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
‘‘(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;
‘‘(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
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));
‘‘(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)’’.
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.—
‘‘(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—
‘‘(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-
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
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;
‘‘(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;
‘‘(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,
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
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-
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
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
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
100 
(2) the day that is 180 days after the date of 
enactment of this Act. 
Passed the House of Representatives June 3, 2013. 
Attest: 
Clerk.
113TH CONGRESS 
1ST SESSION 
H. R. 1919 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic 
Act with respect to the pharmaceutical distribu-
tion supply chain, and for other purposes.