[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6353 Reported in House (RH)]
Union Calendar No. 565
110th CONGRESS
2d Session
H. R. 6353
[Report No. 110-869, Part I]
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
September 23, 2008
Reported from the Committee on Committee on Energy and Commerce with an
amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
September 23, 2008
Additional sponsors: Mr. Davis of Illinois, Mr. Levin, Mrs. Bachmann,
Mrs. Napolitano, and Mr. Souder
September 23, 2008
Committee on the Judiciary discharged; committed to the Committee of
the Whole House on the State of the Union and ordered to be printed
[For text of introduced bill, see copy of bill as introduced on June
24, 2008]
_______________________________________________________________________
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 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.
Union Calendar No. 565
110th CONGRESS
2d Session
H. R. 6353
[Report No. 110-869, Part I]
_______________________________________________________________________
A BILL
To amend the Controlled Substances Act to address online pharmacies.
_______________________________________________________________________
September 23, 2008
Committee on the Judiciary discharged; committed to the Committee of
the Whole House on the State of the Union and ordered to be printed