[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6353 Enrolled Bill (ENR)]
H.R.6353
One Hundred Tenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and eight
An Act
To amend the Controlled Substances Act to address online pharmacies.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Ryan Haight Online Pharmacy Consumer
Protection Act of 2008''.
SEC. 2. REQUIREMENT OF A VALID PRESCRIPTION FOR CONTROLLED SUBSTANCES
DISPENSED BY MEANS OF THE INTERNET.
Section 309 of the Controlled Substances Act (21 U.S.C. 829) is
amended by adding at the end the following:
``(e) Controlled Substances Dispensed by Means of the Internet.--
``(1) No controlled substance that is a prescription drug as
determined under the Federal Food, Drug, and Cosmetic Act may be
delivered, distributed, or dispensed by means of the Internet
without a valid prescription.
``(2) As used in this subsection:
``(A) The term `valid prescription' means a prescription
that is issued for a legitimate medical purpose in the usual
course of professional practice by--
``(i) a practitioner who has conducted at least 1 in-
person medical evaluation of the patient; or
``(ii) a covering practitioner.
``(B)(i) The term `in-person medical evaluation' means a
medical evaluation that is conducted with the patient in the
physical presence of the practitioner, without regard to
whether portions of the evaluation are conducted by other
health professionals.
``(ii) Nothing in clause (i) shall be construed to imply
that 1 in-person medical evaluation demonstrates that a
prescription has been issued for a legitimate medical purpose
within the usual course of professional practice.
``(C) The term `covering practitioner' means, with respect
to a patient, a practitioner who conducts a medical evaluation
(other than an in-person medical evaluation) at the request of
a practitioner who--
``(i) has conducted at least 1 in-person medical
evaluation of the patient or an evaluation of the patient
through the practice of telemedicine, within the previous
24 months; and
``(ii) is temporarily unavailable to conduct the
evaluation of the patient.
``(3) Nothing in this subsection shall apply to--
``(A) the delivery, distribution, or dispensing of a
controlled substance by a practitioner engaged in the practice
of telemedicine; or
``(B) the dispensing or selling of a controlled substance
pursuant to practices as determined by the Attorney General by
regulation, which shall be consistent with effective controls
against diversion.''.
SEC. 3. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT RELATING TO THE
DELIVERY OF CONTROLLED SUBSTANCES BY MEANS OF THE INTERNET.
(a) In General.--Section 102 of the Controlled Substances Act (21
U.S.C. 802) is amended by adding at the end the following:
``(50) The term `Internet' means collectively the myriad of
computer and telecommunications facilities, including equipment and
operating software, which comprise the interconnected worldwide network
of networks that employ the Transmission Control Protocol/Internet
Protocol, or any predecessor or successor protocol to such protocol, to
communicate information of all kinds by wire or radio.
``(51) The term `deliver, distribute, or dispense by means of the
Internet' refers, respectively, to any delivery, distribution, or
dispensing of a controlled substance that is caused or facilitated by
means of the Internet.
``(52) The term `online pharmacy'--
``(A) means a person, entity, or Internet site, whether in the
United States or abroad, that knowingly or intentionally delivers,
distributes, or dispenses, or offers or attempts to deliver,
distribute, or dispense, a controlled substance by means of the
Internet; and
``(B) does not include--
``(i) manufacturers or distributors registered under
subsection (a), (b), (d), or (e) of section 303 who do not
dispense controlled substances to an unregistered individual or
entity;
``(ii) nonpharmacy practitioners who are registered under
section 303(f) and whose activities are authorized by that
registration;
``(iii) any hospital or other medical facility that is
operated by an agency of the United States (including the Armed
Forces), provided such hospital or other facility is registered
under section 303(f);
``(iv) a health care facility owned or operated by an
Indian tribe or tribal organization, only to the extent such
facility is carrying out a contract or compact under the Indian
Self-Determination and Education Assistance Act;
``(v) any agent or employee of any hospital or facility
referred to in clause (iii) or (iv), provided such agent or
employee is lawfully acting in the usual course of business or
employment, and within the scope of the official duties of such
agent or employee, with such hospital or facility, and, with
respect to agents or employees of health care facilities
specified in clause (iv), only to the extent such individuals
are furnishing services pursuant to the contracts or compacts
described in such clause;
``(vi) mere advertisements that do not attempt to
facilitate an actual transaction involving a controlled
substance;
``(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--
``(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.''.
(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 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
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 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 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
``(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.''.
(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).
``(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.
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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.