‘‘(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 au-
thorizes the Secretary to require an application, re-
view, or licensing process for a drug importation fa-
cility, pharmacy, or wholesaler. 
‘‘(2) IMPORTATION BY INDIVIDUALS.—Nothing 
in this section applies to a prescription drug im-
ported by an individual under section 814 or to a 
commercial transaction conducted between an Inter-
net pharmacy and an individual.’’. 
(b) IMPORTATION; FAILURE TO REGISTER.—Section 
801 of the Federal Food, Drug, and Cosmetic Act is 
amended by adding at the end the following: 
‘‘(p) 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 816, 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 816.
‘‘(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.’’. 
SEC. 8. ENFORCEMENT; REGULATIONS; EFFECTIVE DATES. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(hh) Dispensing or offering to dispense a prescrip-
tion drug imported into the United States in violation of 
the requirements of section 812. 
‘‘(ii) The importation or offering for importation of 
a prescription drug in violation of an order under section 
815.
‘‘(jj) 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 816. ’’. 
(b) REGULATIONS; EFFECTIVE DATES.— 
(1) COMMERCIAL IMPORTATION.—With respect 
to carrying out section 812 of the Federal Food, 
Drug, and Cosmetic Act (as added by section 3 of 
this Act): 
(A) The Secretary of Health and Human 
Services (referred to in this subsection as the 
‘‘Secretary’’) shall promulgate interim final reg-
ulations regarding importation of prescription 
drugs from Canada not later than 30 days after 
the date of the enactment of this Act. Such sec-
tion 812 takes effect regarding the importation 
of prescription drugs from Canada upon the ex-
piration of such 30 days, without regard to 
whether the Secretary has promulgated such 
regulations. 
(B) The Secretary shall promulgate in-
terim final regulations regarding importation of 
prescription drugs from permitted countries not 
later than one year after the date of the enact-