IIB 
113TH CONGRESS 
1ST SESSION H. R. 1919 
IN THE SENATE OF THE UNITED STATES 
JUNE 4, 2013 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
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, 
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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. 
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. 
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’— 
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‘‘(A) subject to subparagraph (C), means a 
retail pharmacy, hospital pharmacy, a group of 
chain pharmacies under common ownership and 
control, or any other person authorized by law 
to dispense or administer prescription drugs, to 
the extent such pharmacy, group, or person 
does not act as a wholesale distributor; 
‘‘(B) includes warehouses and distribution 
centers under common ownership or control of 
entities described in subparagraph (A) that are 
members of an affiliated group pursuant to sec-
tion 1504(a) of the Internal Revenue Code of 
1986, to the extent such warehouses and dis-
tribution centers do not act as a wholesale dis-
tributor; and 
‘‘(C) 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 
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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. 
‘‘(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-
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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 
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; 
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‘‘(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 
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-
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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-
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, 
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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. 
‘‘(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 received, 
or to a returns processor for handling of such pre-
scription 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’— 
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‘‘(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-
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 
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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 
‘‘(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— 
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‘‘(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 
‘‘(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, including be-
tween members of an affiliated group (as 
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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-
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; 
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‘‘(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; 
‘‘(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-
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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-
erwise combined or mixed and pro-
duced as a single entity; 
‘‘(II) two or more separate prod-
ucts packaged together in a single 
package or as a unit and comprised of 
a drug and device or a device and bio-
logical product; or 
‘‘(III) two or more finished de-
vices plus one or more drug or biologi-
cal products which are packaged to-
gether in a medical convenience kit 
described in clause (xiii); 
‘‘(xiii) the distribution of a medical 
convenience kit which is a collection of fin-
ished products (consisting of devices or 
drugs) assembled in kit form strictly for 
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the convenience of the purchaser or user 
if— 
‘‘(I) the medical convenience kit 
is assembled in an establishment that 
is registered with the Food and Drug 
Administration as a medical device 
manufacturer; 
‘‘(II) the person who manufactur-
ers the medical convenience kit pur-
chased the prescription drug product 
directly from the manufacturer or 
from a wholesale distributor that pur-
chased the prescription drug product 
directly from the manufacturer; 
‘‘(III) the person who manufac-
turers the medical convenience kit 
does not alter the primary container 
or label of the prescription drug prod-
uct as purchased from the manufac-
turer or wholesale distributor; 
‘‘(IV) the medical convenience kit 
does not contain a controlled sub-
stance (as defined in section 102 of 
the Controlled Substances Act); and 
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‘‘(V) the prescription drug prod-
ucts contained in the medical conven-
ience kit are— 
‘‘(aa) intravenous solutions 
intended for the replenishment of 
fluids and electrolytes; 
‘‘(bb) drugs intended to 
maintain the equilibrium of water 
and minerals in the body; 
‘‘(cc) drugs intended for irri-
gation or reconstitution; 
‘‘(dd) anesthetics; 
‘‘(ee) anticoagulants; 
‘‘(ff) vasopressors; or 
‘‘(gg) sympathicomimetics; 
‘‘(xiv) the distribution of an intra-
venous prescription drug product that, by 
its formulation, is intended for the replen-
ishment of fluids and electrolytes (such as 
sodium, chloride, and potassium) or cal-
ories (such as dextrose and amino acids); 
‘‘(xv) the distribution of an intra-
venous prescription drug product used to 
maintain the equilibrium of water and min-
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erals in the body, such as dialysis solu-
tions; 
‘‘(xvi) the distribution of a prescrip-
tion drug product that is intended for irri-
gation or reconstitution, or sterile water, 
whether intended for such purposes or for 
injection; 
‘‘(xvii) the distribution of compressed 
medical gas; or 
‘‘(xviii)(I) the distribution of a prod-
uct by a dispenser, or a wholesale dis-
tributor acting at the direction of the dis-
penser, to a repackager registered under 
section 510 for the purpose of repackaging 
the drug for use by that dispenser or an-
other health care entity that is under the 
dispenser’s ownership or control, so long as 
the dispenser retains ownership of the pre-
scription drug product; and 
‘‘(II) the saleable or nonsaleable re-
turn by such repackager of such prescrip-
tion drug product. 
‘‘(C) COMPRESSED
MEDICAL
GAS.—For 
purposes of subparagraph (B)(xvii), the term 
‘compressed medical gas’ means any substance 
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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; 
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; 
‘‘(D) the container size; 
‘‘(E) the number of containers; 
‘‘(F) the lot number of the prescription 
drug product; 
‘‘(G) the date of the transaction; 
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‘‘(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 
‘‘(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 
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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; 
‘‘(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 
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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-
lish, by regulation, standards for the exchange of 
transaction history and transaction statement (in 
paper or electronic form) 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 
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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— 
‘‘(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-
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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. 
‘‘(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, 
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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 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-
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). 
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‘‘(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— 
‘‘(I) until the date than is 5 
years after the date of the enactment 
of the Safeguarding America’s Phar-
maceuticals Act of 2013, provide the 
subsequent owner with the transaction 
history and a transaction statement in 
a single document in paper or elec-
tronic form; and 
‘‘(II) on or after such date, pro-
vide the subsequent owner with the 
transaction history and a transaction 
statement in electronic form; and 
‘‘(ii) maintain the transaction infor-
mation for each such transaction for not 
less than 3 years after the date of the 
transaction. 
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‘‘(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-
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 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.—Be-
ginning not later than January 1, 2015, a manufac-
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turer shall ensure that each of its trading partners 
is authorized. 
‘‘(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 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 
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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-
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 
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product is not an illegitimate prescription 
drug product, the manufacturer shall 
promptly notify the Secretary of such de-
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 
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in the possession or control of a trading 
partner is an illegitimate prescription drug 
product, the manufacturer shall take rea-
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 
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possession or control of the manufac-
turer, including any prescription drug 
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 
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by means other than a secure electronic data-
base. 
‘‘(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— 
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‘‘(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) subject to clause (iv), prior to, or 
at the time of, each transaction in which 
the wholesale distributor transfers owner-
ship of a prescription drug product— 
‘‘(I) in the case that the whole-
sale distributor purchased the pre-
scription drug product directly from 
the manufacturer, the exclusive dis-
tributor of the manufacturer, or a re-
packager that purchased directly from 
the manufacturer, provide the subse-
quent owner with transaction history 
and a transaction statement for the 
prescription drug product— 
‘‘(aa) 
if 
the 
subsequent 
owner is a dispenser, on a single 
document in paper or electronic 
form; or 
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‘‘(bb) 
if 
the 
subsequent 
owner is a wholesale distributor, 
through any combination of self- 
generated paper, electronic data, 
or manufacturer-provided infor-
mation on the product package; 
‘‘(II) in the case that the whole-
sale distributor did not purchase the 
prescription drug product as described 
in subclause (I)— 
‘‘(aa) provide the subsequent 
owner with the transaction his-
tory and a transaction statement 
beginning with the wholesale dis-
tributor that did so purchase the 
prescription 
drug 
product 
in 
paper or electronic form; or 
‘‘(bb) pursuant to a written 
agreement between the wholesale 
distributor 
and 
a 
dispenser, 
maintain the transaction history 
and transaction statement on be-
half of the dispenser and if re-
quested by the dispenser, provide 
the 
transaction 
history 
and 
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transaction statement to the dis-
penser in paper or electronic 
form in a timely manner so as to 
permit the dispenser to comply 
with requests pursuant to sub-
section (d)(1)(D); 
‘‘(iii) maintain the transaction infor-
mation for each transaction described in 
clauses (i) and (ii) for not less than 3 
years after the transaction; and 
‘‘(iv) on or after the date that is 5 
years after the date of the enactment of 
the 
Safeguarding 
America’s 
Pharma-
ceuticals Act of 2013, provide the trans-
action history and transaction statement in 
electronic form. 
‘‘(B) INCLUSION
OF
LOT
NUMBER
IN 
TRANSACTION HISTORY.—Until the date that is 
5 years after the date of the enactment of the 
Safeguarding America’s Pharmaceuticals Act of 
2013, the transaction history provided by a 
wholesale distributer under this paragraph shall 
not be required to include the lot number of the 
product or the initial date of the transaction 
from the manufacturer (as such terms are used 
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in subparagraphs (F) and (G) of section 
581(23)). 
‘‘(C) 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 or repack-
ager; 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-
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). 
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‘‘(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-
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 
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. 
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‘‘(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-
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— 
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‘‘(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-
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.— 
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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 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 wholesale distributor 
from prescription drug product in-
tended 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 
product, the wholesale distributor shall 
take reasonable steps to assist a trading 
partner to provide for the disposition of 
the illegitimate prescription drug product. 
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‘‘(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. 
‘‘(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 
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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 
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-
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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 
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-
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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-
imate prescription drug product— 
‘‘(i) a dispenser shall not later than 2 
business days after receiving the request or 
in another such reasonable time as deter-
mined by the Secretary, provide the appli-
cable transaction history and transaction 
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statement which the dispenser received 
from the previous owner; 
‘‘(ii) the information provided by the 
dispenser under clause (i) is not required 
to include the lot number of the product, 
the initial date of the transaction, or the 
initial date of the shipment from the man-
ufacturer unless such information was pro-
vided electronically by the previous owner, 
manufacturer, or wholesale distributor to 
the dispenser; and 
‘‘(iii) a dispenser may respond to the 
request by providing the paper documenta-
tion received from the previous owner or 
by providing electronic 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 
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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 
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-
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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-
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 
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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.— 
‘‘(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 
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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. 
‘‘(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 
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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 such 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 illegit-
imate prescription drug product for not 
less than 3 years after the conclusion of 
the disposition. 
‘‘(C) ELECTRONIC
DATABASE.—A dis-
penser 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 enable responding to requests 
and may provide for data access to other mem-
bers of the pharmaceutical distribution supply 
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chain, as appropriate. The development and op-
eration of such a database shall not relieve a 
dispenser of the requirement under this para-
graph to respond to a verification request sub-
mitted by means other than a secure electronic 
database. 
‘‘(e) REPACKAGER REQUIREMENTS.— 
‘‘(1) PRESCRIPTION
DRUG
PRODUCT
TRAC-
ING.— 
‘‘(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 
transaction, provides transaction history 
and a transaction statement for the pre-
scription drug product; 
‘‘(ii) prior to, or at the time of, each 
transaction in which the repackager trans-
fers ownership of a prescription drug prod-
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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 
product. 
‘‘(B) 
RETURNS
EXCEPTION.—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 
providing the information required under such 
subparagraph. 
‘‘(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 
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suspect prescription drug product or an illegit-
imate prescription drug product, a repackager 
shall, not later than 2 business days after re-
ceiving the request or in such other reasonable 
time as determined by the Secretary, provide 
the applicable transaction history and trans-
action statement for the prescription drug prod-
uct. 
‘‘(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 
‘‘(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). 
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‘‘(3) AUTHORIZED
TRADING
PARTNERS.—Be-
ginning on January 1, 2015, a repackager shall en-
sure 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 
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 
repackager 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 repackager is a suspect 
prescription drug product, a repackager 
shall promptly conduct an investigation to 
determine whether the prescription drug 
product 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 Phar-
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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 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 
product within the possession or con-
trol of the repackager. 
‘‘(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 repackagers shall take reason-
able steps to assist the 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 
repackager is an illegitimate prescription 
drug product, the repackager shall notify 
the Secretary of such determination not 
later than 24 hours after making such de-
termination. 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 
possession or control of the repack-
ager, including any such prescription 
drug product that is subsequently re-
ceived; and 
‘‘(II) perform the activities de-
scribed in clause (i). 
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‘‘(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 disposition. 
‘‘(C) ELECTRONIC DATABASE.—A repack-
ager may satisfy the requirements of this para-
graph 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 pro-
vide 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 repackager 
of the requirement under this paragraph to re-
spond to a verification request submitted by 
means other than a secure electronic database. 
‘‘(D) RETURNED
PRESCRIPTION
DRUG 
PRODUCT.—Beginning not later than 6 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 repackager intends to 
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further 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.—Be-
ginning on January 1, 2015, a third-party logistics 
provider shall ensure that each of its trading part-
ners 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: 
‘‘(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 a 
third-party logistics provider is a suspect 
prescription drug product, a third-party lo-
gistics 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 
product is an illegitimate prescription drug 
product. 
‘‘(ii) CLEARED
PRESCRIPTION
DRUG 
PRODUCT.—If the owner of the prescrip-
tion drug product notifies the third-party 
logistics provider of the determination that 
a suspect prescription drug product is not 
an illegitimate prescription drug product, 
such prescription drug product may be fur-
ther distributed. 
‘‘(iii) RECORDS.—A third-party logis-
tics provider shall keep records of the ac-
tivities described in clauses (i) and (ii) 
with respect to a suspect prescription drug 
product for not less than 3 years after the 
conclusion of the investigation. 
‘‘(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 third-party logistics pro-
vider 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. 
‘‘(ii) 
MAKING
A
NOTIFICATION.— 
Upon determining that a prescription drug 
product in the possession or control of the 
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drug product for not less than 3 years 
after the conclusion of the disposition. 
‘‘(g) DROP SHIPMENTS.—This section does not apply 
to any entity, notwithstanding its status as a wholesale 
distributor or repackager, or other status that is not in-
volved in the physical handling, distribution, or storage of 
a prescription drug product. For purposes of this sub-
section, facilitating the distribution of a prescription drug 
product by providing various administrative services, in-
cluding processing of orders and payments, shall not, by 
itself, be construed as being involved in the handling, dis-
tribution, or storage of a prescription drug product.’’. 
SEC. 3. ENHANCED DRUG DISTRIBUTION SECURITY. 
(a) PILOT PROJECTS.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of the enactment of this Act, the Secretary 
shall establish one or more pilot projects in coordi-
nation with manufacturers, repackagers, wholesale 
distributors, third-party logistics providers, and dis-
pensers to explore and evaluate methods to enhance 
the safety and security of the pharmaceutical dis-
tribution supply chain. 
(2) CONTENT.— 
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(A) IN GENERAL.—The Secretary shall en-
sure that the pilot projects under paragraph (1) 
collectively— 
(i) reflect the diversity of the pharma-
ceutical distribution supply chain; and 
(ii) include participants representative 
of every sector within the pharmaceutical 
distribution supply chain, including partici-
pants representative of small businesses. 
(B) PROJECT DESIGN.—The pilot projects 
shall be designed to— 
(i) utilize the prescription drug prod-
uct identifier for tracing of a prescription 
drug product, which utilization may in-
clude— 
(I) verification of the prescription 
drug product identifier of a prescrip-
tion drug product; and 
(II) the use of aggregation and 
inference; 
(ii) improve the technical capabilities 
of each sector within the pharmaceutical 
supply chain to comply with systems and 
processes needed to utilize the prescription 
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drug product identifiers to enhance tracing 
of a prescription drug product; and 
(iii) conduct such other activities as 
the Secretary determines appropriate to 
explore and evaluate methods to enhance 
the safety and security of the pharma-
ceutical distribution supply chain. 
(b) PUBLIC MEETINGS.— 
(1) IN
GENERAL.—Not later than 6 months 
after the date of the enactment of this Act, and at 
least every 6 months thereafter until the submission 
of the report required by subsection (e)(2), the Sec-
retary shall hold a public meeting to enhance the 
safety and security of the pharmaceutical distribu-
tion supply chain. In conducting such meetings, the 
Secretary shall take all measures reasonable and 
practicable to ensure the protection of confidential 
commercial information and trade secrets. 
(2) CONTENT.—In conducting meetings under 
this subsection, the Secretary shall seek to address, 
in at least one such meeting, each of the following 
topics: 
(A) Best practices in each of the sectors 
within the pharmaceutical distribution supply 
chain to implement the requirements of section 
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582 of the Federal Food, Drug, and Cosmetic 
Act, as added by section 2. 
(B) The costs and benefits of implementa-
tion of such section 582, including the impact 
on each pharmaceutical distribution supply 
chain sector and on public health. 
(C) 
Whether 
additional 
electronic 
traceability requirements, including tracing of 
prescription drug product at the package level, 
are feasible, cost effective, overly burdensome 
on small businesses, and needed to protect pub-
lic health. 
(D) The systems and processes needed to 
utilize the prescription drug product identifiers 
to enhance tracing of prescription drug product 
at the package level, including allowing for 
verification, aggregation, and inference by each 
sector within the pharmaceutical distribution 
supply chain for cases, pallets, totes, and other 
containers of aggregated prescription drug 
product as necessary. 
(E) The technical capabilities and legal au-
thorities, if any, needed to establish an elec-
tronic system that provides for enhanced trac-
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ing of prescription drug product at the package 
level. 
(F) The impact that the requirements, sys-
tems, processes, capabilities, and legal authori-
ties referred to in subparagraphs (C), (D), and 
(E) would have on patient safety, the drug sup-
ply, cost and regulatory burden, the timeliness 
of patient access to prescription drugs, and 
small businesses. 
(c) STUDY OF THE PHARMACEUTICAL DISTRIBUTION 
SUPPLY CHAIN.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study to examine 
implementation of the requirements established 
under subchapter H of chapter V of the Federal 
Food, Drug, and Cosmetic Act, as added by section 
2, in order to inform the regulations promulgated 
under this section. 
(2) CONSIDERATION.—In conducting the study 
under this subsection, the Comptroller General shall 
provide for stakeholder input and shall consider the 
following: 
(A) The implementation of the require-
ments established under such subchapter H 
with respect to— 
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(i) the ability of the health care sys-
tem collectively to maintain patient access 
to medicines; 
(ii) the scalability of such require-
ments, including with respect to prescrip-
tion drug product lines; and 
(iii) the capability of different sectors 
within the pharmaceutical distribution sup-
ply chain, including small businesses, to 
affix and utilize the prescription drug 
product identifier. 
(B) The need for additional legal authori-
ties and activities to address additional gaps in 
the pharmaceutical distribution supply chain, if 
any, after the implementation of the require-
ments established under such subchapter H 
with respect to— 
(i) the systems and processes needed 
to enhance tracing of prescription drug 
product at the package level, including the 
use and evaluation of verification, aggrega-
tion, and inference by each sector within 
the pharmaceutical distribution supply 
chain as necessary; 
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(ii) the impact, feasibility, and cost ef-
fectiveness that additional requirements 
pursuant to this section would have on 
each pharmaceutical distribution supply 
chain sector and the public health; and 
(iii) the systems and processes needed 
to enhance interoperability among trading 
partners. 
(C) Risks to the security and privacy of 
data collected, maintained, or exchanged pursu-
ant to the requirements established under such 
subchapter H. 
(d) SMALL DISPENSERS.— 
(1) IN
GENERAL.—Not later than 10 years 
after the date of the enactment of this Act, the Sec-
retary shall enter into a contract with a private, 
independent consulting firm with relevant expertise 
to conduct a technology and software study on the 
feasibility of dispensers that have 25 or fewer full- 
time employees conducting interoperable, electronic 
tracing of prescription drug products at the package 
level. 
(2) CONDITION.—As a condition of the award 
of a contract under paragraph (1), the private inde-
pendent consulting firm awarded such contract shall 
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agree to consult with dispensers that have 25 or 
fewer full-time employees when conducting the study 
under such subparagraph. 
(3) STUDY
CONTENT.—The study conducted 
under paragraph (1) shall assess whether, with re-
spect to conducting interoperable, electronic tracing 
of prescription drug products at the package level, 
the necessary hardware and software— 
(A) is readily accessible to such dispensers; 
(B) is not prohibitively expensive to obtain, 
install, and maintain for such dispensers; and 
(C) can be integrated into business prac-
tices, such as interoperability with wholesale 
distributors, for such dispensers. 
(4) PUBLICATION.—The Secretary shall pub-
lish— 
(A) the statement of work for the study 
conducted under paragraph (1) for public com-
ment not later than 30 days before commencing 
the study; and 
(B) the final version of such study for pub-
lic comment not later than 30 days after such 
study is completed. 
(5) REPORT TO CONGRESS.—Not later than 30 
days after the date on which the study conducted 
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under paragraph (1) is completed, the Secretary 
shall submit to the Committee on Energy and Com-
merce of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions 
of the Senate, a report on the findings of the study 
and any recommendations to improve the technology 
and software available to small dispensers for pur-
poses of conducting electronic, interoperable tracing 
of prescription drug products at the package level. 
(6) PUBLIC
MEETING.—Not later than 180 
days after the date on which the study conducted 
under paragraph (1) is completed, the Secretary 
shall hold a public meeting at which members of the 
public, including stakeholders, may present their 
views on the study. 
(e) REPORTS.— 
(1) GAO REPORT.—Not later than 12 years 
after the date of the enactment of this Act, the 
Comptroller General shall submit to the Committee 
on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report 
on the results of the study conducted under sub-
section (c). 
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(2) FDA REPORT.—Not later than 12 years 
after the date of the enactment of this Act, the Sec-
retary shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate a report on the results of the 
pilot program conducted under subsection (a), tak-
ing into consideration— 
(A) the comments received during the pub-
lic meetings conducted under subsection (b); 
and 
(B) the results of the study conducted, and 
the public comments received during the public 
meeting held, under subsection (d). 
(f) ESTABLISHMENT
OF
ADDITIONAL
REQUIRE-
MENTS.— 
(1) IN GENERAL.—Notwithstanding any other 
provision of this Act, including the amendments 
made by this Act, not earlier than January 1, 2027, 
and not later than March 1, 2027, the Secretary 
shall issue proposed regulations that establish addi-
tional requirements to prevent a suspect product, il-
legitimate product, or a product that is counterfeit, 
stolen, diverted, or otherwise unfit for distribution 
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from entering into or being further distributed in 
the supply chain, including— 
(A) requirements related to the use of 
interoperable electronic systems and tech-
nologies for enhanced tracing of prescription 
drug product at the package level, which may 
include verification of the prescription drug 
product identifier of a package of prescription 
drug product and enhanced verification of sale-
able returns; 
(B) requirements related to the use of ad-
ditional prescription drug product identifiers or 
prescription drug product identifier technology 
that meet the standards developed under sec-
tion 582(a)(2) of the Federal Food, Drug, and 
Cosmetic Act, as added by section 2; 
(C) requirements related to the use of ag-
gregation, inference, and other methods, which 
shall permit the use of aggregation and infer-
ence for cases, pallets, totes, and other con-
tainers of aggregated prescription drug prod-
ucts by each sector of the pharmaceutical dis-
tribution supply chain, if determined to be nec-
essary components of the systems and tech-
nologies referred to in subparagraph (A); and 
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(D) other data transmission and mainte-
nance requirements and interoperability stand-
ards. 
(2) FLEXIBILITY.—The requirements described 
in paragraph (1) shall provide for flexibility for a 
member of the pharmaceutical supply chain, by— 
(A) with respect to dispensers, allowing a 
dispenser to enter into a written agreement 
with a third party, including an authorized 
wholesale distributor, under which— 
(i) the third party confidentially main-
tains any information required to be main-
tained under such requirements for the 
dispenser; and 
(ii) the dispenser maintains a copy of 
the written agreement and is not relieved 
of the other obligations of the dispenser 
under such requirements; 
(B) establishing a process by which an au-
thorized manufacturer, repackager, wholesale 
distributor, or dispenser may request a waiver 
from any such requirements if the Secretary de-
termines that such requirements would result in 
an undue economic hardship on the manufac-
turer, wholesale distributor, or dispenser; 
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(C) not requiring the adoption of specific 
business systems by a member of the pharma-
ceutical supply chain for the maintenance and 
transmission of prescription drug product trac-
ing data; and 
(D) prescribing alternative methods of 
compliance for small businesses, as specified in 
paragraph (4). 
(3) CONSIDERATIONS.—In issuing proposed 
regulations under paragraph (1), the Secretary shall 
consider— 
(A) the results of, and public comments re-
sulting from, the pilot project conducted under 
subsection (a); 
(B) the public meetings held under sub-
section (b) and public comments from such 
meetings; 
(C) the studies conducted under sub-
sections (c) and (d); 
(D) the reports submitted under subsection 
(e); 
(E) the public health benefits of such regu-
lations compared with the cost of compliance 
with the requirements contained in such regula-
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tions, including with respect to entities of vary-
ing sizes and capabilities; and 
(F) the diversity of the pharmaceutical dis-
tribution supply chain by providing appropriate 
flexibility for each sector in the supply chain, 
including small businesses. 
(4) SMALL BUSINESS PROTECTION.—The Sec-
retary, taking into consideration the study conducted 
under paragraph (d), shall, if the Secretary deter-
mines that the requirements established pursuant to 
paragraph (1) would result in an undue economic 
hardship on small businesses, provide for alternative 
methods of compliance with any such requirement by 
small businesses, including— 
(A) establishing timelines for such compli-
ance (including compliance by dispensers with 
25 or fewer full-time employees) that do not im-
pose undue economic hardship for small busi-
nesses, including dispensers with respect to 
which the study concluded has insufficient 
hardware and software to conduct interoper-
able, electronic tracing of prescription drug 
products at the package level; and 
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(B) establishing a process by which a dis-
penser may request a waiver from any such re-
quirement. 
(5) REGULATIONS.—In issuing regulations to 
carry out this subsection, the Secretary shall— 
(A) issue a notice of proposed rulemaking 
that includes a copy of the proposed rule; 
(B) provide for a period of not less than 
60 days for comments on the proposed rule; 
and 
(C) provide for an effective date of the 
final rule that is 2 years after the date on 
which such final rule is published. 
(6) SUNSET.—The requirements regarding the 
provision and receipt of transaction history and 
transaction statements under section 582 of the 
Federal Food, Drug, and Cosmetic Act, as added by 
section 2, shall cease to be effective on the date on 
which the regulations issued under this section are 
fully implemented. 
(g) DEFINITIONS.—In this section: 
(1) The terms defined in section 581 of the 
Federal Food, Drug, and Cosmetic Act, as added by 
section 2, shall have the same meanings in this sec-
tion as such terms are given in such section 581. 
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(2) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Commissioner of Food and Drugs. 
SEC. 4. NATIONAL STANDARDS FOR WHOLESALE DISTRIBU-
TORS. 
(a) STANDARDS.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed— 
(1) in section 503 (21 U.S.C. 353), by striking 
‘‘(e)(1)(A)’’ and all that follows through ‘‘(3) For 
the purposes of this subsection and subsection (d)— 
’’ and inserting the following: 
‘‘(e) For purposes of subsection (d)—’’; 
(2) in section 503(e) (21 U.S.C. 353(e)), by re-
designating subparagraphs (A) and (B) as para-
graphs (1) and (2), respectively; and 
(3) in subchapter H, as added by section 2, by 
adding at the end the following: 
‘‘SEC. 583. NATIONAL STANDARDS FOR WHOLESALE DIS-
TRIBUTORS. 
‘‘(a) STANDARDS.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish, by regulation, standards for the licensing of 
persons that make wholesale distributions. 
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‘‘(2) REQUIREMENTS.—The standards under 
paragraph (1) shall, with respect to wholesale dis-
tributions, include requirements for— 
‘‘(A) the storage and handling of drugs 
subject to section 503(b)(1), including facility 
requirements; 
‘‘(B) the establishment and maintenance of 
records of the distributions of such drugs; 
‘‘(C) the furnishing of a bond or other 
equivalent means of security in accordance with 
paragraph (3); 
‘‘(D) mandatory background checks and 
fingerprinting of facility managers or des-
ignated representatives; 
‘‘(E) the establishment and implementa-
tion of qualifications for key personnel; 
‘‘(F) the mandatory physical inspection of 
any facility to be used in wholesale distribution 
within a reasonable timeframe from the initial 
application for licensure of the wholesale dis-
tributor; and 
‘‘(G) in accordance with paragraph (5), the 
prohibition of certain persons from engaging in 
wholesale distribution. 
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‘‘(3) BOND OR OTHER SECURITY.—The require-
ments under paragraph (2)(C) shall provide for the 
following: 
‘‘(A) An applicant that is not a govern-
ment-owned-and-operated wholesale distributor, 
for the issuance or renewal of a wholesale dis-
tributor license, shall submit a surety bond of 
$100,000 or other equivalent means of security 
acceptable to the applicable licensing authority. 
‘‘(B) For purposes of subparagraph (A), 
the applicable licensing authority may accept a 
surety bond of less than $100,000 if the annual 
gross receipts of the previous tax year for the 
wholesale distributor is $10,000,000 or less, in 
which case the surety bond may not be less 
than $25,000. 
‘‘(C) If a wholesale distributor can provide 
evidence that it possesses the required bond in 
a State, the requirement for a bond in another 
State is waived. 
‘‘(4) INSPECTIONS.—To satisfy the inspection 
requirement under paragraph (2)(F), the Secretary 
may conduct the inspection, or may accept an in-
spection by— 
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‘‘(A) the government of the State in which 
the facility is located; or 
‘‘(B) a third-party accreditation or inspec-
tion service approved by the Secretary. 
‘‘(5) PROHIBITED PERSONS.—The requirements 
under paragraph (2) shall include requirements to 
prohibit a person from receiving or maintaining li-
censure for wholesale distribution if the person— 
‘‘(A) has been convicted of— 
‘‘(i) any felony for conduct relating to 
wholesale distribution; 
‘‘(ii) any felony violation of section 
301(i) or 301(k); or 
‘‘(iii) any felony violation of section 
1365 of title 18, United States Code, relat-
ing to prescription drug product tam-
pering; or 
‘‘(B) has engaged in a pattern of violating 
the requirements of this section that presents a 
threat of serious adverse health consequences or 
death to humans. 
‘‘(b) REPORTING BY LICENSED WHOLESALE DIS-
TRIBUTORS.— 
‘‘(1) ANNUAL
REPORT.—Beginning not later 
than 1 year after the date of the enactment of this 
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section, each person engaged in wholesale distribu-
tion in interstate commerce shall submit on an an-
nual basis, and update as necessary, a report to the 
Secretary including— 
‘‘(A) the wholesale distributor’s name; 
‘‘(B) the wholesale distributor’s address; 
‘‘(C) a listing of each State in which the 
wholesale distributor is licensed for wholesale 
distribution; and 
‘‘(D) any disciplinary actions taken by a 
State, the Federal Government, or a foreign 
government during the reporting period against 
the wholesale distributor. 
‘‘(2) POSTING ON INTERNET.—The Secretary 
shall post on the public Internet Website of the 
Food and Drug Administration the name of each 
wholesale distributor, and the State in which each 
such distributor is licensed, based on reports under 
paragraph (1). 
‘‘(c) PRESERVATION OF STATE AUTHORITY.—This 
subchapter does not prohibit a State from— 
‘‘(1) licensing wholesale distributors for the 
conduct of wholesale distribution activities in the 
State in accordance with this subchapter; and 
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‘‘(2) collecting fees from wholesale distributors 
in connection with such licensing, 
so long as the State does not require such licensure to 
the extent to which an entity is engaged in third-party 
logistics provider activities. 
‘‘(d) DEFINITION.—In this section, the term ‘whole-
sale distribution’ means the distribution of a drug subject 
to section 503(b)(1) to a person other than a consumer 
or patient, but does not include— 
‘‘(1) intracompany distribution of any drug be-
tween members of an affiliated group (as defined in 
section 1504(a) of the Internal Revenue Code of 
1986); 
‘‘(2) the distribution of a drug, or an offer to 
distribute a drug among hospitals or other health 
care entities which are under common control; 
‘‘(3) the distribution of a drug or an offer to 
distribute a drug for emergency medical reasons, in-
cluding a public health emergency declaration pursu-
ant to section 319 of the Public Health Service Act, 
except that a drug shortage not caused by a public 
health emergency shall not constitute such an emer-
gency medical reason; 
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‘‘(4) dispensing of a drug pursuant to a valid 
prescription executed in accordance with subsection 
503(b)(1); 
‘‘(5) the distribution of minimal quantities of 
drug by a licensed retail pharmacy to a licensed 
practitioner for office use; 
‘‘(6) the distribution of a drug or an offer to 
distribute a drug by a charitable organization to a 
nonprofit affiliate of the organization to the extent 
otherwise permitted by law; 
‘‘(7) the purchase or other acquisition by a dis-
penser, hospital, or other health care entity of a 
drug for use by such dispenser, hospital, or other 
health care entity; 
‘‘(8) the distribution of a drug by the manufac-
turer of such drug; 
‘‘(9) the receipt or transfer of a drug by an au-
thorized third-party logistics provider provided that 
such third-party logistics provider does not take 
ownership of the drug; 
‘‘(10) the transport of a drug by a common car-
rier, provided that the common carrier does not take 
ownership of the drug; 
‘‘(11) the distribution of a drug, or an offer to 
distribute a drug, by an authorized repackager that 
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has taken ownership of the drug and repacked it in 
accordance with section 582(e); 
‘‘(12) saleable drug returns when conducted by 
a dispenser in accordance with section 203.23 of 
title 21, Code of Federal Regulations (or any suc-
cessor regulation); 
‘‘(13) the distribution of a combination pre-
scription 
drug 
product 
described 
in 
section 
581(20)(B)(xii); 
‘‘(14) the distribution of a medical convenience 
kit described in section 581(21)(B)(xiii); 
‘‘(15) the distribution of an intravenous drug 
that, by its formulation, is intended for the replen-
ishment of fluids and electrolytes (such as sodium, 
chloride, and potassium) or calories (such as dex-
trose and amino acids); 
‘‘(16) the distribution of an intravenous drug 
used to maintain the equilibrium of water and min-
erals in the body, such as dialysis solutions; 
‘‘(17) the distribution of a drug that is intended 
for irrigation or reconstitution, or sterile water, 
whether intended for such purposes or for injection; 
‘‘(18) the distribution of compressed medical 
gas (as defined in section 581(21)(C)); 
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‘‘(19) facilitating the distribution of a prescrip-
tion drug product by providing administrative serv-
ices, such as processing of orders and payments, 
without physical handling, distribution, or storage of 
a prescription drug product; or 
‘‘(20)(A) the distribution of a product by a dis-
penser, or a wholesale distributor acting at the di-
rection of the dispenser, to a repackager registered 
under section 510 for the purpose of repackaging 
the drug for use by that dispenser or another health 
care entity that is under the dispenser’s ownership 
or control, so long as the dispenser retains owner-
ship of the prescription drug product; and 
‘‘(B) the saleable or nonsaleable return by such 
repackager of such prescription drug product. 
‘‘(e) EFFECTIVE DATE.—The standards required by 
subsection (a) shall take effect not later than 2 years after 
the date of the enactment of this section. The Secretary 
shall issue the regulations required by subsection (a) not 
later than 1 year after the date of the enactment of this 
Act.’’. 
(b) 
CONFORMING
AMENDMENT.—Section 
804(a)(5)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 384(a)(5)(A)) is amended by striking 
‘‘503(e)(2)(A)’’ and inserting ‘‘583(a)’’. 
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SEC. 5. NATIONAL LICENSURE STANDARDS FOR THIRD- 
PARTY LOGISTICS PROVIDERS. 
Subchapter H of chapter V of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 4, is fur-
ther amended by adding at the end the following: 
‘‘SEC. 584. NATIONAL LICENSURE STANDARDS FOR THIRD- 
PARTY LOGISTICS PROVIDERS. 
‘‘(a) LICENSE REQUIREMENT.—No facility may en-
gage in the activities of a third-party logistics provider in 
any State unless— 
‘‘(1) the facility is licensed— 
‘‘(A) by the State from which the drug is 
distributed by the third-party logistics provider 
in accordance with a qualified licensing pro-
gram, if the State has such a program; or 
‘‘(B) by the Secretary under this section, if 
the State from which the drug is distributed 
does not have such a program; and 
‘‘(2) if the drug is distributed interstate and 
the facility is not licensed by the Secretary under 
paragraph (1)(B), registers with the State into 
which the drug is distributed if such State requires 
such registration. 
‘‘(b) REPORTING BY LICENSED THIRD-PARTY LOGIS-
TICS PROVIDERS.— 
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‘‘(1) ANNUAL
REPORT.—Beginning not later 
than 1 year after the date of the enactment of this 
section, each facility engaged in the activities of a 
third-party logistics provider shall submit on an an-
nual basis, and update as necessary, a report to the 
Secretary including— 
‘‘(A) the facility’s name; 
‘‘(B) the facility’s address; 
‘‘(C) a listing of each jurisdiction (whether 
State or Federal) in which the facility is li-
censed for third-party logistics provider activi-
ties; and 
‘‘(D) any disciplinary actions taken by a 
State or Federal licensing authority during the 
reporting period against the facility. 
‘‘(2) POSTING ON INTERNET.—The Secretary 
shall post on the public Internet Website of the 
Food and Drug Administration the name of each 
third-party logistics provider, and each jurisdiction 
(whether State or Federal) in which the provider is 
licensed, based on reports under paragraph (1). 
‘‘(c) PRESERVATION OF STATE AUTHORITY.—This 
subchapter does not prohibit a State from— 
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‘‘(1) licensing third-party logistic providers for 
the conduct of third-party logistics provider activities 
in the State in accordance with this subchapter; and 
‘‘(2) collecting fees from third-party logistics 
providers in connection with such licensing, 
so long as the State does not require such licensure to 
the extent to which an entity is engaged in wholesale dis-
tribution. 
‘‘(d) COSTS.— 
‘‘(1) AUTHORIZED
LICENSURE
FEES.—In the 
case of a facility engaging in the activities of a 
third-party logistics provider licensed by the Sec-
retary under this section, the Secretary may assess 
and collect a reasonable fee in an amount equal to 
the costs to the Federal Government of establishing 
and administering the licensure program established, 
and conducting period inspections, under this sec-
tion. 
‘‘(2) ADJUSTMENT.—The Secretary shall adjust 
the amount of the fee under paragraph (1) on an 
annual basis, if necessary, to generate an amount of 
revenue equal to the costs referred to in such para-
graph. 
‘‘(3) AVAILABILITY.—Fees assessed and col-
lected under this subsection shall be available for ob-
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ligation only to the extent and in the amount pro-
vided in advance in appropriations Acts. Such fees 
shall remain available until expended. 
‘‘(e) LICENSE REGULATIONS.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish, by regulation, standards, terms, and conditions 
for licensing persons to engage in third-party logis-
tics provider activities. 
‘‘(2) CONTENT.—The regulations under para-
graph (1) shall— 
‘‘(A) include standards relating to eligi-
bility for, and revocation and reissuance of, li-
censes; 
‘‘(B) establish a process by which the ap-
plicable licensing authority will, upon request by 
a third-party logistics provider that is accred-
ited by a third-party accreditation program ap-
proved by the Secretary, issue a license to the 
provider; 
‘‘(C) establish a process by which the Sec-
retary shall issue a license to a third-party lo-
gistics provider if the Secretary is not able to 
approve a third-party accreditation program be-
cause no such program meets the Secretary’s 
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requirements necessary for approval of such a 
third-party accreditation program; 
‘‘(D) require that the third-party logistics 
provider comply with storage practices, as de-
termined by the Secretary, at the provider’s fa-
cilities, including— 
‘‘(i) maintaining access to warehouse 
space of suitable size to facilitate safe op-
erations, including a suitable area to quar-
antine suspect prescription drug product; 
‘‘(ii) maintaining adequate security; 
and 
‘‘(iii) having written policies and pro-
cedures to— 
‘‘(I) address receipt, security, 
storage, inventory, shipment, and dis-
tribution of a prescription drug prod-
uct; 
‘‘(II) identify, record, and report 
confirmed losses or thefts in the 
United States; 
‘‘(III) correct errors and inac-
curacies in inventories; 
‘‘(IV) provide support for manu-
facturer recalls; 
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‘‘(V) prepare for, protect against, 
and address any reasonably foresee-
able crisis that affects security or op-
eration at the facility, such as a 
strike, fire, or flood; 
‘‘(VI) ensure that any expired 
prescription drug product is seg-
regated from other prescription drug 
products and returned to the manu-
facturer or repackager or destroyed; 
‘‘(VII) maintain the capability to 
electronically trace the receipt and 
outbound distribution of a prescrip-
tion drug product, and supplies and 
records of inventory; and 
‘‘(VIII) quarantine or destroy a 
suspect prescription drug product if 
directed to do so by the respective 
manufacturer, wholesale distributor, 
dispenser, or an authorized govern-
ment agency; 
‘‘(E) provide for periodic inspection, as de-
termined by the Secretary, of such facility ware-
house space to ensure compliance with this sec-
tion; 
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‘‘(F) prohibit a facility from having as a 
manager or designated representative anyone 
convicted of any felony violation of section 
301(i) or 301(k) or any felony violation of sec-
tion 1365 of title 18, United States Code, relat-
ing to prescription drug product tampering; 
‘‘(G) 
perform 
mandatory 
background 
checks of the provider’s facility managers or 
designated representatives of such managers; 
‘‘(H) require a third-party logistics pro-
vider to provide to the applicable licensing au-
thority, upon the authority’s request, a list of 
all prescription drug product manufacturers, 
wholesale distributors, and dispensers for whom 
the third-party logistics provider provides serv-
ices at the provider’s facilities; and 
‘‘(I) include procedures under which any 
third-party logistics provider license— 
‘‘(i) will expire on the date that is 3 
years after issuance of the license; and 
‘‘(ii) may be renewed for additional 3- 
year periods. 
‘‘(f) VALIDITY OF LICENSE.—A license issued under 
this section shall remain valid as long as such third-party 
logistics provider remains accredited by the Secretary, 
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subject to renewal under subsection (d). If the Secretary 
finds that the third-party accreditation program dem-
onstrates that all applicable requirements for licensure 
under this section are met, the Secretary shall issue a li-
cense under this section to a third-party logistics provider 
receiving accreditation. 
‘‘(g) QUALIFIED LICENSING PROGRAM DEFINED.— 
In this section, the term ‘qualified licensing program’ 
means a program meeting the requirements of this section 
and the regulations thereunder. 
‘‘(h) EFFECTIVE DATE.—The requirements of this 
section shall take effect not later than 1 year after the 
date of the enactment of this section. The Secretary shall 
issue the regulations required by subsection (d) not later 
than 180 days after the date of the enactment of this sec-
tion.’’. 
SEC. 6. PENALTIES. 
(a) PROHIBITED ACTS.—Section 301(t) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(t)) is 
amended by striking ‘‘or the distribution of drugs in viola-
tion of section 503(e) or the failure to otherwise comply 
with the requirements of section 503(e)’’ and inserting 
‘‘the failure to comply with any requirement of section 
582, engaging in the wholesale distribution of a drug in 
violation of section 583 or the failure to otherwise comply 
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with the requirements of section 583, or engaging in the 
activities of a third-party logistics provider in violation of 
section 584 or the failure to otherwise comply with the 
requirements of section 584’’. 
(b) ENHANCED PENALTY
FOR KNOWING UNLI-
CENSED ACTIVITIES.—Section 303(b)(1)(D) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
333(b)(1)(D)) is amended by striking ‘‘503(e)(2)(A)’’ and 
inserting ‘‘583 or 584’’. 
(c) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(bb) If it is a drug and it fails to bear a prescription 
drug product identifier as required by section 582.’’. 
SEC. 7. UNIFORM NATIONAL POLICY. 
Subchapter H of chapter V of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 5, is fur-
ther amended by adding at the end the following: 
‘‘SEC. 585. UNIFORM NATIONAL POLICY. 
‘‘(a) PREEMPTION OF STATE PRESCRIPTION DRUG 
PRODUCT TRACING AND OTHER REQUIREMENTS.—Be-
ginning on the date of the enactment of the Safeguarding 
America’s Pharmaceuticals Act of 2013, no State or polit-
ical subdivision of a State may establish or continue in 
effect any requirements for tracing drugs through the dis-
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tribution system (including any requirements with respect 
to paper or electronic pedigrees, track and trace, state-
ments of distribution history, transaction history, or 
transaction statements, or verification, investigation, dis-
position, alerts, or recordkeeping relating to the pharma-
ceutical distribution supply chain system) that— 
‘‘(1) are inconsistent with, more stringent than, 
or in addition to any requirements applicable under 
this Act; or 
‘‘(2) are inconsistent with any applicable waiv-
er, exception, or exemption issued by the Secretary 
under section 582(a). 
‘‘(b) STANDARDS OR LICENSURE.— 
‘‘(1) IN GENERAL.—Beginning on the date of 
the enactment of Safeguarding America’s Pharma-
ceuticals Act of 2013, no State or political subdivi-
sion of a State may establish or continue any stand-
ards, requirements, or regulations with respect to 
wholesale drug distributor or third-party logistics 
provider licensure which are inconsistent with, less 
stringent than, in addition to, or more stringent 
than, the standards and requirements under this 
Act. 
‘‘(2) LICENSING
FEES.—Paragraph (1) does 
not affect the authority of a State to collect fees 
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from wholesale drug distributors or third-party logis-
tics providers in connection with State licensing 
under section 583 or 584 pursuant to a licensing 
program meeting the requirements of such sections. 
‘‘(3) ENFORCEMENT, SUSPENSION, AND
REV-
OCATION OF LICENSES.—Notwithstanding paragraph 
(1), a State— 
‘‘(A) may take administrative action, in-
cluding fines, to enforce a licensure requirement 
promulgated by the State in accordance with 
this Act; 
‘‘(B) may provide for the suspension or 
revocation of licenses issued by the State for 
violations of the laws of such State; 
‘‘(C) upon conviction of a person for a vio-
lation of Federal, State, or local controlled sub-
stance laws or regulations, may provide for 
fines, imprisonment, or civil penalties; and 
‘‘(D) may regulate activities of entities li-
censed pursuant to section 583 or 584 in a 
manner that is consistent with the provisions of 
this subchapter.’’. 
SEC. 8. ELECTRONIC LABELING. 
(a) IN GENERAL.—Section 502(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is 
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amended by adding at the end the following new sentence: 
‘‘Required labeling (other than immediate container or 
carton labels) that is intended for use by a physician, a 
pharmacist, or another health care professional, and that 
provides directions for human use of a drug subject to sec-
tion 503(b)(1), may (except as necessary to mitigate a 
safety risk, as specified by the Secretary in regulation) be 
made available by electronic means instead of paper form, 
provided that such labeling complies with all applicable re-
quirements of law, the manufacturer or distributor, as ap-
plicable, affords health care professionals and authorized 
dispensers (as defined in section 581) the opportunity to 
request the labeling in paper form, and after such a re-
quest the manufacturer or distributor promptly provides 
the requested information without additional cost.’’. 
(b) REGULATIONS.—The Secretary of Health and 
Human Services shall promulgate regulations imple-
menting the amendment made by subsection (a). 
(c) APPLICATION.—The last sentence of section 
502(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(f)), as added by subsection (a), shall apply be-
ginning on the earlier of— 
(1) the effective date of final regulations pro-
mulgated under subsection (b); or 
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