I 
113TH CONGRESS 
1ST SESSION H. R. 1919 
To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
pharmaceutical distribution supply chain, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 9, 2013 
Mr. LATTA (for himself, Mr. MATHESON, Mr. UPTON, Mr. DINGELL, Mr. CAS-
SIDY, Mrs. BLACKBURN, Mr. MCKINLEY, Mr. ROGERS of Michigan, Mr. 
BURGESS, Mr. SHIMKUS, Mr. GUTHRIE, Mr. JOHNSON of Ohio, and Mr. 
SCHNEIDER) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to the pharmaceutical distribution supply chain, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Safeguarding America’s Pharmaceuticals Act of 2013’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Pharmaceutical distribution supply chain. 
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Sec. 3. Enhanced drug distribution security. 
Sec. 4. National standards for wholesale distributors. 
Sec. 5. National licensure standards for third-party logistics providers. 
Sec. 6. Penalties. 
Sec. 7. Uniform national policy. 
Sec. 8. Electronic labeling requirement. 
SEC. 2. PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the 
end the following: 
‘‘Subchapter H—Pharmaceutical Distribution 
Supply Chain 
‘‘SEC. 581. DEFINITIONS. 
‘‘In this subchapter: 
‘‘(1) AUTHORIZED.—The term ‘authorized’ 
means— 
‘‘(A) in the case of a manufacturer or re-
packager, having a valid registration in accord-
ance with section 510; and 
‘‘(B) in the case of a wholesale distributor, 
third-party logistics provider, or dispenser, li-
censed (as defined in this section). 
‘‘(2) DISPENSER.—The term ‘dispenser’— 
‘‘(A) subject to subparagraph (B), means a 
retail pharmacy, hospital pharmacy, a group of 
chain pharmacies under common ownership and 
control that do not act as a wholesale dis-
tributor, or any other person authorized by law 
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to dispense or administer prescription drugs 
and the affiliated warehouses or distribution 
centers of such persons under common owner-
ship and control that do not act as a wholesale 
distributor; and 
‘‘(B) does not include a person who only 
dispenses prescription drug product to be used 
in 
animals 
in 
accordance 
with 
section 
512(a)(5). 
‘‘(3) DISPOSITION.—The term ‘disposition’, 
with respect to a prescription drug product within 
the possession and control of an entity— 
‘‘(A) means the removal of such prescrip-
tion drug product, or taking measures to pre-
vent the introduction of such prescription drug 
product, from the pharmaceutical distribution 
supply chain; and 
‘‘(B) may include disposal, return of the 
prescription drug product for disposal, or other 
appropriate handling and other actions such as 
retaining a sample of the prescription drug 
product for additional physical examination or 
laboratory analysis by a manufacturer or regu-
latory or law enforcement agency. 
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‘‘(4) 
DISTRIBUTE
OR
DISTRIBUTION.—The 
terms ‘distribute’ and ‘distribution’ mean the sale, 
purchase, trade, delivery, handling, or storage of a 
prescription drug product. 
‘‘(5) ILLEGITIMATE PRESCRIPTION DRUG PROD-
UCT.—The term ‘illegitimate prescription drug prod-
uct’ means a prescription drug product which a 
manufacturer has confirmed— 
‘‘(A) is counterfeit, diverted, or stolen; 
‘‘(B) is intentionally adulterated such that 
the prescription drug product would result in 
serious adverse health consequences or death to 
humans; or 
‘‘(C) is otherwise unfit for distribution 
such that the prescription drug product is rea-
sonably likely to cause serious adverse human 
health consequences or death. 
‘‘(6) LICENSED.—The term ‘licensed’ means— 
‘‘(A) in the case of a wholesale distributor, 
having a valid license to make wholesale dis-
tributions consistent with the standards under 
section 583; 
‘‘(B) in the case of a third-party logistics 
provider, having a valid license to engage in the 
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activities of a third-party logistics provider in 
accordance with section 584; and 
‘‘(C) in the case of a dispenser, having a 
valid license to dispense prescription drugs 
under State law. 
‘‘(7) MANUFACTURER.—The term ‘manufac-
turer’ means, with respect to a prescription drug 
product— 
‘‘(A) a person that holds an application ap-
proved under section 505 or a license issued 
under section 351 of the Public Health Service 
Act for such prescription drug product, or if 
such prescription drug product is not the sub-
ject of an approved application or license, the 
person who manufactured the prescription drug 
product; 
‘‘(B) a co-licensed partner of the person 
described in subparagraph (A) that obtains the 
prescription drug product directly from the per-
son described in such subparagraph; or 
‘‘(C) a person that— 
‘‘(i) is a member of an affiliated 
group (as defined in section 1504(a) of the 
Internal Revenue Code of 1986) to which 
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a person described in subparagraph (A) or 
(B) is also a member; and 
‘‘(ii) receives the prescription drug 
product directly from a person described in 
subparagraph (A) or (B). 
‘‘(8) PACKAGE.— 
‘‘(A) IN
GENERAL.—The term ‘package’ 
means the smallest individual saleable unit of 
prescription drug product for distribution in 
interstate commerce by a manufacturer or re-
packager that is intended by the manufacturer 
for ultimate sale to the dispenser of such pre-
scription drug product. 
‘‘(B) INDIVIDUAL
SALEABLE
UNIT.—The 
term ‘individual saleable unit’ means the small-
est container of prescription drug product intro-
duced into interstate commerce by the manufac-
turer or repackager that is intended by the 
manufacturer for individual sale to a dispenser. 
‘‘(9) PRESCRIPTION
DRUG.—The term ‘pre-
scription drug’ means a drug for human use subject 
to section 503(b)(1). 
‘‘(10) PRESCRIPTION
DRUG
PRODUCT.—The 
term ‘prescription drug product’ means a prescrip-
tion drug in a finished dosage form for administra-
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tion to a patient without substantial further manu-
facturing (such as capsules, tablets, and lyophilized 
prescription drug products before reconstitution). 
‘‘(11) PRESCRIPTION DRUG PRODUCT IDENTI-
FIER.—The term ‘prescription drug product identi-
fier’ means a standardized graphic that— 
‘‘(A) includes the standardized numerical 
identifier, lot number, and expiration date of a 
prescription drug product; and 
‘‘(B) is in both human-readable form and 
on a machine-readable data carrier that con-
forms to the standards developed by a widely 
recognized international standards development 
organization. 
‘‘(12) QUARANTINE.—The term ‘quarantine’ 
means to store or identify a product, for the purpose 
of preventing distribution or transfer of the product, 
in a physically separate area clearly identified for 
such use, or through use of other procedures such 
as automated designation. 
‘‘(13) REPACKAGER.—The term ‘repackager’ 
means a person who owns or operates an establish-
ment that repacks and relabels a prescription drug 
product or package for further sale or distribution. 
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‘‘(14) RETURN.—The term ‘return’ means pro-
viding prescription drug product to the authorized 
trading partner or trading partners from which such 
prescription drug product was purchased, or to a re-
turns processor for handling of such prescription 
drug product. 
‘‘(15) RETURNS PROCESSOR.—The terms ‘re-
turns processor’ mean a person who owns or oper-
ates an establishment that provides for the disposi-
tion of or otherwise processes saleable and nonsale-
able prescription drug product received from an au-
thorized trading partner such that the prescription 
drug product may be processed for credit to the pur-
chaser, manufacturer, seller, or disposed of for no 
further distribution. 
‘‘(16) SPECIFIC
PATIENT
NEED.—The term 
‘specific patient need’— 
‘‘(A) means with respect to the transfer of 
a prescription drug product from one pharmacy 
to another, to fill a prescription for an identi-
fied patient; and 
‘‘(B) does not include the transfer of a 
prescription drug product from one pharmacy 
to another for the purpose of increasing or re-
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plenishing stock in anticipation of a potential 
need. 
‘‘(17) 
STANDARDIZED
NUMERICAL
IDENTI-
FIER.—The term ‘standardized numerical identifier’ 
means a set of numbers or characters that— 
‘‘(A) is used to uniquely identify each 
package or homogenous case of the prescription 
drug product; and 
‘‘(B) is composed of the National Drug 
Code that corresponds to the specific prescrip-
tion drug product (including the particular 
package configuration) combined with a unique 
alphanumeric serial number of up to 20 char-
acters. 
‘‘(18) SUSPECT
PRESCRIPTION
DRUG
PROD-
UCT.—The term ‘suspect prescription drug product’ 
means a prescription drug product for which there 
is reason to believe that such prescription drug prod-
uct— 
‘‘(A) is potentially counterfeit, diverted, or 
stolen; 
‘‘(B) is potentially intentionally adulterated 
such that the prescription drug product would 
result in serious adverse health consequences or 
death to humans; or 
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‘‘(C) appears otherwise unfit for distribu-
tion such that the prescription drug product 
would result in serious adverse health con-
sequences or death to humans. 
‘‘(19) THIRD-PARTY
LOGISTICS
PROVIDER.— 
The term ‘third-party logistics provider’ means an 
entity that provides or coordinates warehousing, dis-
tribution, or other logistics services of a prescription 
drug product in interstate commerce on behalf of a 
manufacturer, wholesale distributor, or dispenser of 
a prescription drug product, but does not take own-
ership of the prescription drug product, nor have re-
sponsibility to direct the sale or disposition of, the 
prescription drug product. 
‘‘(20) TRADING PARTNER.—The term ‘trading 
partner’ means— 
‘‘(A) a manufacturer, repackager, whole-
sale distributor, or dispenser from whom a 
manufacturer, 
repackager, 
wholesale 
dis-
tributor, or dispenser accepts ownership of a 
prescription drug product or to whom a manu-
facturer, repackager, wholesale distributor, or 
dispenser transfers ownership of a prescription 
drug product; or 
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‘‘(B) a third-party logistics provider from 
whom a manufacturer, repackager, wholesale 
distributor, or dispenser accepts possession of a 
prescription drug product or to whom a manu-
facturer, repackager, wholesale distributor, or 
dispenser transfers possession of a prescription 
drug product. 
‘‘(21) TRANSACTION.— 
‘‘(A) IN GENERAL.—The term ‘transaction’ 
means the transfer in interstate commerce of 
prescription drug product between persons in 
which a change of ownership occurs. 
‘‘(B) EXEMPTIONS.—The term ‘trans-
action’ does not include— 
‘‘(i) intracompany distribution of any 
prescription drug product between mem-
bers of an affiliated group (as defined in 
section 1504(a) of the Internal Revenue 
Code of 1986); 
‘‘(ii) the distribution of a prescription 
drug product among hospitals or other 
health care entities that are under common 
control; 
‘‘(iii) the distribution of a prescription 
drug product for emergency medical rea-
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sons including a public health emergency 
declaration pursuant to section 319 of the 
Public Health Service Act, except that a 
drug shortage not caused by a public 
health emergency shall not constitute an 
emergency medical reason; 
‘‘(iv) the dispensing of a prescription 
drug product pursuant to a valid prescrip-
tion executed in accordance with section 
503(b)(1); 
‘‘(v) the distribution of prescription 
drug product samples by a manufacturer 
or a licensed wholesale distributor in ac-
cordance with section 503(d); 
‘‘(vi) the distribution of blood or blood 
components intended for transfusion; 
‘‘(vii) the distribution of minimal 
quantities of prescription drug product by 
a licensed retail pharmacy to a licensed 
practitioner for office use; 
‘‘(viii) the distribution of a prescrip-
tion drug product by a charitable organiza-
tion to a nonprofit affiliate of the organiza-
tion to the extent otherwise permitted by 
law; 
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‘‘(ix) the distribution of a prescription 
drug product pursuant to the sale or merg-
er of a pharmacy or pharmacies or a 
wholesale distributor or wholesale distribu-
tors, except that any records required to be 
maintained for the prescription drug prod-
uct shall be transferred to the new owner 
of the pharmacy or pharmacies or whole-
sale distributor or wholesale distributors; 
‘‘(x) the dispensing of a prescription 
drug product approved under section 
512(b); 
‘‘(xi) the transfer of prescription drug 
products to or from any facility that is li-
censed by the Nuclear Regulatory Commis-
sion or by a State pursuant to an agree-
ment with such Commission under section 
274 of the Atomic Energy Act of 1954 (42 
U.S.C. 2021); 
‘‘(xii) the distribution of a combina-
tion product that consists of— 
‘‘(I) a product comprised of two 
or more components that are each a 
drug, biological product, or device and 
that are physically, chemically, or oth-
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‘‘(C) COMPRESSED
MEDICAL
GAS.—For 
purposes of subparagraph (B)(xviii), the term 
‘compressed medical gas’ means any substance 
in its gaseous or cryogenic liquid form that 
meets medical purity standards and has appli-
cation in a medical or homecare environment, 
including oxygen and nitrous oxide. 
‘‘(22) 
TRANSACTION
HISTORY.—The 
term 
‘transaction history’ means a statement that— 
‘‘(A) includes the transaction information 
for each transaction conducted with respect to 
a prescription drug product beginning with the 
manufacturer or initial purchase distributor for 
each prior transaction going back to the manu-
facturer of the prescription drug product or to 
the initial purchase distributor; and 
‘‘(B) is in paper or electronic form. 
‘‘(23) TRANSACTION INFORMATION.—The term 
‘transaction information’ means— 
‘‘(A) the proprietary or established name 
or names of the prescription drug product; 
‘‘(B) the strength and dosage form of the 
prescription drug product; 
‘‘(C) the National Drug Code number of 
the prescription drug product; 
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‘‘(D) the container size; 
‘‘(E) the number of containers; 
‘‘(F) the lot number of the prescription 
drug product; 
‘‘(G) the date of the transaction; 
‘‘(H) the business name and address of the 
person from whom ownership is being trans-
ferred; and 
‘‘(I) the business name and address of the 
person to whom ownership is being transferred. 
‘‘(24) TRANSACTION STATEMENT.—The ‘trans-
action statement’ is a statement, which states that 
the manufacturer, repackager, wholesale distributor, 
third-party logistics provider, or dispenser transfer-
ring ownership in a transaction— 
‘‘(A) is authorized; 
‘‘(B) received transaction information and 
a transaction statement as required under sec-
tion 582 from the prior owner of the prescrip-
tion drug product; 
‘‘(C) did not knowingly and intentionally 
ship an illegitimate prescription drug product; 
‘‘(D) did not knowingly and intentionally 
provide false transaction information; and 
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‘‘(E) did not knowingly and intentionally 
alter the transaction history. 
‘‘(25) VERIFICATION AND VERIFY.—The terms 
‘verification’ and ‘verify’— 
‘‘(A) mean determining whether the pre-
scription drug product identifier affixed to, or 
imprinted upon, a package or homogeneous case 
of the prescription drug product corresponds to 
the standardized numerical identifier or lot 
number, and expiration date assigned to the 
prescription 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; 
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‘‘(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 prod-
uct in accordance with the requirements of 
section 582(e). 
‘‘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 enti-
ty meets the definition of more than one of the enti-
ties referred to in the preceding sentence, such enti-
ty shall comply with all applicable requirements of 
this section, but shall not be required to comply with 
duplicative 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-
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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 
developed by a widely recognized international stand-
ards development organization. In establishing such 
standards, the Secretary shall consider the feasibility 
of establishing standardized documentation to be 
used by all members of the pharmaceutical distribu-
tion supply chain to convey the transaction history 
and transaction statement to the subsequent owner 
of a prescription drug product. The Secretary shall 
publish 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 Phar-
maceuticals Act of 2013, the Secretary shall promul-
gate a regulation to— 
‘‘(A) establish a process by which the Sec-
retary may grant, at the request of an author-
ized manufacturer, repackager, wholesale dis-
tributor, or dispenser, a waiver from any of the 
requirements of this section— 
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‘‘(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 
Public Health Service Act; 
‘‘(B) establish a process, with respect to 
the prescription drug product identifier require-
ment under paragraph (2) of subsections (b), 
(c), (d), and (e) through which— 
‘‘(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 un-
able to accommodate a label with sufficient 
space to bear the information required for 
compliance 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 re-
quirements of this section. 
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‘‘(4) GRANDFATHERED
PERSONS
AND
PRE-
SCRIPTION DRUG PRODUCTS.— 
‘‘(A) IN
GENERAL.—Not later than one 
year after the date of the enactment of the 
Safeguarding 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 on the date of 
the enactment of the Safeguarding America’s 
Pharmaceuticals Act of 2013. 
‘‘(B) THIRD-PARTY
LOGISTICS
PROVIDER 
LICENSES.—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 Secretary 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 pre-
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scription drug product identifier may be sub-
mitted to the Secretary in the annual report of 
an establishment, in accordance with section 
314.70(d) of chapter 21, Code of Federal Regu-
lations (or any successor regulation). 
‘‘(b) MANUFACTURER REQUIREMENTS.— 
‘‘(1) PRESCRIPTION
DRUG
PRODUCT
TRAC-
ING.— 
‘‘(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 prescription drug 
product, provide the subsequent owner 
with the transaction history and a trans-
action statement; and 
‘‘(ii) maintain the transaction infor-
mation for each such transaction for not 
less than 3 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 prescription drug product or an illegit-
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imate prescription drug product, a manufac-
turer 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 trans-
action 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-
fier on each package and homogenous case of a pre-
scription drug product intended to be introduced in 
a transaction. Such manufacturer shall maintain a 
copy of the prescription drug product identifier for 
such prescription drug product for not less than 3 
years after the date of the transaction. 
‘‘(3) AUTHORIZED
TRADING
PARTNERS.—Be-
ginning not later than January 1, 2015, a manufac-
turer shall ensure that each of its trading partners 
is authorized. 
‘‘(4) LIST OF AUTHORIZED DISTRIBUTORS OF 
RECORD.—Beginning not later than January 1, 
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2015, each manufacturer of a prescription drug 
shall— 
‘‘(A) maintain a list of the authorized dis-
tributors of record of such drug at the cor-
porate 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: 
‘‘(A) SUSPECT PRESCRIPTION DRUG PROD-
UCT.— 
‘‘(i) IN
GENERAL.—Upon making a 
determination that a prescription drug 
product in the possession or control of the 
manufacturer is a suspect prescription 
drug product, or upon receiving a request 
for verification from the Secretary that a 
prescription drug product within the pos-
session or control of a manufacturer is a 
suspect prescription drug product, a manu-
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TKELLEY on DSK3SPTVN1PROD with BILLS
facturer shall promptly conduct an inves-
tigation in coordination with trading part-
ners, as applicable, to determine whether 
the prescription drug product is an illegit-
imate prescription drug product. Beginning 
not later than 5 years after the date of the 
enactment of the Safeguarding America’s 
Pharmaceuticals Act of 2013, such inves-
tigation 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 
‘‘(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 deter-
mines that a suspect prescription drug 
product is not an illegitimate prescription 
drug product, the manufacturer shall 
promptly notify the Secretary of such de-
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termination and such prescription drug 
product may be further 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 
possession or control of a manufacturer is 
an illegitimate prescription drug product, 
the manufacturer shall— 
‘‘(I) quarantine such prescription 
drug product from prescription drug 
product intended for distribution; and 
‘‘(II) provide for the disposition 
of the illegitimate prescription drug 
product. 
‘‘(ii) TRADING
PARTNER.—Upon de-
termining that a prescription drug product 
in the possession or control of a trading 
partner is an illegitimate prescription drug 
product, the manufacturer shall take rea-
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TKELLEY on DSK3SPTVN1PROD with BILLS
sonable steps to assist a trading partner to 
provide for the disposition of the illegit-
imate prescription drug product. 
‘‘(iii) MAKING
A
NOTIFICATION.— 
Upon determining that a prescription drug 
product in the possession or control of the 
manufacturer is an illegitimate prescrip-
tion drug product, the manufacturer shall 
notify the Secretary of such determination 
not later than 24 hours after making such 
determination. The Secretary shall deter-
mine whether additional trading partner 
notification 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 manufacturer shall— 
‘‘(I) identify all illegitimate pre-
scription drug products that are sub-
ject to such notification and in the 
possession or control of the manufac-
turer, including any prescription drug 
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product 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 disposition. 
‘‘(C) ELECTRONIC
DATABASE.—A manu-
facturer may satisfy the requirements of this 
paragraph through the use of a secure elec-
tronic database 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 access to other members of the 
pharmaceutical distribution supply chain, as ap-
propriate. The development and operation of 
such a database shall not relieve a manufac-
turer of the requirement under this paragraph 
to respond to a verification request submitted 
by means other than a secure electronic data-
base. 
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‘‘(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.— 
‘‘(1) PRESCRIPTION
DRUG
PRODUCT
TRAC-
ING.— 
‘‘(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-
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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 whole-
sale distributor purchased the pre-
scription drug product directly from 
the manufacturer, provide the subse-
quent owner with transaction history 
and a transaction 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 
distributor of the manufacturer, or a 
repackager that purchased directly 
from the manufacturer, provide the 
subsequent owner with transaction 
history beginning with the wholesale 
distributor that did purchase the 
product directly from the manufac-
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TKELLEY on DSK3SPTVN1PROD with BILLS
turer, the exclusive distributor of the 
manufacturer, or a repackager that 
purchased directly from the manufac-
turer; 
‘‘(iii) notwithstanding clause (ii), if 
the wholesale distributor purchased the 
prescription drug product directly from the 
manufacturer, its exclusive distributor, or 
a repackager that purchased directly from 
the manufacturer or its authorized dis-
tributor 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 di-
rectly from the manufacturer, exclu-
sive distributor, or repackager; 
‘‘(II) make available to the imme-
diate subsequent recipient of such 
prescription drug product the infor-
mation required under clause (ii) 
through any combination of self-gen-
erated paper, electronic data, or man-
ufacturer provided information on the 
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TKELLEY on DSK3SPTVN1PROD with BILLS
prescription drug product package; 
and 
‘‘(III) for purposes of subclauses 
(I) and (II), need not include any 
transactions 
occurring 
before 
the 
transfer of the prescription drug prod-
uct 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 
distributor may— 
‘‘(I) accept returned prescription 
drug product without a transaction 
history from a dispenser; and 
‘‘(II) distribute such returned 
prescription drug product with a 
transaction history that begins with 
the wholesale distributor that so ac-
cepted the returned product. 
‘‘(ii) 
NONSALEABLE
RETURNS.—A 
wholesale distributor may return a non-
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TKELLEY on DSK3SPTVN1PROD with BILLS
saleable prescription drug to the manufac-
turer or repackager, to the wholesale dis-
tributor from whom such prescription drug 
was purchased, or to a person acting on 
behalf of such a person, including a re-
turns processor, without providing the in-
formation required under subparagraph 
(A). 
‘‘(C) 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 prescription drug product or an illegit-
imate prescription drug product a wholesale dis-
tributor shall, not later than 2 business days 
after receiving the request or in such other rea-
sonable time as determined by the Secretary, 
provide the applicable transaction history and 
transaction statements for the prescription drug 
product. 
‘‘(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 
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TKELLEY on DSK3SPTVN1PROD with BILLS
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.—Be-
ginning not later than January 1, 2015, a wholesale 
distributor shall ensure that each of its trading part-
ners is authorized. 
‘‘(4) VERIFICATION.—Beginning not later than 
April 1, 2015, a wholesale distributor shall imple-
ment systems to enable the wholesale distributor to 
comply with the following requirements: 
‘‘(A) SUSPECT PRESCRIPTION DRUG PROD-
UCT.— 
‘‘(i) IN
GENERAL.—Upon making a 
determination that a prescription drug 
product in the possession or control of the 
wholesale distributor is a suspect prescrip-
tion drug product, or upon receiving a re-
quest for verification from the Secretary 
that a prescription drug product within the 
possession or control of a wholesale dis-
tributor is a suspect prescription drug 
product, a wholesale distributor shall 
promptly conduct an investigation to deter-
mine whether the prescription drug prod-
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TKELLEY on DSK3SPTVN1PROD with BILLS
uct is an illegitimate prescription drug 
product. Beginning not later than 7 years 
after the date of the enactment of the 
Safeguarding America’s Pharmaceuticals 
Act of 2013, such investigation shall in-
clude— 
‘‘(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 
determination and such prescription drug 
product may be further distributed. 
‘‘(iii) RECORDS.—A wholesale dis-
tributor shall keep records of its investiga-
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TKELLEY on DSK3SPTVN1PROD with BILLS
tion of a suspect prescription drug product 
for not less than 3 years after the conclu-
sion of the investigation. 
‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG 
PRODUCT.— 
‘‘(i) IN
GENERAL.—Upon receiving 
notice that a manufacturer of a prescrip-
tion drug product has determined that a 
prescription drug product in the possession 
or control of a wholesale distributor is an 
illegitimate prescription drug product, the 
wholesale distributor shall— 
‘‘(I) quarantine such prescription 
drug product within the possession or 
control of the manufacturer from pre-
scription drug product intended for 
distribution; and 
‘‘(II) provide for the disposition 
of the illegitimate prescription drug 
product within the possession or con-
trol of the wholesale distributor. 
‘‘(ii) TRADING
PARTNER.—Upon de-
termining that a prescription drug product 
in the possession or control of a trading 
partner is an illegitimate prescription drug 
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product, the wholesale distributor shall 
take reasonable steps to assist a trading 
partner to provide for the disposition of 
the illegitimate prescription drug product. 
‘‘(iii) MAKING
A
NOTIFICATION.— 
Upon determining that a prescription drug 
product in the possession or control of the 
wholesale distributor is an illegitimate pre-
scription drug product, the wholesale dis-
tributor shall notify the Secretary of such 
determination not later than 24 hours 
after making such determination. The Sec-
retary shall determine whether additional 
trading partner notification 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 wholesale distributor shall— 
‘‘(I) identify all illegitimate pre-
scription drug product subject to such 
notification that is in the possession 
or control of the wholesale distributor, 
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TKELLEY on DSK3SPTVN1PROD with BILLS
including any prescription drug prod-
uct 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 disposi-
tion of an illegitimate prescription drug 
product for not less than 3 years after the 
conclusion of the disposition. 
‘‘(C) ELECTRONIC
DATABASE.—A whole-
sale distributor may satisfy the requirements of 
this paragraph through the use of a secure elec-
tronic database 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 access to other members of the 
pharmaceutical distribution supply chain, as ap-
propriate. The development and operation of 
such a database shall not relieve a wholesale 
distributor of the requirement under this para-
graph to respond to a verification request sub-
mitted by means other than a secure electronic 
database. 
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TKELLEY on DSK3SPTVN1PROD with BILLS
‘‘(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 dis-
tributing such prescription drug product, the 
wholesale 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
TRAC-
ING.— 
‘‘(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 
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TKELLEY on DSK3SPTVN1PROD with BILLS
transaction, provides transaction history 
and a transaction statement; 
‘‘(ii) prior to, or at the time of, each 
transaction in which the dispenser trans-
fers ownership of a prescription drug prod-
uct (but not including dispensing to a pa-
tient or returns) shall provide the subse-
quent owner with transaction history and a 
transaction statement for the prescription 
drug product, except that the requirements 
of this clause shall not apply to sales by a 
dispenser to another dispenser to fulfill a 
specific 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
PAR-
TIES.—A dispenser may enter into a written 
agreement with a third party, including an au-
thorized wholesale distributor, under which the 
third party confidentially maintains the trans-
action information required to be maintained 
under this subsection on behalf of the dis-
penser. If a dispenser enters into such an 
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agreement, the dispenser 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 dis-
penser 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 with-
out providing the information required 
under such subparagraph. 
‘‘(D) 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 prescription drug product or an illegit-
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imate prescription drug product, a dispenser 
shall, not later than 2 business days after re-
ceiving the request or in another such reason-
able time as determined by the Secretary, pro-
vide 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 en-
gage in transactions involving a prescription drug 
product only if such prescription drug product is en-
coded with a prescription drug product identifier, ex-
cept as provided in subsection (a)(4). 
‘‘(3) AUTHORIZED
TRADING
PARTNERS.—Be-
ginning 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 
determination that a prescription drug 
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product in the possession or control of the 
dispenser is a suspect prescription drug 
product, or upon receiving a request for 
verification from the Secretary that a pre-
scription drug product within the posses-
sion or control of a dispenser is a suspect 
prescription drug product, a dispenser 
shall promptly conduct an investigation to 
determine 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 prod-
uct; 
‘‘(II) beginning 8 years after the 
date of the enactment of the Safe-
guarding America’s Pharmaceuticals 
Act of 2013, verifying that the prod-
uct identifier of at least 3 packages or 
10 percent of such suspect prescrip-
tion drug product, whichever is great-
er, or all packages, if there are fewer 
than 3, corresponds with the prescrip-
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TKELLEY on DSK3SPTVN1PROD with BILLS
tion drug product identifier for such 
product; 
‘‘(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 de-
termination and such prescription drug 
product may be further dispensed. 
‘‘(iii) RECORDS.—A dispenser shall 
keep records of its investigation of a sus-
pect prescription drug product for not less 
than 3 years after the conclusion of the in-
vestigation. 
‘‘(B) ILLEGITIMATE PRESCRIPTION DRUG 
PRODUCT.— 
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‘‘(i) IN
GENERAL.—Upon receiving 
notice that a manufacturer of a prescrip-
tion drug product has determined that a 
prescription drug product in the possession 
or control of a dispenser is an illegitimate 
prescription 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 
product within the possession or con-
trol 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 reason-
able steps to assist a trading partner to 
provide for the disposition of the illegit-
imate prescription drug product. 
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‘‘(iii) MAKING
A
NOTIFICATION.— 
Upon determining that a prescription drug 
product in the possession or control of the 
dispenser is an illegitimate prescription 
drug product, the dispenser 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 dispenser shall— 
‘‘(I) identify all illegitimate pre-
scription drug products that are sub-
ject to such notification and in the 
possession or control of the dispenser, 
including any prescription drug prod-
uct that is subsequently received; and 
‘‘(II) perform the activities de-
scribed in clause (i). 
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