IB 
Union Calendar No. 65 
113TH CONGRESS 
1ST SESSION H. R. 1919 
[Report No. 113–93] 
To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
pharmaceutical distribution supply chain, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 9, 2013 
Mr. LATTA (for himself, Mr. MATHESON, Mr. UPTON, Mr. DINGELL, Mr. CAS-
SIDY, Mrs. BLACKBURN, Mr. MCKINLEY, Mr. ROGERS of Michigan, Mr. 
BURGESS, Mr. SHIMKUS, Mr. GUTHRIE, Mr. JOHNSON of Ohio, and Mr. 
SCHNEIDER) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
JUNE 3, 2013 
Additional sponsors: Mr. OLSON, Mr. LONG, Mr. LATHAM, Mr. VALADAO, Mr. 
RUSH, Mr. VEASEY, Mr. WALBERG, and Mrs. WALORSKI 
JUNE 3, 2013 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on May 9, 2013] 
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A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to the pharmaceutical distribution supply chain, 
and for other purposes. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Safeguarding America’s Pharmaceuticals Act of 2013’’. 
(b) TABLE OF CONTENTS.—The table of contents of this 
Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Pharmaceutical distribution supply chain. 
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 
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‘‘(B) in the case of a wholesale distributor, 
third-party logistics provider, or dispenser, li-
censed (as defined in this section). 
‘‘(2) DISPENSER.—The term ‘dispenser’— 
‘‘(A) subject to subparagraph (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 distribu-
tion centers do not act as a wholesale distributor; 
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 pos-
session and control of an entity— 
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‘‘(A) means the removal of such prescription 
drug product, or taking measures to prevent the 
introduction of such prescription drug product, 
from the pharmaceutical distribution supply 
chain; and 
‘‘(B) may include disposal, return of the 
prescription drug product for disposal, or other 
appropriate handling and other actions such as 
retaining a sample of the prescription drug 
product for additional physical examination or 
laboratory analysis by a manufacturer or regu-
latory or law enforcement agency. 
‘‘(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 man-
ufacturer has confirmed— 
‘‘(A) is counterfeit, diverted, or stolen; 
‘‘(B) is intentionally adulterated such that 
the prescription drug product would result in se-
rious adverse health consequences or death to hu-
mans; or 
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‘‘(C) is otherwise unfit for distribution such 
that the prescription drug product is reasonably 
likely to cause serious adverse human health con-
sequences 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 ‘manufacturer’ 
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 subject 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 de-
scribed 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 Inter-
nal Revenue Code of 1986) to which a per-
son 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 man-
ufacturer for individual sale to a dispenser. 
‘‘(9) PRESCRIPTION DRUG.—The term ‘prescrip-
tion drug’ means a drug for human use subject to sec-
tion 503(b)(1). 
‘‘(10) PRESCRIPTION DRUG PRODUCT.—The term 
‘prescription drug product’ means a prescription drug 
in a finished dosage form for administration to a pa-
tient without substantial further manufacturing (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 rec-
ognized international standards development or-
ganization. 
‘‘(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 ‘returns 
processor’ mean a person who owns or operates an es-
tablishment that provides for the disposition of or oth-
erwise processes saleable and nonsaleable prescription 
drug product received from an authorized trading 
partner such that the prescription drug product may 
be processed for credit to the purchaser, manufacturer, 
seller, or disposed of for no further distribution. 
‘‘(16) SPECIFIC PATIENT NEED.—The term ‘spe-
cific patient need’— 
‘‘(A) means with respect to the transfer of 
a prescription drug product from one pharmacy 
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to another, to fill a prescription for an identified 
patient; and 
‘‘(B) does not include the transfer of a pre-
scription drug product from one pharmacy to 
another for the purpose of increasing or replen-
ishing stock in anticipation of a potential need. 
‘‘(17) STANDARDIZED NUMERICAL IDENTIFIER.— 
The term ‘standardized numerical identifier’ means a 
set of numbers or characters that— 
‘‘(A) is used to uniquely identify each pack-
age or homogenous case of the prescription drug 
product; and 
‘‘(B) is composed of the National Drug Code 
that corresponds to the specific prescription drug 
product (including the particular package con-
figuration) combined with a unique alpha-
numeric serial number of up to 20 characters. 
‘‘(18) SUSPECT
PRESCRIPTION
DRUG
PROD-
UCT.—The term ‘suspect prescription drug product’ 
means a prescription drug product for which there is 
reason to believe that such prescription drug prod-
uct— 
‘‘(A) is potentially counterfeit, diverted, or 
stolen; 
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wholesale distributor, or dispenser transfers own-
ership of a prescription drug product; or 
‘‘(B) a third-party logistics provider from 
whom a manufacturer, repackager, wholesale dis-
tributor, or dispenser accepts possession of a pre-
scription drug product or to whom a manufac-
turer, repackager, wholesale distributor, or dis-
penser transfers possession of a prescription drug 
product. 
‘‘(21) TRANSACTION.— 
‘‘(A) IN GENERAL.—The term ‘transaction’ 
means the transfer in interstate commerce of pre-
scription drug product between persons in which 
a change of ownership occurs. 
‘‘(B) EXEMPTIONS.—The term ‘transaction’ 
does not include— 
‘‘(i) intracompany distribution of any 
prescription drug product, including be-
tween members of an affiliated group (as 
defined in section 1504(a) of the Internal 
Revenue Code of 1986); 
‘‘(ii) the distribution of a prescription 
drug product among hospitals or other 
health care entities that are under common 
control; 
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tion to the extent otherwise permitted by 
law; 
‘‘(ix) the distribution of a prescription 
drug product pursuant to the sale or merger 
of a pharmacy or pharmacies or a wholesale 
distributor or wholesale distributors, except 
that any records required to be maintained 
for the prescription drug product shall be 
transferred to the new owner of the phar-
macy or pharmacies or wholesale dis-
tributor or wholesale distributors; 
‘‘(x) the dispensing of a prescription 
drug 
product 
approved 
under 
section 
512(b); 
‘‘(xi) the transfer of prescription drug 
products to or from any facility that is li-
censed by the Nuclear Regulatory Commis-
sion or by a State pursuant to an agree-
ment with such Commission under section 
274 of the Atomic Energy Act of 1954 (42 
U.S.C. 2021); 
‘‘(xii) the distribution of a combina-
tion product that consists of— 
‘‘(I) a product comprised of two 
or more components that are each a 
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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 de-
scribed in clause (xiv); 
‘‘(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 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 Ad-
ministration as a medical device man-
ufacturer; 
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‘‘(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 purchased 
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 product 
as purchased from the manufacturer or 
wholesale distributor; 
‘‘(IV) the medical convenience kit 
does not contain a controlled substance 
(as defined in section 102 of the Con-
trolled Substances Act); and 
‘‘(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; 
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‘‘(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 calories 
(such as dextrose and amino acids); 
‘‘(xv) the distribution of an intra-
venous prescription drug product used to 
maintain the equilibrium of water and 
minerals 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; 
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‘‘(xvii) the distribution of compressed 
medical gas; or 
‘‘(xviii)(I) the distribution of a product 
by a dispenser, or a wholesale distributor 
acting at the direction 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 owner-
ship or control, so long as the dispenser re-
tains ownership of the prescription drug 
product; and 
‘‘(II) the saleable or nonsaleable return 
by such repackager of such prescription 
drug product. 
‘‘(C) COMPRESSED
MEDICAL
GAS.—For 
purposes of subparagraph (B)(xviii), the term 
‘compressed medical gas’ means any substance in 
its gaseous or cryogenic liquid form that meets 
medical purity standards and has application in 
a medical or homecare environment, including 
oxygen and nitrous oxide. 
‘‘(22) TRANSACTION HISTORY.—The term ‘trans-
action history’ means a statement that— 
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‘‘(A) includes the transaction information 
for each transaction conducted with respect to a 
prescription drug product beginning with the 
manufacturer or initial purchase distributor for 
each prior transaction going back to the manu-
facturer of the prescription drug product or to 
the initial purchase distributor; and 
‘‘(B) is in paper or electronic form. 
‘‘(23) TRANSACTION
INFORMATION.—The term 
‘transaction information’ means— 
‘‘(A) the proprietary or established name or 
names of the prescription drug product; 
‘‘(B) the strength and dosage form of the 
prescription drug product; 
‘‘(C) the National Drug Code number of the 
prescription drug product; 
‘‘(D) the container size; 
‘‘(E) the number of containers; 
‘‘(F) the lot number of the prescription drug 
product; 
‘‘(G) the date of the transaction; 
‘‘(H) the business name and address of the 
person from whom ownership is being trans-
ferred; and 
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‘‘(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 prescription 
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 
imprinted upon, a package or homogeneous case 
of the prescription drug product corresponds to 
the standardized numerical identifier or lot 
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