[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6353 Introduced in House (IH)]
110th CONGRESS
2d Session
H. R. 6353
To amend the Controlled Substances Act to address online pharmacies.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 24, 2008
Mr. Stupak (for himself, Mr. Smith of Texas, Mrs. Bono Mack, Mr. Daniel
E. Lungren of California, Mr. Gallegly, Mr. Feeney, Mr. Chabot, Mr.
Walz of Minnesota, and Mr. Boucher) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in
addition to the Committee on the Judiciary, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
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 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), (c), or
(d) 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 (25 U.S.C. 450 et seq.);
``(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 (42 U.S.C. 1395m(m)), and that--
``(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 (25 U.S.C. 450 et
seq.);
``(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 (42 U.S.C. 247d); 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
subsection (b) or (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 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 that same
controlled substance other than by means of the
Internet and pursuant to the valid prescription of a
practitioner that meets the applicable requirements of
sections 309(b) or (c) (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) designating the text as paragraph (1); and
(2) inserting after paragraph (1), as so designated by this
Act, 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 subsection, 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 of the Controlled
Substances Act (21 U.S.C. 829).'.
``(d) Notification.--(1) Thirty days prior to offering a controlled
substance for sale, delivery, distribution, or dispensing, the online
pharmacy shall notify the Attorney General, in the 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) 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) 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 the effective date of this section.
``(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 (25 U.S.C. 450 et seq.) 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 (25 U.S.C.
450 et seq.) 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 (C), by striking ``1 gram of''
before ``flunitrazepam'';
(B) 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
(C) by adding at the end the following:
``(E)(i) 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 20 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 ``6
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:
``(g) Offenses Involving Dispensing of Controlled Substances by
Means of the Internet.--(1) 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 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 the submission to the Attorney
General under section 311.
``(3)(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 (47
U.S.C. 231)); 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 (47
U.S.C. 230(c)) 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) Any person who knowingly or intentionally violates this
subsection shall be sentenced in accordance with subsection (b) of this
section.''.
(g) Publication.--Section 403(c) of the Controlled Substances Act
(21 U.S.C. 843(c)) is amended by--
(1) designating the text as paragraph (1); and
(2) adding at the end the following:
``(2)(A) Except as authorized by this title, it shall be unlawful
for any person by means of the Internet to knowingly advertise the sale
or distribution of, or to offer to sell, distribute, or dispense, a
controlled substance.
``(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 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)(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, 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) 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) 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 is created under this subsection.
``(6) 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) Forfeiture of Facilitating Property in Drug Cases.--Section
511(a)(4) of the Controlled Substances Act (21 U.S.C. 881(a)(4)) is
amended to read as follows:
``(4) Any property, real or personal, tangible or
intangible, used or intended to be used to commit, or to
facilitate the commission, of a violation of this title or
title III, and any property traceable thereto.''.
(j) 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) striking ``imprisoned'' and all that follows
through the end of the paragraph and inserting
``sentenced in accordance with section 401(b)(1)(D) of
this title (21 U.S.C. 841(b)(1)(E)).'';
(2) by adding at the end the following:
``(5) In the case of a violation of subsection (a) of this
section involving a controlled substance in schedule III, such
person shall be sentenced in accordance with section
401(b)(1)(E).
``(6) In the case of a violation of subsection (a) of this
section involving a controlled substance in schedule IV (except
a violation involving flunitrazepam), such person shall be
sentenced in accordance with section 401(b)(2).
``(7) In the case of a violation of subsection (a) of this
section 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.
(k) 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).
(l) 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
provides, 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--
(A) shall consult with the Department of Justice,
experts and other affected parties concerning which
penalties for scheduled substances amended by this Act
should be reflected in the Federal sentencing
guidelines; and
(B) 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 a, or establish a new, guideline or
policy statement.
(m) 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.
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