Ryan Haight Online Pharmacy Consumer Protection Act of 2008
PL 110-425 (H.R.6353), enacted 10/15/2008

122 STAT. 4820 
PUBLIC LAW 110–425—OCT. 15, 2008 
Public Law 110–425 
110th Congress 
An Act 
To amend the Controlled Substances Act to address online pharmacies. 
Be it enacted by the Senate and House of Representatives 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 prescription 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 medical 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 evaluation’ means 
a medical evaluation that is conducted 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 construed to imply 
that 1 in-person medical evaluation demonstrates that a 
prescription has been issued for a legitimate medical pur-
pose 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 practice of telemedicine, within the pre-
vious 24 months; and 
‘‘(ii) is temporarily unavailable to conduct the 
evaluation of the patient. 
21 USC 801 
note. 
Ryan Haight 
Online Pharmacy 
Consumer 
Protection Act 
of 2008. 
Oct. 15, 2008 
[H.R. 6353] 
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122 STAT. 4821 
PUBLIC LAW 110–425—OCT. 15, 2008 
‘‘(3) Nothing in this subsection shall apply to— 
‘‘(A) the delivery, distribution, or dispensing of a con-
trolled substance by a practitioner engaged in the practice 
of telemedicine; or 
‘‘(B) the dispensing or selling of a controlled substance 
pursuant to practices as determined by the Attorney Gen-
eral by regulation, which shall be consistent with effective 
controls against diversion.’’. 
SEC. 3. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT 
RELATING TO THE DELIVERY OF CONTROLLED 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 myriad of com-
puter and telecommunications facilities, including 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, 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 knowingly or intentionally 
delivers, distributes, or dispenses, 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 registered under sub-
section (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 activities are authorized 
by that registration; 
‘‘(iii) any hospital or other medical facility that is oper-
ated 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 operated by an 
Indian tribe or tribal organization, only to the extent such 
facility is carrying out 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), provided 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 con-
tracts or compacts described in such clause; 
‘‘(vi) mere advertisements that do not attempt to facili-
tate an actual transaction involving a controlled substance; 
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122 STAT. 4822 
PUBLIC LAW 110–425—OCT. 15, 2008 
‘‘(vii) a person, entity, or Internet site that is not 
in the United States and does not facilitate 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 substances via the Internet consists 
solely of— 
‘‘(I) refilling prescriptions for controlled substances 
in schedule III, IV, or V, as defined in paragraph 
(55); or 
‘‘(II) filling new prescriptions for controlled sub-
stances in schedule III, IV, or V, as defined in para-
graph (56); or 
‘‘(ix) any other persons for whom the Attorney General 
and the Secretary have jointly, by regulation, found it 
to be consistent with effective controls against diversion 
and otherwise consistent with the public health and safety 
to exempt from the definition of an ‘online pharmacy’. 
‘‘(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 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 professional prac-
tice; 
‘‘(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 practi-
tioner— 
‘‘(aa) is exempted from such registration in 
all States under section 302(d); or 
‘‘(bb) is— 
‘‘(AA) an employee or contractor of the 
Department of Veterans Affairs who is acting 
in the scope of such employment or contract; 
and 
‘‘(BB) registered under section 303(f) in 
any State or is utilizing the registration of 
a hospital or clinic operated by the Depart-
ment of Veterans Affairs registered under sec-
tion 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 professional practice; 
‘‘(ii) acting in accordance with applicable State law; 
and 
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122 STAT. 4823 
PUBLIC LAW 110–425—OCT. 15, 2008 
‘‘(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 Depart-
ment of Veterans Affairs who is acting in the scope 
of such employment or contract; and 
‘‘(bb) registered under section 303(f) in any 
State or is using the registration of a hospital 
or clinic operated by the Department of Veterans 
Affairs 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 Indian tribe or tribal 
organization under its contract or compact with the Indian 
Health Service under the Indian Self-Determination and 
Education Assistance Act; 
‘‘(ii) acting within the scope of the employment, con-
tract, or compact described in clause (i); and 
‘‘(iii) who is designated as an Internet Eligible Con-
trolled Substances Provider by the Secretary under section 
311(g)(2); 
‘‘(D)(i) is being conducted during a public health emergency 
declared by the Secretary under section 319 of the Public Health 
Service Act; and 
‘‘(ii) involves patients located in such areas, and such con-
trolled substances, as the Secretary, with the concurrence of 
the Attorney General, designates, provided that such designa-
tion shall not be subject to the procedures prescribed by sub-
chapter II of chapter 5 of title 5, United States Code; 
‘‘(E) is being conducted by a practitioner who has obtained 
from the Attorney General a special registration 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 practitioner 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 contract of that employee 
or contractor; 
‘‘(II) that prevents the patient from being phys-
ically present at a hospital or clinic operated by the 
Department of Veterans Affairs registered under sec-
tion 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 provide care or consultation; and 
‘‘(IV) that requires immediate intervention by a 
health care practitioner using 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— 
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122 STAT. 4824 
PUBLIC LAW 110–425—OCT. 15, 2008 
‘‘(I) is an employee or contractor of the Veterans 
Health Administration acting within the scope of that 
employment or contract; 
‘‘(II) is registered under section 303(f) in any State 
or is utilizing the registration of a hospital or clinic 
operated by the Department of Veterans Affairs reg-
istered 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 circumstances 
that the Attorney General and the Secretary have jointly, by 
regulation, determined to be consistent with effective controls 
against diversion and otherwise consistent with the public 
health and safety. 
‘‘(55) The term ‘refilling prescriptions for controlled substances 
in schedule III, IV, or V’— 
‘‘(A) means the dispensing of a controlled substance 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 prescription 
to an individual for a controlled substance that individual was 
previously prescribed. 
‘‘(56) The term ‘filling new prescriptions for controlled sub-
stances in schedule III, IV, or V’ means filling a prescription for 
an individual for a controlled substance in schedule III, IV, or 
V, if— 
‘‘(A) the pharmacy dispensing that prescription has pre-
viously 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 require-
ments 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 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 profes-
sional practice, determines there is a legitimate medical pur-
pose for the issuance of the new prescription.’’. 
(b) REGISTRATION REQUIREMENTS.—Section 303(f) of the Con-
trolled Substances Act (21 U.S.C. 823(f)) is amended in the matter 
preceding paragraph (1)— 
(1) in the first sentence, by adding after ‘‘schedule II, 
III, IV, or V’’ the following: ‘‘and shall modify the registrations 
of pharmacies so registered to authorize them to dispense con-
trolled substances by means of the Internet’’; and 
(2) in the second sentence, by striking ‘‘if he determines 
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 amended by— 
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122 STAT. 4825 
PUBLIC LAW 110–425—OCT. 15, 2008 
(1) striking ‘‘(d) Every’’ and inserting ‘‘(d)(1) Every’’; and 
(2) adding at the end the following: 
‘‘(2) Each pharmacy with a modified registration under section 
303(f) that authorizes the dispensing of controlled 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 para-
graph, may not require any pharmacy to report any information 
other than the total quantity of each controlled substance that 
the pharmacy has dispensed each month. For purposes of this 
paragraph, 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 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 comply with the 
requirements of State law concerning the licensure 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 INFORMATION.— 
Each online pharmacy shall post in a visible and clear manner 
on the homepage of each Internet site it operates, or on a page 
directly linked thereto in which the hyperlink is also visible and 
clear on the homepage, the following information for each pharmacy 
that delivers, distributes, or dispenses controlled substances pursu-
ant to orders 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 Administration certificate 
of registration. 
‘‘(2) The pharmacy’s telephone number and email address. 
‘‘(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 registered under 
this part to deliver, distribute, or dispense by means of the 
Internet controlled substances. 
Certification. 
21 USC 831. 
Regulations. 
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122 STAT. 4826 
PUBLIC LAW 110–425—OCT. 15, 2008 
‘‘(6) The name, address, telephone number, professional 
degree, and States of licensure of any practitioner who has 
a contractual relationship to provide medical evaluations or 
issue prescriptions for controlled 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 legitimate medical purpose based upon a medical 
relationship with a prescribing practitioner. This includes at 
least one prior in-person medical evaluation or medical evalua-
tion via telemedicine in accordance with applicable require-
ments of section 309.’. 
‘‘(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 dis-
pense 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 General and the applicable State boards 
of pharmacy, under penalty of perjury, that the information 
disclosed on its Internet site under subsection (c) is true 
and accurate; 
‘‘(B) the online pharmacy’s Internet site address and 
a certification that the online pharmacy shall notify the 
Attorney General of any change in the address at least 
30 days in advance; and 
‘‘(C) the Drug Enforcement Administration registration 
numbers of any pharmacies and practitioners referred to 
in subsection (c), as applicable. 
‘‘(3) EXISTING ONLINE PHARMACIES.—An online pharmacy 
that is already operational as of the effective 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, notification, or 
disclosure required under this section shall be considered 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 manner as the Secretary and the 
Attorney General determine appropriate, of the Indian tribes 
or tribal organizations with which the Secretary has contracted 
Regulations. 
Deadline. 
Deadline. 
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122 STAT. 4827 
PUBLIC LAW 110–425—OCT. 15, 2008 
or compacted under the Indian Self-Determination and Edu-
cation Assistance Act for the tribes or tribal organizations 
to provide pharmacy services. 
‘‘(2) DESIGNATIONS.— 
‘‘(A) IN
GENERAL.—The Secretary may designate a 
practitioner described in subparagraph (B) as an Internet 
Eligible Controlled Substances 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 population served by the practi-
tioner is in a sufficiently remote location that access to 
medical services is limited. 
‘‘(B) PRACTITIONERS.—A practitioner described in this 
subparagraph is a practitioner who is an employee or con-
tractor of the Indian Health Service, or is working for 
an Indian tribe or tribal organization under its contract 
or compact under the Indian Self-Determination and Edu-
cation 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 in the practice 
of telemedicine for purposes of section 102(54)(E) if the practi-
tioner, 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 registration of 
a hospital or clinic operated by the Department of 
Veterans Affairs registered under section 303(f). 
‘‘(2) REGULATIONS.—The Attorney General shall, with the 
concurrence of the Secretary, promulgate 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. 
‘‘(3) DENIALS.—Proceedings to deny an application for reg-
istration 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 authorization 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 
accordance 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 
Regulations. 
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122 STAT. 4828 
PUBLIC LAW 110–425—OCT. 15, 2008 
the Attorney General the authorization of that emergency 
prescription. 
‘‘(j) CLARIFICATION CONCERNING PRESCRIPTION TRANSFERS.— 
Any transfer between pharmacies of information relating to a 
prescription for a controlled substance shall meet the applicable 
requirements under regulations promulgated by the Attorney Gen-
eral under this Act.’’. 
(2) TECHNICAL AND CONFORMING AMENDMENTS.—The table 
of contents for the Comprehensive 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 following: 
‘‘Sec. 311. Additional requirements relating to online pharmacies and telemedi-
cine.’’. 
(e) OFFENSES INVOLVING CONTROLLED SUBSTANCES IN SCHED-
ULES III, IV, AND V.—Section 401(b) of the Controlled 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 sentenced to a term of imprisonment 
of not more than 15 years, a fine not to exceed the greater of 
that authorized in accordance 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. 
‘‘(ii) If any person commits such a violation after a prior convic-
tion 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 sentenced 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 indi-
vidual 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 become final,’’ and 
inserting ‘‘after a prior conviction for a felony drug offense 
has become final,’’; and 
(3) in paragraph (3)— 
Penalties. 
Regulations. 
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122 STAT. 4829 
PUBLIC LAW 110–425—OCT. 15, 2008 
(A) by striking ‘‘2 years’’ and inserting ‘‘4 years’’; 
(B) by striking ‘‘after one or more convictions’’ 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 conviction, impose a term of 
supervised release of not more than 1 year, in addition 
to such term of imprisonment.’’. 
(f) OFFENSES INVOLVING DISPENSING
OF CONTROLLED SUB-
STANCES 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 CONTROLLED SUB-
STANCES BY MEANS OF THE INTERNET.— 
‘‘(1) IN GENERAL.—It shall be unlawful for any person to 
knowingly or intentionally— 
‘‘(A) deliver, distribute, or dispense a controlled sub-
stance 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 activity described 
in subparagraph (A) that is not authorized by this title. 
‘‘(2) EXAMPLES.—Examples of activities that violate para-
graph (1) include, but are not limited to, knowingly or inten-
tionally— 
‘‘(A) delivering, distributing, or dispensing a controlled 
substance by means of the Internet by an online pharmacy 
that is not validly registered with a modification author-
izing such activity as required by section 303(f) (unless 
exempt from such registration); 
‘‘(B) writing a prescription for a controlled substance 
for the purpose of delivery, distribution, 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 manner not authorized by sections 303(f) 
or 309(e); 
‘‘(D) offering to fill a prescription for a controlled sub-
stance 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 notification 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 dispensation of 
controlled substances by nonpractitioners 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 information without attempting to 
propose or facilitate an actual transaction involving 
a controlled substance; or 
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122 STAT. 4830 
PUBLIC LAW 110–425—OCT. 15, 2008 
‘‘(iii) except as provided in subparagraph (B), any 
activity that is limited to— 
‘‘(I) the provision of a telecommunications 
service, or of an Internet access service or Internet 
information location tool (as those terms are 
defined in section 231 of the Communications Act 
of 1934); or 
‘‘(II) the transmission, storage, retrieval, 
hosting, formatting, or translation (or any com-
bination thereof) of a communication, without 
selection or alteration of the content of the commu-
nication, except that deletion of a particular 
communication or material made by another per-
son in a manner consistent with section 230(c) 
of the Communications Act of 1934 shall not con-
stitute 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 person who violates paragraph (1). 
‘‘(4) KNOWING OR INTENTIONAL VIOLATION.—Any person who 
knowingly or intentionally violates 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 knowingly or 
intentionally use the Internet, or cause the Internet to be used, 
to advertise the sale of, or to offer to sell, distribute, 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 intentionally causing 
the placement on the Internet of an advertisement that refers 
to or directs prospective buyers to Internet 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 controlled sub-
stances 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 attempting to facilitate 
an actual transaction involving a controlled substance.’’. 
(h) INJUNCTIVE RELIEF.—Section 512 of the Controlled Sub-
stances Act (21 U.S.C. 882) is amended by adding at the end 
the following: 
‘‘(c) STATE CAUSE OF ACTION PERTAINING TO ONLINE PHAR-
MACIES.— 
‘‘(1) IN
GENERAL.—In any case in which the State has 
reason to believe that an interest of the residents 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 
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122 STAT. 4831 
PUBLIC LAW 110–425—OCT. 15, 2008 
bring a civil action 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 compensa-
tion, 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.— 
‘‘(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 district 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 Attorney General 
and the appropriate United States Attorney on the same 
day that the State’s complaint is filed in Federal district 
court of the United States. Such proceedings shall be inde-
pendent of, and not in lieu of, criminal prosecutions 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 Procedure. 
‘‘(3) POWERS CONFERRED BY STATE LAW.—For purposes of 
bringing any civil action under paragraph (1), nothing in this 
Act shall prevent an attorney general of a State from exercising 
the powers conferred on the attorney general of a State by 
the laws of such State to conduct investigations or to administer 
oaths or affirmations or to compel the attendance 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 organization, to the 
extent such tribe or tribal organization is lawfully carrying 
out a contract or compact under the Indian Self-Determina-
tion and Education Assistance Act; or 
‘‘(C) any employee of the United States or such Indian 
tribe or tribal organization, provided such agent or 
employee is acting in the usual course of business or 
Records. 
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122 STAT. 4832 
PUBLIC LAW 110–425—OCT. 15, 2008 
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 controlled sub-
stance in schedule III, IV, or V, (except a violation involving 
flunitrazepam and except a violation involving gamma 
hydroxybutyric 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 inserting ‘‘sentenced 
in accordance with section 401(b)(1)(D).’’; 
(2) by adding at the end the following: 
‘‘(5) In the case of a violation of subsection (a) involving a 
controlled substance in schedule III, such person shall be sentenced 
in accordance with section 401(b)(1). 
‘‘(6) In the case of a violation of subsection (a) involving a 
controlled substance in schedule IV, such person shall be sentenced 
in accordance with section 401(b)(2). 
‘‘(7) In the case of a violation of subsection (a) involving a 
controlled substance in schedule V, such person shall be sentenced 
in accordance with section 401(b)(3).’’; and 
(3) in paragraph (3), by striking ‘‘, nor shall a person 
so sentenced be eligible for parole during the term of such 
a sentence’’ in the final sentence. 
(j) EFFECTIVE DATE.— 
(1) IN GENERAL.—Except as provided in paragraph (2), the 
amendments made by this Act shall take effect 180 days after 
the date of enactment of this Act. 
(2) DEFINITION OF PRACTICE OF TELEMEDICINE.— 
(A) IN GENERAL.—Until the earlier of 3 months after 
the date on which regulations are promulgated to carry 
out section 311(h) of the Controlled Substances Act, as 
amended by this Act, or 15 months after the date of enact-
ment of this Act— 
(i) the definition of the term ‘‘practice of telemedi-
cine’’ in subparagraph (B) of this paragraph shall apply 
for purposes of the Controlled Substances Act; and 
(ii) the definition of the term ‘‘practice of telemedi-
cine’’ in section 102(54) of the Controlled Substances 
Act, as amended by this Act, shall not apply. 
(B) TEMPORARY PHASE-IN OF TELEMEDICINE REGULA-
TION.—During the period specified in subparagraph (A), 
the term ‘‘practice of telemedicine’’ means the practice of 
medicine in accordance with applicable Federal and State 
laws by a practitioner (as that term is defined in section 
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 tele-
communications system referred to in section 1834(m) of 
the Social Security Act (42 U.S.C. 1395m(m)), if the practi-
tioner is using an interactive telecommunications system 
that satisfies the requirements of section 410.78(a)(3) of 
title 42, Code of Federal Regulations. 
Deadline. 
21 USC 802 
note. 
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122 STAT. 4833 
PUBLIC LAW 110–425—OCT. 15, 2008 
(C) RULE
OF
CONSTRUCTION.—Nothing in this sub-
section may be construed to create a precedent that any 
specific course of conduct constitutes the ‘‘practice of tele-
medicine’’ (as that term is defined in section 102(54) of 
the Controlled Substances Act, as amended by this Act) 
after the end of the period specified in subparagraph (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 func-
tions 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 Sen-
tencing Commission, in determining whether to amend, or 
establish new, guidelines or policy statements, to conform the 
Federal sentencing guidelines and policy statements to this 
Act and the 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 establish 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 Administration, in consultation with 
the Department of State, shall submit to Congress a report 
describing— 
(1) the foreign supply chains and sources of controlled 
substances offered for sale without a valid prescription on the 
Internet; 
(2) the efforts and strategy of the Drug Enforcement 
Administration to decrease the foreign supply chain and sources 
of controlled substances offered for sale without a valid prescrip-
tion on the Internet; and 
(3) the efforts of the Drug Enforcement Administration 
to work with domestic and multinational pharmaceutical 
companies and others to build international cooperation and 
a commitment to fight on a global scale the problem of distribu-
tion of controlled substances over the Internet without a valid 
prescription. 
28 USC 994 
note. 
21 USC 802 
note. 
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122 STAT. 4834 
PUBLIC LAW 110–425—OCT. 15, 2008 
LEGISLATIVE HISTORY—H.R. 6353 (S. 980): 
HOUSE REPORTS: No. 110–869, Pt. 1 (Comm. on Energy and Commerce). 
CONGRESSIONAL RECORD, Vol. 154 (2008): 
Sept. 23, considered and passed House. 
Sept. 30, considered and passed Senate. 
SEC. 4. RULE OF CONSTRUCTION. 
Nothing in this Act or the amendments made by this Act 
shall be construed as authorizing, prohibiting, or limiting the use 
of electronic prescriptions for controlled substances. 
Approved October 15, 2008. 
21 USC 802 
note. 
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