code, State, and telephone number of 
the practitioner or group; and 
‘‘(II) the name of each State in 
which each practitioner is licensed or 
otherwise 
authorized 
to 
prescribe 
drugs. 
‘‘(iv) A statement that the Internet 
pharmacy will dispense prescription drugs 
only after receipt of a valid prescription. 
‘‘(C) PROFESSIONAL
SERVICES
REQUIRE-
MENTS.—An Internet pharmacy shall carry out 
the following: 
‘‘(i) Maintain patient medication pro-
files and other related data in a readily ac-
cessible format organized to facilitate con-
sultation with treating providers, care-
givers, and patients. 
‘‘(ii) Conduct prospective drug use re-
views before dispensing medications or 
medical devices. 
‘‘(iii) Ensure patient confidentiality 
and the protection of patient identity and 
patient-specific information, in accordance 
with the regulations promulgated under 
section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 
(42 U.S.C. 1320d–2 note). 
‘‘(iv) Offer interactive and meaningful 
consultation by a licensed pharmacist to 
the caregiver or patient prior to and subse-
quent to the time at which the Internet 
pharmacy dispenses the drug. 
‘‘(v) (I) Establish a mechanism for 
patients to report errors and suspected ad-
verse drug reactions. 
‘‘(II) Document in the reporting 
mechanism the response of the Internet 
pharmacy to those reports. 
‘‘(vi) Develop a system to inform care-
givers and patients about drug recalls. 
‘‘(vii) Educate caregivers and patients 
about the appropriate means of disposing 
of expired, damaged, or unusable medica-
tions. 
‘‘(viii) Assure that the sale of a pre-
scription drug is in accordance with a pre-
scription from the treating provider of the 
individual.
‘‘(ix) (I) Verify the validity of the pre-
scription of an individual by using 1 of the 
following methods: 
‘‘(aa) Receiving from the indi-
vidual or treating provider of the indi-
vidual the prescription of the indi-
vidual by mail (including a private 
carrier), or receiving from the treating 
provider of the individual the prescrip-
tion of the individual by electronic 
mail. 
‘‘(bb) If the prescription is for a 
controlled substance (as defined in 
section 102 of the Controlled Sub-
stances Act (21 U.S.C. 802)), con-
firming with the treating provider the 
information in subclause (II). 
‘‘(II) 
When 
seeking 
verification of a prescription of 
an individual under subclause 
(I)(bb), an Internet pharmacy 
shall provide to the treating pro-
vider the following information:
‘‘(aa) The full name 
and address of the indi-
vidual. 
‘‘(bb) Identification of 
the prescription drug. 
‘‘(cc) The quantity of 
the prescription drug to be 
dispensed. 
‘‘(dd) 
The 
date 
on 
which the individual pre-
sented the prescription to 
the Internet pharmacy. 
‘‘(ee) The date and 
time of the verification re-
quest. 
‘‘(ff) The name of a 
contact person at the Inter-
net pharmacy, including a 
voice 
telephone 
number, 
electronic mail address, and 
facsimile telephone number. 
‘‘(III) 
A 
prescription 
is 
verified under subclause (I)(bb) 
only if 1 of the following occurs:
‘‘(aa) The treating pro-
vider confirms, by direct 
communication 
with 
the 
Internet pharmacy, that the 
prescription is accurate. 
‘‘(bb) The treating pro-
vider informs the Internet 
pharmacy that the prescrip-
tion is inaccurate and pro-
vides the accurate prescrip-
tion. 
‘‘(IV) An Internet pharmacy 
shall not fill a prescription if— 
‘‘(aa) a treating pro-
vider informs the Internet 
pharmacy within 72 hours 
after receipt of a commu-
nication 
under 
subclause 
(I)(bb) that the prescription 
is inaccurate or expired; or 
‘‘(bb) the treating pro-
vider does not respond with-
in that time. 
‘‘(x) Maintain, for such period of time 
as the Secretary shall prescribe by regula-
tion, a record of all direct communications 
with a treating provider regarding the dis-
pensing of a prescription drug, including 
verification of the prescription. 
‘‘(3) LICENSURE PROCEDURE.— 
‘‘(A) ACTION BY SECRETARY.—On receipt 
of a completed licensing application under para-
graph (3), the Secretary shall— 
‘‘(i) assign an identification number 
to each Internet pharmacy; 
‘‘(ii) notify the applicant of the receipt 
of the licensure application; and 
‘‘(iii) not later than 60 days after re-
ceipt of the licensure application, issue a li-
cense if the Internet pharmacy is in com-
pliance with conditions under paragraph 
(3). 
‘‘(B) ELECTRONIC FILING.— 
‘‘(i) IN GENERAL.—For the purpose 
of reducing paperwork and reporting bur-
dens, the Secretary shall require the use of 
electronic methods of submitting to the 
Secretary a licensure application required 
under this section and provide for elec-
tronic methods of receiving the applica-
tions. 
‘‘(ii) AUTHENTICATION.—In providing 
for the electronic submission of such licen-
sure applications under this section, the 
Secretary shall ensure that adequate au-
thentication protocols are used to allow 
identification of the Internet pharmacy and 
validation of the data as appropriate. 
‘‘(4) LIST.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
compile, maintain, and periodically update a list 
of licensees. 
‘‘(B) AVAILABILITY.—The Secretary shall 
make the list described under subparagraph (A) 
and information submitted by the licensee 
under paragraph (2)(B) available to the public 
on an Internet website and through a toll-free 
telephone number. 
‘‘(5) LICENSING FEE.—The Secretary shall es-
tablish a licensing fee that an Internet pharmacy li-
censed by the Secretary under this section shall be 
required to pay to the Secretary. 
‘‘(A) COLLECTION.—
‘‘(i) COLLECTION OF INITIAL YEAR LI-
CENSING FEE.—A licensing fee of $5,000 
shall be payable for the fiscal year in which 
the Internet pharmacy first submits a li-
censing application under this section. 
‘‘(ii) COLLECTION
IN
SUBSEQUENT 
YEARS.—After the licensing fee is paid for 
the first fiscal year, the fee, as modified 
under subparagraph (B), shall be payable 
on or before October 1 of each year. 
‘‘(iii) ONE FEE PER INTERNET PHAR-
MACY.—The licensing fee shall be paid 
only once for each Internet pharmacy for 
a fiscal year in which the fee is payable. 
‘‘(B) FEE AMOUNT.—The amount of the 
licensing fee shall be determined each year by 
the Secretary based on the anticipated costs to 
the Secretary of enforcing the requirements of 
this section in the subsequent fiscal year. 
‘‘(C) ANNUAL FEE DETERMINATION.— 
‘‘(i) IN GENERAL.—Not later than 60 
days before the beginning of each fiscal 
year beginning after September 30, 2005, 
the Secretary shall determine the licensing 
fee for that fiscal year.
‘‘(ii) 
PUBLICATION
OF
FEE 
AMOUNT.—Not later than 60 days before 
each fiscal year, the Secretary shall publish 
the licensing fee under this section for that 
fiscal year and provide for a period of 30 
days for the public to provide written com-
ments on the fee. 
‘‘(D) USE OF FEES.—The licensing fees 
collected under this section shall be used, with-
out further appropriation, to carry out this sec-
tion. 
‘‘(E) FAILURE TO PAY FEE.— 
‘‘(i) DUE DATE.—A licensing fee pay-
able under this section shall be paid by the 
date that is 30 days after the date on 
which the fee is due. 
‘‘(ii) FAILURE TO PAY.—If an Inter-
net pharmacy subject to a fee under this 
section fails to pay the fee by the date 
specified under clause (i), the Secretary 
shall not permit the Internet pharmacy to 
engage in the dispensing of drugs as de-
scribed under this section until all such 
fees owed by the Internet pharmacy are 
paid.
‘‘(F) REPORTS.—Beginning with fiscal 
year 2006, not later than 60 days after the end 
of each fiscal year during which licensing fees 
are collected under this section, the Secretary 
shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the 
House of Representatives a report that de-
scribes— 
‘‘(i) implementation of the licensing 
fee authority during the fiscal year; and 
‘‘(ii) the use by the Secretary of the 
licensing fees collected during the fiscal 
year for which the report is made. 
‘‘(6) TERMINATION
OF
LICENSE.—The Sec-
retary, upon the initiative of the Secretary, may ter-
minate a license issued under subsection (c), after 
notice to the Internet pharmacy and an opportunity 
for a hearing, and if the Secretary determines that 
an Internet pharmacy— 
‘‘(A) has demonstrated a pattern of non-
compliance with this section; 
‘‘(B) has made an untrue statement of ma-
terial fact in its license application; or
‘‘(C) is in violation of any applicable Fed-
eral or State law relating to the dispensing of 
a prescription drug. 
‘‘(7) RENEWAL EVALUATION.— 
‘‘(A) IN GENERAL.—Before renewing a li-
cense of an Internet pharmacy under this sub-
section pursuant to the submission of a renewal 
application, the Secretary shall conduct an eval-
uation to determine whether the Internet phar-
macy is in compliance with this section. 
‘‘(B) EVALUATION.—At the discretion of 
the Secretary and as applicable, an evaluation 
under subparagraph (A) may include testing of 
the Internet pharmacy website or other systems 
through which the Internet pharmacy commu-
nicates with consumers, and a physical inspec-
tion of the records and premises of the phar-
macy. 
‘‘(8) CONTRACT
FOR
OPERATION
OF
PRO-
GRAM.— 
‘‘(A) IN
GENERAL.—The Secretary may 
award a contract under this subsection for the 
operation of the licensing program.