‘‘SEC. 814. REGISTRATION OF CERTAIN IMPORTERS. 
‘‘(a) IN GENERAL.—A drug importation facility, 
pharmacy, Internet pharmacy, or wholesaler engaged in 
the importation or offering for importation of prescription 
drugs into the United States, or in the dispensing of such 
drugs, shall register with the Secretary in accordance with 
this section. 
‘‘(b) REGISTRATION.— 
‘‘(1) IN GENERAL.—To register, the owner, op-
erator, or agent in charge of a drug importation fa-
cility, pharmacy, Internet pharmacy, or wholesaler 
shall submit to the Secretary a registration that dis-
closes— 
‘‘(A) the name and address of each drug 
importation facility, pharmacy, Internet phar-
macy, or wholesaler at which, and all trade 
names under which, the registrant conducts 
business; 
‘‘(B) the name of each prescription drug to 
be imported into the United States by each 
drug importation facility, pharmacy, Internet 
pharmacy, or wholesaler; and 
‘‘(C) the name and address of an agent for 
service of process in the United States. 
‘‘(2) CHANGE
IN
INFORMATION.—The reg-
istrant shall notify the Secretary in a timely manner
of any change in the information provided under 
paragraph (1). 
‘‘(3) PROCEDURE.—Not later than 60 days 
after receipt of a completed registration under para-
graph (1), the Secretary shall— 
‘‘(A) assign a registration number to each 
registered drug importation facility, pharmacy, 
Internet pharmacy, and wholesaler; and 
‘‘(B) notify the registrant of the receipt of 
the registration. 
‘‘(4) LIST.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
compile, maintain, and periodically update a list 
of registrants. 
‘‘(B) AVAILABILITY.—The Secretary shall 
make the list described under subparagraph (A) 
and information submitted by a registrant 
under paragraph (1) available to the public on 
an Internet website and through a toll-free tele-
phone number. 
‘‘(c) ELECTRONIC FILING.— 
‘‘(1) IN GENERAL.—For the purpose of reduc-
ing paperwork and reporting burdens, the Secretary 
shall provide for, and require the use of, electronic 
methods of submitting to the Secretary registrations
required under this section and shall provide for 
electronic methods of receiving the registrations. 
‘‘(2) AUTHENTICATION.—In providing for the 
electronic submission of such registrations under 
this section, the Secretary shall ensure that ade-
quate authentication protocols are used to allow 
identification of the registrant and validation of the 
data as appropriate. 
‘‘(d) EFFECT OF SECTION.— 
‘‘(1) AUTHORITY.—Nothing in this section 
authorizes the Secretary to require an applica-
tion, review, or licensing process for a drug im-
portation facility, pharmacy, or wholesaler. 
‘‘(2) IMPORTATION
BY
INDIVIDUALS.— 
Nothing in this section applies to a prescription 
drug imported by an individual under section 
812 or to a commercial transaction conducted 
between an Internet pharmacy and an indi-
vidual.’’. 
(b) REGULATIONS.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall promulgate regu-
lations to carry out section 814 of the Federal Food, 
Drug, and Cosmetic Act (as added by this section).
(2) EFFECTIVE
DATE.—The requirement of 
registration under section 814 of the Federal Food, 
Drug, and Cosmetic Act takes effect— 
(A) on the effective date of the final regu-
lations under paragraph (1); or 
(B) if the final regulations have not been 
made effective as of the expiration of that pe-
riod, on the date that is 1 year after the date 
of enactment of this Act, subject to compliance 
with the final regulations when the final regula-
tions are made effective. 
(c) IMPORTATION; FAILURE TO REGISTER.—Section 
801 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381) (as amended by section 7(e)) is amended by 
adding at the end the following: 
‘‘(t) FAILURE TO REGISTER.— 
‘‘(1) IN GENERAL.—If a drug importation facil-
ity, pharmacy, Internet pharmacy, or wholesaler en-
gaged in the importation or offering for importation 
of prescription drugs into the United States has not 
submitted a registration to the Secretary in accord-
ance with section 814, a prescription drug that is 
being imported or offered for importation into the 
United States shall not be delivered to the importer, 
owner, or consignee of the prescription drug until
the drug importation facility, pharmacy, Internet 
pharmacy, or wholesaler is registered in accordance 
with section 814. 
‘‘(2) EFFECT OF SUBSECTION (B).—Subsection 
(b) does not authorize the delivery of the prescrip-
tion drug pursuant to the execution of a bond while 
the prescription drug is held under this subsection. 
‘‘(3) REMOVAL.—A prescription drug held 
under this subsection shall be removed to a secure 
facility, as appropriate. 
‘‘(4) NO
TRANSFER.—During the period in 
which a prescription drug is held under this sub-
section, the prescription drug shall not be trans-
ferred by any person from the port of entry into the 
United States for the prescription drug or from the 
secure facility to which the prescription drug has 
been removed.’’. 
(d) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as 
amended by section 7(d)) is amended by adding at the 
end the following: 
‘‘(oo) The failure of a drug importation facility, phar-
macy, Internet pharmacy, or wholesaler engaged in the 
importation or offering for importation of prescription
drugs into the United States, or in the dispensing of such 
drugs, to register in accordance with section 814.’’. 
SEC. 9. MAINTENANCE AND INSPECTION OF RECORDS FOR 
PRESCRIPTION DRUGS. 
The Federal Food, Drug, and Cosmetic Act is amend-
ed by adding after section 814 (as added by section 8) 
the following: 
‘‘SEC. 815. MAINTENANCE AND INSPECTION OF RECORDS 
FOR PRESCRIPTION DRUGS. 
‘‘(a) IN GENERAL.—The Secretary may by regulation 
establish requirements relating to the establishment and 
maintenance, for not longer than 2 years, of records by— 
‘‘(1) a drug importation facility, pharmacy, 
Internet pharmacy, or wholesaler engaged in the im-
portation of prescription drugs into the United 
States, or in the dispensing of such drugs; and 
‘‘(2) any person that processes, packages, dis-
tributes, receives, holds, or transports a prescription 
drug imported under this subchapter. 
‘‘(b) INSPECTION.— 
‘‘(1) IN GENERAL.—If the Secretary has reason 
to believe that a prescription drug imported under 
this subchapter presents a risk to the public health, 
the drug importation facility, pharmacy, Internet 
pharmacy, or wholesaler that imports the prescrip-