PUBLIC LAW 110–425—OCT. 15, 2008 

RYAN HAIGHT ONLINE PHARMACY 

CONSUMER PROTECTION ACT OF 2008 


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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 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 practice of telemedicine, within the previous 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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PUBLIC LAW 110–425—OCT. 15, 2008 122 STAT. 4821 

‘‘(3) Nothing in this subsection shall apply to— 

‘‘(A) the delivery, distribution, or dispensing of a controlled 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 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 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 computer 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 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 activities 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 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 contracts or compacts described in such clause; 

‘‘(vi) mere advertisements that do not attempt to facilitate 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 substances in schedule III, IV, or V, as defined in paragraph (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 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— 

‘‘(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 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 professional practice; 

‘‘(ii) acting in accordance with applicable State law; 

and 


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PUBLIC LAW 110–425—OCT. 15, 2008 122 STAT. 4823 

‘‘(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 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, contract, or compact described in clause (i); and 

‘‘(iii) who is designated as an Internet Eligible Controlled 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 controlled substances, as the Secretary, with the concurrence of 

the Attorney General, designates, provided that such designation shall not be subject to the procedures prescribed by subchapter 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 physically present at a hospital or clinic operated by the 

Department of Veterans 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 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 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 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 substances 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 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 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 legitimate medical purpose for the issuance of the new prescription.’’. 

(b) REGISTRATION REQUIREMENTS.—Section 303(f) of the Controlled 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 controlled 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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PUBLIC LAW 110–425—OCT. 15, 2008 122 STAT. 4825 

(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 paragraph, 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 pursuant 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 evaluation via telemedicine in accordance with applicable requirements 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 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 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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PUBLIC LAW 110–425—OCT. 15, 2008 122 STAT. 4827 

or compacted under the Indian Self-Determination and Education 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 practitioner 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 contractor 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 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 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 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 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 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 General 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 telemedicine.’’. 

(e) OFFENSES INVOLVING CONTROLLED SUBSTANCES IN SCHEDULES 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 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 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 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 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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PUBLIC LAW 110–425—OCT. 15, 2008 122 STAT. 4829 

(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 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 CONTROLLED SUBSTANCES 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 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 activity 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 registered with a modification authorizing 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 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 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 combination thereof) of a communication, without 

selection or alteration of the content of the communication, except that deletion of a particular 

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 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 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 attempting to facilitate 

an actual transaction involving a controlled substance.’’. 

(h) INJUNCTIVE RELIEF.—Section 512 of the Controlled Substances Act (21 U.S.C. 882) is amended by adding 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 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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PUBLIC LAW 110–425—OCT. 15, 2008 122 STAT. 4831 

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 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.— 

‘‘(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 independent 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-Determination 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 substance 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 enactment of this Act— 

(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 TELEMEDICINE REGULATION.—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 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 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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PUBLIC LAW 110–425—OCT. 15, 2008 122 STAT. 4833 

(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 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 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 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 prescription 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 distribution 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. 

Æ 

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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