195 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of the enactment of this subsection, 
the Secretary shall, by guidance, specify— 
‘‘(A) the unique facility identifier system 
to be used to meet the requirements of— 
‘‘(i) 
subsections 
(b)(1), 
(c), 
and 
(i)(1)(A) of this section; and 
‘‘(ii) section 801(s) (relating to reg-
istration of commercial importers); and 
‘‘(B) the form, manner, and timing of sub-
missions of unique facility identifiers under the 
provisions specified in subparagraph (A). 
‘‘(2) CONSIDERATION.—In developing the guid-
ance under paragraph (1), the Secretary shall take 
into account the utilization of existing unique identi-
fication schemes and compatibility with customs 
automated systems.’’. 
(d) IMPORTATION.—Section 801(a) (21 U.S.C. 
381(a)) is amended by inserting ‘‘or (5) for an article that 
is a drug, the appropriate unique facility identifiers under 
subsection (s) (relating to commercial importers) and sec-
tion 510(i) (relating to foreign establishments), as speci-
fied by the Secretary, are not provided,’’ before ‘‘then such 
article shall be refused admission’’. 
VerDate Mar 15 2010 
22:01 May 25, 2012
Jkt 019200
PO 00000
Frm 00195
Fmt 6652
Sfmt 6201
E:\BILLS\H5651.RH
H5651
srobinson on DSK4SPTVN1PROD with BILLS
196 
SEC. 809. DOCUMENTATION FOR ADMISSIBILITY OF IM-
PORTS. 
Section 801 (21 U.S.C. 381) is amended by adding 
at the end the following: 
‘‘(r) DOCUMENTATION.— 
‘‘(1) SUBMISSION.—The Secretary may require, 
in consultation with the Secretary of Homeland Se-
curity acting through U.S. Customs and Border Pro-
tection as determined appropriate by the Secretary, 
the submission of documentation or other informa-
tion for a drug that is imported or offered for im-
port into the United States. 
‘‘(2) REFUSAL
OF
ADMISSION.—A drug im-
ported or offered for import into the United States 
shall be refused admission unless all documentation 
and information the Secretary requires under this 
Act, the Public Health Service Act, or both, as ap-
propriate, for such article is submitted. 
‘‘(3) REGULATIONS.— 
‘‘(A) DOCUMENTS
AND
INFORMATION.— 
The Secretary shall issue a regulation to specify 
the documentation or other information that is 
described in paragraph (1). Such information 
may include— 
‘‘(i) information demonstrating the 
regulatory status of the drug, such as the 
VerDate Mar 15 2010 
22:01 May 25, 2012
Jkt 019200
PO 00000
Frm 00196
Fmt 6652
Sfmt 6201
E:\BILLS\H5651.RH
H5651
srobinson on DSK4SPTVN1PROD with BILLS
197 
new drug application, abbreviated new 
drug application, or investigational new 
drug or Drug Master File number; 
‘‘(ii) facility information, such as 
proof of registration and the unique facility 
identifier; and 
‘‘(iii) indication of compliance with 
current good manufacturing practice, such 
as satisfactory testing results, certifi-
cations relating to satisfactory inspections, 
and compliance with the country of export 
regulations. 
‘‘(B) EXEMPTION.—The Secretary may, by 
regulation, exempt drugs imported for research 
purposes only and other types of drug imports 
from some or all of the requirements of this 
subsection. 
‘‘(4) EFFECTIVE DATE.—The final rule under 
paragraph (3)(A) shall take effect not less than 180 
days after the Secretary promulgates such final 
rule.’’. 
SEC. 810. REGISTRATION OF COMMERCIAL IMPORTERS. 
(a) PROHIBITIONS.—Section 301 (21 U.S.C. 331) is 
amended by adding at the end the following: 
VerDate Mar 15 2010 
22:01 May 25, 2012
Jkt 019200
PO 00000
Frm 00197
Fmt 6652
Sfmt 6201
E:\BILLS\H5651.RH
H5651
srobinson on DSK4SPTVN1PROD with BILLS
198 
‘‘(aaa) The failure to register in accordance with sec-
tion 801(s).’’. 
(b) REGISTRATION.—Section 801 (21 U.S.C. 381), 
as amended by section 810, is further amended by adding 
at the end the following: 
‘‘(s) REGISTRATION OF COMMERCIAL IMPORTERS.— 
‘‘(1) REGISTRATION.—The Secretary shall re-
quire a commercial importer of drugs— 
‘‘(A) to be registered with the Secretary in 
a form and manner specified by the Secretary; 
and 
‘‘(B) consistent with the guidance under 
section 510(q), to submit, at the time of reg-
istration, a unique identifier for the principal 
place of business for which the importer is re-
quired to register under this subsection. 
‘‘(2) REGULATIONS.— 
‘‘(A) IN GENERAL.—The Secretary, in con-
sultation with the Secretary of Homeland Secu-
rity acting through U.S. Customs and Border 
Protection, shall promulgate regulations to es-
tablish good importer practices that specify the 
measures an importer shall take to ensure im-
ported drugs are in compliance with the re-
VerDate Mar 15 2010 
22:01 May 25, 2012
Jkt 019200
PO 00000
Frm 00198
Fmt 6652
Sfmt 6201
E:\BILLS\H5651.RH
H5651
srobinson on DSK4SPTVN1PROD with BILLS
199 
quirements of this Act and the Public Health 
Service Act. 
‘‘(B) EXPEDITED
CLEARANCE
FOR
CER-
TAIN IMPORTERS.—In promulgating good im-
porter practice regulations under subparagraph 
(A), the Secretary may, as appropriate, take 
into account differences among importers and 
types of imports, and, based on the level of risk 
posed by the imported drug, provide for expe-
dited clearance for those importers that volun-
teer to participate in partnership programs for 
highly compliant companies. 
‘‘(3) DISCONTINUANCE
OF
REGISTRATION.— 
The Secretary shall discontinue the registration of 
any commercial importer of drugs that fails to com-
ply with the regulations promulgated under this sub-
section. 
‘‘(4) EXEMPTIONS.—The Secretary, by notice 
in the Federal Register, may establish exemptions 
from the requirements of this subsection.’’. 
(c) MISBRANDING.—Section 502(o) (21 U.S.C. 352) 
is amended by inserting ‘‘if it is a drug and was imported 
or offered for import by a commercial importer of drugs 
not duly registered under section 801(s),’’ after ‘‘not duly 
registered under section 510,’’. 
VerDate Mar 15 2010 
22:01 May 25, 2012
Jkt 019200
PO 00000
Frm 00199
Fmt 6652
Sfmt 6201
E:\BILLS\H5651.RH
H5651
srobinson on DSK4SPTVN1PROD with BILLS