69–006 

110TH CONGRESS REPT. 110–869 " ! HOUSE OF REPRESENTATIVES 2d Session Part 1 

RYAN HAIGHT ONLINE PHARMACY CONSUMER 

PROTECTION ACT OF 2008 

SEPTEMBER 23, 2008.—Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 

Mr. DINGELL, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 6353] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 6353) to amend the Controlled Substances Act to address online pharmacies, having considered the same, report favorably thereon with an amendment and recommend that the bill as 

amended do pass. 

CONTENTS 

Page 

Amendment .............................................................................................................. 1 

Purpose and Summary ............................................................................................ 11 

Background and Need for Legislation .................................................................... 11 

Hearings ................................................................................................................... 12 

Committee Consideration ........................................................................................ 12 

Committee Votes ...................................................................................................... 12 

Committee Oversight Findings ............................................................................... 12 

Statement of General Performance Goals and Objectives .................................... 12 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 12 

Earmarks and Tax and Tariff Benefits .................................................................. 12 

Committee Cost Estimate ....................................................................................... 13 

Congressional Budget Office Estimate ................................................................... 13 

Federal Mandates Statement ................................................................................. 15 

Advisory Committee Statement .............................................................................. 15 

Constitutional Authority Statement ...................................................................... 15 

Applicability to Legislative Branch ........................................................................ 15 

Section-by-Section Analysis of the Legislation ...................................................... 15 

Changes in Existing Law Made by the Bill, as Reported ..................................... 17 

AMENDMENT

The amendment is as follows: 


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Strike all after the enacting clause and insert the following: 

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. 

‘‘(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); 


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‘‘(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; 

‘‘(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 

‘‘(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— 


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‘‘(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— 

‘‘(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.’’. 


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(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— 

(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 pharmacistin-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. 

‘‘(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 AttorVerDate Aug 31 2005 04:20 Sep 29, 2008 Jkt 069006 PO 00000 Frm 00005 Fmt 6659 Sfmt 6621 E:\HR\OC\HR869P1.XXX HR869P1

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ney 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 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 emerVerDate Aug 31 2005 04:20 Sep 29, 2008 Jkt 069006 PO 00000 Frm 00006 Fmt 6659 Sfmt 6621 E:\HR\OC\HR869P1.XXX HR869P1

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gency 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 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)— 

(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 


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‘‘(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 

‘‘(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.’’. 


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(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 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 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). 


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10 

‘‘(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. 

(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. 


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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 limiting the use of electronic prescriptions for controlled 

substances. 

PURPOSE AND SUMMARY

The purpose of H.R. 6353, the Ryan Haight Online Pharmacy 

Consumer Protection Act of 2008, is to amend the Controlled Substances Act to prohibit the delivery, distribution, or dispensing of 

controlled substances over the Internet without a valid prescription. 

In an effort to address concerns about the purchase of controlled 

substances through online pharmacies, H.R. 6353 defines a ‘‘valid 

prescription’’ as a prescription that is issued for a legitimate purpose by a practitioner who has conducted at least one in-person 

medical evaluation of the patient. 

H.R. 6353 imposes registration and reporting requirements on 

online pharmacies. H.R. 6353 requires an online pharmacy to: (1) 

display on its Internet homepage a statement that it complies with 

the requirements of this Act; (2) comply with State laws for the licensure of pharmacies in each State in which it operates or sells 

controlled substances; (3) post on its Internet homepage specified 

information, including the name, address, and telephone number of 

the pharmacy, the qualifications of its pharmacist-in-charge, and a 

certification of its registration under this Act; and (4) notify the Attorney General and applicable State boards of pharmacy at least 30 

days prior to offering to sell, deliver, distribute, or dispense controlled substances over the Internet. 

H.R. 6353 increases criminal penalties involving controlled substances in Schedules II, IV, and V of the Controlled Substances 

Act. H.R. 6353 also authorizes States to apply for injunctions or obtain damages and other civil remedies against online pharmacies 

that are deemed a threat to State residents. 

BACKGROUND AND NEED FOR LEGISLATION

According to the Drug Enforcement Agency (DEA), nearly 7 million Americans are abusing prescription drugs, more than the numbers who are abusing cocaine, heroin, hallucinogens, Ecstasy, and 

inhalants, combined. The number of individuals abusing prescription drugs has increased 80 percent in the last 6 years. 

Prescription pain relievers have replaced marijuana and cocaine 

as new drug users’ drug of choice. Nearly 1 in 10 high school seniors admits to abusing powerful prescription painkillers. A shocking 

40 percent of teenagers and an almost equal number of their parents think abusing prescription painkillers is safer than abusing 

‘‘street’’ drugs. Prescription pain relievers appear to be among the 

drugs most heavily dispensed by certain Internet pharmacies 

through prescriptions that are issued based on online questionnaires. This practice has been abused by rogue pharmacy sites that 

dispense large quantities of addictive substances to customers seeking access to prescription painkillers, leading to instances of addiction, overdose, and death. As of July 2004, DEA investigations had 

discovered 14 deaths or overdoses and 15 persons who have entered 

rehabilitation or sustained injuries from drugs obtained over the 

Internet. 


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The Internet, through Internet pharmacies, has become one of 

the fastest growing methods used today to purchase huge quantities of controlled pharmaceuticals. It is estimated there are between 400 and 1,000 Web sites that both dispense and offer a prescribing service, half of which are located in foreign countries. 

HEARINGS

No hearings were held in connection with H.R. 6353. 

COMMITTEE CONSIDERATION

On Wednesday, September 17, 2008, the full Committee met in 

open markup session and ordered H.R. 6353 favorably reported to 

the House, amended, by a voice vote. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion 

to report legislation and amendments thereto. No record votes were 

taken on amendments or in connection with ordering H.R. 6353 reported to the House. A motion by Mr. Dingell to order H.R. 6353 

favorably reported to the House, amended, was agreed to by a voice 

vote. 

COMMITTEE OVERSIGHT FINDINGS

Regarding clause 3(c)(1) of rule XIII of the Rules of the House 

of Representatives, the oversight findings of the Committee regarding H.R. 6353 are reflected in this report. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

The objective of H.R. 6353 is to counter the growing sale of controlled substances over the Internet without adequate medical 

oversight. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

Regarding compliance with clause 3(c)(2) of rule XIII of the Rules 

of the House of Representatives, the Committee adopts as its own 

the estimate of budget authority and revenues regarding H.R. 6353 

prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974. The 

Committee finds that the bill would result in no new or increased 

entitlement authority or tax expenditures. 

EARMARKS AND TAX AND TARIFF BENEFITS

Regarding compliance with clause 9 of rule XXI of the Rules of 

the House of Representatives, H.R. 6353 does not contain any congressional earmarks, limited tax benefits, or limited tariff benefits 

as defined in clause 9(d), 9(e), or 9(f) of rule XXI. 


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13 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate on H.R. 6353 

prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate on H.R. 6353 

provided by the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974: 

SEPTEMBER 23, 2008. 

Hon. JOHN D. DINGELL, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 6353, the Ryan Haight 

Online Pharmacy Consumer Protection Act of 2008. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Mark Grabowicz, who 

can be reached at 226–2860. 

Sincerely, 

PETER R. ORSZAG. 

Enclosure. 

H.R. 6353—Ryan Haight Online Pharmacy Consumer Protection 

Act of 2008 

Summary: H.R. 6353 would permit the Drug Enforcement Administration (DEA) to authorize certain pharmacies to distribute 

controlled substances using the Internet. CBO estimates that implementing H.R. 6353 would have no significant net cost to the federal government. Enacting the bill could affect direct spending and 

revenues, but CBO estimates that any net effects would not be significant. 

H.R. 6353 contains an intergovernmental mandate as defined in 

the Unfunded Mandates Reform Act (UMRA) because it would preempt state regulations of controlled substances that are manufactured, distributed, or dispensed via the Internet. CBO estimates, 

however, that states would incur little, if any, costs as a result of 

that preemption, and the costs to comply with the mandate would 

be well below the threshold established in UMRA ($68 million in 

2008, adjusted annually for inflation). 

The bill’s registration and reporting requirements and the requirement of a valid prescription for Internet distribution of controlled substances constitute private-sector mandates as defined in 

UMRA. CBO estimates that the direct costs of those mandates 

would not exceed the threshold established in UMRA for privatesector mandates ($136 million in 2008, adjusted annually for inflation). 

Estimated cost to the Federal Government: 

SPENDING SUBJECT TO APPROPRIATION

H.R. 6353 would establish new crimes and increase penalties for 

activities relating to illegal use of controlled substances. Because 


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14 

the bill would establish new offenses, the government would be 

able to pursue cases that it otherwise would not be able to prosecute. We expect that H.R. 6353 would apply to a relatively small 

number of offenders, however, so any increase in costs for law enforcement, court proceedings, or prison operations would not be significant. Any such costs would be subject to the availability of appropriated funds. 

DIRECT SPENDING AND REVENUES

H.R. 6353 would permit the DEA to authorize certain pharmacies to distribute controlled substances using the Internet. The 

agency currently charges a registration fee of $551 for a three-year 

period. Based on information from the DEA about the likely number of new registrants resulting from enactment of H.R. 6353, CBO 

estimates that the agency would collect less than $1 million each 

year. The DEA would spend those fees without further appropriation, mostly in the same year, to conduct inspections and carry out 

administrative activities related to the new registrants. Thus, CBO 

estimates that H.R. 6353 would have no significant net effect on 

DEA spending. 

Because those prosecuted and convicted under H.R. 6353 could 

be subject to criminal fines, the federal government might collect 

additional fines if the legislation is enacted. Criminal fines are recorded as revenues, then deposited in the Crime Victims Fund, and 

later spent. CBO expects that any additional revenues and direct 

spending would not be significant because of the small number of 

cases likely to be affected. 

Estimated impact on State, local, and tribal governments: H.R. 

6353 contains an intergovernmental mandate as defined in UMRA 

because it would preempt state regulations of controlled substances 

that are manufactured, distributed, or dispensed via the Internet. 

Under current law, states license pharmacies and doctors to dispense controlled substances within each state. This bill would prohibit the sale of controlled substances that are sold over the Internet without a prescription and would require doctors to have at 

least one in-person consultation with patients for whom they prescribe controlled medications. Currently, all states allow medications to be purchased via the Internet, but some states do not specifically require in-person consultations for prescriptions. Enacting 

this provision would preempt state authority. CBO estimates, however, that states would incur little, if any costs, as a result of that 

preemption, and the costs to comply with the mandate would be 

well below the threshold established in UMRA ($68 million in 

2008, adjusted annually for inflation). 

Estimated impact on the private sector: The bill’s registration 

and reporting requirements and the requirement of a valid prescription for Internet distribution of controlled substances would 

constitute private-sector mandates as defined by UMRA. CBO estimates that the direct costs of those mandates would not exceed the 

threshold established in UMRA ($136 million in 2008, adjusted annually for inflation). 

Previous CBO estimate: On October 25, 2007, CBO transmitted 

a cost estimate for S. 980, the Ryan Haight Online Pharmacy Consumer Protection Act of 2007, as ordered reported by the Senate 


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15 

Committee on the Judiciary on September 27, 2007. The two bills 

are similar, and the cost estimates are nearly identical. 

Estimate prepared by: Federal Costs: Mark Grabowicz; Impact 

on State, Local, and Tribal Governments: Lisa Ramirez-Branum; 

Impact on the Private Sector: Colin Baker. 

Estimate approved by: Peter H. Fontaine, Assistant Director for 

Budget Analysis. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates regarding H.R. 6353 prepared by the Director of the Congressional Budget Office pursuant to section 423 of the Unfunded Mandates Reform Act. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act would be created by H.R. 6353. 

CONSTITUTIONAL AUTHORITY STATEMENT

Pursuant to clause 3(d)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee finds that the Constitutional authority for H.R. 6353 is provided in Article I, section 8, clause 3, 

which grants Congress the power to regulate commerce with foreign nations, among the several States, and with the Indian Tribes. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that H.R. 6353 does not relate to the terms 

and conditions of employment or access to public services or accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act of 1995. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title 

Section 1 establishes the short title as the Ryan Haight Online 

Pharmacy Consumer Protection Act of 2008. 

Section 2. Requirement of a valid prescription for controlled substances dispensed by means of the Internet 

Section 2 adds a new section 309(e) to the Controlled Substances 

Act requiring a valid prescription for the delivery or distribution of 

a controlled substance that is a prescription drug. A ‘‘valid prescription’’ is defined as a prescription issued for a legitimate medical purpose in the usual course of professional practice, by a practitioner who has conducted at least one in-person medical evaluation of the patient, or a covering practitioner (as requested by a 

practitioner who had conducted an in-person medical evaluation of 

the patient within the past 24 months). Certain telemedicine practices are exempted from the in-person medical evaluation requirement. 


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Section 3. Amendments to the Controlled Substances Act relating to 

the delivery of controlled substances by means of the Internet 

Section 3(a) defines the following terms: Internet; deliver, distribute, or dispense by means of the Internet; online pharmacy; and 

practice of telemedicine. 

Section 3(a) exempts from the definition of ‘‘online pharmacy’’ 

non-pharmacy practitioners, hospitals, or medical facilities operated by agencies of the United States, health facilities owned by Indian Tribes carrying out contracts or compacts under the Indian 

Self Determination and Education Assistance Act, and mere advertisements that do not attempt to facilitate an actual transaction. 

Section 3(a) exempts pharmacies that use the Internet only to receive refill orders, or requests to contact a patient’s physician. 

Section 3(b) requires pharmacies that seek to dispense controlled 

substances via the Internet to receive a modification of their existing registration to dispense controlled substances by means of the 

Internet. 

Section 3(c) requires pharmacies with a modified registration to 

report to the Attorney General the total quantity of each controlled 

substance dispensed per month. Reporting is required only when 

pharmacies dispense at least 100 or more controlled substance prescriptions per month or 500 or more controlled substance dosage 

units per month. 

Section 3(d) requires pharmacies to clearly display notification 

that they comply with the requirements of this Act. Pharmacies 

must post information regarding: name and address of the pharmacy as it appears on its DEA registration; a list of States in 

which the pharmacy is licensed to distribute prescription drugs or 

controlled substances; name and degree of pharmacist in charge; 

contact information for the pharmacist in charge; and the name 

and contact information of any practitioners with a contractual relationship to issue controlled substance prescriptions. Pharmacies 

must notify the U.S. Attorney General and State boards of pharmacy 30 days before delivering, distributing, or dispensing a controlled substance. 

Section 3(d) authorizes the Secretary to designate certain practitioners as ‘‘Internet Eligible Controlled Substance Providers’’ and 

allows the U.S. Attorney General to issue special registrations for 

the practice of telemedicine. Section 3(d) describes reporting criteria for emergency prescriptions issued under the Veterans Health 

Administration emergency telemedicine exemption. Section 3(d) 

clarifies that any transfer of prescription information from one 

pharmacy to another must meet applicable requirements in the 

Controlled Substances Act. 

Section 3(e) increases the penalties for all illegal distributions of 

Schedule III, IV, and V controlled substances. For Schedule III controlled substances, maximum penalties are increased to 10 years 

for first offenders and 20 years for repeat offenders, or 15 and 30 

years, respectively, if death or serious bodily injury results. For 

Schedule IV substances, the new penalties are 5 years for first offenders and 10 years for repeat offenders. For Schedule V repeat 

offenders, the maximum penalty increases to four years. Supervised release terms after imprisonment for a Schedule V offense 

are also authorized. 


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Section 3(f) clarifies that knowingly or intentionally delivering, 

distributing, or dispensing controlled substances over the Internet 

in violation of this Act can be prosecuted and penalized just like 

hand-to-hand distributions. This provision does not apply, however, 

to persons who register and follow the requirements of this Act, to 

those who merely advocate usage or list pricing information, but do 

not promote or facilitate an actual transaction involving a controlled substance, or to anyone providing telecommunications or 

Internet services who are not acting in concert with persons violating this Act. 

Section 3(g) clarifies that Internet sales of controlled substances 

must follow the terms of this Act. The Act does not apply to material that advocates the use of controlled substances or does not attempt to facilitate an actual transaction. 

Section 3(h) authorizes State Attorneys General to file civil lawsuits in Federal court against online businesses if the residents of 

a State are threatened or adversely affected by noncompliance, so 

long as the U.S. Attorney General is notified in advance and given 

a chance to intervene within 120 days. 

Section 3(j) applies the same penalty changes made to the Controlled Substances Act to the Import and Export Act. 

Section 3(k) establishes an effective date of 180 days after enactment. Section 3(k) also creates a temporary definition for ‘‘practice 

of telemedicine’’ that will apply for the first 15 months following 

enactment. 

Section 3(l) authorizes the U.S. Attorney General to promulgate 

and enforce any rules, regulations, and procedures as necessary for 

the efficient execution of functions under this Act. The United 

States Sentencing Commission is authorized to add or modify the 

Sentencing Guidelines as warranted. The Commission, however, 

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. 

Section 3(m) requires the DEA to provide a report to Congress 

within 180 days after enactment, and annually for 2 additional 

years, describing the foreign supply chains and sources of controlled substances illegally offered over the Internet, and the DEA’s 

efforts and strategies to confront these global challenges. 

Section 4. Rule of construction 

Section 4 clarifies that nothing in the Act shall be construed as 

authorizing, prohibiting, or limiting the use of electronic prescribing for controlled substances. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

existing law in which no change is proposed is shown in roman): 


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COMPREHENSIVE DRUG ABUSE PREVENTION AND 

CONTROL ACT OF 1970 

* * * * * * * 

TABLE OF CONTENTS

TITLE II—CONTROL AND ENFORCEMENT

PART A—SHORT TITLE; FINDINGS AND DECLARATION; DEFINITIONS

Sec. 100. Short title. 

* * * * * * * 

PART C—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF

CONTROLLED SUBSTANCES; PIPERIDINE REPORTING

Sec. 301. Rules and regulations. 

* * * * * * * 

Sec. 311. Additional requirements relating to online pharmacies and telemedicine. 

* * * * * * * 

TITLE II—CONTROL AND ENFORCEMENT 

PART A—SHORT TITLE; FINDINGS AND DECLARATION; DEFINITIONS

SHORT TITLE

SEC. 100. This title may be cited as the ‘‘Controlled Substances 

Act’’. 

* * * * * * * 

DEFINITIONS

SEC. 102. As used in this title: 

(1) * * * 

* * * * * * * 

(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; 


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(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; 

(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; 


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(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 

(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— 


wwoods2 on PRODPC68 with REPORTS
21 

(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— 

(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’’); 


wwoods2 on PRODPC68 with REPORTS
22 

(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. 

* * * * * * * 

PART C—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND

DISPENSERS OF CONTROLLED SUBSTANCES; PIPERIDINE REPORTING

* * * * * * * 

REGISTRATION REQUIREMENTS

SEC. 303. (a) * * * 

* * * * * * * 

(f) The Attorney General shall register practitioners (including 

pharmacies, as distinguished from pharmacists) to dispense, or conduct research with, controlled substances in schedule II, III, IV, or 

V and shall modify the registrations of pharmacies so registered to 

authorize them to dispense controlled substances by means of the 

Internet, if the applicant is authorized to dispense, or conduct research with respect to, controlled substances under the laws of the 

State in which he practices. The Attorney General may deny an application for such registration øif he determines that the issuance 

of such registration¿ or such modification of registration if the Attorney General determines that the issuance of such registration or 

modification would be inconsistent with the public interest. In determining the public interest, the following factors shall be considered: 

(1) * * * 

* * * * * * * 

RECORDS AND REPORTS OF REGISTRANTS

SEC. 307. (a) * * * 

* * * * * * * 

ø(d) Every¿ (d)(1) Every manufacturer registered under section 

303 shall, at such time or times and in such form as the Attorney 

General may require, make periodic reports to the Attorney General of every sale, delivery or other disposal by him of any controlled substance, and each distributor shall make such reports 

with respect to narcotic controlled substances, identifying by the 

registration number assigned under this title the person or establishment (unless exempt from registration under section 302(d) to 

whom such sale, delivery, or other disposal was made. 

(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 


wwoods2 on PRODPC68 with REPORTS
23 

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. 

* * * * * * * 

PRESCRIPTIONS

SEC. 309. (a) * * * 

* * * * * * * 

(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. 

(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 GenVerDate Aug 31 2005 04:20 Sep 29, 2008 Jkt 069006 PO 00000 Frm 00023 Fmt 6659 Sfmt 6603 E:\HR\OC\HR869P1.XXX HR869P1

wwoods2 on PRODPC68 with REPORTS
24 

eral by regulation, which shall be consistent with effective 

controls against diversion. 

* * * * * * * 

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. 

(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 onVerDate Aug 31 2005 04:20 Sep 29, 2008 Jkt 069006 PO 00000 Frm 00024 Fmt 6659 Sfmt 6603 E:\HR\OC\HR869P1.XXX HR869P1

wwoods2 on PRODPC68 with REPORTS
25 

line 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 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 


wwoods2 on PRODPC68 with REPORTS
26 

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 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. 

PART D—OFFENSES AND PENALTIES

PROHIBITED ACTS A—PENALTIES

SEC. 401. (a) * * * 

(b) Except as otherwise provided in section 409, 418, 419, or 420 

any person who violates subsection (a) of this section shall be sentenced as follows: 


wwoods2 on PRODPC68 with REPORTS
27 

(1)(A) * * * 

* * * * * * * 

(D) In the case of less than 50 kilograms of marihuana, except 

in the case of 50 or more marihuana plants regardless of weight, 

10 kilograms of hashish, or one kilogram of hashish oil øor in the 

case of any controlled substance in schedule III (other than gamma 

hydroxybutyric acid), or 30 milligrams of flunitrazepam¿, such person shall, except as provided in paragraphs (4) and (5) of this subsection, be sentenced to a term of imprisonment of not more than 

5 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18, United States Code, or 

$250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both. 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 10 years, a fine not to exceed the 

greater of twice that authorized in accordance with the provisions 

of title 18, United State Code, or $500,000 if the defendant is an 

individual or $2,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, any sentence imposing a term of imprisonment under this paragraph shall, 

in the absence of such a prior conviction, impose a special parole 

term 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. 

(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 the case of a controlled substance in schedule IV, such person shall be sentenced to a term of imprisonment of not more than 

ø3 years¿ 5 years, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18, United States 

Code, or $250,000 if the defendant is an individual or $1,000,000 


wwoods2 on PRODPC68 with REPORTS
28 

if the defendant is other than an individual, or both. If any person 

commits such a violation øafter one or more prior convictions of 

him for an offense punishable under this paragraph, or for a felony 

under any other provision of this title or title III or other law of 

a State, the United States, or a foreign country relating to narcotic 

drugs, marihuana, or depressant or stimulant substances, have become final,¿ 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 ø6 years¿ 10 years, a fine not to exceed the 

greater of twice the authorized in accordance with the provisions 

of title 18, United States Code, or $500,000 if the defendant is an 

individual or $2,000,000 if the defendant is other than an individual, or both. Any sentence imposing a term of imprisonment 

under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least one year 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 

2 years in addition to such term of imprisonment. 

(3) In the case of a controlled substance in schedule V, such person shall be sentenced to a term of imprisonment of not more than 

1 year, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18, United States Code, or 

$100,000 if the defendant is an individual or $250,000 if the defendant is other than an individual, or both. If any person commits 

such a violation øafter one or more convictions of him for an offense 

punishable under this paragraph, or for a crime under any other 

provision of this title or title III or other law of a State, the United 

States, or a foreign country relating to narcotic drugs, marihuana, 

or depressant or stimulant substances, have become final,¿ 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 

ø2 years¿ 4 years, a fine not to exceed the provisions of title 18, United States Code, or $200,000 if the defendant is an individual 

or $500,000 if the defendant is other than an individual, or both. 

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. 

* * * * * * * 

(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 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 authorVerDate Aug 31 2005 04:20 Sep 29, 2008 Jkt 069006 PO 00000 Frm 00028 Fmt 6659 Sfmt 6603 E:\HR\OC\HR869P1.XXX HR869P1

wwoods2 on PRODPC68 with REPORTS
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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 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 

(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). 

* * * * * * * 

PROHIBITED ACTS C—PENALTIES

SEC. 403. (a) * * * 

* * * * * * * 

ø(c)¿ (c)(1) It shall be unlawful for any person to place in any 

newspaper, magazine, handbill, or other publications, any written 

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wwoods2 on PRODPC68 with REPORTS
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ing illegally to receive, buy, or distribute a Schedule I controlled 

substance. As used in this section the term ‘‘advertisement’’ includes, in addition to its ordinary meaning, such advertisements as 

those for a catalog of Schedule I controlled substances and any 

similar written advertisement that has the purpose of seeking or 

offering illegally to receive, buy, or distribute a Schedule I controlled substance. The term ‘‘advertisement’’ does not include material which merely advocates the use of a similar material, which 

advocates a position or practice, and does not attempt to propose 

or facilitate an actual transaction in a Schedule I controlled substance. 

(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. 

* * * * * * * 

PART E—ADMINISTRATIVE AND ENFORCEMENT PROVISIONS

* * * * * * * 

INJUNCTIONS

SEC. 512. (a) * * * 

* * * * * * * 

(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 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.— 


wwoods2 on PRODPC68 with REPORTS
31 

(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 employment, and within the scope of the official duties of such 

agent or employee therewith. 

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32 

TITLE III—IMPORTATION AND EXPORTATION; 

AMENDMENTS AND REPEALS OF REVENUE LAWS 

SHORT TITLE

SEC. 1000. This title may be cited as the ‘‘Controlled Substances 

Import and Export Act’’. 

* * * * * * * 

PART A—IMPORTATION AND EXPORTATION

* * * * * * * 

PROHIBITED ACTS A—PENALTIES

SEC. 1010. (a) * * * 

(b)(1) * * * 

* * * * * * * 

(3) In the case of a violation under subsection (a) of this section 

involving a controlled substance in schedule I or II, gamma hydroxybutyric acid (including when scheduled as an approved drug product for purposes of section 3(a)(1)(B) of the Hillory J. Farias and 

Samantha Reid Date-Rape Drug Prohibition Act of 2000), or 

flunitrazepam, the person committing such violation shall, except 

as provided in paragraphs (1), (2), and (4), 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 less than twenty years and 

not more than life, a fine not to exceed the greater of 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. 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 30 years and if death or serious 

bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of 

twice that authorized in accordance with the provisions of title 18, 

United States Code, or $2,000,000 if the defendant is an individual 

or $10,000,000 if the defendant is other than an individual, or both. 

Notwithstanding section 3583 of title 18, any sentence imposing a 

term of imprisonment under this paragraph shall, in the absence 

of such a prior conviction, impose a term of suspervised release of 

at least 3 years in addition to such term of imprisonment and shall, 

if there was such a prior conviction, impose a term of suspervised 

release of at least 6 years in addition to such term of imprisonment. Notwithstanding the prior sentence, and notwithstanding 

any other provision of law, the court shall not place on probation 

or suspend the sentence of any person sentenced under the provisions of this paragraph which provide for a mandatory term of imprisonment if death or serious bodily injury resultsø, nor shall a 

person so sentenced be eligible for parole during the term of such 

a sentence¿. 

(4) In the case of a violation under subsection (a) with respect to 

less than 50 kilograms of marihuana except in the case of 100 or 

more marihuana plants regardless of weight, less than 10 kiloVerDate Aug 31 2005 04:20 Sep 29, 2008 Jkt 069006 PO 00000 Frm 00032 Fmt 6659 Sfmt 6601 E:\HR\OC\HR869P1.XXX HR869P1

wwoods2 on PRODPC68 with REPORTS
33 

grams of hashish, or less than one kilogram of hashish oil, øor 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)¿ the person committing such violation 

shall be øimprisoned not more than five years, or be fined not to 

exceed the greater of that authorized in accordance with the provisions of title 18, United States Code, or $250,000 if the defendant 

is an individual or $1,000,000 if the defendant is other than an individual, or both.¿ sentenced in accordance with section 

401(b)(1)(D). 

(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). 

* * * * * * * 

Æ 


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