses of this subclause, a ‘high risk’ 
may include a specific high risk that 
could increase the likelihood that ille-
gitimate product will enter the phar-
maceutical distribution supply chain 
and other high risks as determined by 
the Secretary in guidance pursuant to 
subsection (h). 
‘‘(iii) RESPONDING
TO
A
NOTIFICA-
TION.—Upon the receipt of a notification 
from the Secretary or a trading partner 
that a determination has been made that a 
product is an illegitimate product, a manu-
facturer shall identify all illegitimate prod-
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uct subject to such notification that is in 
the possession or control of the manufac-
turer, including any product that is subse-
quently received, and shall perform the ac-
tivities described in subparagraph (A). 
‘‘(iv) 
TERMINATING
A
NOTIFICA-
TION.—Upon making a determination, in 
consultation with the Secretary, that a no-
tification is no longer necessary, a manu-
facturer shall promptly notify immediate 
trading partners that the manufacturer no-
tified pursuant to clause (ii) that such no-
tification has been terminated. 
‘‘(v) RECORDS.—A manufacturer shall 
keep records of the disposition of an illegit-
imate product for not less than 6 years 
after the conclusion of the disposition. 
‘‘(C) REQUESTS FOR VERIFICATION.—Be-
ginning 4 years after the date of enactment of 
the Drug Supply Chain Security Act, upon re-
ceiving a request for verification from an au-
thorized repackager, wholesale distributor, or 
dispenser that is in possession or control of a 
product such person believes to be manufac-
tured by such manufacturer, a manufacturer 
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PWALKER on DSK7TPTVN1PROD with BILLS
shall, not later than 24 hours after receiving 
the request for verification or in other such rea-
sonable time as determined by the Secretary, 
based on the circumstances of the request, no-
tify the person making the request whether the 
product identifier, including the standardized 
numerical identifier, that is the subject of the 
request corresponds to the product identifier af-
fixed or imprinted by the manufacturer. If a 
manufacturer responding to a request for 
verification identifies a product identifier that 
does not correspond to that affixed or imprinted 
by the manufacturer, the manufacturer shall 
treat such product as suspect product and con-
duct an investigation as described in subpara-
graph (A). If the manufacturer has reason to 
believe the product is an illegitimate product, 
the manufacturer shall advise the person mak-
ing the request of such belief at the time such 
manufacturer responds to the request for 
verification. 
‘‘(D) ELECTRONIC DATABASE.—A manu-
facturer may satisfy the requirements of this 
paragraph by developing a secure electronic 
database or utilizing a secure electronic data-
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PWALKER on DSK7TPTVN1PROD with BILLS
‘‘(I) beginning 7 years after the 
date of enactment of the Drug Supply 
Chain Security Act, verifying whether 
the lot number of a suspect product 
corresponds with the lot number for 
such product; 
‘‘(II) beginning 7 years after the 
date of enactment of such Act, 
verifying that the product identifier, 
including the standardized numerical 
identifier, of at least 3 packages or 10 
percent of such suspect product, 
whichever is greater, or all packages, 
if there are fewer than 3, corresponds 
with the product identifier for such 
product; 
‘‘(III) validating any applicable 
transaction history and transaction in-
formation in the possession of the dis-
penser; and 
‘‘(IV) otherwise investigating to 
determine whether the product is an 
illegitimate product. 
‘‘(iii) CLEARED PRODUCT.—If the dis-
penser makes the determination that a sus-
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