Ryan Haight Online Pharmacy Consumer Protection Act of 2008

PUBLIC LAW 110–425—OCT. 15, 2008

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RYAN HAIGHT ONLINE PHARMACY
CONSUMER PROTECTION ACT OF 2008

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PUBLIC LAW 110–425—OCT. 15, 2008

Public Law 110–425
110th Congress
An Act
Oct. 15, 2008
[H.R. 6353]
Ryan Haight
Online Pharmacy
Consumer
Protection Act
of 2008.
21 USC 801
note.

To amend the Controlled Substances Act to address online pharmacies.

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Ryan Haight Online Pharmacy
Consumer Protection Act of 2008’’.
SEC. 2. REQUIREMENT OF A VALID PRESCRIPTION FOR CONTROLLED
SUBSTANCES DISPENSED BY MEANS OF THE INTERNET.

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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.

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‘‘(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.

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(a) IN GENERAL.—Section 102 of the Controlled Substances
Act (21 U.S.C. 802) is amended by adding at the end the following:
‘‘(50) The term ‘Internet’ means collectively the myriad of computer and telecommunications facilities, including equipment and
operating software, which comprise the interconnected worldwide
network of networks that employ the Transmission Control Protocol/
Internet Protocol, or any predecessor or successor protocol to such
protocol, to communicate information of all kinds by wire or radio.
‘‘(51) The term ‘deliver, distribute, or dispense by means of
the Internet’ refers, respectively, to any delivery, distribution, or
dispensing of a controlled substance that is caused or facilitated
by means of the Internet.
‘‘(52) The term ‘online pharmacy’—
‘‘(A) means a person, entity, or Internet site, whether in
the United States or abroad, that knowingly or intentionally
delivers, distributes, or dispenses, or offers or attempts to
deliver, distribute, or dispense, a controlled substance by means
of the Internet; and
‘‘(B) does not include—
‘‘(i) manufacturers or distributors registered under subsection (a), (b), (d), or (e) of section 303 who do not dispense
controlled substances to an unregistered individual or
entity;
‘‘(ii) nonpharmacy practitioners who are registered
under section 303(f) and whose activities are authorized
by that registration;
‘‘(iii) any hospital or other medical facility that is operated by an agency of the United States (including the
Armed Forces), provided such hospital or other facility
is registered under section 303(f);
‘‘(iv) a health care facility owned or operated by an
Indian tribe or tribal organization, only to the extent such
facility is carrying out a contract or compact under the
Indian Self-Determination and Education Assistance Act;
‘‘(v) any agent or employee of any hospital or facility
referred to in clause (iii) or (iv), provided such agent or
employee is lawfully acting in the usual course of business
or employment, and within the scope of the official duties
of such agent or employee, with such hospital or facility,
and, with respect to agents or employees of health care
facilities specified in clause (iv), only to the extent such
individuals are furnishing services pursuant to the contracts or compacts described in such clause;
‘‘(vi) mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance;

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‘‘(vii) a person, entity, or Internet site that is not
in the United States and does not facilitate the delivery,
distribution, or dispensing of a controlled substance by
means of the Internet to any person in the United States;
‘‘(viii) a pharmacy registered under section 303(f) whose
dispensing of controlled substances via the Internet consists
solely of—
‘‘(I) refilling prescriptions for controlled substances
in schedule III, IV, or V, as defined in paragraph
(55); or
‘‘(II) filling new prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (56); or
‘‘(ix) any other persons for whom the Attorney General
and the Secretary have jointly, by regulation, found it
to be consistent with effective controls against diversion
and otherwise consistent with the public health and safety
to exempt from the definition of an ‘online pharmacy’.
‘‘(53) The term ‘homepage’ means the opening or main page
or screen of the website of an online pharmacy that is viewable
on the Internet.
‘‘(54) The term ‘practice of telemedicine’ means, for purposes
of this title, the practice of medicine in accordance with applicable
Federal and State laws by a practitioner (other than a pharmacist)
who is at a location remote from the patient and is communicating
with the patient, or health care professional who is treating the
patient, using a telecommunications system referred to in section
1834(m) of the Social Security Act, which practice—
‘‘(A) is being conducted—
‘‘(i) while the patient is being treated by, and physically
located in, a hospital or clinic registered under section
303(f); and
‘‘(ii) by a practitioner—
‘‘(I) acting in the usual course of professional practice;
‘‘(II) acting in accordance with applicable State
law; and
‘‘(III) registered under section 303(f) in the State
in which the patient is located, unless the practitioner—
‘‘(aa) is exempted from such registration in
all States under section 302(d); or
‘‘(bb) is—
‘‘(AA) an employee or contractor of the
Department of Veterans Affairs who is acting
in the scope of such employment or contract;
and
‘‘(BB) registered under section 303(f) in
any State or is utilizing the registration of
a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);
‘‘(B) is being conducted while the patient is being treated
by, and in the physical presence of, a practitioner—
‘‘(i) acting in the usual course of professional practice;
‘‘(ii) acting in accordance with applicable State law;
and

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‘‘(iii) registered under section 303(f) in the State in
which the patient is located, unless the practitioner—
‘‘(I) is exempted from such registration in all States
under section 302(d); or
‘‘(II) is—
‘‘(aa) an employee or contractor of the Department of Veterans Affairs who is acting in the scope
of such employment or contract; and
‘‘(bb) registered under section 303(f) in any
State or is using the registration of a hospital
or clinic operated by the Department of Veterans
Affairs registered under section 303(f);
‘‘(C) is being conducted by a practitioner—
‘‘(i) who is an employee or contractor of the Indian
Health Service, or is working for an Indian tribe or tribal
organization under its contract or compact with the Indian
Health Service under the Indian Self-Determination and
Education Assistance Act;
‘‘(ii) acting within the scope of the employment, contract, or compact described in clause (i); and
‘‘(iii) who is designated as an Internet Eligible Controlled Substances Provider by the Secretary under section
311(g)(2);
‘‘(D)(i) is being conducted during a public health emergency
declared by the Secretary under section 319 of the Public Health
Service Act; and
‘‘(ii) involves patients located in such areas, and such controlled substances, as the Secretary, with the concurrence of
the Attorney General, designates, provided that such designation shall not be subject to the procedures prescribed by subchapter II of chapter 5 of title 5, United States Code;
‘‘(E) is being conducted by a practitioner who has obtained
from the Attorney General a special registration under section
311(h);
‘‘(F) is being conducted—
‘‘(i) in a medical emergency situation—
‘‘(I) that prevents the patient from being in the
physical presence of a practitioner registered under
section 303(f) who is an employee or contractor of
the Veterans Health Administration acting in the usual
course of business and employment and within the
scope of the official duties or contract of that employee
or contractor;
‘‘(II) that prevents the patient from being physically present at a hospital or clinic operated by the
Department of Veterans Affairs registered under section 303(f);
‘‘(III) during which the primary care practitioner
of the patient or a practitioner otherwise practicing
telemedicine within the meaning of this paragraph
is unable to provide care or consultation; and
‘‘(IV) that requires immediate intervention by a
health care practitioner using controlled substances
to prevent what the practitioner reasonably believes
in good faith will be imminent and serious clinical
consequences, such as further injury or death; and
‘‘(ii) by a practitioner that—

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‘‘(I) is an employee or contractor of the Veterans
Health Administration acting within the scope of that
employment or contract;
‘‘(II) is registered under section 303(f) in any State
or is utilizing the registration of a hospital or clinic
operated by the Department of Veterans Affairs registered under section 303(f); and
‘‘(III) issues a controlled substance prescription in
this emergency context that is limited to a maximum
of a 5-day supply which may not be extended or refilled;
or
‘‘(G) is being conducted under any other circumstances
that the Attorney General and the Secretary have jointly, by
regulation, determined to be consistent with effective controls
against diversion and otherwise consistent with the public
health and safety.
‘‘(55) The term ‘refilling prescriptions for controlled substances
in schedule III, IV, or V’—
‘‘(A) means the dispensing of a controlled substance in
schedule III, IV, or V in accordance with refill instructions
issued by a practitioner as part of a valid prescription that
meets the requirements of subsections (b) and (c) of section
309, as appropriate; and
‘‘(B) does not include the issuance of a new prescription
to an individual for a controlled substance that individual was
previously prescribed.
‘‘(56) The term ‘filling new prescriptions for controlled substances in schedule III, IV, or V’ means filling a prescription for
an individual for a controlled substance in schedule III, IV, or
V, if—
‘‘(A) the pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other
than by means of the Internet and pursuant to the valid
prescription of a practitioner that meets the applicable requirements of subsections (b) and (c) of section 309 (in this paragraph
referred to as the ‘original prescription’);
‘‘(B) the pharmacy contacts the practitioner who issued
the original prescription at the request of that individual to
determine whether the practitioner will authorize the issuance
of a new prescription for that individual for the controlled
substance described in subparagraph (A); and
‘‘(C) the practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription.’’.
(b) REGISTRATION REQUIREMENTS.—Section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) is amended in the matter
preceding paragraph (1)—
(1) in the first sentence, by adding after ‘‘schedule II,
III, IV, or V’’ the following: ‘‘and shall modify the registrations
of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet’’; and
(2) in the second sentence, by striking ‘‘if he determines
that the issuance of such registration’’ and inserting ‘‘or such
modification of registration if the Attorney General determines
that the issuance of such registration or modification’’.
(c) REPORTING REQUIREMENTS.—Section 307(d) of the Controlled
Substances Act (21 U.S.C. 827(d)) is amended by—

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(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

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‘‘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.

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21 USC 831.

Certification.

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‘‘(6) The name, address, telephone number, professional
degree, and States of licensure of any practitioner who has
a contractual relationship to provide medical evaluations or
issue prescriptions for controlled substances, through referrals
from the website or at the request of the owner or operator
of the website, or any employee or agent thereof.
‘‘(7) The following statement, unless revised by the Attorney
General by regulation: ‘This online pharmacy will only dispense
a controlled substance to a person who has a valid prescription
issued for a legitimate medical purpose based upon a medical
relationship with a prescribing practitioner. This includes at
least one prior in-person medical evaluation or medical evaluation via telemedicine in accordance with applicable requirements of section 309.’.
‘‘(d) NOTIFICATION.—
‘‘(1) IN GENERAL.—Thirty days prior to offering a controlled
substance for sale, delivery, distribution, or dispensing, the
online pharmacy shall notify the Attorney General, in such
form and manner as the Attorney General shall determine,
and the State boards of pharmacy in any States in which
the online pharmacy offers to sell, deliver, distribute, or dispense controlled substances.
‘‘(2) CONTENTS.—The notification required under paragraph
(1) shall include—
‘‘(A) the information required to be posted on the online
pharmacy’s Internet site under subsection (c) and shall
notify the Attorney General and the applicable State boards
of pharmacy, under penalty of perjury, that the information
disclosed on its Internet site under subsection (c) is true
and accurate;
‘‘(B) the online pharmacy’s Internet site address and
a certification that the online pharmacy shall notify the
Attorney General of any change in the address at least
30 days in advance; and
‘‘(C) the Drug Enforcement Administration registration
numbers of any pharmacies and practitioners referred to
in subsection (c), as applicable.
‘‘(3) EXISTING ONLINE PHARMACIES.—An online pharmacy
that is already operational as of the effective date of this
section, shall notify the Attorney General and applicable State
boards of pharmacy in accordance with this subsection not
later than 30 days after such date.
‘‘(e) DECLARATION OF COMPLIANCE.—On and after the date on
which it makes the notification under subsection (d), each online
pharmacy shall display on the homepage of its Internet site, in
such form as the Attorney General shall by regulation require,
a declaration that it has made such notification to the Attorney
General.
‘‘(f) REPORTS.—Any statement, declaration, notification, or
disclosure required under this section shall be considered a report
required to be kept under this part.
‘‘(g) NOTICE AND DESIGNATIONS CONCERNING INDIAN TRIBES.—
‘‘(1) IN GENERAL.—For purposes of sections 102(52) and
512(c)(6)(B), the Secretary shall notify the Attorney General,
at such times and in such manner as the Secretary and the
Attorney General determine appropriate, of the Indian tribes
or tribal organizations with which the Secretary has contracted

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or compacted under the Indian Self-Determination and Education Assistance Act for the tribes or tribal organizations
to provide pharmacy services.
‘‘(2) DESIGNATIONS.—
‘‘(A) IN GENERAL.—The Secretary may designate a
practitioner described in subparagraph (B) as an Internet
Eligible Controlled Substances Provider. Such designations
shall be made only in cases where the Secretary has found
that there is a legitimate need for the practitioner to be
so designated because the population served by the practitioner is in a sufficiently remote location that access to
medical services is limited.
‘‘(B) PRACTITIONERS.—A practitioner described in this
subparagraph is a practitioner who is an employee or contractor of the Indian Health Service, or is working for
an Indian tribe or tribal organization under its contract
or compact under the Indian Self-Determination and Education Assistance Act with the Indian Health Service.
‘‘(h) SPECIAL REGISTRATION FOR TELEMEDICINE.—
‘‘(1) IN GENERAL.—The Attorney General may issue to a
practitioner a special registration to engage in the practice
of telemedicine for purposes of section 102(54)(E) if the practitioner, upon application for such special registration—
‘‘(A) demonstrates a legitimate need for the special
registration; and
‘‘(B) is registered under section 303(f) in the State
in which the patient will be located when receiving the
telemedicine treatment, unless the practitioner—
‘‘(i) is exempted from such registration in all States
under section 302(d); or
‘‘(ii) is an employee or contractor of the Department
of Veterans Affairs who is acting in the scope of such
employment or contract and is registered under section
303(f) in any State or is utilizing the registration of
a hospital or clinic operated by the Department of
Veterans Affairs registered under section 303(f).
‘‘(2) REGULATIONS.—The Attorney General shall, with the
concurrence of the Secretary, promulgate regulations specifying
the limited circumstances in which a special registration under
this subsection may be issued and the procedures for obtaining
such a special registration.
‘‘(3) DENIALS.—Proceedings to deny an application for registration under this subsection shall be conducted in accordance
with section 304(c).
‘‘(i) REPORTING OF TELEMEDICINE BY VHA DURING MEDICAL
EMERGENCY SITUATIONS.—
‘‘(1) IN GENERAL.—Any practitioner issuing a prescription
for a controlled substance under the authorization to conduct
telemedicine during a medical emergency situation described
in section 102(54)(F) shall report to the Secretary of Veterans
Affairs the authorization of that emergency prescription, in
accordance with such requirements as the Secretary of Veterans
Affairs shall, by regulation, establish.
‘‘(2) TO ATTORNEY GENERAL.—Not later than 30 days after
the date that a prescription described in subparagraph (A)
is issued, the Secretary of Veterans Affairs shall report to

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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 SCHEDIII, 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)—

ULES

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Penalties.

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(A) by striking ‘‘2 years’’ and inserting ‘‘4 years’’;
(B) by striking ‘‘after one or more convictions’’ and
all that follows through ‘‘have become final,’’ and inserting
‘‘after a prior conviction for a felony drug offense has
become final,’’; and
(C) by adding at the end the following ‘‘Any sentence
imposing a term of imprisonment under this paragraph
may, if there was a prior conviction, impose a term of
supervised release of not more than 1 year, in addition
to such term of imprisonment.’’.
(f) OFFENSES INVOLVING DISPENSING OF CONTROLLED SUBSTANCES BY MEANS OF THE INTERNET.—Section 401 of the Controlled
Substances Act (21 U.S.C. 841) is amended by adding at the end
the following:
‘‘(h) OFFENSES INVOLVING DISPENSING OF CONTROLLED SUBSTANCES BY MEANS OF THE INTERNET.—
‘‘(1) IN GENERAL.—It shall be unlawful for any person to
knowingly or intentionally—
‘‘(A) deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by
this title; or
‘‘(B) aid or abet (as such terms are used in section
2 of title 18, United States Code) any activity described
in subparagraph (A) that is not authorized by this title.
‘‘(2) EXAMPLES.—Examples of activities that violate paragraph (1) include, but are not limited to, knowingly or intentionally—
‘‘(A) delivering, distributing, or dispensing a controlled
substance by means of the Internet by an online pharmacy
that is not validly registered with a modification authorizing such activity as required by section 303(f) (unless
exempt from such registration);
‘‘(B) writing a prescription for a controlled substance
for the purpose of delivery, distribution, or dispensation
by means of the Internet in violation of section 309(e);
‘‘(C) serving as an agent, intermediary, or other entity
that causes the Internet to be used to bring together a
buyer and seller to engage in the dispensing of a controlled
substance in a manner not authorized by sections 303(f)
or 309(e);
‘‘(D) offering to fill a prescription for a controlled substance based solely on a consumer’s completion of an online
medical questionnaire; and
‘‘(E) making a material false, fictitious, or fraudulent
statement or representation in a notification or declaration
under subsection (d) or (e), respectively, of section 311.
‘‘(3) INAPPLICABILITY.—
‘‘(A) This subsection does not apply to—
‘‘(i) the delivery, distribution, or dispensation of
controlled substances by nonpractitioners to the extent
authorized by their registration under this title;
‘‘(ii) the placement on the Internet of material
that merely advocates the use of a controlled substance
or includes pricing information without attempting to
propose or facilitate an actual transaction involving
a controlled substance; or

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‘‘(iii) except as provided in subparagraph (B), any
activity that is limited to—
‘‘(I) the provision of a telecommunications
service, or of an Internet access service or Internet
information location tool (as those terms are
defined in section 231 of the Communications Act
of 1934); or
‘‘(II) the transmission, storage, retrieval,
hosting, formatting, or translation (or any combination thereof) of a communication, without
selection or alteration of the content of the communication, except that deletion of a particular
communication or material made by another person in a manner consistent with section 230(c)
of the Communications Act of 1934 shall not constitute such selection or alteration of the content
of the communication.
‘‘(B) The exceptions under subclauses (I) and (II) of
subparagraph (A)(iii) shall not apply to a person acting
in concert with a person who violates paragraph (1).
‘‘(4) KNOWING OR INTENTIONAL VIOLATION.—Any person who
knowingly or intentionally violates this subsection shall be
sentenced in accordance with subsection (b).’’.
(g) PUBLICATION.—Section 403(c) of the Controlled Substances
Act (21 U.S.C. 843(c)) is amended by—
(1) striking ‘‘(c)’’ and inserting ‘‘(c)(1)’’; and
(2) adding at the end the following:
‘‘(2)(A) It shall be unlawful for any person to knowingly or
intentionally use the Internet, or cause the Internet to be used,
to advertise the sale of, or to offer to sell, distribute, or dispense,
a controlled substance where such sale, distribution, or dispensing
is not authorized by this title or by the Controlled Substances
Import and Export Act.
‘‘(B) Examples of activities that violate subparagraph (A)
include, but are not limited to, knowingly or intentionally causing
the placement on the Internet of an advertisement that refers
to or directs prospective buyers to Internet sellers of controlled
substances who are not registered with a modification under section
303(f).
‘‘(C) Subparagraph (A) does not apply to material that either—
‘‘(i) merely advertises the distribution of controlled substances by nonpractitioners to the extent authorized by their
registration under this title; or
‘‘(ii) merely advocates the use of a controlled substance
or includes pricing information without attempting to facilitate
an actual transaction involving a controlled substance.’’.
(h) INJUNCTIVE RELIEF.—Section 512 of the Controlled Substances Act (21 U.S.C. 882) is amended by adding at the end
the following:
‘‘(c) STATE CAUSE OF ACTION PERTAINING TO ONLINE PHARMACIES.—
‘‘(1) IN GENERAL.—In any case in which the State has
reason to believe that an interest of the residents of that
State has been or is being threatened or adversely affected
by the action of a person, entity, or Internet site that violates
the provisions of section 303(f), 309(e), or 311, the State may

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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

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Records.

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21 USC 802
note.

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Deadline.

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PUBLIC LAW 110–425—OCT. 15, 2008

employment, and within the scope of the official duties
of such agent or employee therewith.’’.
(i) IMPORT AND EXPORT ACT.—Section 1010(b) of the Controlled
Substances Import and Export Act (21 U.S.C. 960(b)) is amended—
(1) in paragraph (4)—
(A) by striking ‘‘or any quantity of a controlled substance in schedule III, IV, or V, (except a violation involving
flunitrazepam and except a violation involving gamma
hydroxybutyric acid)’’;
(B) by inserting ‘‘or’’ before ‘‘less than one kilogram
of hashish oil’’; and
(C) by striking ‘‘imprisoned’’ and all that follows
through the end of the paragraph and inserting ‘‘sentenced
in accordance with section 401(b)(1)(D).’’;
(2) by adding at the end the following:
‘‘(5) In the case of a violation of subsection (a) involving a
controlled substance in schedule III, such person shall be sentenced
in accordance with section 401(b)(1).
‘‘(6) In the case of a violation of subsection (a) involving a
controlled substance in schedule IV, such person shall be sentenced
in accordance with section 401(b)(2).
‘‘(7) In the case of a violation of subsection (a) involving a
controlled substance in schedule V, such person shall be sentenced
in accordance with section 401(b)(3).’’; and
(3) in paragraph (3), by striking ‘‘, nor shall a person
so sentenced be eligible for parole during the term of such
a sentence’’ in the final sentence.
(j) EFFECTIVE DATE.—
(1) IN GENERAL.—Except as provided in paragraph (2), the
amendments made by this Act shall take effect 180 days after
the date of enactment of this Act.
(2) DEFINITION OF PRACTICE OF TELEMEDICINE.—
(A) IN GENERAL.—Until the earlier of 3 months after
the date on which regulations are promulgated to carry
out section 311(h) of the Controlled Substances Act, as
amended by this Act, or 15 months after the date of enactment of this Act—
(i) the definition of the term ‘‘practice of telemedicine’’ in subparagraph (B) of this paragraph shall apply
for purposes of the Controlled Substances Act; and
(ii) the definition of the term ‘‘practice of telemedicine’’ in section 102(54) of the Controlled Substances
Act, as amended by this Act, shall not apply.
(B) TEMPORARY PHASE-IN OF TELEMEDICINE REGULATION.—During the period specified in subparagraph (A),
the term ‘‘practice of telemedicine’’ means the practice of
medicine in accordance with applicable Federal and State
laws by a practitioner (as that term is defined in section
102 of the Controlled Substances Act (21 U.S.C. 802)) (other
than a pharmacist) who is at a location remote from the
patient and is communicating with the patient, or health
care professional who is treating the patient, using a telecommunications system referred to in section 1834(m) of
the Social Security Act (42 U.S.C. 1395m(m)), if the practitioner is using an interactive telecommunications system
that satisfies the requirements of section 410.78(a)(3) of
title 42, Code of Federal Regulations.

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(C) RULE OF CONSTRUCTION.—Nothing in this subsection may be construed to create a precedent that any
specific course of conduct constitutes the ‘‘practice of telemedicine’’ (as that term is defined in section 102(54) of
the 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.
Approved October 15, 2008.

LEGISLATIVE HISTORY—H.R. 6353 (S. 980):
HOUSE REPORTS: No. 110–869, Pt. 1 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 154 (2008):
Sept. 23, considered and passed House.
Sept. 30, considered and passed Senate.
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Æ

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