IB 
Union Calendar No. 565 
110TH CONGRESS 
2D SESSION 
H. R. 6353 
[Report No. 110–869, Part I] 
To amend the Controlled Substances Act to address online pharmacies. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 24, 2008 
Mr. STUPAK (for himself, Mr. SMITH of Texas, Mrs. BONO MACK, Mr. DAN-
IEL E. LUNGREN of California, Mr. GALLEGLY, Mr. FEENEY, Mr. 
CHABOT, Mr. WALZ of Minnesota, and Mr. BOUCHER) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on the Judiciary, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
SEPTEMBER 23, 2008 
Reported from the Committee on Committee on Energy and Commerce with 
an amendment 
[Strike out all after the enacting clause and insert the part printed in italic] 
SEPTEMBER 23, 2008 
Additional sponsors: Mr. DAVIS of Illinois, Mr. LEVIN, Mrs. BACHMANN, Mrs. 
NAPOLITANO, and Mr. SOUDER 
SEPTEMBER 23, 2008 
Committee on the Judiciary discharged; committed to the Committee of the 
Whole House on the State of the Union and ordered to be printed 
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[For text of introduced bill, see copy of bill as introduced on June 24, 2008] 
A BILL 
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, 
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 following: 
‘‘(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, distributed, 
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-
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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. 
‘‘(B)(i) The term ‘in-person medical evalua-
tion’ 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-person 
medical evaluation of the patient or an 
evaluation of the patient through the prac-
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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— 
‘‘(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 Sub-
stances 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 
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predecessor or successor protocol to such protocol, to commu-
nicate 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, 
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 Inter-
net; and 
‘‘(B) does not include— 
‘‘(i) manufacturers or distributors registered 
under subsection (a), (b), (d), or (e) of section 
303 who do not dispense controlled substances to 
an unregistered individual or entity; 
‘‘(ii) nonpharmacy practitioners who are 
registered under section 303(f) and whose activi-
ties 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 
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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 a 
contract or compact under the Indian Self-Deter-
mination 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 employees of 
health care facilities specified in clause (iv), only 
to the extent such individuals are furnishing 
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 
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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 substances 
via the Internet consists solely of— 
‘‘(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 Attor-
ney General and the Secretary have jointly, by 
regulation, found it to be consistent with effective 
controls against diversion and otherwise con-
sistent with the public health and safety to ex-
empt 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 accordance 
with applicable Federal and State laws by a practitioner 
(other than a pharmacist) who is at a location remote from 
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the patient and is communicating with the patient, or 
health care professional who is treating the patient, using 
a telecommunications system referred to in section 1834(m) 
of the Social Security Act, which practice— 
‘‘(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 
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‘‘(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 De-
partment of Veterans Affairs reg-
istered 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 registration 
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 reg-
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istration of a hospital or clinic oper-
ated by the Department of Veterans Af-
fairs registered under section 303(f); 
‘‘(C) is being conducted by a practitioner— 
‘‘(i) who is an employee or contractor of the 
Indian Health Service, or is working for an In-
dian tribe or tribal organization under its con-
tract or compact with the Indian Health Service 
under the Indian Self-Determination and Edu-
cation Assistance Act; 
‘‘(ii) acting within the scope of the employ-
ment, contract, or compact described in clause 
(i); and 
‘‘(iii) who is designated as an Internet Eli-
gible Controlled Substances Provider by the Sec-
retary under section 311(g)(2); 
‘‘(D)(i) is being conducted during a public 
health emergency declared by the Secretary under sec-
tion 319 of the Public Health Service Act; and 
‘‘(ii) involves patients located in such areas, and 
such controlled substances, as the Secretary, with the 
concurrence of the Attorney General, designates, pro-
vided that such designation shall not be subject to the 
procedures prescribed by subchapter II of chapter 5 of 
title 5, United States Code; 
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‘‘(E) is being conducted by a practitioner who 
has obtained from the Attorney General a special reg-
istration under section 311(h); 
‘‘(F) is being conducted— 
‘‘(i) in a medical emergency situation— 
‘‘(I) that prevents the patient from 
being in the physical presence of a practi-
tioner registered under section 303(f) who is 
an employee or contractor of the Veterans 
Health Administration acting in the usual 
course of business and employment and 
within the scope of the official duties or con-
tract of that employee or contractor; 
‘‘(II) that prevents the patient from 
being physically present at a hospital or 
clinic operated by the Department of Vet-
erans 
Affairs 
registered 
under 
section 
303(f); 
‘‘(III) during which the primary care 
practitioner of the patient or a practitioner 
otherwise practicing telemedicine within the 
meaning of this paragraph is unable to pro-
vide care or consultation; and 
‘‘(IV) that requires immediate inter-
vention by a health care practitioner using 
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controlled substances to prevent what the 
practitioner reasonably believes in good 
faith will be imminent and serious clinical 
consequences, such as further injury or 
death; and 
‘‘(ii) by a practitioner that— 
‘‘(I) is an employee or contractor of the 
Veterans Health Administration acting 
within the scope of that employment or con-
tract; 
‘‘(II) is registered under section 303(f) 
in any State or is utilizing the registration 
of a hospital or clinic operated by the De-
partment of Veterans Affairs registered 
under section 303(f); and 
‘‘(III) issues a controlled substance 
prescription in this emergency context that 
is limited to a maximum of a 5-day supply 
which may not be extended or refilled; or 
‘‘(G) is being conducted under any other cir-
cumstances that the Attorney General and the Sec-
retary have jointly, by regulation, determined to be 
consistent with effective controls against diversion 
and otherwise consistent with the public health and 
safety. 
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‘‘(55) The term ‘refilling prescriptions for controlled 
substances in schedule III, IV, or V’— 
‘‘(A) means the dispensing of a controlled sub-
stance in schedule III, IV, or V in accordance with 
refill instructions issued by a practitioner as part of 
a valid prescription that meets the requirements of 
subsections (b) and (c) of section 309, as appropriate; 
and 
‘‘(B) does not include the issuance of a new pre-
scription to an individual for a controlled substance 
that individual was previously prescribed. 
‘‘(56) The term ‘filling new prescriptions for controlled 
substances in schedule III, IV, or V’ means filling a pre-
scription for an individual for a controlled substance in 
schedule III, IV, or V, if— 
‘‘(A) the pharmacy dispensing that prescription 
has previously dispensed to the patient a controlled 
substance other than by means of the Internet and 
pursuant to the valid prescription of a practitioner 
that meets the applicable requirements of subsections 
(b) and (c) of section 309 (in this paragraph referred 
to as the ‘original prescription’); 
‘‘(B) the pharmacy contacts the practitioner who 
issued the original prescription at the request of that 
individual to determine whether the practitioner will 
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authorize the issuance of a new prescription for that 
individual for the controlled substance described in 
subparagraph (A); and 
‘‘(C) the practitioner, acting in the usual course 
of professional practice, determines there is a legiti-
mate medical purpose for the issuance of the new pre-
scription.’’. 
(b) REGISTRATION REQUIREMENTS.—Section 303(f) of 
the Controlled Substances Act (21 U.S.C. 823(f)) is amend-
ed in the matter preceding paragraph (1)— 
(1) in the first sentence, by adding after ‘‘sched-
ule II, III, IV, or V’’ the following: ‘‘and shall modify 
the registrations of pharmacies so registered to au-
thorize them to dispense controlled substances by 
means of the Internet’’; and 
(2) in the second sentence, by striking ‘‘if he de-
termines that the issuance of such registration’’ and 
inserting ‘‘or such modification of registration if the 
Attorney General determines that the issuance of such 
registration or modification’’. 
(c) REPORTING REQUIREMENTS.—Section 307(d) of 
the Controlled Substances Act (21 U.S.C. 827(d)) is amend-
ed by— 
(1) striking ‘‘(d) Every’’ and inserting ‘‘(d)(1) 
Every’’; and 
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(2) adding at the end the following: 
‘‘(2) Each pharmacy with a modified registration 
under section 303(f) that authorizes the dispensing of con-
trolled substances by means of the Internet shall report to 
the Attorney General the controlled substances it dispenses, 
in the amount specified, and in such time and manner as 
the Attorney General by regulation shall require, except that 
the Attorney General, under this paragraph, may not re-
quire any pharmacy to report any information other than 
the total quantity of each controlled substance that the phar-
macy has dispensed each month. For purposes of this para-
graph, no reporting shall be required unless the pharmacy 
has met 1 of the following thresholds in the month for which 
the reporting is required: 
‘‘(A) 100 or more prescriptions dispensed. 
‘‘(B) 5,000 or more dosage units of all controlled 
substances combined.’’. 
(d) ONLINE PRESCRIPTION REQUIREMENTS.— 
(1) IN GENERAL.—The Controlled Substances Act 
is amended by inserting after section 310 (21 U.S.C. 
830) the following: 
‘‘ADDITIONAL REQUIREMENTS RELATING TO ONLINE 
PHARMACIES AND TELEMEDICINE 
‘‘SEC. 311. (a) IN GENERAL.—An online pharmacy 
shall display in a visible and clear manner on its homepage 
a statement that it complies with the requirements of this 
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section with respect to the delivery or sale or offer for sale 
of controlled substances and shall at all times display on 
the homepage of its Internet site a declaration of compliance 
in accordance with this section. 
‘‘(b) LICENSURE.—Each online pharmacy shall com-
ply with the requirements of State law concerning the licen-
sure of pharmacies in each State from which it, and in 
each State to which it, delivers, distributes, or dispenses or 
offers to deliver, distribute, or dispense controlled substances 
by means of the Internet, pursuant to applicable licensure 
requirements, as determined by each such State. 
‘‘(c) INTERNET PHARMACY SITE DISCLOSURE INFOR-
MATION.—Each online pharmacy shall post in a visible and 
clear manner on the homepage of each Internet site it oper-
ates, or on a page directly linked thereto in which the 
hyperlink is also visible and clear on the homepage, the fol-
lowing information for each pharmacy that delivers, dis-
tributes, or dispenses controlled substances pursuant to or-
ders made on, through, or on behalf of, that website: 
‘‘(1) The name and address of the pharmacy as 
it appears on the pharmacy’s Drug Enforcement Ad-
ministration certificate of registration. 
‘‘(2) The pharmacy’s telephone number and 
email address. 
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‘‘(3) The name, professional degree, and States of 
licensure of the pharmacist-in-charge, and a telephone 
number at which the pharmacist-in-charge can be 
contacted. 
‘‘(4) A list of the States in which the pharmacy 
is licensed to dispense controlled substances. 
‘‘(5) A certification that the pharmacy is reg-
istered under this part to deliver, distribute, or dis-
pense by means of the Internet controlled substances. 
‘‘(6) The name, address, telephone number, pro-
fessional degree, and States of licensure of any practi-
tioner who has a contractual relationship to provide 
medical evaluations or issue prescriptions for con-
trolled substances, through referrals from the website 
or at the request of the owner or operator of the 
website, or any employee or agent thereof. 
‘‘(7) The following statement, unless revised by 
the Attorney General by regulation: ‘This online 
pharmacy will only dispense a controlled substance to 
a person who has a valid prescription issued for a le-
gitimate medical purpose based upon a medical rela-
tionship with a prescribing practitioner. This in-
cludes at least one prior in-person medical evaluation 
or medical evaluation via telemedicine in accordance 
with applicable requirements of section 309.’. 
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‘‘(d) NOTIFICATION.— 
‘‘(1) IN GENERAL.—Thirty days prior to offering 
a controlled substance for sale, delivery, distribution, 
or dispensing, the online pharmacy shall notify the 
Attorney General, in such form and manner as the 
Attorney General shall determine, and the State 
boards of pharmacy in any States in which the online 
pharmacy offers to sell, deliver, distribute, or dispense 
controlled substances. 
‘‘(2) 
CONTENTS.—The 
notification 
required 
under paragraph (1) shall include— 
‘‘(A) the information required to be posted 
on the online pharmacy’s Internet site under 
subsection (c) and shall notify the Attorney Gen-
eral and the applicable State boards of phar-
macy, under penalty of perjury, that the infor-
mation disclosed on its Internet site under sub-
section (c) is true and accurate; 
‘‘(B) the online pharmacy’s Internet site ad-
dress and a certification that the online phar-
macy shall notify the Attorney General of any 
change in the address at least 30 days in ad-
vance; and 
‘‘(C) the Drug Enforcement Administration 
registration numbers of any pharmacies and 
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practitioners referred to in subsection (c), as ap-
plicable. 
‘‘(3) EXISTING ONLINE PHARMACIES.—An online 
pharmacy that is already operational as of the effec-
tive date of this section, shall notify the Attorney 
General and applicable State boards of pharmacy in 
accordance with this subsection not later than 30 
days after such date. 
‘‘(e) DECLARATION OF COMPLIANCE.—On and after 
the date on which it makes the notification under subsection 
(d), each online pharmacy shall display on the homepage 
of its Internet site, in such form as the Attorney General 
shall by regulation require, a declaration that it has made 
such notification to the Attorney General. 
‘‘(f) REPORTS.—Any statement, declaration, notifica-
tion, or disclosure required under this section shall be con-
sidered a report required to be kept under this part. 
‘‘(g) NOTICE AND DESIGNATIONS CONCERNING INDIAN 
TRIBES.— 
‘‘(1) IN
GENERAL.—For purposes of sections 
102(52) and 512(c)(6)(B), the Secretary shall notify 
the Attorney General, at such times and in such man-
ner as the Secretary and the Attorney General deter-
mine appropriate, of the Indian tribes or tribal orga-
nizations with which the Secretary has contracted or 
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compacted under the Indian Self-Determination and 
Education Assistance Act for the tribes or tribal orga-
nizations to provide pharmacy services. 
‘‘(2) DESIGNATIONS.— 
‘‘(A) IN GENERAL.—The Secretary may des-
ignate a practitioner described in subparagraph 
(B) as an Internet Eligible Controlled Sub-
stances Provider. Such designations shall be 
made only in cases where the Secretary has 
found that there is a legitimate need for the 
practitioner to be so designated because the pop-
ulation served by the practitioner is in a suffi-
ciently remote location that access to medical 
services is limited. 
‘‘(B) PRACTITIONERS.—A practitioner de-
scribed in this subparagraph is a practitioner 
who is an employee or contractor of the Indian 
Health Service, or is working for an Indian tribe 
or tribal organization under its contract or com-
pact under the Indian Self-Determination and 
Education Assistance Act with the Indian 
Health Service. 
‘‘(h) SPECIAL REGISTRATION FOR TELEMEDICINE.— 
‘‘(1) IN GENERAL.—The Attorney General may 
issue to a practitioner a special registration to engage 
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in the practice of telemedicine for purposes of section 
102(54)(E) if the practitioner, upon application for 
such special registration— 
‘‘(A) demonstrates a legitimate need for the 
special registration; and 
‘‘(B) is registered under section 303(f) in 
the State in which the patient will be located 
when receiving the telemedicine treatment, unless 
the practitioner— 
‘‘(i) is exempted from such registration 
in all States under section 302(d); or 
‘‘(ii) is an employee or contractor of 
the Department of Veterans Affairs who is 
acting in the scope of such employment or 
contract and is registered under section 
303(f) in any State or is utilizing the reg-
istration of a hospital or clinic operated by 
the Department of Veterans Affairs reg-
istered under section 303(f). 
‘‘(2) 
REGULATIONS.—The 
Attorney 
General 
shall, with the concurrence of the Secretary, promul-
gate regulations specifying the limited circumstances 
in which a special registration under this subsection 
may be issued and the procedures for obtaining such 
a special registration. 
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‘‘(3) DENIALS.—Proceedings to deny an applica-
tion for registration under this subsection shall be 
conducted in accordance with section 304(c). 
‘‘(i) REPORTING OF TELEMEDICINE BY VHA DURING 
MEDICAL EMERGENCY SITUATIONS.— 
‘‘(1) IN GENERAL.—Any practitioner issuing a 
prescription for a controlled substance under the au-
thorization to conduct telemedicine during a medical 
emergency situation described in section 102(54)(F) 
shall report to the Secretary of Veterans Affairs the 
authorization of that emergency prescription, in ac-
cordance with such requirements as the Secretary of 
Veterans Affairs shall, by regulation, establish. 
‘‘(2) TO ATTORNEY GENERAL.—Not later than 30 
days after the date that a prescription described in 
subparagraph (A) is issued, the Secretary of Veterans 
Affairs shall report to the Attorney General the au-
thorization of that emergency prescription. 
‘‘(j) 
CLARIFICATION
CONCERNING
PRESCRIPTION 
TRANSFERS.—Any transfer between pharmacies of infor-
mation relating to a prescription for a controlled substance 
shall meet the applicable requirements under regulations 
promulgated by the Attorney General under this Act.’’. 
(2) 
TECHNICAL
AND
CONFORMING
AMEND-
MENTS.—The table of contents for the Comprehensive 
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Drug Abuse Prevention and Control Act of 1970 
(Public Law 91–513; 84 Stat. 1236) is amended by 
inserting after the item relating to section 310 the fol-
lowing: 
‘‘Sec. 311. Additional requirements relating to online pharmacies and telemedi-
cine.’’. 
(e) OFFENSES INVOLVING CONTROLLED SUBSTANCES 
IN SCHEDULES III, IV, AND V.—Section 401(b) of the Con-
trolled Substances Act (21 U.S.C. 841(b)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (D), by striking ‘‘or in 
the case of any controlled substance in schedule 
III (other than gamma hydroxybutyric acid), or 
30 milligrams of flunitrazepam’’; and 
(B) by adding at the end the following: 
‘‘(E)(i) Except as provided in subparagraphs (C) and 
(D), in the case of any controlled substance in schedule III, 
such person shall be sentenced to a term of imprisonment 
of not more than 10 years and if death or serious bodily 
injury results from the use of such substance shall be sen-
tenced to a term of imprisonment of not more than 15 years, 
a fine not to exceed the greater of that authorized in accord-
ance with the provisions of title 18, United States Code, 
or $500,000 if the defendant is an individual or $2,500,000 
if the defendant is other than an individual, or both. 
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‘‘(ii) If any person commits such a violation after a 
prior conviction for a felony drug offense has become final, 
such person shall be sentenced to a term of imprisonment 
of not more than 20 years and if death or serious bodily 
injury results from the use of such substance shall be sen-
tenced to a term of imprisonment of not more than 30 years, 
a fine not to exceed the greater of twice that authorized in 
accordance with the provisions of title 18, United States 
Code, or $1,000,000 if the defendant is an individual or 
$5,000,000 if the defendant is other than an individual, or 
both. 
‘‘(iii) Any sentence imposing a term of imprisonment 
under this subparagraph shall, in the absence of such a 
prior conviction, impose a term of supervised release of at 
least 2 years in addition to such term of imprisonment and 
shall, if there was such a prior conviction, impose a term 
of supervised release of at least 4 years in addition to such 
term of imprisonment.’’; 
(2) in paragraph (2)— 
(A) by striking ‘‘3 years’’ and inserting ‘‘5 
years’’; 
(B) by striking ‘‘6 years’’ and inserting ‘‘10 
years’’; 
(C) by striking ‘‘after one or more prior 
convictions’’ and all that follows through ‘‘have 
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become final,’’ and inserting ‘‘after a prior con-
viction for a felony drug offense has become 
final,’’; and 
(3) in paragraph (3)— 
(A) by striking ‘‘2 years’’ and inserting ‘‘4 
years’’; 
(B) by striking ‘‘after one or more convic-
tions’’ and all that follows through ‘‘have become 
final,’’ and inserting ‘‘after a prior conviction 
for a felony drug offense has become final,’’; and 
(C) by adding at the end the following ‘‘Any 
sentence imposing a term of imprisonment under 
this paragraph may, if there was a prior convic-
tion, impose a term of supervised release of not 
more than 1 year, in addition to such term of 
imprisonment.’’. 
(f) OFFENSES
INVOLVING
DISPENSING
OF
CON-
TROLLED SUBSTANCES BY MEANS OF THE INTERNET.— 
Section 401 of the Controlled Substances Act (21 U.S.C. 
841) is amended by adding at the end the following: 
‘‘(h) OFFENSES INVOLVING DISPENSING
OF CON-
TROLLED SUBSTANCES BY MEANS OF THE INTERNET.— 
‘‘(1) IN GENERAL.—It shall be unlawful for any 
person to knowingly or intentionally— 
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‘‘(A) deliver, distribute, or dispense a con-
trolled substance by means of the Internet, except 
as authorized by this title; or 
‘‘(B) aid or abet (as such terms are used in 
section 2 of title 18, United States Code) any ac-
tivity described in subparagraph (A) that is not 
authorized by this title. 
‘‘(2) EXAMPLES.—Examples of activities that 
violate paragraph (1) include, but are not limited to, 
knowingly or intentionally— 
‘‘(A) delivering, distributing, or dispensing 
a controlled substance by means of the Internet 
by an online pharmacy that is not validly reg-
istered with a modification authorizing such ac-
tivity as required by section 303(f) (unless ex-
empt from such registration); 
‘‘(B) writing a prescription for a controlled 
substance for the purpose of delivery, distribu-
tion, or dispensation by means of the Internet in 
violation of section 309(e); 
‘‘(C) serving as an agent, intermediary, or 
other entity that causes the Internet to be used 
to bring together a buyer and seller to engage in 
the dispensing of a controlled substance in a 
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manner not authorized by sections 303(f) or 
309(e); 
‘‘(D) offering to fill a prescription for a 
controlled substance based solely on a consumer’s 
completion of an online medical questionnaire; 
and 
‘‘(E) making a material false, fictitious, or 
fraudulent statement or representation in a noti-
fication or declaration under subsection (d) or 
(e), respectively, of section 311. 
‘‘(3) INAPPLICABILITY.— 
‘‘(A) This subsection does not apply to— 
‘‘(i) the delivery, distribution, or dis-
pensation of controlled substances by non-
practitioners to the extent authorized by 
their registration under this title; 
‘‘(ii) the placement on the Internet of 
material that merely advocates the use of a 
controlled substance or includes pricing in-
formation without attempting to propose or 
facilitate an actual transaction involving a 
controlled substance; or 
‘‘(iii) except as provided in subpara-
graph (B), any activity that is limited to— 
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‘‘(I) the provision of a tele-
communications service, or of an Inter-
net access service or Internet informa-
tion location tool (as those terms are 
defined in section 231 of the Commu-
nications Act of 1934); or 
‘‘(II) the transmission, storage, re-
trieval, hosting, formatting, or trans-
lation (or any combination thereof) of 
a communication, without selection or 
alteration of the content of the commu-
nication, except that deletion of a par-
ticular communication or material 
made by another person in a manner 
consistent with section 230(c) of the 
Communications Act of 1934 shall not 
constitute such selection or alteration 
of the content of the communication. 
‘‘(B) The exceptions under subclauses (I) 
and (II) of subparagraph (A)(iii) shall not 
apply to a person acting in concert with a per-
son who violates paragraph (1). 
‘‘(4) KNOWING
OR
INTENTIONAL
VIOLATION.— 
Any person who knowingly or intentionally violates 
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this subsection shall be sentenced in accordance with 
subsection (b).’’. 
(g) PUBLICATION.—Section 403(c) of the Controlled 
Substances Act (21 U.S.C. 843(c)) is amended by— 
(1) striking ‘‘(c)’’ and inserting ‘‘(c)(1)’’; and 
(2) adding at the end the following: 
‘‘(2)(A) It shall be unlawful for any person to know-
ingly or intentionally use the Internet, or cause the Internet 
to be used, to advertise the sale of, or to offer to sell, dis-
tribute, or dispense, a controlled substance where such sale, 
distribution, or dispensing is not authorized by this title 
or by the Controlled Substances Import and Export Act. 
‘‘(B) Examples of activities that violate subparagraph 
(A) include, but are not limited to, knowingly or inten-
tionally causing the placement on the Internet of an adver-
tisement that refers to or directs prospective buyers to Inter-
net sellers of controlled substances who are not registered 
with a modification under section 303(f). 
‘‘(C) Subparagraph (A) does not apply to material 
that either— 
‘‘(i) merely advertises the distribution of con-
trolled substances by nonpractitioners to the extent 
authorized by their registration under this title; or 
‘‘(ii) merely advocates the use of a controlled 
substance or includes pricing information without at-
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tempting to facilitate an actual transaction involving 
a controlled substance.’’. 
(h) INJUNCTIVE RELIEF.—Section 512 of the Con-
trolled Substances Act (21 U.S.C. 882) is amended by add-
ing at the end the following: 
‘‘(c) STATE CAUSE OF ACTION PERTAINING TO ONLINE 
PHARMACIES.— 
‘‘(1) IN GENERAL.—In any case in which the 
State has reason to believe that an interest of the resi-
dents of that State has been or is being threatened or 
adversely affected by the action of a person, entity, or 
Internet site that violates the provisions of section 
303(f), 309(e), or 311, the State may bring a civil ac-
tion on behalf of such residents in a district court of 
the United States with appropriate jurisdiction— 
‘‘(A) to enjoin the conduct which violates 
this section; 
‘‘(B) to enforce compliance with this section; 
‘‘(C) to obtain damages, restitution, or other 
compensation, including civil penalties under 
section 402(b); and 
‘‘(D) to obtain such other legal or equitable 
relief as the court may find appropriate. 
‘‘(2) SERVICE; INTERVENTION.— 
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‘‘(A) Prior to filing a complaint under 
paragraph (1), the State shall serve a copy of the 
complaint upon the Attorney General and upon 
the United States Attorney for the judicial dis-
trict in which the complaint is to be filed. In 
any case where such prior service is not feasible, 
the State shall serve the complaint on the Attor-
ney General and the appropriate United States 
Attorney on the same day that the State’s com-
plaint is filed in Federal district court of the 
United States. Such proceedings shall be inde-
pendent of, and not in lieu of, criminal prosecu-
tions or any other proceedings under this title or 
any other laws of the United States. 
‘‘(B) Upon receiving notice respecting a 
civil action pursuant to this section, the United 
States shall have the right to intervene in such 
action and, upon so intervening, to be heard on 
all matters arising therein, and to file petitions 
for appeal. 
‘‘(C) Service of a State’s complaint on the 
United States as required in this paragraph 
shall be made in accord with the requirements of 
rule 4(i)(1) of the Federal Rule of Civil Proce-
dure. 
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‘‘(3) POWERS CONFERRED BY STATE LAW.—For 
purposes of bringing any civil action under para-
graph (1), nothing in this Act shall prevent an attor-
ney general of a State from exercising the powers con-
ferred on the attorney general of a State by the laws 
of such State to conduct investigations or to admin-
ister oaths or affirmations or to compel the attend-
ance of witnesses of or the production of documentary 
or other evidence. 
‘‘(4) VENUE.—Any civil action brought under 
paragraph (1) in a district court of the United States 
may be brought in the district in which the defendant 
is found, is an inhabitant, or transacts business or 
wherever venue is proper under section 1391 of title 
28, United States Code. Process in such action may 
be served in any district in which the defendant is an 
inhabitant or in which the defendant may be found. 
‘‘(5) NO PRIVATE RIGHT OF ACTION.—No private 
right of action is created under this subsection. 
‘‘(6) LIMITATION.—No civil action may be 
brought under paragraph (1) against— 
‘‘(A) the United States; 
‘‘(B) an Indian Tribe or tribal organiza-
tion, to the extent such tribe or tribal organiza-
tion is lawfully carrying out a contract or com-
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pact under the Indian Self-Determination and 
Education Assistance Act; or 
‘‘(C) any employee of the United States or 
such Indian tribe or tribal organization, pro-
vided such agent or employee is acting in the 
usual course of business or employment, and 
within the scope of the official duties of such 
agent or employee therewith.’’. 
(i) IMPORT AND EXPORT ACT.—Section 1010(b) of the 
Controlled Substances Import and Export Act (21 U.S.C. 
960(b)) is amended— 
(1) in paragraph (4)— 
(A) by striking ‘‘or any quantity of a con-
trolled substance in schedule III, IV, or V, (ex-
cept a violation involving flunitrazepam and ex-
cept a violation involving gamma hydroxy-
butyric acid)’’; 
(B) by inserting ‘‘or’’ before ‘‘less than one 
kilogram of hashish oil’’; and 
(C) by striking ‘‘imprisoned’’ and all that 
follows through the end of the paragraph and in-
serting ‘‘sentenced in accordance with section 
401(b)(1)(D).’’; 
(2) by adding at the end the following: 
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(i) the definition of the term ‘‘practice 
of telemedicine’’ in subparagraph (B) of 
this paragraph shall apply for purposes of 
the Controlled Substances Act; and 
(ii) the definition of the term ‘‘practice 
of telemedicine’’ in section 102(54) of the 
Controlled Substances Act, as amended by 
this Act, shall not apply. 
(B) TEMPORARY PHASE-IN OF TELEMEDI-
CINE REGULATION.—During the period specified 
in subparagraph (A), the term ‘‘practice of tele-
medicine’’ means the practice of medicine in ac-
cordance with applicable Federal and State laws 
by a practitioner (as that term is defined in sec-
tion 102 of the Controlled Substances Act (21 
U.S.C. 802)) (other than a pharmacist) who is 
at a location remote from the patient and is 
communicating with the patient, or health care 
professional who is treating the patient, using a 
telecommunications system referred to in section 
1834(m) of the Social Security Act (42 U.S.C. 
1395m(m)), if the practitioner is using an inter-
active telecommunications system that satisfies 
the requirements of section 410.78(a)(3) of title 
42, Code of Federal Regulations. 
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(C) RULE OF CONSTRUCTION.—Nothing in 
this subsection may be construed to create a 
precedent that any specific course of conduct 
constitutes the ‘‘practice of telemedicine’’ (as that 
term is defined in section 102(54) of the Con-
trolled Substances Act, as amended by this Act) 
after the end of the period specified in subpara-
graph (A). 
(k) GUIDELINES AND REGULATIONS.— 
(1) IN GENERAL.—The Attorney General may 
promulgate and enforce any rules, regulations, and 
procedures which may be necessary and appropriate 
for the efficient execution of functions under this Act 
or the amendments made by this Act, and, with the 
concurrence of the Secretary of Health and Human 
Services where this Act or the amendments made by 
this Act so provide, promulgate any interim rules 
necessary for the implementation of this Act or the 
amendments made by this Act, prior to its effective 
date. 
(2) 
SENTENCING
GUIDELINES.—The 
United 
States Sentencing Commission, in determining wheth-
er to amend, or establish new, guidelines or policy 
statements, to conform the Federal sentencing guide-
lines and policy statements to this Act and the 
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amendments made by this Act, should not construe 
any change in the maximum penalty for a violation 
involving a controlled substance in a particular 
schedule as being the sole reason to amend, or estab-
lish a new, guideline or policy statement. 
(l) ANNUAL REPORT.—Not later than 180 days after 
the date of enactment of this Act, and annually for 2 years 
after the initial report, the Drug Enforcement Administra-
tion, in consultation with the Department of State, shall 
submit to Congress a report describing— 
(1) the foreign supply chains and sources of con-
trolled substances offered for sale without a valid pre-
scription on the Internet; 
(2) the efforts and strategy of the Drug Enforce-
ment Administration to decrease the foreign supply 
chain and sources of controlled substances offered for 
sale without a valid prescription on the Internet; and 
(3) the efforts of the Drug Enforcement Adminis-
tration to work with domestic and multinational 
pharmaceutical companies and others to build inter-
national cooperation and a commitment to fight on 
a global scale the problem of distribution of controlled 
substances over the Internet without a valid prescrip-
tion. 
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SEC. 4. RULE OF CONSTRUCTION. 
Nothing in this Act or the amendments made by this 
Act shall be construed as authorizing, prohibiting, or lim-
iting the use of electronic prescriptions for controlled sub-
stances. 
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Union Calendar No. 565 
110TH CONGRESS 
2D SESSION 
H. R. 6353 
[Report No. 110–869, Part I] 
A BILL 
To amend the Controlled Substances Act to address 
online pharmacies. 
SEPTEMBER 23, 2008 
Committee on the Judiciary discharged; committed to the 
Committee of the Whole House on the State of the 
Union and ordered to be printed 
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