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 further 
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 para-
graph (1)(B), registers with the State into which the 
drug is distributed if such State requires such reg-
istration. 
‘‘(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 sec-
tion, each facility engaged in the activities of a third- 
party logistics provider shall submit on an annual 
basis, and update as necessary, a report to the Sec-
retary 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 licensed 
for third-party logistics provider activities; 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 (wheth-
er 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 
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‘‘(2) collecting fees from third-party logistics pro-
viders 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 distribu-
tion. 
‘‘(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 Secretary 
under this section, the Secretary may assess and col-
lect a reasonable fee in an amount equal to the costs 
to the Federal Government of establishing and admin-
istering the licensure program established, and con-
ducting period inspections, under this section. 
‘‘(2) ADJUSTMENT.—The Secretary shall adjust 
the amount of the fee under paragraph (1) on an an-
nual basis, if necessary, to generate an amount of rev-
enue equal to the costs referred to in such paragraph. 
‘‘(3) AVAILABILITY.—Fees assessed and collected 
under this subsection shall be available for obligation 
only to the extent and in the amount provided in ad-
vance in appropriations Acts. Such fees shall remain 
available until expended. 
‘‘(e) LICENSE REGULATIONS.— 
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‘‘(1) IN GENERAL.—The Secretary shall establish, 
by regulation, standards, terms, and conditions for li-
censing persons to engage in third-party logistics pro-
vider 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 appli-
cable licensing authority will, upon request by a 
third-party logistics provider that is accredited 
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 logis-
tics provider if the Secretary is not able to ap-
prove a third-party accreditation program be-
cause no such program meets the Secretary’s re-
quirements necessary for approval of such a 
third-party accreditation program; 
‘‘(D) require that the third-party logistics 
provider comply with storage practices, as deter-
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mined by the Secretary, at the provider’s facili-
ties, including— 
‘‘(i) maintaining access to warehouse 
space of suitable size to facilitate safe oper-
ations, 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, stor-
age, inventory, shipment, and distribu-
tion of a prescription drug product; 
‘‘(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 foreseeable 
crisis that affects security or operation 
at the facility, such as a strike, fire, or 
flood; 
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‘‘(VI) ensure that any expired 
prescription drug product is segregated 
from other prescription drug products 
and returned to the manufacturer or 
repackager or destroyed; 
‘‘(VII) maintain the capability to 
electronically trace the receipt and out-
bound distribution of a prescription 
drug product, and supplies and records 
of inventory; and 
‘‘(VIII) quarantine or destroy a 
suspect prescription drug product if di-
rected to do so by the respective manu-
facturer, wholesale distributor, dis-
penser, or an authorized government 
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-
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