Online Pharmacy Consumer Protection Act of 2006 - Amends the Controlled Substances Act to impose registration and reporting requirements on pharmacies that seek to deliver, distribute, or dispense over the Internet a controlled substance or prescription drug (online pharmacies). Exempts pharmacies that merely advertise on the Internet. Prohibits the delivery, distribution, or dispensing of a controlled substance or prescription drug over the Internet without a valid prescription issued pursuant to a medical evaluation conducted in the presence of a registered medical practitioner.
Requires an online pharmacy to include on its website: (1) a statement that it complies with the requirements of this Act; (2) identifying information, including its physical address, phone numbers, and email address; (3) the qualifications of its pharmacist-in-charge and the practitioners who prescribe controlled substances or prescription drugs; and (4) a list of states in which it is licensed.
Increases criminal penalties for certain controlled substances offenses. Imposes criminal penalties for the unlawful delivery, distribution, or dispensing of controlled substances or prescription drugs over the Internet.
Authorizes a state attorney general to apply for injunctions or obtain damages and other civil remedies against an online pharmacy that poses a threat to the residents of such state.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3834 Introduced in Senate (IS)]
109th CONGRESS
2d Session
S. 3834
To amend the Controlled Substances Act to address online pharmacies.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
August 3, 2006
Mr. Sessions (for himself and Mrs. Feinstein) introduced the following
bill; which was read twice and referred to the Committee on the
Judiciary
_______________________________________________________________________
A BILL
To amend the Controlled Substances Act to address online pharmacies.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Online Pharmacy Consumer Protection
Act of 2006''.
SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT RELATING TO THE
DELIVERY OF CONTROLLED SUBSTANCES OR PRESCRIPTION DRUGS
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:
``(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.
``(48) The term `deliver, distribute, or dispense by means
of the Internet' refers, respectively, to any delivery,
distribution, or dispensing of a controlled substance or
prescription drug that is caused or facilitated by means of the
Internet.
``(49) The term `online pharmacy'--
``(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 or
prescription drug 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 or prescription drugs;
``(ii) nonpharmacy practitioners who are
registered under section 303(f); or
``(iii) mere advertisements that do not
attempt to facilitate an actual transaction
involving a controlled substance or
prescription drug.
``(50) The term `prescription drug' means a prescription
drug as determined under the Federal Food, Drug, and Cosmetic
Act.
``(51) The term `homepage' means the first page of a
website that is viewable on the Internet.''.
(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 or Prescription Drugs by
Means of the Internet.--(1) A pharmacy that seeks to deliver,
distribute, or dispense by means of the Internet a controlled substance
or prescription drug shall obtain a separate 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 or prescription
drug 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 or prescription drugs
dispensed under such registration, in such manner and accompanied by
such information as the Attorney General by regulation shall
require.''.
(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:
``(e) Controlled Substances and Prescription Drugs Dispensed by
Means of the Internet.--(1) 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 that is based upon a qualifying
medical relationship by a practitioner registered by the
Attorney General under this part;
``(B) the term `qualifying medical relationship'--
``(i) means a medical relationship that exists when
the practitioner--
``(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
``(II) conducts a medical evaluation of the
patient as a covering practitioner and is not
prescribing a controlled substance in schedule
I, II, III, or IV; and
``(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
``(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.
``(2) In addition to the requirements of subsections (a) through
(c), no controlled substance or prescription drug may be delivered,
distributed, or dispensed by means of the Internet without a valid
prescription.''.
(e) Online Prescription Requirements.--The Controlled Substances
Act is amended by adding 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 or prescription drugs
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 or prescription drugs 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 or prescription drug 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 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 or prescription drug 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 or prescription drugs 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 or
prescription drugs on behalf of the online pharmacy is
registered under this part to deliver, distribute, or
dispense by means of the Internet controlled substances
or prescription drugs.
``(4) The name, address, professional degree, and licensure
of practitioners who prescribe controlled substances or
prescription drugs on the basis of information obtained through
the Internet site.
``(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 or prescription drug 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 or prescription drug 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
or prescription drugs.
``(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.''.
(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--
(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 inserting 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'';
(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.''
(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:
``(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.
``(2) Violations of this subsection include--
``(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 dispensing by means of the Internet in violation
of subsection 309(e); and
``(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).
``(3) This subsection does not apply to--
``(A) the distribution of controlled substances by
nonpractitioners to the extent authorized by their registration
under this title;
``(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
``(C)(i) the dispensing or selling of a prescription drug
pursuant to telemedicine practices sponsored by--
``(I) a hospital that has in effect a provider
agreement under title XVIII of the Social Security Act
(relating to the Medicare program); or
``(II) a group practice that has not fewer than 100
physicians who have in effect provider agreements under
such title; or
``(ii) the dispensing or selling of a prescription drug
pursuant to practices that promote the public health, as
determined by the Secretary of Health and Human Services by
regulation.
``(4) Any person who knowingly or intentionally violates this
subsection shall be sentenced in accordance with subsection (b) of this
section.''.
(h) Offenses Involving the Dispensing of Prescription Drugs by
Means of the Internet.--
(1) In general.--Part D of the Controlled Substances Act
(21 U.S.C. 841 et seq.) is amended by inserting after section
403 the following:
``SEC. 403A. PENALTY FOR UNLAWFUL SALE OF PRESCRIPTION DRUGS BY MEANS
OF THE INTERNET.
``(a) Prohibited Act.--
``(1) In general.--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 prescription drug.
``(2) Violations.--Violations of this subsection include--
``(A) delivering, distributing, or dispensing a
prescription drug by means of the Internet by a
pharmacy not registered under section 303(i);
``(B) writing a prescription for a prescription
drug for the purpose of dispensing by means of the
Internet in violation of subsection 309(e); and
``(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 prescription drug in a manner not authorized by
sections 303(i) or 309(e).
``(b) Penalties.--Any person who violates subsection (a)--
``(1) shall be fined under title 18, United States Code,
imprisoned not more than 1 year, or both; or
``(2) if the violation was committed after 1 or more prior
convictions of the offender for an offense punishable under
subsection (a), or for a crime under any other provision of
this title or title III or any other law of the United States
relating to narcotic drugs, marijuana, or depressant or
stimulant substances have become final, shall be fined under
title 18, United States Code, imprisoned not more than 2 years,
or both.
``(c) Forfeiture.--
``(1) A person convicted of a violation of subsection (a)
shall forfeit to the United States any interest of such person
in any property involved in or derived from such violation.
``(2) Any property subject to forfeiture under paragraph
(1) may be forfeited to the United States in accordance with
the procedures under chapter 46 of title 18, United States
Code.
``(d) Exceptions.--Subsections (a) through (c) do not apply to--
``(1) the dispensing or selling of a prescription drug
pursuant to telemedicine practices sponsored by--
``(A) a hospital that has in effect a provider
agreement under title XVIII of the Social Security Act
(relating to the Medicare program); or
``(B) a group practice that has not fewer than 100
physicians who have in effect provider agreements under
such title; or
``(2) the dispensing or selling of a prescription drug
pursuant to practices that promote the public health, as
determined by the Secretary of Health and Human Services by
regulation.''.
(2) Conforming amendment.--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 403 the following:
``403A. Penalty for Unlawful Sale of Prescription Drugs By Means of the
Internet.''.
(i) 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) 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 or
prescription drug except as authorized by this title.
``(B) Violations of this paragraph include causing the placement on
the Internet of an advertisement that refers to or directs prospective
buyers to sellers of controlled substances or prescription drugs who
are not registered under section 303(i).
``(C) This paragraph does not apply to material that either--
``(i) advertises the distribution of controlled substances
or prescription drugs by nonpractitioners to the extent
authorized by their registration under this title; or
``(ii) merely advocates the use of a controlled substance
or prescription drug or includes pricing information without
attempting to facilitate an actual transaction involving a
controlled substance or prescription drug.''.
(j) 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.''.
(k) 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.''.
(l) 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.
(m) Effective Date.--The amendments made by this Act shall become
effective 60 days after the date of enactment of this Act.
(n) 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 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.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S8848)
Read twice and referred to the Committee on the Judiciary.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line