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, whole-
sale distributors, and dispensers for whom the 
third-party logistics provider provides services 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, sub-
ject to renewal under subsection (d). If the Secretary finds 
that the third-party accreditation program demonstrates 
that all applicable requirements for licensure under this sec-
tion are met, the Secretary shall issue a license under this 
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section to a third-party logistics provider receiving accredi-
tation. 
‘‘(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 sec-
tion 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 section.’’. 
SEC. 6. PENALTIES. 
(a) PROHIBITED ACTS.—Section 301(t) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(t)) is amend-
ed by striking ‘‘or the distribution of drugs in violation 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 sec-
tion 583 or the failure to otherwise comply with the require-
ments 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 sec-
tion 584’’. 
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(b) ENHANCED PENALTY FOR KNOWING UNLICENSED 
ACTIVITIES.—Section 303(b)(1)(D) of the Federal 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 amended 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 further 
amended by adding at the end the following: 
‘‘SEC. 585. UNIFORM NATIONAL POLICY. 
‘‘(a) PREEMPTION OF STATE PRESCRIPTION DRUG 
PRODUCT TRACING AND OTHER REQUIREMENTS.—Begin-
ning 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 ef-
fect any requirements for tracing drugs through the dis-
tribution system (including any requirements with respect 
to paper or electronic pedigrees, track and trace, statements 
of distribution history, transaction history, or transaction 
statements, or verification, investigation, disposition, alerts, 
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or recordkeeping relating to the pharmaceutical 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 subdivision 
of a State may establish or continue any standards, 
requirements, or regulations with respect to wholesale 
drug distributor or third-party logistics provider li-
censure 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 logistics 
providers in connection with State licensing under 
section 583 or 584 pursuant to a licensing program 
meeting the requirements of such sections. 
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‘‘(3) ENFORCEMENT, SUSPENSION, AND REVOCA-
TION 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 rev-
ocation of licenses issued by the State for viola-
tions 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 man-
ner 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 direc-
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