number, and expiration date assigned to the pre-
scription drug product by the manufacturer or 
the repackager, as applicable; and 
‘‘(B) include making the determination 
under subparagraph (A) using human-readable 
or machine-readable methods. 
‘‘(26) WHOLESALE
DISTRIBUTOR.—The term 
‘wholesale distributor’— 
‘‘(A) means a person engaged in wholesale 
distribution (as defined in section 583); and 
‘‘(B) excludes— 
‘‘(i) a manufacturer, a co-licensed 
partner of a manufacturer, or a third-party 
logistics provider, or a dispenser who does 
not engage in such wholesale distribution; 
‘‘(ii) a repackager engaged in such 
wholesale distribution; or 
‘‘(iii) the distribution of prescription 
drug product or an offer to distribute pre-
scription drug product by an authorized re-
packager that has taken ownership or pos-
session of the prescription drug product and 
repacked the prescription drug product in 
accordance with the requirements of section 
582(e). 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘SEC. 582. REQUIREMENTS. 
‘‘(a) IN GENERAL.— 
‘‘(1) COMPLIANCE REQUIRED.—An entity that is 
a manufacturer, repackager, wholesale distributor, 
third-party logistics provider, or dispenser shall com-
ply with the requirements of this section. If an entity 
meets the definition of more than one of the entities 
referred to in the preceding sentence, such entity shall 
comply with all applicable requirements of this sec-
tion, but shall not be required to comply with dupli-
cative requirements. 
‘‘(2) STANDARDS.—The Secretary shall, in con-
sultation with other appropriate Federal officials, 
manufacturers, repackagers, wholesale distributors, 
third-party logistics providers, and dispensers, estab-
lish, by regulation, standards for the exchange of 
transaction information for purposes of complying 
with this section. The standards established under this 
paragraph shall be in accordance with a form devel-
oped by a widely recognized international standards 
development organization. In establishing such stand-
ards, the Secretary shall consider the feasibility of es-
tablishing standardized documentation to be used by 
all members of the pharmaceutical distribution sup-
ply chain to convey the transaction history and 
transaction statement to the subsequent owner of a 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
prescription drug product. The Secretary shall pub-
lish such standards not later than 180 days after the 
date of the enactment of the Safeguarding America’s 
Pharmaceuticals Act of 2013. 
‘‘(3) 
WAIVERS, 
EXCEPTIONS, 
AND
EXEMP-
TIONS.—Not later than one year after the date of the 
enactment of the Safeguarding America’s Pharma-
ceuticals Act of 2013, the Secretary shall promulgate 
a regulation to— 
‘‘(A) establish a process by which the Sec-
retary may grant, at the request of an authorized 
manufacturer, repackager, wholesale distributor, 
or dispenser, a waiver from any of the require-
ments of this section— 
‘‘(i) if the Secretary determines that 
such requirements would result in an undue 
economic hardship; or 
‘‘(ii) for emergency medical reasons, 
including a public health emergency dec-
laration pursuant to section 319 of the Pub-
lic Health Service Act; 
‘‘(B) establish a process, with respect to the 
prescription drug product identifier requirement 
under paragraph (2) of subsections (b), (c), (d), 
and (e) through which— 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00023
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(i) a manufacturer or repackager 
may request a waiver with respect to pre-
scription drug products that are packaged 
in a container too small or otherwise unable 
to accommodate a label with sufficient space 
to bear the information required for compli-
ance with such requirement; and 
‘‘(ii) the Secretary determines whether 
to waive such requirement; and 
‘‘(C) establish a process by which the Sec-
retary may add the prescription drug products 
or transactions that are exempt from the require-
ments of this section. 
‘‘(4) GRANDFATHERED PERSONS AND PRESCRIP-
TION DRUG PRODUCTS.— 
‘‘(A) IN GENERAL.—Not later than one year 
after the date of the enactment of the Safe-
guarding America’s Pharmaceuticals Act of 
2013, the Secretary shall specify, by regulation, 
whether and under what circumstances the pre-
scription drug product identifier requirement 
under paragraph (2) of subsections (b), (c), (d), 
and (e) shall apply to a prescription drug prod-
uct that is in the supply chain or in a manufac-
turer’s inventory on the date of the enactment of 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00024
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
the Safeguarding America’s Pharmaceuticals Act 
of 2013. 
‘‘(B) THIRD-PARTY LOGISTICS PROVIDER LI-
CENSES.—Until the date that is 1 year after the 
effective date of the third-party logistics provider 
licensing requirements under section 584, a 
third-party logistics provider shall be considered 
‘licensed’ under section 581(6)(B) unless the Sec-
retary has made a finding that the third-party 
logistics provider does not utilize good handling 
and distribution practices and publishes notice 
thereof. 
‘‘(C) LABEL CHANGES.—Changes made to 
package labels solely to incorporate the prescrip-
tion drug product identifier may be submitted to 
the Secretary in the annual report of an estab-
lishment, in accordance with section 314.70(d) of 
chapter 21, Code of Federal Regulations (or any 
successor regulation). 
‘‘(b) MANUFACTURER REQUIREMENTS.— 
‘‘(1) PRESCRIPTION DRUG 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 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00025
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
transfers ownership of a prescription drug 
product, provide the subsequent owner with 
the transaction history and a transaction 
statement; and 
‘‘(ii) maintain the transaction infor-
mation for each such transaction for not 
less than 3 years after the date of the trans-
action. 
‘‘(B) REQUESTS FOR INFORMATION.—Upon 
a request by the Secretary or other appropriate 
Federal or State official, in the event of a recall 
or for the purpose of investigating a suspect pre-
scription drug product or an illegitimate pre-
scription drug product, a manufacturer shall, 
not later than 2 business days after receiving the 
request or in such reasonable time as determined 
by the Secretary, provide to the Secretary or 
other official, the applicable transaction history 
and transaction statement for the prescription 
drug product. 
‘‘(2) PRESCRIPTION
DRUG
PRODUCT
IDENTI-
FIER.—Beginning not later than 5 years after the 
date of the enactment of the Safeguarding America’s 
Pharmaceuticals Act of 2013, a manufacturer shall 
affix or imprint a prescription drug product identi-
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00026
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
fier on each package and homogenous case of a pre-
scription drug product intended to be introduced in 
a transaction. Such manufacturer shall maintain the 
information in the prescription drug product identi-
fier for such prescription drug product for not less 
than 3 years after the date of the transaction. 
‘‘(3) AUTHORIZED TRADING PARTNERS.—Begin-
ning not later than January 1, 2015, a manufacturer 
shall ensure that each of its trading partners is au-
thorized. 
‘‘(4) LIST
OF
AUTHORIZED
DISTRIBUTORS
OF 
RECORD.—Beginning not later than January 1, 2015, 
each manufacturer of a prescription drug shall— 
‘‘(A) maintain a list of the authorized dis-
tributors of record of such drug at the corporate 
offices of such manufacturer; 
‘‘(B) make such list publicly available, in-
cluding placement on the Internet Website of 
such manufacturer; and 
‘‘(C) update such list not less than once per 
quarter. 
‘‘(5) VERIFICATION.—Beginning not later than 
January 1, 2015, a manufacturer shall implement 
systems and processes to enable the manufacturer to 
comply with the following requirements: 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00027
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(A) SUSPECT PRESCRIPTION DRUG PROD-
UCT.— 
‘‘(i) IN GENERAL.—Upon making a de-
termination that a prescription drug prod-
uct in the possession or control of the manu-
facturer is a suspect prescription drug 
product, or upon receiving a request for 
verification from the Secretary that a pre-
scription drug product within the possession 
or control of a manufacturer is a suspect 
prescription drug product, a manufacturer 
shall promptly conduct an investigation in 
coordination with trading partners, as ap-
plicable, to determine whether the prescrip-
tion drug product is an illegitimate pre-
scription drug product. Beginning not later 
than 5 years after the date of the enactment 
of the Safeguarding America’s Pharma-
ceuticals Act of 2013, such investigation 
shall include— 
‘‘(I) verifying the prescription 
drug product at the package level; 
‘‘(II) validating any applicable 
transaction history in the possession of 
the manufacturer; and 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00028
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(III) otherwise investigating to 
determine whether the prescription 
drug product is an illegitimate pre-
scription drug product. 
‘‘(ii) CLEARED
PRESCRIPTION
DRUG 
PRODUCT.—If the manufacturer determines 
that a suspect prescription drug product is 
not an illegitimate prescription drug prod-
uct, the manufacturer shall promptly notify 
the Secretary of such determination and 
such prescription drug product may be fur-
ther distributed. 
‘‘(iii) 
RECORDS.—A 
manufacturer 
shall keep records of its investigation of a 
suspect prescription drug product for not 
less than 3 years after the conclusion of the 
investigation. 
‘‘(B) ILLEGITIMATE
PRESCRIPTION
DRUG 
PRODUCT.— 
‘‘(i) IN GENERAL.—Upon determining 
that a prescription drug product in the pos-
session or control of a manufacturer is an 
illegitimate prescription drug product, the 
manufacturer shall— 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00029
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(I) quarantine such prescription 
drug product from prescription drug 
product intended for distribution; and 
‘‘(II) provide for the disposition of 
the illegitimate prescription drug prod-
uct. 
‘‘(ii) TRADING PARTNER.—Upon deter-
mining that a prescription drug product in 
the possession or control of a trading part-
ner is an illegitimate prescription drug 
product, the manufacturer shall take reason-
able steps to assist a trading partner to pro-
vide for the disposition of the illegitimate 
prescription drug product. 
‘‘(iii) MAKING A NOTIFICATION.—Upon 
determining that a prescription drug prod-
uct in the possession or control of the manu-
facturer is an illegitimate prescription drug 
product, the manufacturer shall notify the 
Secretary of such determination not later 
than 24 hours after making such determina-
tion. The Secretary shall determine whether 
additional trading partner notification is 
appropriate. 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00030
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(iv) RESPONDING
TO
A
NOTIFICA-
TION.—Upon the receipt of a notification 
from the Secretary that a determination has 
been made that a prescription drug product 
is an illegitimate prescription drug product, 
a manufacturer shall— 
‘‘(I) identify all illegitimate pre-
scription drug products that are sub-
ject to such notification and in the pos-
session or control of the manufacturer, 
including any prescription drug prod-
uct that is subsequently received; and 
‘‘(II) perform the activities de-
scribed in clause (i). 
‘‘(v) RECORDS.—A manufacturer shall 
keep records of the disposition of an illegit-
imate prescription drug product for not less 
than 3 years after the conclusion of the dis-
position. 
‘‘(C) ELECTRONIC DATABASE.—A manufac-
turer may satisfy the requirements of this para-
graph through the use of a secure electronic data-
base developed and operated by the manufacturer 
or another entity. The owner of such database 
shall establish the requirements and processes to 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00031
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
respond to requests and may provide for data ac-
cess to other members of the pharmaceutical dis-
tribution supply chain, as appropriate. The de-
velopment and operation of such a database shall 
not relieve a manufacturer of the requirement 
under 
this 
paragraph 
to 
respond 
to 
a 
verification request submitted by means other 
than a secure electronic database. 
‘‘(D) 
RETURNED
PRESCRIPTION
DRUG 
PRODUCT.—Beginning not later than 5 years 
after the date of the enactment of the Safe-
guarding America’s Pharmaceuticals Act of 
2013, upon receipt of a returned prescription 
drug product that the manufacturer intends to 
further distribute, before further distributing 
such prescription drug product, the manufac-
turer shall— 
‘‘(i) verify the prescription drug prod-
uct identifier for each sealed homogeneous 
case of such prescription drug product; or 
‘‘(ii) if such prescription drug product 
is not in a sealed homogeneous case, verify 
the prescription drug product identifier on 
each package. 
‘‘(c) WHOLESALE DISTRIBUTOR REQUIREMENTS.— 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00032
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(1) PRESCRIPTION DRUG PRODUCT TRACING.— 
‘‘(A) IN
GENERAL.—Beginning not later 
than April 1, 2015, a wholesale distributor 
shall— 
‘‘(i) not accept ownership of a pre-
scription drug product unless the previous 
owner prior to, or at the time of, the trans-
action provides the applicable transaction 
history and a transaction statement for the 
prescription drug product; 
‘‘(ii) prior to, or at the time of, each 
transaction in which the wholesale dis-
tributor transfers ownership of a prescrip-
tion drug product— 
‘‘(I) in the case that the wholesale 
distributor purchased the prescription 
drug product directly from the manu-
facturer, provide the subsequent owner 
with transaction history and a trans-
action statement for the prescription 
drug product; or 
‘‘(II) in the case that the whole-
sale distributor did not purchase the 
prescription 
drug 
product 
directly 
from the manufacturer, the exclusive 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00033
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
distributor of the manufacturer, or a 
repackager that purchased directly 
from the manufacturer, provide the 
subsequent owner with transaction his-
tory beginning with the wholesale dis-
tributor that did purchase the product 
directly from the manufacturer, the ex-
clusive distributor of the manufacturer, 
or a repackager that purchased directly 
from the manufacturer; 
‘‘(iii) notwithstanding clause (ii), if 
the wholesale distributor purchased the pre-
scription drug product directly from the 
manufacturer, its exclusive distributor, or a 
repackager that purchased directly from the 
manufacturer or its authorized distributor 
of record— 
‘‘(I) provide an initial purchase 
transaction statement on the invoice to 
the customer, stating that the wholesale 
distributor purchased the prescription 
drug product package directly from the 
manufacturer, exclusive distributor, or 
repackager; 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00034
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(II) make available to the imme-
diate subsequent recipient of such pre-
scription drug product the information 
required under clause (ii) through any 
combination of self-generated paper, 
electronic data, or manufacturer-pro-
vided information on the prescription 
drug product package; and 
‘‘(III) for purposes of subclauses 
(I) and (II), need not include any 
transactions occurring before the trans-
fer of the prescription drug product to 
the wholesale distributor; and 
‘‘(iv) maintain the transaction infor-
mation for each transaction described in 
clauses (i) and (ii) for not less than 3 years 
after the transaction. 
‘‘(B) RETURNS EXCEPTION.— 
‘‘(i) SALEABLE
RETURNS.—Notwith-
standing subparagraph (A), a wholesale dis-
tributor may— 
‘‘(I) accept returned prescription 
drug product without a transaction 
history from a dispenser or repackager; 
and 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00035
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(II) distribute such returned pre-
scription drug product with a trans-
action history that begins with the 
wholesale distributor that so accepted 
the returned product. 
‘‘(ii) 
NONSALEABLE
RETURNS.—A 
wholesale distributor may return a nonsale-
able prescription drug to the manufacturer 
or repackager, to the wholesale distributor 
from whom such prescription drug was pur-
chased, or to a person acting on behalf of 
such a person, including a returns proc-
essor, without providing the information re-
quired under subparagraph (A). 
‘‘(C) REQUESTS FOR INFORMATION.—Upon 
a request by the Secretary or other appropriate 
Federal or State official, in the event of a recall 
or for the purpose of investigating a suspect pre-
scription drug product or an illegitimate pre-
scription drug product a wholesale distributor 
shall, not later than 2 business days after receiv-
ing the request or in such other reasonable time 
as determined by the Secretary, provide the ap-
plicable transaction history and transaction 
statements for the prescription drug product. 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00036
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(2) PRESCRIPTION
DRUG
PRODUCT
IDENTI-
FIER.—Beginning not later than 7 years after the 
date of the enactment of the Safeguarding America’s 
Pharmaceuticals Act of 2013, a wholesale distributor 
may engage in transactions involving a prescription 
drug product only if such prescription drug product 
is encoded with a prescription drug product identi-
fier, except as provided in subsection (a)(4). 
‘‘(3) AUTHORIZED TRADING PARTNERS.—Begin-
ning not later than January 1, 2015, a wholesale dis-
tributor shall ensure that each of its trading partners 
is authorized. 
‘‘(4) VERIFICATION.—Beginning not later than 
April 1, 2015, a wholesale distributor shall implement 
systems to enable the wholesale distributor to comply 
with the following requirements: 
‘‘(A) SUSPECT PRESCRIPTION DRUG PROD-
UCT.— 
‘‘(i) IN GENERAL.—Upon making a de-
termination that a prescription drug prod-
uct in the possession or control of the whole-
sale distributor is a suspect prescription 
drug product, or upon receiving a request 
for verification from the Secretary that a 
prescription drug product within the posses-
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00037
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
sion or control of a wholesale distributor is 
a suspect prescription drug product, a 
wholesale distributor shall promptly conduct 
an investigation to determine whether the 
prescription drug product is an illegitimate 
prescription drug product. Beginning not 
later than 7 years after the date of the en-
actment of the Safeguarding America’s 
Pharmaceuticals Act of 2013, such inves-
tigation shall include— 
‘‘(I) verifying a package of the 
prescription drug product; 
‘‘(II) validating any applicable 
transaction history in the possession of 
the wholesale distributor; and 
‘‘(III) otherwise investigating to 
determine whether the prescription 
drug product is an illegitimate pre-
scription drug product. 
‘‘(ii) CLEARED
PRESCRIPTION
DRUG 
PRODUCT.—If the wholesale distributor de-
termines that a suspect prescription drug 
product is not an illegitimate prescription 
drug product, the wholesale distributor shall 
promptly notify the Secretary of such deter-
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00038
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
mination and such prescription drug prod-
uct may be further distributed. 
‘‘(iii) RECORDS.—A wholesale dis-
tributor shall keep records of its investiga-
tion of a suspect prescription drug product 
for not less than 3 years after the conclusion 
of the investigation. 
‘‘(B) ILLEGITIMATE
PRESCRIPTION
DRUG 
PRODUCT.— 
‘‘(i) IN GENERAL.—Upon receiving no-
tice that a manufacturer of a prescription 
drug product has determined that a pre-
scription drug product in the possession or 
control of a wholesale distributor is an ille-
gitimate prescription drug product, the 
wholesale distributor shall— 
‘‘(I) quarantine such prescription 
drug product within the possession or 
control of the wholesale distributor 
from prescription drug product in-
tended for distribution; and 
‘‘(II) provide for the disposition of 
the illegitimate prescription drug prod-
uct within the possession or control of 
the wholesale distributor. 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00039
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(I) identify all illegitimate pre-
scription drug product subject to such 
notification that is in the possession or 
control of the wholesale distributor, in-
cluding any prescription drug product 
that is subsequently received; and 
‘‘(II) perform the activities de-
scribed in clause (i). 
‘‘(v) 
RECORDS.—A 
wholesale 
dis-
tributor shall keep records of the disposition 
of an illegitimate prescription drug product 
for not less than 3 years after the conclusion 
of the disposition. 
‘‘(C) ELECTRONIC DATABASE.—A wholesale 
distributor may satisfy the requirements of this 
paragraph through the use of a secure electronic 
database developed and operated by the manu-
facturer or another entity. The owner of such 
database shall establish the requirements and 
processes to respond to requests and may provide 
for data access to other members of the pharma-
ceutical distribution supply chain, as appro-
priate. The development and operation of such a 
database shall not relieve a wholesale distributor 
of the requirement under this paragraph to re-
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00041
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
spond to a verification request submitted by 
means other than a secure electronic database. 
‘‘(D) 
RETURNED
PRESCRIPTION
DRUG 
PRODUCT.—Beginning not later than 7 years 
after the date of the enactment of the Safe-
guarding America’s Pharmaceuticals Act of 
2013, upon receipt of a returned prescription 
drug product that the wholesale distributor in-
tends to further distribute, before further distrib-
uting such prescription drug product, the whole-
sale distributor shall— 
‘‘(i) verify the prescription drug prod-
uct identifier for each sealed homogeneous 
case of such prescription drug product; or 
‘‘(ii) if such prescription drug product 
is not in a sealed homogeneous case, verify 
the prescription drug product identifier on 
each package. 
‘‘(d) DISPENSER REQUIREMENTS.— 
‘‘(1) PRESCRIPTION DRUG PRODUCT TRACING.— 
‘‘(A) IN
GENERAL.—Beginning not later 
than July 1, 2015, a dispenser— 
‘‘(i) shall not accept ownership of a 
prescription drug product, unless the pre-
vious owner prior to, or at the time of, the 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00042
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
transaction, provides transaction history 
and a transaction statement; 
‘‘(ii) prior to, or at the time of, each 
transaction in which the dispenser transfers 
ownership of a prescription drug product 
(but not including dispensing to a patient 
or returns) shall provide the subsequent 
owner with transaction history and a trans-
action statement for the prescription drug 
product, except that the requirements of this 
clause shall not apply to sales by a dis-
penser to another dispenser to fulfill a spe-
cific patient need; and 
‘‘(iii) shall maintain transaction infor-
mation for a period of not less than 3 years 
after the date of the transaction. 
‘‘(B) AGREEMENTS WITH THIRD PARTIES.— 
A dispenser may enter into a written agreement 
with a third party, including an authorized 
wholesale distributor, under which the third 
party confidentially maintains the transaction 
information required to be maintained under 
this subsection on behalf of the dispenser. If a 
dispenser enters into such an agreement, the dis-
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00043
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
penser shall maintain a copy of the written 
agreement. 
‘‘(C) RETURNS EXCEPTION.— 
‘‘(i) SALEABLE
RETURNS.—Notwith-
standing subparagraph (A)(ii), a dispenser 
may return prescription drug product to the 
trading partner from which the dispenser 
obtained the prescription drug product 
without providing the information required 
under such subparagraph. 
‘‘(ii) NONSALEABLE
RETURNS.—Not-
withstanding subparagraph (A)(ii), a dis-
penser may return a nonsaleable prescrip-
tion drug to the manufacturer or repack-
ager, to the wholesale distributor from 
whom such prescription drug was pur-
chased, to a returns processor, or to a per-
son acting on behalf of such persons without 
providing the information required under 
such subparagraph. 
‘‘(D) REQUESTS FOR INFORMATION.—Upon 
a request by the Secretary or other appropriate 
Federal or State official, in the event of a recall 
or for the purpose of investigating a suspect pre-
scription drug product or an illegitimate pre-
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00044
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
scription drug product, a dispenser shall, not 
later than 2 business days after receiving the re-
quest or in another such reasonable time as de-
termined by the Secretary, provide lot level 
transaction information. 
‘‘(2) PRESCRIPTION
DRUG
PRODUCT
IDENTI-
FIER.—Beginning not later than 8 years after the 
date of the enactment of the Safeguarding America’s 
Pharmaceuticals Act of 2013, a dispenser may engage 
in transactions involving a prescription drug product 
only if such prescription drug product is encoded 
with a prescription drug product identifier, except as 
provided in subsection (a)(4). 
‘‘(3) AUTHORIZED TRADING PARTNERS.—Begin-
ning not later than January 1, 2015, a dispenser 
shall ensure that each of its trading partners is au-
thorized. 
‘‘(4) VERIFICATION.—Beginning not later than 
January 1, 2015, a dispenser shall implement sys-
tems to enable the dispenser to comply with the fol-
lowing requirements: 
‘‘(A) SUSPECT PRESCRIPTION DRUG PROD-
UCT.— 
‘‘(i) IN GENERAL.—Upon making a de-
termination that a prescription drug prod-
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00045
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
uct in the possession or control of the dis-
penser is a suspect prescription drug prod-
uct, or upon receiving a request for 
verification from the Secretary that a pre-
scription drug product within the possession 
or control of a dispenser is a suspect pre-
scription drug product, a dispenser shall 
promptly conduct an investigation to deter-
mine whether the prescription drug product 
is an illegitimate prescription drug product. 
Such investigation shall include— 
‘‘(I) verifying whether the lot 
number of a suspect prescription drug 
product corresponds with the lot num-
ber for such prescription drug product; 
‘‘(II) beginning 8 years after the 
date of the enactment of the Safe-
guarding America’s Pharmaceuticals 
Act of 2013, verifying that the product 
identifier of at least 3 packages or 10 
percent of such suspect prescription 
drug product, whichever is greater, or 
all packages, if there are fewer than 3, 
corresponds with the prescription drug 
product identifier for such product; 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00046
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(III) validating any applicable 
transaction history in the possession of 
the dispenser; and 
‘‘(IV) otherwise investigating to 
determine whether the prescription 
drug product is an illegitimate pre-
scription drug product. 
‘‘(ii) CLEARED
PRESCRIPTION
DRUG 
PRODUCT.—If the dispenser makes the de-
termination that a suspect prescription 
drug product is not an illegitimate pre-
scription drug product, the dispenser shall 
promptly notify the Secretary of such deter-
mination and such prescription drug prod-
uct may be further dispensed. 
‘‘(iii) RECORDS.—A dispenser shall 
keep records of its investigation of a suspect 
prescription drug product for not less than 
3 years after the conclusion of the investiga-
tion. 
‘‘(B) ILLEGITIMATE
PRESCRIPTION
DRUG 
PRODUCT.— 
‘‘(i) IN GENERAL.—Upon receiving no-
tice that a manufacturer of a prescription 
drug product has determined that a pre-
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00047
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
scription drug product in the possession or 
control of a dispenser is an illegitimate pre-
scription 
drug 
product, 
the 
dispenser 
shall— 
‘‘(I) quarantine such prescription 
drug product within the possession or 
control of the dispenser from prescrip-
tion drug product intended for dis-
tribution; and 
‘‘(II) provide for the disposition of 
the illegitimate prescription drug prod-
uct within the possession or control of 
the dispenser. 
‘‘(ii) TRADING PARTNERS.—Upon de-
termining that a prescription drug product 
in the possession or control of a trading 
partner is an illegitimate prescription drug 
product, the dispenser shall take reasonable 
steps to assist a trading partner to provide 
for the disposition of the illegitimate pre-
scription drug product. 
‘‘(iii) MAKING A NOTIFICATION.—Upon 
determining that a prescription drug prod-
uct in the possession or control of the dis-
penser is an illegitimate prescription drug 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00048
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
product, the dispenser shall notify the Sec-
retary of such determination not later than 
24 hours after making such determination. 
The Secretary shall determine whether addi-
tional trading partner notification is ap-
propriate. 
‘‘(iv) RESPONDING
TO
A
NOTIFICA-
TION.—Upon the receipt of a notification 
from the Secretary that a determination has 
been made that a prescription drug product 
is an illegitimate prescription drug product, 
a dispenser shall— 
‘‘(I) identify all illegitimate pre-
scription drug products that are sub-
ject to such notification and in the pos-
session or control of the dispenser, in-
cluding any prescription drug product 
that is subsequently received; and 
‘‘(II) perform the activities de-
scribed in clause (i). 
‘‘(v) RECORDS.—A dispenser shall keep 
records of the disposition of an illegitimate 
prescription drug product for not less than 
3 years after the conclusion of the disposi-
tion. 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00049
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(C) ELECTRONIC DATABASE.—A dispenser 
may satisfy the requirements of this paragraph 
through the use of a secure electronic database 
developed and operated by the manufacturer or 
another entity. The owner of such database shall 
establish the requirements and processes to enable 
responding to requests and may provide for data 
access to other members of the pharmaceutical 
distribution supply chain, as appropriate. The 
development and operation of such a database 
shall not relieve a dispenser of the requirement 
under 
this 
paragraph 
to 
respond 
to 
a 
verification request submitted by means other 
than a secure electronic database. 
‘‘(e) REPACKAGER REQUIREMENTS.— 
‘‘(1) PRESCRIPTION DRUG PRODUCT TRACING.— 
‘‘(A) IN
GENERAL.—Beginning not later 
than April 1, 2015, with respect to a prescrip-
tion drug product received by a repackager from 
a wholesale distributor, and beginning not later 
than January 1, 2015, with respect to any other 
prescription drug product, a repackager shall— 
‘‘(i) not accept ownership of a pre-
scription drug product unless the previous 
owner, prior to, or at the time of, the trans-
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00050
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
action, provides transaction history and a 
transaction statement for the prescription 
drug product; 
‘‘(ii) prior to, or at the time of, each 
transaction in which the repackager trans-
fers ownership of a prescription drug prod-
uct, provide the subsequent owner with 
transaction history and a transaction state-
ment; 
‘‘(iii) maintain the transaction infor-
mation for each transaction described in 
clause (i) or (ii) for not less than 3 years 
after the transaction; and 
‘‘(iv) maintain records that allow the 
repackager to associate the prescription 
drug product identifier the repackager af-
fixes or imprints with the prescription drug 
product identifier assigned by the original 
manufacturer of the prescription drug prod-
uct. 
‘‘(B) NONSALEABLE
RETURNS.—Notwith-
standing subparagraph (A)(ii), a repackager 
may return prescription drug product to the 
trading partner from whom the repackager ob-
tained the prescription drug product without 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00051
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
providing the information required under such 
subparagraph. 
‘‘(C) REQUESTS FOR INFORMATION.—Upon 
a request by the Secretary or other appropriate 
Federal or State official, in the event of a recall 
or for the purpose of investigating a suspect pre-
scription drug product or an illegitimate pre-
scription drug product, a repackager shall, not 
later than 2 business days after receiving the re-
quest or in such other reasonable time as deter-
mined by the Secretary, provide the applicable 
transaction history and transaction statement 
for the prescription drug product. 
‘‘(2) PRESCRIPTION
DRUG
PRODUCT
IDENTI-
FIER.—Beginning not later than 6 years after the 
date of the enactment of the Safeguarding America’s 
Pharmaceuticals Act of 2013, a repackager— 
‘‘(A) shall affix or imprint a prescription 
drug product identifier to each package and ho-
mogenous case of prescription drug product in-
tended to be introduced in a transaction; 
‘‘(B) shall maintain the prescription drug 
product identifier for such prescription drug 
product for not less than 3 years after the date 
of the transaction; and 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00052
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(C) may engage in transactions involving 
a prescription drug product only if such pre-
scription drug product is encoded with a pre-
scription drug product identifier except as pro-
vided in subsection (a)(4). 
‘‘(3) AUTHORIZED TRADING PARTNERS.—Begin-
ning on January 1, 2015, a repackager shall ensure 
that each of its trading partners is authorized. 
‘‘(4) VERIFICATION.—Beginning not later than 
January 1, 2015, a repackager shall implement sys-
tems to enable the repackager to comply with the fol-
lowing requirements: 
‘‘(A) SUSPECT PRESCRIPTION DRUG PROD-
UCT.— 
‘‘(i) IN GENERAL.—Upon making a de-
termination that a prescription drug prod-
uct in the possession or control of the re-
packager is a suspect prescription drug 
product, or upon receiving a request for 
verification from the Secretary that a pre-
scription drug product within the possession 
or control of a repackager is a suspect pre-
scription drug product, a repackager shall 
promptly conduct an investigation to deter-
mine whether the prescription drug product 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00053
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
is an illegitimate prescription drug product, 
including— 
‘‘(I) beginning not later than 6 
years after the date of the enactment of 
the Safeguarding America’s Pharma-
ceuticals Act of 2013, verifying the pre-
scription drug product at the package 
level; 
‘‘(II) validating any applicable 
transaction information in the posses-
sion of the repackager; and 
‘‘(III) otherwise investigating to 
determine whether the prescription 
drug product is an illegitimate pre-
scription drug product. 
‘‘(ii) CLEARED
PRESCRIPTION
DRUG 
PRODUCT.—If the repackager determines 
that a suspect prescription drug product is 
not an illegitimate prescription drug prod-
uct, the repackager shall promptly notify 
the Secretary of such determination and 
such prescription drug product may be fur-
ther distributed. 
‘‘(iii) RECORDS.—A repackager shall 
keep records of its investigation of a suspect 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00054
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
prescription drug product for not less than 
3 years after the conclusion of the investiga-
tion. 
‘‘(B) ILLEGITIMATE
PRESCRIPTION
DRUG 
PRODUCT.— 
‘‘(i) IN GENERAL.—Upon receiving no-
tice that a manufacturer of a prescription 
drug product has determined that a pre-
scription drug product in the possession or 
control of a repackager is an illegitimate 
prescription drug product, the repackager 
shall— 
‘‘(I) quarantine such prescription 
drug product within the possession or 
control of the repackager from pre-
scription drug product intended for 
distribution; and 
‘‘(II) provide for the disposition of 
the illegitimate prescription drug prod-
uct within the possession or control of 
the repackager. 
‘‘(ii) TRADING PARTNER.—Upon deter-
mining that a prescription drug product in 
the possession or control of a trading part-
ner is an illegitimate prescription drug 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00055
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
product, the repackagers shall take reason-
able steps to assist the trading partner to 
provide for the disposition of the illegit-
imate prescription drug product. 
‘‘(iii) MAKING A NOTIFICATION.—Upon 
determining that a prescription drug prod-
uct in the possession or control of the re-
packager is an illegitimate prescription 
drug product, the repackager shall notify 
the Secretary of such determination not 
later than 24 hours after making such deter-
mination. The Secretary shall determine 
whether additional trading partner notifi-
cation is appropriate. 
‘‘(iv) RESPONDING
TO
A
NOTIFICA-
TION.—Upon the receipt of a notification 
from the Secretary that a determination has 
been made that a prescription drug product 
is an illegitimate prescription drug product, 
a repackager shall— 
‘‘(I) identify all illegitimate pre-
scription drug products that are sub-
ject to such notification and in the pos-
session or control of the repackager, in-
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00056
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
cluding any prescription drug product 
that is subsequently received; and 
‘‘(II) perform the activities de-
scribed in clause (i). 
‘‘(v) RECORDS.—A repackager shall 
keep records of the disposition of an illegit-
imate prescription drug product for not less 
than 3 years after the conclusion of the dis-
position. 
‘‘(C) ELECTRONIC
DATABASE.—A repack-
ager may satisfy the requirements of this para-
graph through the use of a secure electronic data-
base developed and operated by the manufacturer 
or another entity. The owner of such database 
shall establish the requirements and processes to 
respond to requests and may provide for data ac-
cess to other members of the pharmaceutical dis-
tribution supply chain, as appropriate. The de-
velopment and operation of such a database shall 
not relieve a repackager of the requirement under 
this paragraph to respond to a verification re-
quest submitted by means other than a secure 
electronic database. 
‘‘(D) 
RETURNED
PRESCRIPTION
DRUG 
PRODUCT.—Beginning not later than 6 years 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00057
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
after the date of the enactment of the Safe-
guarding America’s Pharmaceuticals Act of 
2013, upon receipt of a returned prescription 
drug product that the repackager intends to fur-
ther distribute, before further distributing such 
prescription 
drug 
product, 
the 
repackager 
shall— 
‘‘(i) verify the prescription drug prod-
uct identifier for each sealed homogeneous 
case of such prescription drug product; or 
‘‘(ii) if such prescription drug product 
is not in a sealed homogeneous case, verify 
the prescription drug product identifier on 
each package. 
‘‘(f) THIRD-PARTY LOGISTICS PROVIDER REQUIRE-
MENTS.— 
‘‘(1) AUTHORIZED TRADING PARTNERS.—Begin-
ning on January 1, 2015, a third-party logistics pro-
vider shall ensure that each of its trading partners is 
authorized. 
‘‘(2) VERIFICATION.—Beginning not later than 
January 1, 2015, a third-party logistics provider 
shall implement systems to enable the third-party lo-
gistics provider to comply with the following require-
ments: 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00058
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
‘‘(A) SUSPECT PRESCRIPTION DRUG PROD-
UCT.— 
‘‘(i) IN GENERAL.—Upon making a de-
termination that a prescription drug prod-
uct in the possession or control of a third- 
party logistics provider is a suspect pre-
scription drug product, a third-party logis-
tics provider shall promptly notify the 
owner of such prescription drug product of 
the need to conduct an investigation to de-
termine whether the prescription drug prod-
uct is an illegitimate prescription drug 
product. 
‘‘(ii) CLEARED
PRESCRIPTION
DRUG 
PRODUCT.—If the owner of the prescription 
drug product notifies the third-party logis-
tics provider of the determination that a 
suspect prescription drug product is not an 
illegitimate prescription drug product, such 
prescription drug product may be further 
distributed. 
‘‘(iii) RECORDS.—A third-party logis-
tics provider shall keep records of the activi-
ties described in clauses (i) and (ii) with re-
spect to a suspect prescription drug product 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00059
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS
for not less than 3 years after the conclusion 
of the investigation. 
‘‘(B) ILLEGITIMATE
PRESCRIPTION
DRUG 
PRODUCT.— 
‘‘(i) IN GENERAL.—Upon receiving no-
tice that a manufacturer of a prescription 
drug product has determined that a pre-
scription drug product in the possession or 
control of a third-party logistics provider is 
an illegitimate prescription drug product, 
the third-party logistics provider shall— 
‘‘(I) quarantine such prescription 
drug product within the possession or 
control of the third-party logistics pro-
vider from prescription drug product 
intended for distribution; 
‘‘(II) promptly notify the owner of 
such prescription drug product of the 
need to provide for the disposition of 
such prescription drug product; and 
‘‘(III) promptly transfer posses-
sion of the prescription drug product 
to the owner of such prescription drug 
product to provide for the disposition 
of the prescription drug product. 
VerDate Mar 15 2010 
20:57 Jun 03, 2013
Jkt 029200
PO 00000
Frm 00060
Fmt 6652
Sfmt 6203
E:\BILLS\H1919.RH
H1919
mstockstill on DSK4VPTVN1PROD with BILLS