[DOCID: f:hr869p1.110]
From the House Reports Online via GPO Access
[wais.access.gpo.gov]
110th Congress Rept. 110-869
HOUSE OF REPRESENTATIVES
2d Session Part 1
======================================================================
RYAN HAIGHT ONLINE PHARMACY CONSUMER PROTECTION ACT OF 2008
_______
September 23, 2008.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Dingell, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 6353]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 6353) to amend the Controlled Substances Act to
address online pharmacies, having considered the same, report
favorably thereon with an amendment and recommend that the bill
as amended do pass.
CONTENTS
Page
Amendment........................................................ 1
Purpose and Summary.............................................. 11
Background and Need for Legislation.............................. 11
Hearings......................................................... 12
Committee Consideration.......................................... 12
Committee Votes.................................................. 12
Committee Oversight Findings..................................... 12
Statement of General Performance Goals and Objectives............ 12
New Budget Authority, Entitlement Authority, and Tax Expenditures 12
Earmarks and Tax and Tariff Benefits............................. 12
Committee Cost Estimate.......................................... 13
Congressional Budget Office Estimate............................. 13
Federal Mandates Statement....................................... 15
Advisory Committee Statement..................................... 15
Constitutional Authority Statement............................... 15
Applicability to Legislative Branch.............................. 15
Section-by-Section Analysis of the Legislation................... 15
Changes in Existing Law Made by the Bill, as Reported............ 17
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Ryan Haight Online Pharmacy Consumer
Protection Act of 2008''.
SEC. 2. REQUIREMENT OF A VALID PRESCRIPTION FOR CONTROLLED SUBSTANCES
DISPENSED BY MEANS OF THE INTERNET.
Section 309 of the Controlled Substances Act (21 U.S.C. 829) is
amended by adding at the end the following:
``(e) Controlled Substances Dispensed by Means of the Internet.--
``(1) No controlled substance that is a prescription drug as
determined under the Federal Food, Drug, and Cosmetic Act may
be delivered, distributed, or dispensed by means of the
Internet without a valid prescription.
``(2) As used in this subsection:
``(A) The term `valid prescription' means a
prescription that is issued for a legitimate medical
purpose in the usual course of professional practice
by--
``(i) a practitioner who has conducted at
least 1 in-person medical evaluation of the
patient; or
``(ii) a covering practitioner.
``(B)(i) The term `in-person medical evaluation'
means a medical evaluation that is conducted with the
patient in the physical presence of the practitioner,
without regard to whether portions of the evaluation
are conducted by other health professionals.
``(ii) Nothing in clause (i) shall be construed to
imply that 1 in-person medical evaluation demonstrates
that a prescription has been issued for a legitimate
medical purpose within the usual course of professional
practice.
``(C) The term `covering practitioner' means, with
respect to a patient, a practitioner who conducts a
medical evaluation (other than an in-person medical
evaluation) at the request of a practitioner who--
``(i) has conducted at least 1 in-person
medical evaluation of the patient or an
evaluation of the patient through the practice
of telemedicine, within the previous 24 months;
and
``(ii) is temporarily unavailable to conduct
the evaluation of the patient.
``(3) Nothing in this subsection shall apply to--
``(A) the delivery, distribution, or dispensing of a
controlled substance by a practitioner engaged in the
practice of telemedicine; or
``(B) the dispensing or selling of a controlled
substance pursuant to practices as determined by the
Attorney General by regulation, which shall be
consistent with effective controls against
diversion.''.
SEC. 3. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT RELATING TO THE
DELIVERY OF CONTROLLED SUBSTANCES BY MEANS OF THE
INTERNET.
(a) In General.--Section 102 of the Controlled Substances Act (21
U.S.C. 802) is amended by adding at the end the following:
``(50) The term `Internet' means collectively the myriad of computer
and telecommunications facilities, including equipment and operating
software, which comprise the interconnected worldwide network of
networks that employ the Transmission Control Protocol/Internet
Protocol, or any predecessor or successor protocol to such protocol, to
communicate information of all kinds by wire or radio.
``(51) The term `deliver, distribute, or dispense by means of the
Internet' refers, respectively, to any delivery, distribution, or
dispensing of a controlled substance that is caused or facilitated by
means of the Internet.
``(52) The term `online pharmacy'--
``(A) means a person, entity, or Internet site, whether in
the United States or abroad, that knowingly or intentionally
delivers, distributes, or dispenses, or offers or attempts to
deliver, distribute, or dispense, a controlled substance by
means of the Internet; and
``(B) does not include--
``(i) manufacturers or distributors registered under
subsection (a), (b), (d), or (e) of section 303 who do
not dispense controlled substances to an unregistered
individual or entity;
``(ii) nonpharmacy practitioners who are registered
under section 303(f) and whose activities are
authorized by that registration;
``(iii) any hospital or other medical facility that
is operated by an agency of the United States
(including the Armed Forces), provided such hospital or
other facility is registered under section 303(f);
``(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.
Purpose and Summary
The purpose of H.R. 6353, the Ryan Haight Online Pharmacy
Consumer Protection Act of 2008, is to amend the Controlled
Substances Act to prohibit the delivery, distribution, or
dispensing of controlled substances over the Internet without a
valid prescription.
In an effort to address concerns about the purchase of
controlled substances through online pharmacies, H.R. 6353
defines a ``valid prescription'' as a prescription that is
issued for a legitimate purpose by a practitioner who has
conducted at least one in-person medical evaluation of the
patient.
H.R. 6353 imposes registration and reporting requirements
on online pharmacies. H.R. 6353 requires an online pharmacy to:
(1) display on its Internet homepage a statement that it
complies with the requirements of this Act; (2) comply with
State laws for the licensure of pharmacies in each State in
which it operates or sells controlled substances; (3) post on
its Internet homepage specified information, including the
name, address, and telephone number of the pharmacy, the
qualifications of its pharmacist-in-charge, and a certification
of its registration under this Act; and (4) notify the Attorney
General and applicable State boards of pharmacy at least 30
days prior to offering to sell, deliver, distribute, or
dispense controlled substances over the Internet.
H.R. 6353 increases criminal penalties involving controlled
substances in Schedules II, IV, and V of the Controlled
Substances Act. H.R. 6353 also authorizes States to apply for
injunctions or obtain damages and other civil remedies against
online pharmacies that are deemed a threat to State residents.
Background and Need for Legislation
According to the Drug Enforcement Agency (DEA), nearly 7
million Americans are abusing prescription drugs, more than the
numbers who are abusing cocaine, heroin, hallucinogens,
Ecstasy, and inhalants, combined. The number of individuals
abusing prescription drugs has increased 80 percent in the last
6 years.
Prescription pain relievers have replaced marijuana and
cocaine as new drug users' drug of choice. Nearly 1 in 10 high
school seniors admits to abusing powerful prescription
painkillers. A shocking 40 percent of teenagers and an almost
equal number of their parents think abusing prescription
painkillers is safer than abusing ``street'' drugs.
Prescription pain relievers appear to be among the drugs most
heavily dispensed by certain Internet pharmacies through
prescriptions that are issued based on online questionnaires.
This practice has been abused by rogue pharmacy sites that
dispense large quantities of addictive substances to customers
seeking access to prescription painkillers, leading to
instances of addiction, overdose, and death. As of July 2004,
DEA investigations had discovered 14 deaths or overdoses and 15
persons who have entered rehabilitation or sustained injuries
from drugs obtained over the Internet.
The Internet, through Internet pharmacies, has become one
of the fastest growing methods used today to purchase huge
quantities of controlled pharmaceuticals. It is estimated there
are between 400 and 1,000 Web sites that both dispense and
offer a prescribing service, half of which are located in
foreign countries.
Hearings
No hearings were held in connection with H.R. 6353.
Committee Consideration
On Wednesday, September 17, 2008, the full Committee met in
open markup session and ordered H.R. 6353 favorably reported to
the House, amended, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto. No
record votes were taken on amendments or in connection with
ordering H.R. 6353 reported to the House. A motion by Mr.
Dingell to order H.R. 6353 favorably reported to the House,
amended, was agreed to by a voice vote.
Committee Oversight Findings
Regarding clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the oversight findings of the
Committee regarding H.R. 6353 are reflected in this report.
Statement of General Performance Goals and Objectives
The objective of H.R. 6353 is to counter the growing sale
of controlled substances over the Internet without adequate
medical oversight.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Regarding compliance with clause 3(c)(2) of rule XIII of
the Rules of the House of Representatives, the Committee adopts
as its own the estimate of budget authority and revenues
regarding H.R. 6353 prepared by the Director of the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974. The Committee finds that the
bill would result in no new or increased entitlement authority
or tax expenditures.
Earmarks and Tax and Tariff Benefits
Regarding compliance with clause 9 of rule XXI of the Rules
of the House of Representatives, H.R. 6353 does not contain any
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.
Committee Cost Estimate
The Committee adopts as its own the cost estimate on H.R.
6353 prepared by the Director of the Congressional Budget
Office pursuant to section 402 of the Congressional Budget Act
of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate on
H.R. 6353 provided by the Congressional Budget Office pursuant
to section 402 of the Congressional Budget Act of 1974:
September 23, 2008.
Hon. John D. Dingell,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 6353, the Ryan
Haight Online Pharmacy Consumer Protection Act of 2008.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Mark
Grabowicz, who can be reached at 226-2860.
Sincerely,
Peter R. Orszag.
Enclosure.
H.R. 6353--Ryan Haight Online Pharmacy Consumer Protection Act of 2008
Summary: H.R. 6353 would permit the Drug Enforcement
Administration (DEA) to authorize certain pharmacies to
distribute controlled substances using the Internet. CBO
estimates that implementing H.R. 6353 would have no significant
net cost to the federal government. Enacting the bill could
affect direct spending and revenues, but CBO estimates that any
net effects would not be significant.
H.R. 6353 contains an intergovernmental mandate as defined
in the Unfunded Mandates Reform Act (UMRA) because it would
preempt state regulations of controlled substances that are
manufactured, distributed, or dispensed via the Internet. CBO
estimates, however, that states would incur little, if any,
costs as a result of that preemption, and the costs to comply
with the mandate would be well below the threshold established
in UMRA ($68 million in 2008, adjusted annually for inflation).
The bill's registration and reporting requirements and the
requirement of a valid prescription for Internet distribution
of controlled substances constitute private-sector mandates as
defined in UMRA. CBO estimates that the direct costs of those
mandates would not exceed the threshold established in UMRA for
private-sector mandates ($136 million in 2008, adjusted
annually for inflation).
Estimated cost to the Federal Government:
SPENDING SUBJECT TO APPROPRIATION
H.R. 6353 would establish new crimes and increase penalties
for activities relating to illegal use of controlled
substances. Because the bill would establish new offenses, the
government would be able to pursue cases that it otherwise
would not be able to prosecute. We expect that H.R. 6353 would
apply to a relatively small number of offenders, however, so
any increase in costs for law enforcement, court proceedings,
or prison operations would not be significant. Any such costs
would be subject to the availability of appropriated funds.
DIRECT SPENDING AND REVENUES
H.R. 6353 would permit the DEA to authorize certain
pharmacies to distribute controlled substances using the
Internet. The agency currently charges a registration fee of
$551 for a three-year period. Based on information from the DEA
about the likely number of new registrants resulting from
enactment of H.R. 6353, CBO estimates that the agency would
collect less than $1 million each year. The DEA would spend
those fees without further appropriation, mostly in the same
year, to conduct inspections and carry out administrative
activities related to the new registrants. Thus, CBO estimates
that H.R. 6353 would have no significant net effect on DEA
spending.
Because those prosecuted and convicted under H.R. 6353
could be subject to criminal fines, the federal government
might collect additional fines if the legislation is enacted.
Criminal fines are recorded as revenues, then deposited in the
Crime Victims Fund, and later spent. CBO expects that any
additional revenues and direct spending would not be
significant because of the small number of cases likely to be
affected.
Estimated impact on State, local, and tribal governments:
H.R. 6353 contains an intergovernmental mandate as defined in
UMRA because it would preempt state regulations of controlled
substances that are manufactured, distributed, or dispensed via
the Internet. Under current law, states license pharmacies and
doctors to dispense controlled substances within each state.
This bill would prohibit the sale of controlled substances that
are sold over the Internet without a prescription and would
require doctors to have at least one in-person consultation
with patients for whom they prescribe controlled medications.
Currently, all states allow medications to be purchased via the
Internet, but some states do not specifically require in-person
consultations for prescriptions. Enacting this provision would
preempt state authority. CBO estimates, however, that states
would incur little, if any costs, as a result of that
preemption, and the costs to comply with the mandate would be
well below the threshold established in UMRA ($68 million in
2008, adjusted annually for inflation).
Estimated impact on the private sector: The bill's
registration and reporting requirements and the requirement of
a valid prescription for Internet distribution of controlled
substances would constitute private-sector mandates as defined
by UMRA. CBO estimates that the direct costs of those mandates
would not exceed the threshold established in UMRA ($136
million in 2008, adjusted annually for inflation).
Previous CBO estimate: On October 25, 2007, CBO transmitted
a cost estimate for S. 980, the Ryan Haight Online Pharmacy
Consumer Protection Act of 2007, as ordered reported by the
Senate Committee on the Judiciary on September 27, 2007. The
two bills are similar, and the cost estimates are nearly
identical.
Estimate prepared by: Federal Costs: Mark Grabowicz; Impact
on State, Local, and Tribal Governments: Lisa Ramirez-Branum;
Impact on the Private Sector: Colin Baker.
Estimate approved by: Peter H. Fontaine, Assistant Director
for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates regarding H.R. 6353 prepared by the Director of the
Congressional Budget Office pursuant to section 423 of the
Unfunded Mandates Reform Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act would be created by H.R.
6353.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for H.R. 6353 is provided in Article
I, section 8, clause 3, which grants Congress the power to
regulate commerce with foreign nations, among the several
States, and with the Indian Tribes.
Applicability to Legislative Branch
The Committee finds that H.R. 6353 does not relate to the
terms and conditions of employment or access to public services
or accommodations within the meaning of section 102(b)(3) of
the Congressional Accountability Act of 1995.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 establishes the short title as the Ryan Haight
Online Pharmacy Consumer Protection Act of 2008.
Section 2. Requirement of a valid prescription for controlled
substances dispensed by means of the Internet
Section 2 adds a new section 309(e) to the Controlled
Substances Act requiring a valid prescription for the delivery
or distribution of a controlled substance that is a
prescription drug. A ``valid prescription'' is defined as a
prescription issued for a legitimate medical purpose in the
usual course of professional practice, by a practitioner who
has conducted at least one in-person medical evaluation of the
patient, or a covering practitioner (as requested by a
practitioner who had conducted an in-person medical evaluation
of the patient within the past 24 months). Certain telemedicine
practices are exempted from the in-person medical evaluation
requirement.
Section 3. Amendments to the Controlled Substances Act relating to the
delivery of controlled substances by means of the Internet
Section 3(a) defines the following terms: Internet;
deliver, distribute, or dispense by means of the Internet;
online pharmacy; and practice of telemedicine.
Section 3(a) exempts from the definition of ``online
pharmacy'' non-pharmacy practitioners, hospitals, or medical
facilities operated by agencies of the United States, health
facilities owned by Indian Tribes carrying out contracts or
compacts under the Indian Self Determination and Education
Assistance Act, and mere advertisements that do not attempt to
facilitate an actual transaction.
Section 3(a) exempts pharmacies that use the Internet only
to receive refill orders, or requests to contact a patient's
physician.
Section 3(b) requires pharmacies that seek to dispense
controlled substances via the Internet to receive a
modification of their existing registration to dispense
controlled substances by means of the Internet.
Section 3(c) requires pharmacies with a modified
registration to report to the Attorney General the total
quantity of each controlled substance dispensed per month.
Reporting is required only when pharmacies dispense at least
100 or more controlled substance prescriptions per month or 500
or more controlled substance dosage units per month.
Section 3(d) requires pharmacies to clearly display
notification that they comply with the requirements of this
Act. Pharmacies must post information regarding: name and
address of the pharmacy as it appears on its DEA registration;
a list of States in which the pharmacy is licensed to
distribute prescription drugs or controlled substances; name
and degree of pharmacist in charge; contact information for the
pharmacist in charge; and the name and contact information of
any practitioners with a contractual relationship to issue
controlled substance prescriptions. Pharmacies must notify the
U.S. Attorney General and State boards of pharmacy 30 days
before delivering, distributing, or dispensing a controlled
substance.
Section 3(d) authorizes the Secretary to designate certain
practitioners as ``Internet Eligible Controlled Substance
Providers'' and allows the U.S. Attorney General to issue
special registrations for the practice of telemedicine. Section
3(d) describes reporting criteria for emergency prescriptions
issued under the Veterans Health Administration emergency
telemedicine exemption. Section 3(d) clarifies that any
transfer of prescription information from one pharmacy to
another must meet applicable requirements in the Controlled
Substances Act.
Section 3(e) increases the penalties for all illegal
distributions of Schedule III, IV, and V controlled substances.
For Schedule III controlled substances, maximum penalties are
increased to 10 years for first offenders and 20 years for
repeat offenders, or 15 and 30 years, respectively, if death or
serious bodily injury results. For Schedule IV substances, the
new penalties are 5 years for first offenders and 10 years for
repeat offenders. For Schedule V repeat offenders, the maximum
penalty increases to four years. Supervised release terms after
imprisonment for a Schedule V offense are also authorized.
Section 3(f) clarifies that knowingly or intentionally
delivering, distributing, or dispensing controlled substances
over the Internet in violation of this Act can be prosecuted
and penalized just like hand-to-hand distributions. This
provision does not apply, however, to persons who register and
follow the requirements of this Act, to those who merely
advocate usage or list pricing information, but do not promote
or facilitate an actual transaction involving a controlled
substance, or to anyone providing telecommunications or
Internet services who are not acting in concert with persons
violating this Act.
Section 3(g) clarifies that Internet sales of controlled
substances must follow the terms of this Act. The Act does not
apply to material that advocates the use of controlled
substances or does not attempt to facilitate an actual
transaction.
Section 3(h) authorizes State Attorneys General to file
civil lawsuits in Federal court against online businesses if
the residents of a State are threatened or adversely affected
by noncompliance, so long as the U.S. Attorney General is
notified in advance and given a chance to intervene within 120
days.
Section 3(j) applies the same penalty changes made to the
Controlled Substances Act to the Import and Export Act.
Section 3(k) establishes an effective date of 180 days
after enactment. Section 3(k) also creates a temporary
definition for ``practice of telemedicine'' that will apply for
the first 15 months following enactment.
Section 3(l) authorizes the U.S. Attorney General to
promulgate and enforce any rules, regulations, and procedures
as necessary for the efficient execution of functions under
this Act. The United States Sentencing Commission is authorized
to add or modify the Sentencing Guidelines as warranted. The
Commission, however, should not construe any change in the
maximum penalty for a violation involving a controlled
substance in a particular schedule as being the sole reason to
amend, or establish a new guideline or policy statement.
Section 3(m) requires the DEA to provide a report to
Congress within 180 days after enactment, and annually for 2
additional years, describing the foreign supply chains and
sources of controlled substances illegally offered over the
Internet, and the DEA's efforts and strategies to confront
these global challenges.
Section 4. Rule of construction
Section 4 clarifies that nothing in the Act shall be
construed as authorizing, prohibiting, or limiting the use of
electronic prescribing for controlled substances.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970
* * * * * * *
table of contents
title ii--control and enforcement
Part A--Short Title; Findings and Declaration; Definitions
Sec. 100. Short title.
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
Sec. 301. Rules and regulations.
* * * * * * *
Sec. 311. Additional requirements relating to online pharmacies and
telemedicine.
* * * * * * *
TITLE II--CONTROL AND ENFORCEMENT
Part A--Short Title; Findings and Declaration; Definitions
short title
Sec. 100. This title may be cited as the ``Controlled
Substances Act''.
* * * * * * *
DEFINITIONS
Sec. 102. As used in this title:
(1) * * *
* * * * * * *
(50) The term ``Internet'' means collectively the myriad of
computer and telecommunications facilities, including equipment
and operating software, which comprise the interconnected
worldwide network of networks that employ the Transmission
Control Protocol/Internet Protocol, or any predecessor or
successor protocol to such protocol, to communicate information
of all kinds by wire or radio.
(51) The term ``deliver, distribute, or dispense by means of
the Internet'' refers, respectively, to any delivery,
distribution, or dispensing of a controlled substance that is
caused or facilitated by means of the Internet.
(52) The term ``online pharmacy''--
(A) means a person, entity, or Internet site, whether
in the United States or abroad, that knowingly or
intentionally delivers, distributes, or dispenses, or
offers or attempts to deliver, distribute, or dispense,
a controlled substance by means of the Internet; and
(B) does not include--
(i) manufacturers or distributors registered
under subsection (a), (b), (d), or (e) of
section 303 who do not dispense controlled
substances to an unregistered individual or
entity;
(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.
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
REGISTRATION REQUIREMENTS
Sec. 303. (a) * * *
* * * * * * *
(f) The Attorney General shall register practitioners
(including pharmacies, as distinguished from pharmacists) to
dispense, or conduct research with, controlled substances in
schedule II, III, IV, or V and shall modify the registrations
of pharmacies so registered to authorize them to dispense
controlled substances by means of the Internet, if the
applicant is authorized to dispense, or conduct research with
respect to, controlled substances under the laws of the State
in which he practices. The Attorney General may deny an
application for such registration [if he determines that the
issuance of such registration] or such modification of
registration if the Attorney General determines that the
issuance of such registration or modification would be
inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
(1) * * *
* * * * * * *
RECORDS AND REPORTS OF REGISTRANTS
Sec. 307. (a) * * *
* * * * * * *
[(d) Every] (d)(1) Every manufacturer registered under
section 303 shall, at such time or times and in such form as
the Attorney General may require, make periodic reports to the
Attorney General of every sale, delivery or other disposal by
him of any controlled substance, and each distributor shall
make such reports with respect to narcotic controlled
substances, identifying by the registration number assigned
under this title the person or establishment (unless exempt
from registration under section 302(d) to whom such sale,
delivery, or other disposal was made.
(2) Each pharmacy with a modified registration under section
303(f) that authorizes the dispensing of controlled substances
by means of the Internet shall report to the Attorney General
the controlled substances it dispenses, in the amount
specified, and in such time and manner as the Attorney General
by regulation shall require, except that the Attorney General,
under this paragraph, may not require any pharmacy to report
any information other than the total quantity of each
controlled substance that the pharmacy has dispensed each
month. For purposes of this paragraph, no reporting shall be
required unless the pharmacy has met 1 of the following
thresholds in the month for which the reporting is required:
(A) 100 or more prescriptions dispensed.
(B) 5,000 or more dosage units of all controlled
substances combined.
* * * * * * *
PRESCRIPTIONS
Sec. 309. (a) * * *
* * * * * * *
(e) Controlled Substances Dispensed by Means of the
Internet.--
(1) No controlled substance that is a prescription
drug as determined under the Federal Food, Drug, and
Cosmetic Act may be delivered, distributed, or
dispensed by means of the Internet without a valid
prescription.
(2) As used in this subsection:
(A) The term ``valid prescription'' means a
prescription that is issued for a legitimate
medical purpose in the usual course of
professional practice by--
(i) a practitioner who has conducted
at least 1 in-person medical evaluation
of the patient; or
(ii) a covering practitioner.
(B)(i) The term ``in-person medical
evaluation'' means a medical evaluation that is
conducted with the patient in the physical
presence of the practitioner, without regard to
whether portions of the evaluation are
conducted by other health professionals.
(ii) Nothing in clause (i) shall be construed
to imply that 1 in-person medical evaluation
demonstrates that a prescription has been
issued for a legitimate medical purpose within
the usual course of professional practice.
(C) The term ``covering practitioner'' means,
with respect to a patient, a practitioner who
conducts a medical evaluation (other than an
in-person medical evaluation) at the request of
a practitioner who--
(i) has conducted at least 1 in-
person medical evaluation of the
patient or an evaluation of the patient
through the practice of telemedicine,
within the previous 24 months; and
(ii) is temporarily unavailable to
conduct the evaluation of the patient.
(3) Nothing in this subsection shall apply to--
(A) the delivery, distribution, or dispensing
of a controlled substance by a practitioner
engaged in the practice of telemedicine; or
(B) the dispensing or selling of a controlled
substance pursuant to practices as determined
by the Attorney General by regulation, which
shall be consistent with effective controls
against diversion.
* * * * * * *
ADDITIONAL REQUIREMENTS RELATING TO ONLINE PHARMACIES AND TELEMEDICINE
Sec. 311. (a) In General.--An online pharmacy shall display
in a visible and clear manner on its homepage a statement that
it complies with the requirements of this section with respect
to the delivery or sale or offer for sale of controlled
substances and shall at all times display on the homepage of
its Internet site a declaration of compliance in accordance
with this section.
(b) Licensure.--Each online pharmacy shall comply with the
requirements of State law concerning the licensure of
pharmacies in each State from which it, and in each State to
which it, delivers, distributes, or dispenses or offers to
deliver, distribute, or dispense controlled substances by means
of the Internet, pursuant to applicable licensure requirements,
as determined by each such State.
(c) Internet Pharmacy Site Disclosure Information.--Each
online pharmacy shall post in a visible and clear manner on the
homepage of each Internet site it operates, or on a page
directly linked thereto in which the hyperlink is also visible
and clear on the homepage, the following information for each
pharmacy that delivers, distributes, or dispenses controlled
substances pursuant to orders made on, through, or on behalf
of, that website:
(1) The name and address of the pharmacy as it
appears on the pharmacy's Drug Enforcement
Administration certificate of registration.
(2) The pharmacy's telephone number and email
address.
(3) The name, professional degree, and States of
licensure of the pharmacist-in-charge, and a telephone
number at which the pharmacist-in-charge can be
contacted.
(4) A list of the States in which the pharmacy is
licensed to dispense controlled substances.
(5) A certification that the pharmacy is registered
under this part to deliver, distribute, or dispense by
means of the Internet controlled substances.
(6) The name, address, telephone number, professional
degree, and States of licensure of any practitioner who
has a contractual relationship to provide medical
evaluations or issue prescriptions for controlled
substances, through referrals from the website or at
the request of the owner or operator of the website, or
any employee or agent thereof.
(7) The following statement, unless revised by the
Attorney General by regulation: ``This online pharmacy
will only dispense a controlled substance to a person
who has a valid prescription issued for a legitimate
medical purpose based upon a medical relationship with
a prescribing practitioner. This includes at least one
prior in-person medical evaluation or medical
evaluation via telemedicine in accordance with
applicable requirements of section 309.''.
(d) Notification.--
(1) In general.--Thirty days prior to offering a
controlled substance for sale, delivery, distribution,
or dispensing, the 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.
Part D--Offenses and Penalties
PROHIBITED ACTS A--PENALTIES
Sec. 401. (a) * * *
(b) Except as otherwise provided in section 409, 418, 419, or
420 any person who violates subsection (a) of this section
shall be sentenced as follows:
(1)(A) * * *
* * * * * * *
(D) In the case of less than 50 kilograms of marihuana,
except in the case of 50 or more marihuana plants regardless of
weight, 10 kilograms of hashish, or one kilogram of hashish oil
[or in the case of any controlled substance in schedule III
(other than gamma hydroxybutyric acid), or 30 milligrams of
flunitrazepam], such person shall, except as provided in
paragraphs (4) and (5) of this subsection, be sentenced to a
term of imprisonment of not more than 5 years, a fine not to
exceed the greater of that authorized in accordance with the
provisions of title 18, United States Code, or $250,000 if the
defendant is an individual or $1,000,000 if the defendant is
other than an individual, or both. If any person commits such a
violation after a prior conviction for a felony drug offense
has become final, such person shall be sentenced to a term of
imprisonment of not more than 10 years, a fine not to exceed
the greater of twice that authorized in accordance with the
provisions of title 18, United State Code, or $500,000 if the
defendant is an individual or $2,000,000 if the defendant is
other than an individual, or both. Notwithstanding section 3583
of title 18, any sentence imposing a term of imprisonment under
this paragraph shall, in the absence of such a prior
conviction, impose a special parole term of at least 2 years in
addition to such term of imprisonment and shall, if there was
such a prior conviction, impose a term of supervised release of
at least 4 years in addition to such term of imprisonment.
(E)(i) Except as provided in subparagraphs (C) and (D), in
the case of any controlled substance in schedule III, such
person shall be sentenced to a term of imprisonment of not more
than 10 years and if death or serious bodily injury results
from the use of such substance shall be sentenced to a term of
imprisonment of not more than 15 years, a fine not to exceed
the greater of that authorized in accordance with the
provisions of title 18, United States Code, or $500,000 if the
defendant is an individual or $2,500,000 if the defendant is
other than an individual, or both.
(ii) If any person commits such a violation after a prior
conviction for a felony drug offense has become final, such
person shall be sentenced to a term of imprisonment of not more
than 20 years and if death or serious bodily injury results
from the use of such substance shall be sentenced to a term of
imprisonment of not more than 30 years, a fine not to exceed
the greater of twice that authorized in accordance with the
provisions of title 18, United States Code, or $1,000,000 if
the defendant is an individual or $5,000,000 if the defendant
is other than an individual, or both.
(iii) Any sentence imposing a term of imprisonment under this
subparagraph shall, in the absence of such a prior conviction,
impose a term of supervised release of at least 2 years in
addition to such term of imprisonment and shall, if there was
such a prior conviction, impose a term of supervised release of
at least 4 years in addition to such term of imprisonment.
(2) In the case of a controlled substance in schedule IV,
such person shall be sentenced to a term of imprisonment of not
more than [3 years] 5 years, a fine not to exceed the greater
of that authorized in accordance with the provisions of title
18, United States Code, or $250,000 if the defendant is an
individual or $1,000,000 if the defendant is other than an
individual, or both. If any person commits such a violation
[after one or more prior convictions of him for an offense
punishable under this paragraph, or for a felony under any
other provision of this title or title III or other law of a
State, the United States, or a foreign country relating to
narcotic drugs, marihuana, or depressant or stimulant
substances, have become final,] after a prior conviction for a
felony drug offense has become final, such person shall be
sentenced to a term of imprisonment of not more than [6 years]
10 years, a fine not to exceed the greater of twice the
authorized in accordance with the provisions of title 18,
United States Code, or $500,000 if the defendant is an
individual or $2,000,000 if the defendant is other than an
individual, or both. Any sentence imposing a term of
imprisonment under this paragraph shall, in the absence of such
a prior conviction, impose a term of supervised release of at
least one year in addition to such term of imprisonment and
shall, if there was such a prior conviction, impose a term of
supervised release of at least 2 years in addition to such term
of imprisonment.
(3) In the case of a controlled substance in schedule V, such
person shall be sentenced to a term of imprisonment of not more
than 1 year, a fine not to exceed the greater of that
authorized in accordance with the provisions of title 18,
United States Code, or $100,000 if the defendant is an
individual or $250,000 if the defendant is other than an
individual, or both. If any person commits such a violation
[after one or more convictions of him for an offense punishable
under this paragraph, or for a crime under any other provision
of this title or title III or other law of a State, the United
States, or a foreign country relating to narcotic drugs,
marihuana, or depressant or stimulant substances, have become
final,] after a prior conviction for a felony drug offense has
become final, such person shall be sentenced to a term of
imprisonment of not more than [2 years] 4 years, a fine not to
exceed the provisions of title 18, United States Code, or
$200,000 if the defendant is an individual or $500,000 if the
defendant is other than an individual, or both. Any sentence
imposing a term of imprisonment under this paragraph may, if
there was a prior conviction, impose a term of supervised
release of not more than 1 year, in addition to such term of
imprisonment.
* * * * * * *
(h) Offenses Involving Dispensing of Controlled 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).
* * * * * * *
PROHIBITED ACTS C--PENALTIES
Sec. 403. (a) * * *
* * * * * * *
[(c)] (c)(1) It shall be unlawful for any person to place in
any newspaper, magazine, handbill, or other publications, any
written advertisement knowing that it has the purpose of
seeking or offering illegally to receive, buy, or distribute a
Schedule I controlled substance. As used in this section the
term ``advertisement'' includes, in addition to its ordinary
meaning, such advertisements as those for a catalog of Schedule
I controlled substances and any similar written advertisement
that has the purpose of seeking or offering illegally to
receive, buy, or distribute a Schedule I controlled substance.
The term ``advertisement'' does not include material which
merely advocates the use of a similar material, which advocates
a position or practice, and does not attempt to propose or
facilitate an actual transaction in a Schedule I controlled
substance.
(2)(A) It shall be unlawful for any person to knowingly or
intentionally use the Internet, or cause the Internet to be
used, to advertise the sale of, or to offer to sell,
distribute, or dispense, a controlled substance where such
sale, distribution, or dispensing is not authorized by this
title or by the Controlled Substances Import and Export Act.
(B) Examples of activities that violate subparagraph (A)
include, but are not limited to, knowingly or intentionally
causing the placement on the Internet of an advertisement that
refers to or directs prospective buyers to Internet sellers of
controlled substances who are not registered with a
modification under section 303(f).
(C) Subparagraph (A) does not apply to material that either--
(i) merely advertises the distribution of controlled
substances by nonpractitioners to the extent authorized
by their registration under this title; or
(ii) merely advocates the use of a controlled
substance or includes pricing information without
attempting to facilitate an actual transaction
involving a controlled substance.
* * * * * * *
Part E--Administrative and Enforcement Provisions
* * * * * * *
INJUNCTIONS
Sec. 512. (a) * * *
* * * * * * *
(c) State Cause of Action Pertaining to Online Pharmacies.--
(1) In general.--In any case in which the State has
reason to believe that an interest of the residents of
that State has been or is being threatened or adversely
affected by the action of a person, entity, or Internet
site that violates the provisions of section 303(f),
309(e), or 311, the State may bring a civil action on
behalf of such residents in a district court of the
United States with appropriate jurisdiction--
(A) to enjoin the conduct which violates this
section;
(B) to enforce compliance with this section;
(C) to obtain damages, restitution, or other
compensation, including civil penalties under
section 402(b); and
(D) to obtain such other legal or equitable
relief as the court may find appropriate.
(2) Service; intervention.--
(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.
* * * * * * *
TITLE III--IMPORTATION AND EXPORTATION; AMENDMENTS AND REPEALS OF
REVENUE LAWS
short title
Sec. 1000. This title may be cited as the ``Controlled
Substances Import and Export Act''.
* * * * * * *
Part A--Importation and Exportation
* * * * * * *
PROHIBITED ACTS A--PENALTIES
Sec. 1010. (a) * * *
(b)(1) * * *
* * * * * * *
(3) In the case of a violation under subsection (a) of this
section involving a controlled substance in schedule I or II,
gamma hydroxybutyric acid (including when scheduled as an
approved drug product for purposes of section 3(a)(1)(B) of the
Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition
Act of 2000), or flunitrazepam, the person committing such
violation shall, except as provided in paragraphs (1), (2), and
(4), be sentenced to a term of imprisonment of not more than 20
years and if death or serious bodily injury results from the
use of such substance shall be sentenced to a term of
imprisonment of not less than twenty years and not more than
life, a fine not to exceed the greater of that authorized in
accordance with the provisions of title 18, United States Code,
or $1,000,000 if the defendant is an individual or $5,000,000
if the defendant is other than an individual, or both. If any
person commits such a violation after a prior conviction for a
felony drug offense has become final, such person shall be
sentenced to a term of imprisonment of not more than 30 years
and if death or serious bodily injury results from the use of
such substance shall be sentenced to life imprisonment, a fine
not to exceed the greater of twice that authorized in
accordance with the provisions of title 18, United States Code,
or $2,000,000 if the defendant is an individual or $10,000,000
if the defendant is other than an individual, or both.
Notwithstanding section 3583 of title 18, any sentence imposing
a term of imprisonment under this paragraph shall, in the
absence of such a prior conviction, impose a term of
suspervised release of at least 3 years in addition to such
term of imprisonment and shall, if there was such a prior
conviction, impose a term of suspervised release of at least 6
years in addition to such term of imprisonment. Notwithstanding
the prior sentence, and notwithstanding any other provision of
law, the court shall not place on probation or suspend the
sentence of any person sentenced under the provisions of this
paragraph which provide for a mandatory term of imprisonment if
death or serious bodily injury results[, nor shall a person so
sentenced be eligible for parole during the term of such a
sentence].
(4) In the case of a violation under subsection (a) with
respect to less than 50 kilograms of marihuana except in the
case of 100 or more marihuana plants regardless of weight, less
than 10 kilograms of hashish, or less than one kilogram of
hashish oil, [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)] the person committing such violation
shall be [imprisoned not more than five years, or be fined not
to exceed the greater of that authorized in accordance with the
provisions of title 18, United States Code, or $250,000 if the
defendant is an individual or $1,000,000 if the defendant is
other than an individual, or both.] sentenced in accordance
with section 401(b)(1)(D).
(5) In the case of a violation of subsection (a) involving a
controlled substance in schedule III, such person shall be
sentenced in accordance with section 401(b)(1).
(6) In the case of a violation of subsection (a) involving a
controlled substance in schedule IV, such person shall be
sentenced in accordance with section 401(b)(2).
(7) In the case of a violation of subsection (a) involving a
controlled substance in schedule V, such person shall be
sentenced in accordance with section 401(b)(3).
* * * * * * *
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