H. R. 3204—52 
‘‘(D) provide for periodic inspection by the licensing 
authority, as determined by the Secretary, of such facility 
warehouse space to ensure compliance with this section; 
‘‘(E) prohibit a facility from having as a manager or 
designated representative anyone convicted of any felony 
violation of subsection (i) or (k) of section 301 or any 
violation of section 1365 of title 18, United States Code 
relating to product tampering; 
‘‘(F) provide for mandatory background checks of a 
facility manager or a designated representative of such 
manager; 
‘‘(G) require a third-party logistics provider to provide 
the applicable licensing authority, upon a request by such 
authority, a list of all product manufacturers, wholesale 
distributors, and dispensers for whom the third-party logis-
tics provider provides services at such facility; and 
‘‘(H) include procedures under which any third-party 
logistics provider license— 
‘‘(i) expires on the date that is 3 years after 
issuance of the license; and 
‘‘(ii) may be renewed for additional 3-year periods. 
‘‘(3) PROCEDURE.—In promulgating the regulations under 
this subsection, the Secretary shall, notwithstanding section 
553 of title 5, United States Code— 
‘‘(A) issue a notice of proposed rulemaking that includes 
a copy of the proposed regulation; 
‘‘(B) provide a period of not less than 60 days for 
comments on the proposed regulation; and 
‘‘(C) provide that the final regulation takes effect upon 
the expiration of 1 year after the date that such final 
regulation is issued. 
‘‘(e) VALIDITY.—A license issued under this section shall remain 
valid as long as such third-party logistics provider remains licensed 
consistent with this section. If the Secretary finds that the third- 
party accreditation program demonstrates that all applicable 
requirements for licensure under this section are met, the Secretary 
shall issue a license under this section to a third-party logistics 
provider receiving accreditation, pursuant to subsection (d)(2)(A). 
‘‘SEC. 585. UNIFORM NATIONAL POLICY. 
‘‘(a) PRODUCT TRACING AND OTHER REQUIREMENTS.—Beginning 
on the date of enactment of the Drug Supply Chain Security Act, 
no State or political subdivision of a State may establish or continue 
in effect any requirements for tracing products through the distribu-
tion system (including any requirements with respect to statements 
of distribution history, transaction history, transaction information, 
or transaction statement of a product as such product changes 
ownership in the supply chain, or verification, investigation, disposi-
tion, notification, or recordkeeping relating to such systems, 
including paper or electronic pedigree systems or for tracking and 
tracing drugs throughout the distribution system) which are incon-
sistent with, more stringent than, or in addition to, any require-
ments applicable under section 503(e) (as amended by such Act) 
or this subchapter (or regulations issued thereunder), or which 
are inconsistent with— 
‘‘(1) any waiver, exception, or exemption pursuant to section 
581 or 582; or
H. R. 3204—53 
‘‘(2) any restrictions specified in section 582. 
‘‘(b) WHOLESALE DISTRIBUTOR AND THIRD-PARTY LOGISTICS PRO-
VIDER STANDARDS.— 
‘‘(1) IN
GENERAL.—Beginning on the date of enactment 
of the Drug Supply Chain Security Act, no State or political 
subdivision of a State may establish or continue any standards, 
requirements, or regulations with respect to wholesale prescrip-
tion drug distributor or third-party logistics provider licensure 
that are inconsistent with, less stringent than, directly related 
to, or covered by the standards and requirements applicable 
under section 503(e) (as amended by such Act), in the case 
of a wholesale distributor, or section 584, in the case of a 
third-party logistics provider. 
‘‘(2) STATE
REGULATION
OF
THIRD-PARTY
LOGISTICS
PRO-
VIDERS.—No State shall regulate third-party logistics providers 
as wholesale distributors. 
‘‘(3) ADMINISTRATION
FEES.—Notwithstanding paragraph 
(1), a State may administer fee collections for effectuating the 
wholesale drug distributor and third-party logistics provider 
licensure requirements under sections 503(e) (as amended by 
the Drug Supply Chain Security Act), 583, and 584. 
‘‘(4) ENFORCEMENT, SUSPENSION, AND REVOCATION.—Not-
withstanding paragraph (1), a State— 
‘‘(A) may take administrative action, including fines, 
to enforce a requirement promulgated by the State in 
accordance with section 503(e) (as amended by the Drug 
Supply Chain Security Act) or this subchapter; 
‘‘(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 violations of Federal, State, 
or local drug laws or regulations, may provide for fines, 
imprisonment, or civil penalties; and 
‘‘(D) may regulate activities of licensed entities in a 
manner that is consistent with product tracing require-
ments under section 582. 
‘‘(c) EXCEPTION.—Nothing in this section shall be construed 
to preempt State requirements related to the distribution of 
prescription drugs if such requirements are not related to product 
tracing as described in subsection (a) or wholesale distributor and 
third-party logistics provider licensure as described in subsection 
(b) applicable under section 503(e) (as amended by the Drug Supply 
Chain Security Act) or this subchapter (or regulations issued there-
under).’’. 
SEC. 206. PENALTIES. 
(a) PROHIBITED ACT.—Section 301(t) (21 U.S.C. 331(t)), is 
amended— 
(1) by striking ‘‘or’’ after ‘‘the requirements of section 
503(d),’’; and 
(2) by inserting ‘‘, failure to comply with the requirements 
under section 582, the failure to comply with the requirements 
under section 584, as applicable,’’ after ‘‘in violation of section 
503(e)’’. 
(b) MISBRANDING.—Section 502 (21 U.S.C. 352), as amended 
by section 103, is further amended by adding at the end the fol-
lowing:
H. R. 3204—54 
‘‘(cc) If it is a drug and it fails to bear the product identifier 
as required by section 582.’’. 
SEC. 207. CONFORMING AMENDMENT. 
(a) IN GENERAL.—Section 303(b)(1)(D) (21 U.S.C. 333(b)(1)(D)) 
is amended by striking ‘‘503(e)(2)(A)’’ and inserting ‘‘503(e)(1)’’. 
(b) EFFECTIVE DATE.—The amendment made by subsection (a) 
shall take effect on January 1, 2015. 
SEC. 208. SAVINGS CLAUSE. 
Except as provided in the amendments made by paragraphs 
(1), (2), and (3) of section 204(a) and by section 206(a), nothing 
in this title (including the amendments made by this title) shall 
be construed as altering any authority of the Secretary of Health 
and Human Services with respect to a drug subject to section 
503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(b)(1)) under any other provision of such Act or the Public 
Health Service Act (42 U.S.C. 201 et seq.). 
Speaker of the House of Representatives. 
Vice President of the United States and
President of the Senate.