[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>