[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 980 Reported in Senate (RS)]
Calendar No. 617
110th CONGRESS
2d Session
S. 980
To amend the Controlled Substances Act to address online pharmacies.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 23, 2007
Mrs. Feinstein (for herself, Mr. Sessions, Mr. Biden, Mr. Coleman, Mr.
Leahy, and Mr. Cornyn) introduced the following bill; which was read
twice and referred to the Committee on the Judiciary
March 12, 2008
Reported by Mr. Leahy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Controlled Substances Act to address online pharmacies.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Online Pharmacy Consumer
Protection Act of 2007''.</DELETED>
<DELETED>SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT RELATING
TO THE DELIVERY OF CONTROLLED SUBSTANCES BY MEANS OF THE
INTERNET.</DELETED>
<DELETED> (a) In General.--Section 102 of the Controlled Substances
Act (21 U.S.C. 802) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(47) 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.</DELETED>
<DELETED> ``(48) 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.</DELETED>
<DELETED> ``(49) The term `online pharmacy'--</DELETED>
<DELETED> ``(A) means a person, entity, or Internet
site, whether in the United States or abroad, that
delivers, distributes, or dispenses, or offers to
deliver, distribute, or dispense, a controlled
substance by means of the Internet; and</DELETED>
<DELETED> ``(B) does not include--</DELETED>
<DELETED> ``(i) manufacturers or
distributors registered under subsection (a),
(b), (c), or (d) of section 303 who do not
dispense controlled substances;</DELETED>
<DELETED> ``(ii) nonpharmacy practitioners
who are registered under section
303(f);</DELETED>
<DELETED> ``(iii) mere advertisements that
do not attempt to facilitate an actual
transaction involving a controlled substance;
or</DELETED>
<DELETED> ``(iv) a person, entity, or
Internet site which 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.</DELETED>
<DELETED> ``(50) The term `homepage' means the first page of
the website of an online pharmacy that is viewable on the
Internet.''.</DELETED>
<DELETED> (b) Registration Requirements.--Section 303 of the
Controlled Substances Act (21 U.S.C. 823) is amended by adding at the
end the following new subsection:</DELETED>
<DELETED> ``(i) Dispenser of Controlled Substances by Means of the
Internet.--(1) A pharmacy that seeks to deliver, distribute, or
dispense by means of the Internet a controlled substance shall obtain a
registration specifically authorizing such activity, in accordance with
regulations promulgated by the Attorney General. In determining whether
to grant an application for such registration, the Attorney General
shall apply the factors set forth in subsection (f).</DELETED>
<DELETED> ``(2) Registration under this subsection shall be in
addition to, and not in lieu of, registration under subsection
(f).</DELETED>
<DELETED> ``(3) This subsection does not apply to pharmacies that
merely advertise by means of the Internet but do not attempt to
facilitate an actual transaction involving a controlled substance by
means of the Internet.''.</DELETED>
<DELETED> (c) Reporting Requirements.--Section 307(d) of the
Controlled Substances Act (21 U.S.C. 827(d)) is amended by--</DELETED>
<DELETED> (1) designating the text as paragraph (1);
and</DELETED>
<DELETED> (2) inserting after paragraph (1), as so
designated by this Act, the following new paragraph:</DELETED>
<DELETED> ``(2) A pharmacy registered under section 303(i) shall
report to the Attorney General the controlled substances dispensed
under such registration, in such manner and accompanied by such
information as the Attorney General by regulation shall
require.''.</DELETED>
<DELETED> (d) Online Prescription Requirement.--Section 309 of the
Controlled Substances Act (21 U.S.C. 829) is amended by adding at the
end the following new subsection:</DELETED>
<DELETED> ``(e) Controlled Substances Dispensed by Means of the
Internet.--(1) As used in this subsection--</DELETED>
<DELETED> ``(A) the term `valid prescription' means a
prescription that is issued for a legitimate medical purpose in
the usual course of professional practice that is based upon a
qualifying medical relationship by a practitioner registered by
the Attorney General under this part;</DELETED>
<DELETED> ``(B) the term `qualifying medical relationship'--
</DELETED>
<DELETED> ``(i) means a medical relationship that
exists when the practitioner--</DELETED>
<DELETED> ``(I) has conducted at least one
medical evaluation with the user in the
physical presence of the practitioner, without
regard to whether portions of the evaluation
are conducted by other health professionals;
or</DELETED>
<DELETED> ``(II) conducts a medical
evaluation of the patient as a covering
practitioner and is not prescribing a
controlled substance in schedule II, III, or
IV; and</DELETED>
<DELETED> ``(ii) shall not be construed to imply
that one medical evaluation described in clause (i)
demonstrates that a prescription has been issued for a
legitimate medical purpose within the usual course of
professional practice; and</DELETED>
<DELETED> ``(C) the term `covering practitioner' means, with
respect to a patient, a practitioner who conducts a medical
evaluation, without regard to whether the medical evaluation of
the patient involved is an in-person evaluation, at the request
of a practitioner who has conducted at least one in-person
medical evaluation of the patient and is temporarily
unavailable to conduct the evaluation of the patient.</DELETED>
<DELETED> ``(2) In addition to the requirements of subsections (a)
through (c), no controlled substance may be delivered, distributed, or
dispensed by means of the Internet without a valid
prescription.</DELETED>
<DELETED> ``(3) Nothing in this subsection shall apply to--
</DELETED>
<DELETED> ``(A) the dispensing of a controlled substance
pursuant to telemedicine practices sponsored by--</DELETED>
<DELETED> ``(i) a hospital that has in effect a
provider agreement under title XVIII of the Social
Security Act; or</DELETED>
<DELETED> ``(ii) a group practice that has not fewer
than 100 physicians who have in effect provider
agreements under such title; or</DELETED>
<DELETED> ``(B) the dispensing or selling of a controlled
substance pursuant to practices as determined by the Attorney
General by regulation.''.</DELETED>
<DELETED> (e) Online Prescription Requirements.--The Controlled
Substances Act is amended by adding after section 310 (21 U.S.C. 830)
the following:</DELETED>
<DELETED>``online pharmacy licensing and disclosure
requirements</DELETED>
<DELETED> ``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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(c) Compliance.--No online pharmacy or practitioner
shall deliver, distribute, or dispense by means of the Internet a
controlled substance without a valid prescription (as defined in
section 309(e)) and each online pharmacy shall comply with all
applicable requirements of Federal and State law.</DELETED>
<DELETED> ``(d) Internet Site Disclosure Information.--Each online
pharmacy site shall post in a visible and clear manner on the homepage
of its Internet site or on a page directly linked from its homepage the
following:</DELETED>
<DELETED> ``(1) The name of the owner, street address of the
online pharmacy's principal place of business, telephone
number, and email address.</DELETED>
<DELETED> ``(2) A list of the States in which the online
pharmacy, and any pharmacy which dispenses, delivers, or
distributes a controlled substance on behalf of the online
pharmacy, is licensed to dispense controlled substances or
prescription drugs and any applicable license number.</DELETED>
<DELETED> ``(3) For each pharmacy identified on its license
in each State in which it is licensed to engage in the practice
of pharmacy and for each pharmacy which dispenses or ships
controlled substances on behalf of the online
pharmacy:</DELETED>
<DELETED> ``(A) The name of the pharmacy.</DELETED>
<DELETED> ``(B) The street address of the
pharmacy.</DELETED>
<DELETED> ``(C) The name, professional degree, and
licensure of the pharmacist-in-charge.</DELETED>
<DELETED> ``(D) The telephone number at which the
pharmacist-in-charge can be contacted.</DELETED>
<DELETED> ``(E) A certification that each pharmacy
which dispenses or ships controlled substances on
behalf of the online pharmacy is registered under this
part to deliver, distribute, or dispense by means of
the Internet controlled substances.</DELETED>
<DELETED> ``(4) The name, address, professional degree, and
licensure of practitioners who provide medical consultations
through the website for the purpose of providing
prescriptions.</DELETED>
<DELETED> ``(5) A telephone number or numbers at which the
practitioners described in paragraph (4) may be
contacted.</DELETED>
<DELETED> ``(6) 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, which includes at least one prior in-person
medical evaluation. This online pharmacy complies with section
309(e) of the Controlled Substances Act (21 U.S.C.
829(e)).'.</DELETED>
<DELETED> ``(e) Notification.--(1) Thirty days prior to offering a
controlled substance for sale, delivery, distribution, or dispensing,
the online pharmacy shall notify the Attorney General, in the form and
manner as the Attorney General shall determine, and the State boards of
pharmacy in any States in which the online pharmacy offers to sell,
deliver, distribute, or dispense controlled substances.</DELETED>
<DELETED> ``(2) The notification required under paragraph (1) shall
include--</DELETED>
<DELETED> ``(A) the information required to be posted on the
online pharmacy's Internet site under subsection (d) 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 to subsection (d) is true
and accurate;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(C) the Drug Enforcement Administration
registration numbers of any pharmacies and practitioners
referred to in subsection (d), as applicable.</DELETED>
<DELETED> ``(3) An online pharmacy that is already operational as of
the effective date of this section, shall notify the Attorney General
and applicable State boards of pharmacy in accordance with this
subsection not later than 30 days after the effective date of this
section.</DELETED>
<DELETED> ``(f) Declaration of Compliance.--On and after the date on
which it makes the notification under subsection (e), 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.</DELETED>
<DELETED> ``(g) Reports.--Any statement, declaration, notification,
or disclosure required under this section shall be considered a report
required to be kept under this part.''.</DELETED>
<DELETED> (f) 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--</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) in subparagraph (C), by striking ``1
gram of'' before ``flunitrazepam'';</DELETED>
<DELETED> (B) in subparagraph (D), by striking ``or
in the case of any controlled substance in schedule III
(other than gamma hydroxybutyric acid), or 30
milligrams of flunitrazepam''; and</DELETED>
<DELETED> (C) by inserting at the end the
following:</DELETED>
<DELETED> ``(E)(i) In the case of any controlled substance
in schedule III, such person shall be sentenced to a term of
imprisonment of not more than 10 years and if death or serious
bodily injury results from the use of such substance shall be
sentenced to a term of imprisonment of not more than 20 years,
a fine not to exceed the greater of that authorized in
accordance with the provisions of title 18, or $500,000 if the
defendant is an individual or $2,500,000 if the defendant is
other than an individual, or both.</DELETED>
<DELETED> ``(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, or $1,000,000 if the defendant is
an individual or $5,000,000 if the defendant is other than an
individual, or both.</DELETED>
<DELETED> ``(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'';</DELETED>
<DELETED> (2) in paragraph (2) by--</DELETED>
<DELETED> (A) striking ``3 years'' and inserting ``5
years'';</DELETED>
<DELETED> (B) striking ``6 years'' and inserting
``10 years'';</DELETED>
<DELETED> (C) 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</DELETED>
<DELETED> (3) in paragraph (3) by--</DELETED>
<DELETED> (A) striking ``2 years'' and inserting ``6
years'';</DELETED>
<DELETED> (B) 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</DELETED>
<DELETED> (C) 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.''</DELETED>
<DELETED> (g) 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:</DELETED>
<DELETED> ``(g) Offenses Involving Dispensing of Controlled
Substances by Means of the Internet.--(1) Except as authorized by this
title, it shall be unlawful for any person to knowingly or
intentionally cause or facilitate the delivery, distribution, or
dispensing by means of the Internet of a controlled
substance.</DELETED>
<DELETED> ``(2) Violations of this subsection include--</DELETED>
<DELETED> ``(A) delivering, distributing, or dispensing a
controlled substance by means of the Internet by a pharmacy not
registered under section 303(i);</DELETED>
<DELETED> ``(B) writing a prescription for a controlled
substance for the purpose of delivery, distribution, or
dispensation by means of the Internet in violation of
subsection 309(e);</DELETED>
<DELETED> ``(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(i) or
309(e); and</DELETED>
<DELETED> ``(D) making a material false, fictitious, or
fraudulent statement or representation in the submission to the
Attorney General under section 311.</DELETED>
<DELETED> ``(3) This subsection does not apply to--</DELETED>
<DELETED> ``(A) the delivery, distribution, or dispensation
of controlled substances by nonpractitioners to the extent
authorized by their registration under this title;</DELETED>
<DELETED> ``(B) 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</DELETED>
<DELETED> ``(C) any activity that is limited to--</DELETED>
<DELETED> ``(i) the provision of a
telecommunications service, or of an Internet access
service or Internet information location tool (as those
terms are defined in section 231 of the Communications
Act of 1934 (47 U.S.C. 231)); or</DELETED>
<DELETED> ``(ii) the transmission, storage,
retrieval, hosting, formatting, or translation (or any
combination thereof) of a communication, without
selection or alteration of the content of the
communication, except that deletion of a particular
communication or material made by another person in a
manner consistent with section 230(c) of the
Communications Act of 1934 (47 U.S.C. 230(c)) shall not
constitute such selection or alteration of the content
of the communication.</DELETED>
<DELETED> ``(4) Any person who knowingly or intentionally violates
this subsection shall be sentenced in accordance with subsection (b) of
this section.''.</DELETED>
<DELETED> (h) Publication.--Section 403(c) of the Controlled
Substances Act (21 U.S.C. 843(c)) is amended by--</DELETED>
<DELETED> (1) designating the text as paragraph (1);
and</DELETED>
<DELETED> (2) adding at the end the following:</DELETED>
<DELETED> ``(2)(A) It shall be unlawful for any person to 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
except as authorized by this title.</DELETED>
<DELETED> ``(B) Violations of this paragraph include 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 under section 303(i).</DELETED>
<DELETED> ``(C) This paragraph does not apply to material that
either--</DELETED>
<DELETED> ``(i) advertises the distribution of controlled
substances by nonpractitioners to the extent authorized by
their registration under this title; or</DELETED>
<DELETED> ``(ii) merely advocates the use of a controlled
substance or includes pricing information without attempting to
facilitate an actual transaction involving a controlled
substance.''.</DELETED>
<DELETED> (i) Injunctive Relief.--Section 512 of the Controlled
Substances Act (21 U.S.C. 882) is amended by adding to the end of the
section the following new subsection:</DELETED>
<DELETED> ``(c) State Cause of Action Pertaining to Online
Pharmacies.--(1) In any case in which the State has reason to believe
that an interest of the residents of that State has been or is being
threatened or adversely affected by the action of a person, entity, or
Internet site that violates the provisions of section 303(i), 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--</DELETED>
<DELETED> ``(A) to enjoin the conduct which violates this
section;</DELETED>
<DELETED> ``(B) to enforce compliance with this
section;</DELETED>
<DELETED> ``(C) to obtain damages, restitution, or other
compensation, including civil penalties under section 402(b);
and</DELETED>
<DELETED> ``(D) to obtain such other legal or equitable
relief as the court may find appropriate.</DELETED>
<DELETED> ``(2)(A) Prior to filing a complaint under paragraph (1),
the State shall serve a copy of the complaint upon the Attorney General
and upon the United States Attorney for the judicial district in which
the complaint is to be filed. In any case where such prior service is
not feasible, the State shall serve the complaint on the Attorney
General and the appropriate United States Attorney on the same day that
the State's complaint is filed in Federal district court of the United
States. Such proceedings shall be independent of, and not in lieu of,
criminal prosecutions or any other proceedings under this title or any
other laws of the United States.</DELETED>
<DELETED> ``(B)(i) Not later than 120 days after the later of the
date on which a State's complaint is served on the Attorney General and
the appropriate United States Attorney, or the date on which the
complaint is filed, the United States shall have the right to intervene
as a party in any action filed by a State under paragraph
(1).</DELETED>
<DELETED> ``(ii) After the 120-day period described in clause (i)
has elapsed, the United States may, for good cause shown, intervene as
a party in an action filed by a State under paragraph (1).</DELETED>
<DELETED> ``(iii) Notice and an opportunity to be heard with respect
to intervention shall be afforded the State that filed the original
complaint in any action in which the United States files a complaint in
intervention under clause (i) or a motion to intervene under clause
(ii).</DELETED>
<DELETED> ``(iv) The United States may file a petition for appeal of
a judicial determination in any action filed by a State under this
section.</DELETED>
<DELETED> ``(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 Federal Rule of Civil Procedure 4(i)(1).</DELETED>
<DELETED> ``(3) For purposes of bringing any civil action under
paragraph (1), nothing in this Act shall prevent an attorney general of
a State from exercising the powers conferred on the attorney general of
a State by the laws of such State to conduct investigations or to
administer oaths or affirmations or to compel the attendance of
witnesses of or the production of documentary or other
evidence.</DELETED>
<DELETED> ``(4) Any civil action brought under paragraph (1) in a
district court of the United States may be brought in the district in
which the defendant is found, is an inhabitant, or transacts business
or wherever venue is proper under section 1391 of title 28, United
States Code. Process in such action may be served in any district in
which the defendant is an inhabitant or in which the defendant may be
found.</DELETED>
<DELETED> ``(5) No private right of action is created under this
subsection.''.</DELETED>
<DELETED> (j) Forfeiture of Facilitating Property in Drug Cases.--
Section 511(a)(4) of the Controlled Substances Act (21 U.S.C.
881(a)(4)) is amended to read as follows:</DELETED>
<DELETED> ``(4) Any property, real or personal, tangible or
intangible, used or intended to be used to commit, or to
facilitate the commission, of a violation of this title or
title III, and any property traceable thereto.''.</DELETED>
<DELETED> (k) Import and Export Act.--Section 1010(b) of the
Controlled Substances Import and Export Act (21 U.S.C. 960(b)) is
amended--</DELETED>
<DELETED> (1) in paragraph (4) by--</DELETED>
<DELETED> (A) 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)'';</DELETED>
<DELETED> (B) inserting ``, or'' before ``less than
one kilogram of hashish oil''; and</DELETED>
<DELETED> (C) striking ``imprisoned'' and all that
follows through the end of the paragraph and inserting
``sentenced in accordance with section 401(b)(1)(D) of
this title (21 U.S.C. 841(b)(1)(E)).'';</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(5) In the case of a violation of subsection (a) of this
section involving a controlled substance in schedule III, such person
shall be sentenced in accordance with section 401(b)(1)(E).</DELETED>
<DELETED> ``(6) In the case of a violation of subsection (a) of this
section involving a controlled substance in schedule IV (except a
violation involving flunitrazepam), such person shall be sentenced in
accordance with section 401(b)(2).</DELETED>
<DELETED> ``(7) In the case of a violation of subsection (a) of this
section involving a controlled substance in schedule V, such person
shall be sentenced in accordance with section 401(b)(3).'';
and</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (l) Effective Date.--The amendments made by this Act shall
become effective 60 days after the date of enactment of this
Act.</DELETED>
<DELETED> (m) Guidelines and Regulations.--</DELETED>
<DELETED> (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 subtitle, including any
interim rules necessary for the immediate implementation of
this Act, on its effective date.</DELETED>
<DELETED> (2) Sentencing guidelines.--The United States
Sentencing Commission, in determining whether to amend, or
establish new, guidelines or policy statements, to conform the
guidelines and policy statements to this Act and the amendments
made by this Act, may not construe any change in the maximum
penalty for a violation involving a controlled substance in a
particular schedule as requiring an amendment to, or
establishing a new, guideline or policy statement.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Ryan Haight Online Pharmacy Consumer
Protection Act of 2007''.
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 new subsection:
``(e) Controlled Substances Dispensed by Means of the Internet.--
``(1) No controlled substance may be delivered,
distributed, or dispensed by means of the Internet without a
valid prescription.
``(2) As used in this subsection:
``(A) The term `valid prescription' means a
prescription that is issued for a legitimate medical
purpose in the usual course of professional practice
by--
``(i) a practitioner who has conducted at
least one 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 one 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 one in-person
medical evaluation of the patient during the
24-month period ending on the date of that
medical evaluation; 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 if--
``(i) the telemedicine is being conducted
while the patient is being treated by, and
physically located in, a hospital or clinic
registered under section 303(f), and the
practitioner conducting the practice of
telemedicine is registered under section 303(f)
in the State in which the patient is located
and is acting in the usual course of
professional practice and in accordance with
applicable State law;
``(ii) the telemedicine is being conducted
while the patient is being treated by, and in
the physical presence of, a practitioner
registered under section 303(f) who is acting
in the usual course of professional practice,
and the practitioner conducting the practice of
telemedicine is registered under section 303(f)
in the State in which the patient is located
and is acting in the usual course of
professional practice and in accordance with
applicable State law; or
``(iii) the telemedicine 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; or
``(B) the dispensing or selling of a controlled
substance pursuant to practices as determined by the
Attorney General by regulation, which shall be
consistent with effective controls against
diversion.''.
SEC. 3. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT RELATING TO THE
DELIVERY OF CONTROLLED SUBSTANCES BY MEANS OF THE
INTERNET.
(a) In General.--Section 102 of the Controlled Substances Act (21
U.S.C. 802) is amended by adding at the end the following:
``(50) The term `Internet' means collectively the myriad of
computer and telecommunications facilities, including equipment
and operating software, which comprise the interconnected
worldwide network of networks that employ the Transmission
Control Protocol/Internet Protocol, or any predecessor or
successor protocol to such protocol, to communicate information
of all kinds by wire or radio.
``(51) The term `deliver, distribute, or dispense by means
of the Internet' refers, respectively, to any delivery,
distribution, or dispensing of a controlled substance that is
caused or facilitated by means of the Internet.
``(52) The term `online pharmacy'--
``(A) means a person, entity, or Internet site,
whether in the United States or abroad, that knowingly
or intentionally delivers, distributes, or dispenses,
or offers or attempts to deliver, distribute, or
dispense, a controlled substance by means of the
Internet; and
``(B) does not include--
``(i) manufacturers or distributors
registered under subsection (a), (b), (c), or
(d) of section 303 who do not dispense
controlled substances to an unregistered
individual or entity;
``(ii) nonpharmacy practitioners who are
registered under section 303(f) and whose
activities are authorized by that registration;
``(iii) mere advertisements that do not
attempt to facilitate an actual transaction
involving a controlled substance; or
``(iv) a person, entity, or Internet site
which 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.
``(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 the
practice of medicine in accordance with applicable Federal and
State laws by a practitioner (other than a pharmacist) who is
at a location remote from the patient and is communicating with
the patient, or health care professional who is treating the
patient, using a telecommunications system referred to in
section 1834(m) of the Social Security Act (42 U.S.C.
1395m(m)).''.
(b) Registration Requirements.--Section 303 of the Controlled
Substances Act (21 U.S.C. 823) is amended by adding at the end the
following new subsection:
``(i) Dispenser of Controlled Substances by Means of the
Internet.--(1) An online pharmacy shall obtain a registration
specifically authorizing such activity, in accordance with regulations
promulgated by the Attorney General. In determining whether to grant an
application for such registration, the Attorney General shall apply the
factors set forth in subsection (f).
``(2) Registration under this subsection shall be in addition to,
and not in lieu of, registration under subsection (f).
``(3) This subsection does not apply to pharmacies that merely
advertise by means of the Internet but do not attempt to facilitate an
actual transaction involving a controlled substance by means of the
Internet.''.
(c) Reporting Requirements.--Section 307(d) of the Controlled
Substances Act (21 U.S.C. 827(d)) is amended by--
(1) designating the text as paragraph (1); and
(2) inserting after paragraph (1), as so designated by this
Act, the following new paragraph:
``(2) A pharmacy registered under section 303(i) shall report to
the Attorney General the controlled substances dispensed under such
registration, in such manner and accompanied by such information as the
Attorney General by regulation shall require.''.
(d) Online Prescription Requirements.--The Controlled Substances
Act is amended by inserting after section 310 (21 U.S.C. 830) the
following:
``online pharmacy licensing and disclosure requirements
``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.
``(c) Compliance.--No online pharmacy or practitioner shall
deliver, distribute, or dispense by means of the Internet a controlled
substance without a valid prescription (as defined in section 309(e))
and each online pharmacy shall comply with all applicable requirements
of Federal and State law.
``(d) Internet Pharmacy Site Disclosure Information.--Each online
pharmacy site shall post in a visible and clear manner on the homepage
of its Internet site or on a page directly linked from its homepage the
following:
``(1) The name of the owner, street address of the online
pharmacy's principal place of business, telephone number, and
email address.
``(2) A list of the States in which the online pharmacy,
and any pharmacy which dispenses, delivers, or distributes a
controlled substance on behalf of the online pharmacy, is
licensed to dispense controlled substances or prescription
drugs and any applicable license number.
``(3) For each pharmacy identified on its license in each
State in which it is licensed to engage in the practice of
pharmacy and for each pharmacy which dispenses or ships
controlled substances on behalf of the online pharmacy:
``(A) The name of the pharmacy.
``(B) The street address of the pharmacy.
``(C) The name, professional degree, and licensure
of the pharmacist-in-charge.
``(D) The telephone number at which the pharmacist-
in-charge can be contacted.
``(E) A certification that each pharmacy which
dispenses or ships controlled substances on behalf of
the online pharmacy is registered under this part to
deliver, distribute, or dispense by means of the
Internet controlled substances.
``(4) The name, address, professional degree, and licensure
of practitioners who provide medical consultations through the
website for the purpose of providing prescriptions.
``(5) A telephone number or numbers at which the
practitioners described in paragraph (4) may be contacted.
``(6) 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, which
includes at least one prior in-person medical evaluation. This
online pharmacy complies with section 309(e) of the Controlled
Substances Act (21 U.S.C. 829(e)).'.
``(e) Notification.--(1) Thirty days prior to offering a controlled
substance for sale, delivery, distribution, or dispensing, the online
pharmacy shall notify the Attorney General, in the form and manner as
the Attorney General shall determine, and the State boards of pharmacy
in any States in which the online pharmacy offers to sell, deliver,
distribute, or dispense controlled substances.
``(2) The notification required under paragraph (1) shall include--
``(A) the information required to be posted on the online
pharmacy's Internet site under subsection (d) 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 to subsection (d) 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 (d), as applicable.
``(3) An online pharmacy that is already operational as of the
effective date of this section, shall notify the Attorney General and
applicable State boards of pharmacy in accordance with this subsection
not later than 30 days after the effective date of this section.
``(f) Declaration of Compliance.--On and after the date on which it
makes the notification under subsection (e), 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.
``(g) Reports.--Any statement, declaration, notification, or
disclosure required under this section shall be considered a report
required to be kept under this part.''.
(e) Offenses Involving Controlled Substances in Schedules III, IV,
and V.--Section 401(b) of the Controlled Substances Act (21 U.S.C.
841(b)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (C), by striking ``1 gram of''
before ``flunitrazepam'';
(B) in subparagraph (D), by striking ``or in the
case of any controlled substance in schedule III (other
than gamma hydroxybutyric acid), or 30 milligrams of
flunitrazepam''; and
(C) by adding at the end the following:
``(E)(i) In the case of any controlled substance in
schedule III, such person shall be sentenced to a term of
imprisonment of not more than 10 years and if death or serious
bodily injury results from the use of such substance shall be
sentenced to a term of imprisonment of not more than 20 years,
a fine not to exceed the greater of that authorized in
accordance with the provisions of title 18, 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, 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) by--
(A) striking ``3 years'' and inserting ``5 years'';
(B) striking ``6 years'' and inserting ``10
years''; and
(C) 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) by--
(A) striking ``2 years'' and inserting ``6 years'';
(B) 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) 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) Except as authorized by this title, it
shall be unlawful for any person to knowingly or intentionally cause or
facilitate the delivery, distribution, or dispensing by means of the
Internet of a controlled substance.
``(2) Examples of activities that violate paragraph (1) include,
but are not limited to, knowingly or intentionally--
``(A) delivering, distributing, or dispensing a controlled
substance by means of the Internet by a pharmacy not registered
under section 303(i);
``(B) writing a prescription for a controlled substance for
the purpose of delivery, distribution, or dispensation by means
of the Internet in violation of subsection 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(i) or
309(e); and
``(D) making a material false, fictitious, or fraudulent
statement or representation in the submission to the Attorney
General under section 311.
``(3)(A) This subsection does not apply to--
``(i) the delivery, distribution, or dispensation of
controlled substances by nonpractitioners to the extent
authorized by their registration under this title;
``(ii) the placement on the Internet of material that
merely advocates the use of a controlled substance or includes
pricing information without attempting to propose or facilitate
an actual transaction involving a controlled substance; or
``(iii) except as provided in subparagraph (B), any
activity that is limited to--
``(I) the provision of a telecommunications
service, or of an Internet access service or Internet
information location tool (as those terms are defined
in section 231 of the Communications Act of 1934 (47
U.S.C. 231)); or
``(II) the transmission, storage, retrieval,
hosting, formatting, or translation (or any combination
thereof) of a communication, without selection or
alteration of the content of the communication, except
that deletion of a particular communication or material
made by another person in a manner consistent with
section 230(c) of the Communications Act of 1934 (47
U.S.C. 230(c)) shall not constitute such selection or
alteration of the content of the communication.
``(B) The exceptions under subclauses (I) and (II) of subparagraph
(A)(iii) shall not apply to a person acting in concert with a person
who violates subsection (g)(1).
``(4) Any person who knowingly or intentionally violates this
subsection shall be sentenced in accordance with subsection (b) of this
section.''.
(g) Publication.--Section 403(c) of the Controlled Substances Act
(21 U.S.C. 843(c)) is amended by--
(1) designating the text as paragraph (1); and
(2) adding at the end the following:
``(2)(A) Except as authorized by this title, it shall be unlawful
for any person by means of the Internet, to knowingly advertise the
sale or distribution of, or to offer to sell, distribute, or dispense,
a controlled substance.
``(B) Examples of activities that violate subparagraph (A) include,
but are not limited to, knowingly or intentionally causing the
placement on the Internet of an advertisement that refers to or directs
prospective buyers to Internet sellers of controlled substances who are
not registered under section 303(i).
``(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 to the end of the section the
following new subsection:
``(c) State Cause of Action Pertaining to Online Pharmacies.--(1)
In any case in which the State has reason to believe that an interest
of the residents of that State has been or is being threatened or
adversely affected by the action of a person, entity, or Internet site
that violates the provisions of section 303(i), 309(e), or 311, the
State may bring a civil action on behalf of such residents in a
district court of the United States with appropriate jurisdiction--
``(A) to enjoin the conduct which violates this section;
``(B) to enforce compliance with this section;
``(C) to obtain damages, restitution, or other
compensation, including civil penalties under section 402(b);
and
``(D) to obtain such other legal or equitable relief as the
court may find appropriate.
``(2)(A) Prior to filing a complaint under paragraph (1), the State
shall serve a copy of the complaint upon the Attorney General and upon
the United States Attorney for the judicial district in which the
complaint is to be filed. In any case where such prior service is not
feasible, the State shall serve the complaint on the Attorney General
and the appropriate United States Attorney on the same day that the
State's complaint is filed in Federal district court of the United
States. Such proceedings shall be independent of, and not in lieu of,
criminal prosecutions or any other proceedings under this title or any
other laws of the United States.
``(B)(i) Not later than 120 days after the later of the date on
which a State's complaint is served on the Attorney General and the
appropriate United States Attorney, or the date on which the complaint
is filed, the United States shall have the right to intervene as a
party in any action filed by a State under paragraph (1).
``(ii) After the 120-day period described in clause (i) has
elapsed, the United States may, for good cause shown, intervene as a
party in an action filed by a State under paragraph (1).
``(iii) Notice and an opportunity to be heard with respect to
intervention shall be afforded the State that filed the original
complaint in any action in which the United States files a complaint in
intervention under clause (i) or a motion to intervene under clause
(ii).
``(iv) The United States may file a petition for appeal of a
judicial determination in any action filed by a State under this
section.
``(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 Federal Rule of Civil Procedure 4(i)(1).
``(3) For purposes of bringing any civil action under paragraph
(1), nothing in this Act shall prevent an attorney general of a State
from exercising the powers conferred on the attorney general of a State
by the laws of such State to conduct investigations or to administer
oaths or affirmations or to compel the attendance of witnesses of or
the production of documentary or other evidence.
``(4) Any civil action brought under paragraph (1) in a district
court of the United States may be brought in the district in which the
defendant is found, is an inhabitant, or transacts business or wherever
venue is proper under section 1391 of title 28, United States Code.
Process in such action may be served in any district in which the
defendant is an inhabitant or in which the defendant may be found.
``(5) No private right of action is created under this
subsection.''.
(i) Forfeiture of Facilitating Property in Drug Cases.--Section
511(a)(4) of the Controlled Substances Act (21 U.S.C. 881(a)(4)) is
amended to read as follows:
``(4) Any property, real or personal, tangible or
intangible, used or intended to be used to commit, or to
facilitate the commission, of a violation of this title or
title III, and any property traceable thereto.''.
(j) Import and Export Act.--Section 1010(b) of the Controlled
Substances Import and Export Act (21 U.S.C. 960(b)) is amended--
(1) in paragraph (4) by--
(A) 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) inserting ``, or'' before ``less than one
kilogram of hashish oil''; and
(C) striking ``imprisoned'' and all that follows
through the end of the paragraph and inserting
``sentenced in accordance with section 401(b)(1)(D) of
this title (21 U.S.C. 841(b)(1)(E)).'';
(2) by adding at the end the following:
``(5) In the case of a violation of subsection (a) of this section
involving a controlled substance in schedule III, such person shall be
sentenced in accordance with section 401(b)(1)(E).
``(6) In the case of a violation of subsection (a) of this section
involving a controlled substance in schedule IV (except a violation
involving flunitrazepam), such person shall be sentenced in accordance
with section 401(b)(2).
``(7) In the case of a violation of subsection (a) of this section
involving a controlled substance in schedule V, such person shall be
sentenced in accordance with section 401(b)(3).''; and
(3) in paragraph (3), by striking ``, nor shall a person so
sentenced be eligible for parole during the term of such a
sentence'' in the final sentence.
(k) Effective Date.--The amendments made by this Act shall become
effective 60 days after the date of enactment of this Act.
(l) Guidelines and Regulations.--
(1) In general.--The Attorney General may promulgate and
enforce any rules, regulations, and procedures which may be
necessary and appropriate for the efficient execution of
functions under this subtitle, including any interim rules
necessary for the immediate implementation of this Act, on its
effective date.
(2) Sentencing guidelines.--The United States Sentencing
Commission, in determining whether to amend, or establish new,
guidelines or policy statements, to conform the Federal
sentencing guidelines and policy statements to this Act and the
amendments made by this Act--
(A) shall consult with the Department of Justice,
experts and other affected parties concerning which
penalties for scheduled substances amended by this Act
should be reflected in the Federal sentencing
guidelines; and
(B) should not construe any change in the maximum
penalty for a violation involving a controlled
substance in a particular schedule as being the sole
reason to amend a, or establish a new, guideline or
policy statement.
(m) Annual Report.--Not later than 180 days after the date of
enactment of this Act, and annually for 2 years after the initial
report, the Drug Enforcement Administration, in consultation with the
Department of State, shall submit to Congress a report describing--
(1) the foreign supply chains and sources of controlled
substances offered for sale without a valid prescription on the
Internet;
(2) the efforts and strategy of the Drug Enforcement
Administration to decrease the foreign supply chain and sources
of controlled substances offered for sale without a valid
prescription on the Internet; and
(3) the efforts of the Drug Enforcement Administration to
work with domestic and multinational pharmaceutical companies
and others to build international cooperation and a commitment
to fight on a global scale the problem of distribution of
controlled substances over the Internet without a valid
prescription.
Calendar No. 617
110th CONGRESS
2d Session
S. 980
_______________________________________________________________________
A BILL
To amend the Controlled Substances Act to address online pharmacies.
_______________________________________________________________________
March 12, 2008
Reported with an amendment