II 
110TH CONGRESS 
2D SESSION 
H. R. 6353 
IN THE SENATE OF THE UNITED STATES 
SEPTEMBER 25 (legislative day, SEPTEMBER 17), 2008 
Received 
AN ACT 
To amend the Controlled Substances Act to address online 
pharmacies. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Ryan Haight Online 
Pharmacy Consumer Protection Act of 2008’’. 
SEC. 2. REQUIREMENT OF A VALID PRESCRIPTION FOR 
CONTROLLED SUBSTANCES DISPENSED BY 
MEANS OF THE INTERNET. 
Section 309 of the Controlled Substances Act (21 
U.S.C. 829) is amended by adding at the end the fol-
lowing: 
‘‘(e) CONTROLLED
SUBSTANCES
DISPENSED
BY 
MEANS OF THE INTERNET.— 
‘‘(1) No controlled substance that is a prescrip-
tion drug as determined under the Federal Food, 
Drug, and Cosmetic Act may be delivered, distrib-
uted, or dispensed by means of the Internet without 
a valid prescription. 
‘‘(2) As used in this subsection: 
‘‘(A) The term ‘valid prescription’ means a 
prescription that is issued for a legitimate med-
ical purpose in the usual course of professional 
practice by— 
‘‘(i) a practitioner who has conducted 
at least 1 in-person medical evaluation of 
the patient; or 
‘‘(ii) a covering practitioner. 
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‘‘(B)(i) The term ‘in-person medical eval-
uation’ means a medical evaluation that is con-
ducted with the patient in the physical presence 
of the practitioner, without regard to whether 
portions of the evaluation are conducted by 
other health professionals. 
‘‘(ii) Nothing in clause (i) shall be con-
strued to imply that 1 in-person medical evalua-
tion demonstrates that a prescription has been 
issued for a legitimate medical purpose within 
the usual course of professional practice. 
‘‘(C) The term ‘covering practitioner’ 
means, with respect to a patient, a practitioner 
who conducts a medical evaluation (other than 
an in-person medical evaluation) at the request 
of a practitioner who— 
‘‘(i) has conducted at least 1 in-per-
son medical evaluation of the patient or an 
evaluation of the patient through the prac-
tice of telemedicine, within the previous 24 
months; and 
‘‘(ii) is temporarily unavailable to con-
duct the evaluation of the patient. 
‘‘(3) Nothing in this subsection shall apply to— 
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‘‘(A) the delivery, distribution, or dis-
pensing of a controlled substance by a practi-
tioner engaged in the practice of telemedicine; 
or 
‘‘(B) the dispensing or selling of a con-
trolled substance pursuant to practices as deter-
mined by the Attorney General by regulation, 
which shall be consistent with effective controls 
against diversion.’’. 
SEC. 3. AMENDMENTS TO THE CONTROLLED SUBSTANCES 
ACT RELATING TO THE DELIVERY OF CON-
TROLLED SUBSTANCES BY MEANS OF THE 
INTERNET. 
(a) IN GENERAL.—Section 102 of the Controlled 
Substances Act (21 U.S.C. 802) is amended by adding at 
the end the following: 
‘‘(50) The term ‘Internet’ means collectively the myr-
iad of computer and telecommunications facilities, includ-
ing equipment and operating software, which comprise the 
interconnected worldwide network of networks that employ 
the Transmission Control Protocol/Internet Protocol, or 
any predecessor or successor protocol to such protocol, to 
communicate information of all kinds by wire or radio. 
‘‘(51) The term ‘deliver, distribute, or dispense by 
means of the Internet’ refers, respectively, to any delivery, 
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distribution, or dispensing of a controlled substance that 
is caused or facilitated by means of the Internet. 
‘‘(52) The term ‘online pharmacy’— 
‘‘(A) means a person, entity, or Internet site, 
whether in the United States or abroad, that know-
ingly or intentionally delivers, distributes, or dis-
penses, or offers or attempts to deliver, distribute, or 
dispense, a controlled substance by means of the 
Internet; and 
‘‘(B) does not include— 
‘‘(i) manufacturers or distributors reg-
istered under subsection (a), (b), (d), or (e) of 
section 303 who do not dispense controlled sub-
stances to an unregistered individual or entity; 
‘‘(ii) nonpharmacy practitioners who are 
registered under section 303(f) and whose ac-
tivities are authorized by that registration; 
‘‘(iii) any hospital or other medical facility 
that is operated by an agency of the United 
States (including the Armed Forces), provided 
such hospital or other facility is registered 
under section 303(f); 
‘‘(iv) a health care facility owned or oper-
ated by an Indian tribe or tribal organization, 
only to the extent such facility is carrying out 
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a contract or compact under the Indian Self- 
Determination and Education Assistance Act; 
‘‘(v) any agent or employee of any hospital 
or facility referred to in clause (iii) or (iv), pro-
vided such agent or employee is lawfully acting 
in the usual course of business or employment, 
and within the scope of the official duties of 
such agent or employee, with such hospital or 
facility, and, with respect to agents or employ-
ees of health care facilities specified in clause 
(iv), only to the extent such individuals are fur-
nishing services pursuant to the contracts or 
compacts described in such clause; 
‘‘(vi) mere advertisements that do not at-
tempt to facilitate an actual transaction involv-
ing a controlled substance; 
‘‘(vii) a person, entity, or Internet site that 
is not in the United States and does not facili-
tate the delivery, distribution, or dispensing of 
a controlled substance by means of the Internet 
to any person in the United States; 
‘‘(viii) a pharmacy registered under section 
303(f) whose dispensing of controlled sub-
stances via the Internet consists solely of— 
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‘‘(I) refilling prescriptions for con-
trolled substances in schedule III, IV, or 
V, as defined in paragraph (55); or 
‘‘(II) filling new prescriptions for con-
trolled substances in schedule III, IV, or 
V, as defined in paragraph (56); or 
‘‘(ix) any other persons for whom the At-
torney General and the Secretary have jointly, 
by regulation, found it to be consistent with ef-
fective controls against diversion and otherwise 
consistent with the public health and safety to 
exempt from the definition of an ‘online phar-
macy’. 
‘‘(53) The term ‘homepage’ means the opening or 
main page or screen of the website of an online pharmacy 
that is viewable on the Internet. 
‘‘(54) The term ‘practice of telemedicine’ means, for 
purposes of this title, the practice of medicine in accord-
ance with applicable Federal and State laws by a practi-
tioner (other than a pharmacist) who is at a location re-
mote from the patient and is communicating with the pa-
tient, or health care professional who is treating the pa-
tient, using a telecommunications system referred to in 
section 1834(m) of the Social Security Act, which prac-
tice— 
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‘‘(A) is being conducted— 
‘‘(i) while the patient is being treated by, 
and physically located in, a hospital or clinic 
registered under section 303(f); and 
‘‘(ii) by a practitioner— 
‘‘(I) acting in the usual course of pro-
fessional practice; 
‘‘(II) acting in accordance with appli-
cable State law; and 
‘‘(III) registered under section 303(f) 
in the State in which the patient is located, 
unless the practitioner— 
‘‘(aa) is exempted from such reg-
istration in all States under section 
302(d); or 
‘‘(bb) is— 
‘‘(AA) an employee or con-
tractor of the Department of Vet-
erans Affairs who is acting in the 
scope of such employment or con-
tract; and 
‘‘(BB) registered under sec-
tion 303(f) in any State or is uti-
lizing the registration of a hos-
pital or clinic operated by the 
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Department of Veterans Affairs 
registered under section 303(f); 
‘‘(B) is being conducted while the patient is 
being treated by, and in the physical presence of, a 
practitioner— 
‘‘(i) acting in the usual course of profes-
sional practice; 
‘‘(ii) acting in accordance with applicable 
State law; and 
‘‘(iii) registered under section 303(f) in the 
State in which the patient is located, unless the 
practitioner— 
‘‘(I) is exempted from such registra-
tion in all States under section 302(d); or 
‘‘(II) is— 
‘‘(aa) an employee or contractor 
of the Department of Veterans Affairs 
who is acting in the scope of such em-
ployment or contract; and 
‘‘(bb) registered under section 
303(f) in any State or is using the 
registration of a hospital or clinic op-
erated by the Department of Veterans 
Affairs 
registered 
under 
section 
303(f); 
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