[Congressional Record (Bound Edition), Volume 154 (2008), Part 15]
[House]
[Pages 20306-20312]
[From the U.S. Government Publishing Office, www.gpo.gov]




      RYAN HAIGHT ONLINE PHARMACY CONSUMER PROTECTION ACT OF 2008

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 6353) to amend the Controlled Substances Act to address 
online pharmacies, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 6353

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Ryan Haight Online Pharmacy 
     Consumer Protection Act of 2008''.

     SEC. 2. REQUIREMENT OF A VALID PRESCRIPTION FOR CONTROLLED 
                   SUBSTANCES DISPENSED BY MEANS OF THE INTERNET.

       Section 309 of the Controlled Substances Act (21 U.S.C. 
     829) is amended by adding at the end the following:
       ``(e) Controlled Substances Dispensed by Means of the 
     Internet.--
       ``(1) No controlled substance that is a prescription drug 
     as determined under the Federal Food, Drug, and Cosmetic Act 
     may be delivered, distributed, or dispensed by means of the 
     Internet without a valid prescription.
       ``(2) As used in this subsection:
       ``(A) The term `valid prescription' means a prescription 
     that is issued for a legitimate medical purpose in the usual 
     course of professional practice by--
       ``(i) a practitioner who has conducted at least 1 in-person 
     medical evaluation of the patient; or
       ``(ii) a covering practitioner.
       ``(B)(i) The term `in-person medical evaluation' means a 
     medical evaluation that is conducted with the patient in the 
     physical presence of the practitioner, without regard to 
     whether portions of the evaluation are conducted by other 
     health professionals.
       ``(ii) Nothing in clause (i) shall be construed to imply 
     that 1 in-person medical evaluation demonstrates that a 
     prescription has been issued for a legitimate medical purpose 
     within the usual course of professional practice.
       ``(C) The term `covering practitioner' means, with respect 
     to a patient, a practitioner who conducts a medical 
     evaluation (other than an in-person medical evaluation) at 
     the request of a practitioner who--
       ``(i) has conducted at least 1 in-person medical evaluation 
     of the patient or an evaluation of the patient through the 
     practice of telemedicine, within the previous 24 months; and

[[Page 20307]]

       ``(ii) is temporarily unavailable to conduct the evaluation 
     of the patient.
       ``(3) Nothing in this subsection shall apply to--
       ``(A) the delivery, distribution, or dispensing of a 
     controlled substance by a practitioner engaged in the 
     practice of telemedicine; or
       ``(B) the dispensing or selling of a controlled substance 
     pursuant to practices as determined by the Attorney General 
     by regulation, which shall be consistent with effective 
     controls against diversion.''.

     SEC. 3. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT RELATING 
                   TO THE DELIVERY OF CONTROLLED SUBSTANCES BY 
                   MEANS OF THE INTERNET.

       (a) In General.--Section 102 of the Controlled Substances 
     Act (21 U.S.C. 802) is amended by adding at the end the 
     following:
       ``(50) The term `Internet' means collectively the myriad of 
     computer and telecommunications facilities, including 
     equipment and operating software, which comprise the 
     interconnected worldwide network of networks that employ the 
     Transmission Control Protocol/Internet Protocol, or any 
     predecessor or successor protocol to such protocol, to 
     communicate information of all kinds by wire or radio.
       ``(51) The term `deliver, distribute, or dispense by means 
     of the Internet' refers, respectively, to any delivery, 
     distribution, or dispensing of a controlled substance that is 
     caused or facilitated by means of the Internet.
       ``(52) The term `online pharmacy'--
       ``(A) means a person, entity, or Internet site, whether in 
     the United States or abroad, that knowingly or intentionally 
     delivers, distributes, or dispenses, or offers or attempts to 
     deliver, distribute, or dispense, a controlled substance by 
     means of the Internet; and
       ``(B) does not include--
       ``(i) manufacturers or distributors registered under 
     subsection (a), (b), (d), or (e) of section 303 who do not 
     dispense controlled substances to an unregistered individual 
     or entity;
       ``(ii) nonpharmacy practitioners who are registered under 
     section 303(f) and whose activities are authorized by that 
     registration;
       ``(iii) any hospital or other medical facility that is 
     operated by an agency of the United States (including the 
     Armed Forces), provided such hospital or other facility is 
     registered under section 303(f);
       ``(iv) a health care facility owned or operated by an 
     Indian tribe or tribal organization, only to the extent such 
     facility is carrying out a contract or compact under the 
     Indian Self-Determination and Education Assistance Act;
       ``(v) any agent or employee of any hospital or facility 
     referred to in clause (iii) or (iv), provided such agent or 
     employee is lawfully acting in the usual course of business 
     or employment, and within the scope of the official duties of 
     such agent or employee, with such hospital or facility, and, 
     with respect to agents or employees of health care facilities 
     specified in clause (iv), only to the extent such individuals 
     are furnishing services pursuant to the contracts or compacts 
     described in such clause;
       ``(vi) mere advertisements that do not attempt to 
     facilitate an actual transaction involving a controlled 
     substance;
       ``(vii) a person, entity, or Internet site that is not in 
     the United States and does not facilitate the delivery, 
     distribution, or dispensing of a controlled substance by 
     means of the Internet to any person in the United States;
       ``(viii) a pharmacy registered under section 303(f) whose 
     dispensing of controlled substances via the Internet consists 
     solely of--
       ``(I) refilling prescriptions for controlled substances in 
     schedule III, IV, or V, as defined in paragraph (55); or
       ``(II) filling new prescriptions for controlled substances 
     in schedule III, IV, or V, as defined in paragraph (56); or
       ``(ix) any other persons for whom the Attorney General and 
     the Secretary have jointly, by regulation, found it to be 
     consistent with effective controls against diversion and 
     otherwise consistent with the public health and safety to 
     exempt from the definition of an `online pharmacy'.
       ``(53) The term `homepage' means the opening or main page 
     or screen of the website of an online pharmacy that is 
     viewable on the Internet.
       ``(54) The term `practice of telemedicine' means, for 
     purposes of this title, the practice of medicine in 
     accordance with applicable Federal and State laws by a 
     practitioner (other than a pharmacist) who is at a location 
     remote from the patient and is communicating with the 
     patient, or health care professional who is treating the 
     patient, using a telecommunications system referred to in 
     section 1834(m) of the Social Security Act, which practice--
       ``(A) is being conducted--
       ``(i) while the patient is being treated by, and physically 
     located in, a hospital or clinic registered under section 
     303(f); and
       ``(ii) by a practitioner--
       ``(I) acting in the usual course of professional practice;
       ``(II) acting in accordance with applicable State law; and
       ``(III) registered under section 303(f) in the State in 
     which the patient is located, unless the practitioner--

       ``(aa) is exempted from such registration in all States 
     under section 302(d); or
       ``(bb) is--

       ``(AA) an employee or contractor of the Department of 
     Veterans Affairs who is acting in the scope of such 
     employment or contract; and
       ``(BB) registered under section 303(f) in any State or is 
     utilizing the registration of a hospital or clinic operated 
     by the Department of Veterans Affairs registered under 
     section 303(f);
       ``(B) is being conducted while the patient is being treated 
     by, and in the physical presence of, a practitioner--
       ``(i) acting in the usual course of professional practice;
       ``(ii) acting in accordance with applicable State law; and
       ``(iii) registered under section 303(f) in the State in 
     which the patient is located, unless the practitioner--
       ``(I) is exempted from such registration in all States 
     under section 302(d); or
       ``(II) is--

       ``(aa) an employee or contractor of the Department of 
     Veterans Affairs who is acting in the scope of such 
     employment or contract; and
       ``(bb) registered under section 303(f) in any State or is 
     using the registration of a hospital or clinic operated by 
     the Department of Veterans Affairs registered under section 
     303(f);

       ``(C) is being conducted by a practitioner--
       ``(i) who is an employee or contractor of the Indian Health 
     Service, or is working for an Indian tribe or tribal 
     organization under its contract or compact with the Indian 
     Health Service under the Indian Self-Determination and 
     Education Assistance Act;
       ``(ii) acting within the scope of the employment, contract, 
     or compact described in clause (i); and
       ``(iii) who is designated as an Internet Eligible 
     Controlled Substances Provider by the Secretary under section 
     311(g)(2);
       ``(D)(i) is being conducted during a public health 
     emergency declared by the Secretary under section 319 of the 
     Public Health Service Act; and
       ``(ii) involves patients located in such areas, and such 
     controlled substances, as the Secretary, with the concurrence 
     of the Attorney General, designates, provided that such 
     designation shall not be subject to the procedures prescribed 
     by subchapter II of chapter 5 of title 5, United States Code;
       ``(E) is being conducted by a practitioner who has obtained 
     from the Attorney General a special registration under 
     section 311(h);
       ``(F) is being conducted--
       ``(i) in a medical emergency situation--
       ``(I) that prevents the patient from being in the physical 
     presence of a practitioner registered under section 303(f) 
     who is an employee or contractor of the Veterans Health 
     Administration acting in the usual course of business and 
     employment and within the scope of the official duties or 
     contract of that employee or contractor;
       ``(II) that prevents the patient from being physically 
     present at a hospital or clinic operated by the Department of 
     Veterans Affairs registered under section 303(f);
       ``(III) during which the primary care practitioner of the 
     patient or a practitioner otherwise practicing telemedicine 
     within the meaning of this paragraph is unable to provide 
     care or consultation; and
       ``(IV) that requires immediate intervention by a health 
     care practitioner using controlled substances to prevent what 
     the practitioner reasonably believes in good faith will be 
     imminent and serious clinical consequences, such as further 
     injury or death; and
       ``(ii) by a practitioner that--
       ``(I) is an employee or contractor of the Veterans Health 
     Administration acting within the scope of that employment or 
     contract;
       ``(II) is registered under section 303(f) in any State or 
     is utilizing the registration of a hospital or clinic 
     operated by the Department of Veterans Affairs registered 
     under section 303(f); and
       ``(III) issues a controlled substance prescription in this 
     emergency context that is limited to a maximum of a 5-day 
     supply which may not be extended or refilled; or
       ``(G) is being conducted under any other circumstances that 
     the Attorney General and the Secretary have jointly, by 
     regulation, determined to be consistent with effective 
     controls against diversion and otherwise consistent with the 
     public health and safety.
       ``(55) The term `refilling prescriptions for controlled 
     substances in schedule III, IV, or V'--
       ``(A) means the dispensing of a controlled substance in 
     schedule III, IV, or V in accordance with refill instructions 
     issued by a practitioner as part of a valid prescription that 
     meets the requirements of subsections (b) and (c) of section 
     309, as appropriate; and
       ``(B) does not include the issuance of a new prescription 
     to an individual for a controlled substance that individual 
     was previously prescribed.
       ``(56) The term `filling new prescriptions for controlled 
     substances in schedule III, IV, or V' means filling a 
     prescription for an individual for a controlled substance in 
     schedule III, IV, or V, if--
       ``(A) the pharmacy dispensing that prescription has 
     previously dispensed to the patient a controlled substance 
     other than by means of the Internet and pursuant to the valid 
     prescription of a practitioner that meets the applicable 
     requirements of subsections (b) and (c) of section 309 (in 
     this paragraph referred to as the `original prescription');
       ``(B) the pharmacy contacts the practitioner who issued the 
     original prescription at the request of that individual to 
     determine whether the practitioner will authorize the 
     issuance of a new prescription for that individual for the 
     controlled substance described in subparagraph (A); and
       ``(C) the practitioner, acting in the usual course of 
     professional practice, determines there is a legitimate 
     medical purpose for the issuance of the new prescription.''.

[[Page 20308]]

       (b) Registration Requirements.--Section 303(f) of the 
     Controlled Substances Act (21 U.S.C. 823(f)) is amended in 
     the matter preceding paragraph (1)--
       (1) in the first sentence, by adding after ``schedule II, 
     III, IV, or V'' the following: ``and shall modify the 
     registrations of pharmacies so registered to authorize them 
     to dispense controlled substances by means of the Internet''; 
     and
       (2) in the second sentence, by striking ``if he determines 
     that the issuance of such registration'' and inserting ``or 
     such modification of registration if the Attorney General 
     determines that the issuance of such registration or 
     modification''.
       (c) Reporting Requirements.--Section 307(d) of the 
     Controlled Substances Act (21 U.S.C. 827(d)) is amended by--
       (1) striking ``(d) Every'' and inserting ``(d)(1) Every''; 
     and
       (2) adding at the end the following:
       ``(2) Each pharmacy with a modified registration under 
     section 303(f) that authorizes the dispensing of controlled 
     substances by means of the Internet shall report to the 
     Attorney General the controlled substances it dispenses, in 
     the amount specified, and in such time and manner as the 
     Attorney General by regulation shall require, except that the 
     Attorney General, under this paragraph, may not require any 
     pharmacy to report any information other than the total 
     quantity of each controlled substance that the pharmacy has 
     dispensed each month. For purposes of this paragraph, no 
     reporting shall be required unless the pharmacy has met 1 of 
     the following thresholds in the month for which the reporting 
     is required:
       ``(A) 100 or more prescriptions dispensed.
       ``(B) 5,000 or more dosage units of all controlled 
     substances combined.''.
       (d) Online Prescription Requirements.--
       (1) In general.--The Controlled Substances Act is amended 
     by inserting after section 310 (21 U.S.C. 830) the following:


      ``additional requirements relating to online pharmacies and 
                              telemedicine

       ``Sec. 311.  (a) In General.--An online pharmacy shall 
     display in a visible and clear manner on its homepage a 
     statement that it complies with the requirements of this 
     section with respect to the delivery or sale or offer for 
     sale of controlled substances and shall at all times display 
     on the homepage of its Internet site a declaration of 
     compliance in accordance with this section.
       ``(b) Licensure.--Each online pharmacy shall comply with 
     the requirements of State law concerning the licensure of 
     pharmacies in each State from which it, and in each State to 
     which it, delivers, distributes, or dispenses or offers to 
     deliver, distribute, or dispense controlled substances by 
     means of the Internet, pursuant to applicable licensure 
     requirements, as determined by each such State.
       ``(c) Internet Pharmacy Site Disclosure Information.--Each 
     online pharmacy shall post in a visible and clear manner on 
     the homepage of each Internet site it operates, or on a page 
     directly linked thereto in which the hyperlink is also 
     visible and clear on the homepage, the following information 
     for each pharmacy that delivers, distributes, or dispenses 
     controlled substances pursuant to orders made on, through, or 
     on behalf of, that website:
       ``(1) The name and address of the pharmacy as it appears on 
     the pharmacy's Drug Enforcement Administration certificate of 
     registration.
       ``(2) The pharmacy's telephone number and email address.
       ``(3) The name, professional degree, and States of 
     licensure of the pharmacist-in-charge, and a telephone number 
     at which the pharmacist-in-charge can be contacted.
       ``(4) A list of the States in which the pharmacy is 
     licensed to dispense controlled substances.
       ``(5) A certification that the pharmacy is registered under 
     this part to deliver, distribute, or dispense by means of the 
     Internet controlled substances.
       ``(6) The name, address, telephone number, professional 
     degree, and States of licensure of any practitioner who has a 
     contractual relationship to provide medical evaluations or 
     issue prescriptions for controlled substances, through 
     referrals from the website or at the request of the owner or 
     operator of the website, or any employee or agent thereof.
       ``(7) The following statement, unless revised by the 
     Attorney General by regulation: `This online pharmacy will 
     only dispense a controlled substance to a person who has a 
     valid prescription issued for a legitimate medical purpose 
     based upon a medical relationship with a prescribing 
     practitioner. This includes at least one prior in-person 
     medical evaluation or medical evaluation via telemedicine in 
     accordance with applicable requirements of section 309.'.
       ``(d) Notification.--
       ``(1) In general.--Thirty days prior to offering a 
     controlled substance for sale, delivery, distribution, or 
     dispensing, the online pharmacy shall notify the Attorney 
     General, in such form and manner as the Attorney General 
     shall determine, and the State boards of pharmacy in any 
     States in which the online pharmacy offers to sell, deliver, 
     distribute, or dispense controlled substances.
       ``(2) Contents.--The notification required under paragraph 
     (1) shall include--
       ``(A) the information required to be posted on the online 
     pharmacy's Internet site under subsection (c) and shall 
     notify the Attorney General and the applicable State boards 
     of pharmacy, under penalty of perjury, that the information 
     disclosed on its Internet site under subsection (c) is true 
     and accurate;
       ``(B) the online pharmacy's Internet site address and a 
     certification that the online pharmacy shall notify the 
     Attorney General of any change in the address at least 30 
     days in advance; and
       ``(C) the Drug Enforcement Administration registration 
     numbers of any pharmacies and practitioners referred to in 
     subsection (c), as applicable.
       ``(3) Existing online pharmacies.--An online pharmacy that 
     is already operational as of the effective date of this 
     section, shall notify the Attorney General and applicable 
     State boards of pharmacy in accordance with this subsection 
     not later than 30 days after such date.
       ``(e) Declaration of Compliance.--On and after the date on 
     which it makes the notification under subsection (d), each 
     online pharmacy shall display on the homepage of its Internet 
     site, in such form as the Attorney General shall by 
     regulation require, a declaration that it has made such 
     notification to the Attorney General.
       ``(f) Reports.--Any statement, declaration, notification, 
     or disclosure required under this section shall be considered 
     a report required to be kept under this part.
       ``(g) Notice and Designations Concerning Indian Tribes.--
       ``(1) In general.--For purposes of sections 102(52) and 
     512(c)(6)(B), the Secretary shall notify the Attorney 
     General, at such times and in such manner as the Secretary 
     and the Attorney General determine appropriate, of the Indian 
     tribes or tribal organizations with which the Secretary has 
     contracted or compacted under the Indian Self-Determination 
     and Education Assistance Act for the tribes or tribal 
     organizations to provide pharmacy services.
       ``(2) Designations.--
       ``(A) In general.--The Secretary may designate a 
     practitioner described in subparagraph (B) as an Internet 
     Eligible Controlled Substances Provider. Such designations 
     shall be made only in cases where the Secretary has found 
     that there is a legitimate need for the practitioner to be so 
     designated because the population served by the practitioner 
     is in a sufficiently remote location that access to medical 
     services is limited.
       ``(B) Practitioners.--A practitioner described in this 
     subparagraph is a practitioner who is an employee or 
     contractor of the Indian Health Service, or is working for an 
     Indian tribe or tribal organization under its contract or 
     compact under the Indian Self-Determination and Education 
     Assistance Act with the Indian Health Service.
       ``(h) Special Registration for Telemedicine.--
       ``(1) In general.--The Attorney General may issue to a 
     practitioner a special registration to engage in the practice 
     of telemedicine for purposes of section 102(54)(E) if the 
     practitioner, upon application for such special 
     registration--
       ``(A) demonstrates a legitimate need for the special 
     registration; and
       ``(B) is registered under section 303(f) in the State in 
     which the patient will be located when receiving the 
     telemedicine treatment, unless the practitioner--
       ``(i) is exempted from such registration in all States 
     under section 302(d); or
       ``(ii) is an employee or contractor of the Department of 
     Veterans Affairs who is acting in the scope of such 
     employment or contract and is registered under section 303(f) 
     in any State or is utilizing the registration of a hospital 
     or clinic operated by the Department of Veterans Affairs 
     registered under section 303(f).
       ``(2) Regulations.--The Attorney General shall, with the 
     concurrence of the Secretary, promulgate regulations 
     specifying the limited circumstances in which a special 
     registration under this subsection may be issued and the 
     procedures for obtaining such a special registration.
       ``(3) Denials.--Proceedings to deny an application for 
     registration under this subsection shall be conducted in 
     accordance with section 304(c).
       ``(i) Reporting of Telemedicine by VHA During Medical 
     Emergency Situations.--
       ``(1) In general.--Any practitioner issuing a prescription 
     for a controlled substance under the authorization to conduct 
     telemedicine during a medical emergency situation described 
     in section 102(54)(F) shall report to the Secretary of 
     Veterans Affairs the authorization of that emergency 
     prescription, in accordance with such requirements as the 
     Secretary of Veterans Affairs shall, by regulation, 
     establish.
       ``(2) To attorney general.--Not later than 30 days after 
     the date that a prescription described in subparagraph (A) is 
     issued, the Secretary of Veterans Affairs shall report to the 
     Attorney General the authorization of that emergency 
     prescription.
       ``(j) Clarification Concerning Prescription Transfers.--Any 
     transfer between pharmacies of information relating to a 
     prescription for a controlled substance shall meet the 
     applicable requirements under regulations promulgated by the 
     Attorney General under this Act.''.
       (2) Technical and conforming amendments.--The table of 
     contents for the Comprehensive Drug Abuse Prevention and 
     Control Act of 1970 (Public Law 91-513; 84 Stat. 1236) is 
     amended by inserting after the item relating to section 310 
     the following:

``Sec. 311. Additional requirements relating to online pharmacies and 
              telemedicine.''.
       (e) Offenses Involving Controlled Substances in Schedules 
     III, IV, and V.--Section 401(b) of the Controlled Substances 
     Act (21 U.S.C. 841(b)) is amended--

[[Page 20309]]

       (1) in paragraph (1)--
       (A) in subparagraph (D), by striking ``or in the case of 
     any controlled substance in schedule III (other than gamma 
     hydroxybutyric acid), or 30 milligrams of flunitrazepam''; 
     and
       (B) by adding at the end the following:
       ``(E)(i) Except as provided in subparagraphs (C) and (D), 
     in the case of any controlled substance in schedule III, such 
     person shall be sentenced to a term of imprisonment of not 
     more than 10 years and if death or serious bodily injury 
     results from the use of such substance shall be sentenced to 
     a term of imprisonment of not more than 15 years, a fine not 
     to exceed the greater of that authorized in accordance with 
     the provisions of title 18, United States Code, or $500,000 
     if the defendant is an individual or $2,500,000 if the 
     defendant is other than an individual, or both.
       ``(ii) If any person commits such a violation after a prior 
     conviction for a felony drug offense has become final, such 
     person shall be sentenced to a term of imprisonment of not 
     more than 20 years and if death or serious bodily injury 
     results from the use of such substance shall be sentenced to 
     a term of imprisonment of not more than 30 years, a fine not 
     to exceed the greater of twice that authorized in accordance 
     with the provisions of title 18, United States Code, or 
     $1,000,000 if the defendant is an individual or $5,000,000 if 
     the defendant is other than an individual, or both.
       ``(iii) Any sentence imposing a term of imprisonment under 
     this subparagraph shall, in the absence of such a prior 
     conviction, impose a term of supervised release of at least 2 
     years in addition to such term of imprisonment and shall, if 
     there was such a prior conviction, impose a term of 
     supervised release of at least 4 years in addition to such 
     term of imprisonment.'';
       (2) in paragraph (2)--
       (A) by striking ``3 years'' and inserting ``5 years'';
       (B) by striking ``6 years'' and inserting ``10 years'';
       (C) by striking ``after one or more prior convictions'' and 
     all that follows through ``have become final,'' and inserting 
     ``after a prior conviction for a felony drug offense has 
     become final,''; and
       (3) in paragraph (3)--
       (A) by striking ``2 years'' and inserting ``4 years'';
       (B) by striking ``after one or more convictions'' and all 
     that follows through ``have become final,'' and inserting 
     ``after a prior conviction for a felony drug offense has 
     become final,''; and
       (C) by adding at the end the following ``Any sentence 
     imposing a term of imprisonment under this paragraph may, if 
     there was a prior conviction, impose a term of supervised 
     release of not more than 1 year, in addition to such term of 
     imprisonment.''.
       (f) Offenses Involving Dispensing of Controlled Substances 
     by Means of the Internet.--Section 401 of the Controlled 
     Substances Act (21 U.S.C. 841) is amended by adding at the 
     end the following:
       ``(h) Offenses Involving Dispensing of Controlled 
     Substances by Means of the Internet.--
       ``(1) In general.--It shall be unlawful for any person to 
     knowingly or intentionally--
       ``(A) deliver, distribute, or dispense a controlled 
     substance by means of the Internet, except as authorized by 
     this title; or
       ``(B) aid or abet (as such terms are used in section 2 of 
     title 18, United States Code) any activity described in 
     subparagraph (A) that is not authorized by this title.
       ``(2) Examples.--Examples of activities that violate 
     paragraph (1) include, but are not limited to, knowingly or 
     intentionally--
       ``(A) delivering, distributing, or dispensing a controlled 
     substance by means of the Internet by an online pharmacy that 
     is not validly registered with a modification authorizing 
     such activity as required by section 303(f) (unless exempt 
     from such registration);
       ``(B) writing a prescription for a controlled substance for 
     the purpose of delivery, distribution, or dispensation by 
     means of the Internet in violation of section 309(e);
       ``(C) serving as an agent, intermediary, or other entity 
     that causes the Internet to be used to bring together a buyer 
     and seller to engage in the dispensing of a controlled 
     substance in a manner not authorized by sections 303(f) or 
     309(e);
       ``(D) offering to fill a prescription for a controlled 
     substance based solely on a consumer's completion of an 
     online medical questionnaire; and
       ``(E) making a material false, fictitious, or fraudulent 
     statement or representation in a notification or declaration 
     under subsection (d) or (e), respectively, of section 311.
       ``(3) Inapplicability.--
       ``(A) This subsection does not apply to--
       ``(i) the delivery, distribution, or dispensation of 
     controlled substances by nonpractitioners to the extent 
     authorized by their registration under this title;
       ``(ii) the placement on the Internet of material that 
     merely advocates the use of a controlled substance or 
     includes pricing information without attempting to propose or 
     facilitate an actual transaction involving a controlled 
     substance; or
       ``(iii) except as provided in subparagraph (B), any 
     activity that is limited to--

       ``(I) the provision of a telecommunications service, or of 
     an Internet access service or Internet information location 
     tool (as those terms are defined in section 231 of the 
     Communications Act of 1934); or
       ``(II) the transmission, storage, retrieval, hosting, 
     formatting, or translation (or any combination thereof) of a 
     communication, without selection or alteration of the content 
     of the communication, except that deletion of a particular 
     communication or material made by another person in a manner 
     consistent with section 230(c) of the Communications Act of 
     1934 shall not constitute such selection or alteration of the 
     content of the communication.

       ``(B) The exceptions under subclauses (I) and (II) of 
     subparagraph (A)(iii) shall not apply to a person acting in 
     concert with a person who violates paragraph (1).
       ``(4) Knowing or intentional violation.--Any person who 
     knowingly or intentionally violates this subsection shall be 
     sentenced in accordance with subsection (b).''.
       (g) Publication.--Section 403(c) of the Controlled 
     Substances Act (21 U.S.C. 843(c)) is amended by--
       (1) striking ``(c)'' and inserting ``(c)(1)''; and
       (2) adding at the end the following:
       ``(2)(A) It shall be unlawful for any person to knowingly 
     or intentionally use the Internet, or cause the Internet to 
     be used, to advertise the sale of, or to offer to sell, 
     distribute, or dispense, a controlled substance where such 
     sale, distribution, or dispensing is not authorized by this 
     title or by the Controlled Substances Import and Export Act.
       ``(B) Examples of activities that violate subparagraph (A) 
     include, but are not limited to, knowingly or intentionally 
     causing the placement on the Internet of an advertisement 
     that refers to or directs prospective buyers to Internet 
     sellers of controlled substances who are not registered with 
     a modification under section 303(f).
       ``(C) Subparagraph (A) does not apply to material that 
     either--
       ``(i) merely advertises the distribution of controlled 
     substances by nonpractitioners to the extent authorized by 
     their registration under this title; or
       ``(ii) merely advocates the use of a controlled substance 
     or includes pricing information without attempting to 
     facilitate an actual transaction involving a controlled 
     substance.''.
       (h) Injunctive Relief.--Section 512 of the Controlled 
     Substances Act (21 U.S.C. 882) is amended by adding at the 
     end the following:
       ``(c) State Cause of Action Pertaining to Online 
     Pharmacies.--
       ``(1) In general.--In any case in which the State has 
     reason to believe that an interest of the residents of that 
     State has been or is being threatened or adversely affected 
     by the action of a person, entity, or Internet site that 
     violates the provisions of section 303(f), 309(e), or 311, 
     the State may bring a civil action on behalf of such 
     residents in a district court of the United States with 
     appropriate jurisdiction--
       ``(A) to enjoin the conduct which violates this section;
       ``(B) to enforce compliance with this section;
       ``(C) to obtain damages, restitution, or other 
     compensation, including civil penalties under section 402(b); 
     and
       ``(D) to obtain such other legal or equitable relief as the 
     court may find appropriate.
       ``(2) Service; intervention.--
       ``(A) Prior to filing a complaint under paragraph (1), the 
     State shall serve a copy of the complaint upon the Attorney 
     General and upon the United States Attorney for the judicial 
     district in which the complaint is to be filed. In any case 
     where such prior service is not feasible, the State shall 
     serve the complaint on the Attorney General and the 
     appropriate United States Attorney on the same day that the 
     State's complaint is filed in Federal district court of the 
     United States. Such proceedings shall be independent of, and 
     not in lieu of, criminal prosecutions or any other 
     proceedings under this title or any other laws of the United 
     States.
       ``(B) Upon receiving notice respecting a civil action 
     pursuant to this section, the United States shall have the 
     right to intervene in such action and, upon so intervening, 
     to be heard on all matters arising therein, and to file 
     petitions for appeal.
       ``(C) Service of a State's complaint on the United States 
     as required in this paragraph shall be made in accord with 
     the requirements of rule 4(i)(1) of the Federal Rule of Civil 
     Procedure.
       ``(3) Powers conferred by state law.--For purposes of 
     bringing any civil action under paragraph (1), nothing in 
     this Act shall prevent an attorney general of a State from 
     exercising the powers conferred on the attorney general of a 
     State by the laws of such State to conduct investigations or 
     to administer oaths or affirmations or to compel the 
     attendance of witnesses of or the production of documentary 
     or other evidence.
       ``(4) Venue.--Any civil action brought under paragraph (1) 
     in a district court of the United States may be brought in 
     the district in which the defendant is found, is an 
     inhabitant, or transacts business or wherever venue is proper 
     under section 1391 of title 28, United States Code. Process 
     in such action may be served in any district in which the 
     defendant is an inhabitant or in which the defendant may be 
     found.
       ``(5) No private right of action.--No private right of 
     action is created under this subsection.
       ``(6) Limitation.--No civil action may be brought under 
     paragraph (1) against--
       ``(A) the United States;
       ``(B) an Indian Tribe or tribal organization, to the extent 
     such tribe or tribal organization is lawfully carrying out a 
     contract or compact under the Indian Self-Determination and 
     Education Assistance Act; or

[[Page 20310]]

       ``(C) any employee of the United States or such Indian 
     tribe or tribal organization, provided such agent or employee 
     is acting in the usual course of business or employment, and 
     within the scope of the official duties of such agent or 
     employee therewith.''.
       (i) Import and Export Act.--Section 1010(b) of the 
     Controlled Substances Import and Export Act (21 U.S.C. 
     960(b)) is amended--
       (1) in paragraph (4)--
       (A) by striking ``or any quantity of a controlled substance 
     in schedule III, IV, or V, (except a violation involving 
     flunitrazepam and except a violation involving gamma 
     hydroxybutyric acid)'';
       (B) by inserting ``or'' before ``less than one kilogram of 
     hashish oil''; and
       (C) by striking ``imprisoned'' and all that follows through 
     the end of the paragraph and inserting ``sentenced in 
     accordance with section 401(b)(1)(D).'';
       (2) by adding at the end the following:
       ``(5) In the case of a violation of subsection (a) 
     involving a controlled substance in schedule III, such person 
     shall be sentenced in accordance with section 401(b)(1).
       ``(6) In the case of a violation of subsection (a) 
     involving a controlled substance in schedule IV, such person 
     shall be sentenced in accordance with section 401(b)(2).
       ``(7) In the case of a violation of subsection (a) 
     involving a controlled substance in schedule V, such person 
     shall be sentenced in accordance with section 401(b)(3).''; 
     and
       (3) in paragraph (3), by striking ``, nor shall a person so 
     sentenced be eligible for parole during the term of such a 
     sentence'' in the final sentence.
       (j) Effective Date.--
       (1) In general.--Except as provided in paragraph (2), the 
     amendments made by this Act shall take effect 180 days after 
     the date of enactment of this Act.
       (2) Definition of practice of telemedicine.--
       (A) In general.--Until the earlier of 3 months after the 
     date on which regulations are promulgated to carry out 
     section 311(h) of the Controlled Substances Act, as amended 
     by this Act, or 15 months after the date of enactment of this 
     Act--
       (i) the definition of the term ``practice of telemedicine'' 
     in subparagraph (B) of this paragraph shall apply for 
     purposes of the Controlled Substances Act; and
       (ii) the definition of the term ``practice of 
     telemedicine'' in section 102(54) of the Controlled 
     Substances Act, as amended by this Act, shall not apply.
       (B) Temporary phase-in of telemedicine regulation.--During 
     the period specified in subparagraph (A), the term ``practice 
     of telemedicine'' means the practice of medicine in 
     accordance with applicable Federal and State laws by a 
     practitioner (as that term is defined in section 102 of the 
     Controlled Substances Act (21 U.S.C. 802)) (other than a 
     pharmacist) who is at a location remote from the patient and 
     is communicating with the patient, or health care 
     professional who is treating the patient, using a 
     telecommunications system referred to in section 1834(m) of 
     the Social Security Act (42 U.S.C. 1395m(m)), if the 
     practitioner is using an interactive telecommunications 
     system that satisfies the requirements of section 
     410.78(a)(3) of title 42, Code of Federal Regulations.
       (C) Rule of construction.--Nothing in this subsection may 
     be construed to create a precedent that any specific course 
     of conduct constitutes the ``practice of telemedicine'' (as 
     that term is defined in section 102(54) of the Controlled 
     Substances Act, as amended by this Act) after the end of the 
     period specified in subparagraph (A).
       (k) Guidelines and Regulations.--
       (1) In general.--The Attorney General may promulgate and 
     enforce any rules, regulations, and procedures which may be 
     necessary and appropriate for the efficient execution of 
     functions under this Act or the amendments made by this Act, 
     and, with the concurrence of the Secretary of Health and 
     Human Services where this Act or the amendments made by this 
     Act so provide, promulgate any interim rules necessary for 
     the implementation of this Act or the amendments made by this 
     Act, prior to its effective date.
       (2) Sentencing guidelines.--The United States Sentencing 
     Commission, in determining whether to amend, or establish 
     new, guidelines or policy statements, to conform the Federal 
     sentencing guidelines and policy statements to this Act and 
     the amendments made by this Act, should not construe any 
     change in the maximum penalty for a violation involving a 
     controlled substance in a particular schedule as being the 
     sole reason to amend, or establish a new, guideline or policy 
     statement.
       (l) Annual Report.--Not later than 180 days after the date 
     of enactment of this Act, and annually for 2 years after the 
     initial report, the Drug Enforcement Administration, in 
     consultation with the Department of State, shall submit to 
     Congress a report describing--
       (1) the foreign supply chains and sources of controlled 
     substances offered for sale without a valid prescription on 
     the Internet;
       (2) the efforts and strategy of the Drug Enforcement 
     Administration to decrease the foreign supply chain and 
     sources of controlled substances offered for sale without a 
     valid prescription on the Internet; and
       (3) the efforts of the Drug Enforcement Administration to 
     work with domestic and multinational pharmaceutical companies 
     and others to build international cooperation and a 
     commitment to fight on a global scale the problem of 
     distribution of controlled substances over the Internet 
     without a valid prescription.

     SEC. 4. RULE OF CONSTRUCTION.

       Nothing in this Act or the amendments made by this Act 
     shall be construed as authorizing, prohibiting, or limiting 
     the use of electronic prescriptions for controlled 
     substances.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Texas (Mr. Burgess) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days to revise and extend their remarks and 
include extraneous material on the bill under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in strong support of H.R. 6353, the Ryan Haight 
Online Pharmacy Consumer Protection Act of 2008. This legislation 
addresses serious concerns about the purchase of controlled substances 
through online pharmacies.
  According to the Drug Enforcement Agency, nearly seven million 
Americans are abusing prescription drugs, more than the number who are 
abusing cocaine, heroin, hallucinogens, ecstasy and inhalants combined.
  Prescription pain relievers are new drug users' drug of choice. 
Nearly one in 10 high school seniors admits to abusing powerful 
prescription pain relievers. And prescription pain relievers appear to 
be among the drugs most heavily dispensed by certain Internet 
pharmacies using prescriptions that are issued based on online 
questionnaires. Most times, the doctor providing the prescription has 
never seen the patient or even had a conversation with them. This 
practice has sometimes been abused by rogue sites and it has led to 
instances of addiction, overdose and death.
  H.R. 6353 will go a long way in combating this harmful practice. The 
bill prohibits the delivery, distribution, or dispensing of controlled 
substances over the Internet without a valid prescription. A valid 
prescription is defined as a prescription that is issued for a 
legitimate purpose by a practitioner who has conducted at least one in-
person medical evaluation of the patient.
  H.R. 6353 also imposes new registration and reporting requirements 
for online pharmacies. The legislation before us also increases 
criminal penalties involving controlled substances in Schedules II, IV 
and V of the Controlled Substances Act.
  H.R. 6353 is named after Ryan Haight, a young man who unfortunately 
was the victim of illegal sales of pharmaceuticals through the 
Internet. Ryan died on February 12, 2001 at the age of 18 from an 
overdose of prescription drugs he had purchased on the Internet. Ryan 
was prescribed the drugs by a doctor whom he never saw and was never 
examined by, and an Internet pharmacy delivered them to his home.
  H.R. 6353 is the result of the leadership of Representative Bart 
Stupak and the hard work and cooperation of the Democratic and 
Republican members of the Energy and Commerce Committee and the 
Judiciary Committee.
  The bill is a bipartisan product. It enjoys the support of the 
administration and the National Association of Chain Drug Stores.
  I strongly urge all of my colleagues to vote to prevent another 
needless death similar to that of Ryan Haight and vote for the passage 
of this bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume 
and rise in support of H.R. 6353. I would like to commend Congressman 
Bart Stupak and Ranking Member Lamar Smith of the Judiciary Committee 
for their work on this bill.
  This bill prohibits the delivery, distribution or dispensing of 
controlled substances over the Internet without a valid prescription. 
Ryan Haight overdosed and died on February 12, 2001

[[Page 20311]]

on narcotics that he had purchased over the Internet. He was prescribed 
the medication from a doctor on the Internet, and the doctor never 
examined the patient. He was 17 when he purchased the narcotics and 18 
when he died.
  This bill will provide the Drug Enforcement Agency better tools to 
combat rogue Internet sites that are peddling narcotics to our 
children.
  I urge Members to support this legislation.
  Mr. Speaker, I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield 5 minutes to the gentlewoman from 
California. Again, Mrs. Capps has played such an important role on this 
and other bills of this nature that are important. Reading about this 
legislation, it really is so crucial.
  Mrs. CAPPS. I thank our chairman for yielding and for his leadership.
  Mr. Speaker, I rise in support of H.R. 6353, the Ryan Haight Online 
Pharmacy bill. And in doing so, I want to pay tribute to its author, 
Bart Stupak, who would be here giving this statement except that his 
voice ran out tonight. So I am stepping in on his behalf, but it is 
something that I truly support as well.
  Nearly 7 million Americans are abusing prescription drugs; more than 
the number of individuals who are abusing cocaine, heroin, 
hallucinogens, ecstasy and inhalants all combined.
  Over the past 6 years, we have witnessed a dramatic 80 percent 
increase in prescription drug abuse from 3.8 million to 7 million. 
That's more than double. A large number of individuals are obtaining 
their prescription drugs over the Internet through rogue Internet 
pharmacies.
  Purchasing drugs online without a valid prescription can be simple: A 
consumer just types the name of the drug into a search engine, quickly 
identifies a site selling the medication, fills out a brief 
questionnaire, and then clicks to purchase.
  The risks of self-medicating, however, can include potential adverse 
reactions from inappropriately prescribed medicines, dangerous drug 
interactions, use of counterfeit or tainted products, and addiction to 
habit-forming substances.
  Several of these illegitimate sites failed to produce information 
about potential adverse side effects, effectiveness, and where the 
pharmacies are located.
  A 2004 GAO study obtained 68 samples of 11 different prescription 
drugs, each from a different Web site. GAO found that 45 online 
pharmacies provided a prescription based on their own medical 
questionnaire or had no prescription requirement. Among the drugs GAO 
obtained without prescription were those with special safety 
restrictions and highly addictive narcotic pain killers.
  The tragic case of Ryan Haight has already been mentioned. His mother 
has testified before Congress and is nationally known. Ryan died at the 
age of 18, as has been stated, from an overdose of pain killers, 
including Vicodin. He ordered these over the Internet without a 
legitimate prescription while he was a 17-year-old minor.
  The Ryan Haight Online Pharmacy Consumer Protection Act would bar the 
sale or distribution of all controlled substances via the Internet 
without a valid prescription. In order for a prescription to be valid, 
it must be issued by a practitioner who has conducted at least one in-
person examination of the particular patient.
  H.R. 6353 would also require online pharmacies to clearly display on 
their Web site a statement of compliance with U.S. laws and DEA 
regulations. This would allow consumers to clearly identify which 
pharmacies are safe and which are not.
  This legislation also creates a new Federal cause of action that 
would allow a State attorney general to shut down a rogue site selling 
controlled substances in any State and increase the penalties for all 
illegal distributions of controlled substances classified as Schedule 
III, IV or V substances.
  This legislation is supported by the administration, including the 
DEA and FDA, the Chain Drug Stores, Go Daddy, eBay, Federation of State 
Medical Boards, and the Fraternal Order of Police.
  I encourage all of my colleagues to vote in favor of this 
legislation. I thank Congressman Lamar Smith, Congresswoman Mary Bono 
Mack, Senator Feinstein, Chairman Dingell and Ranking Member Barton. I 
also want to thank Virgil Miller, Ryan Long, Caroline Lynch and Jeff 
Spalding with the committee staff, and Erika Orloff of Mr. Stupak's 
personal staff for their hard work on this bill.
  Mr. BURGESS. I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, I want to urge, strongly, passage of this 
important bill regarding consumer protection for controlled substances.
  Mr. SMITH of Texas. Mr. Speaker, America is no stranger to the plague 
of illegal drugs and drug addiction. For decades, Congress has fought 
to curb the flow of drugs such as heroin, cocaine, and marijuana into 
our country.
  Today, America is facing a new threat--prescription drug abuse. 
According to the Office of National Drug Control Policy, prescription 
drugs now rank second--only behind marijuana--as America's drug of 
choice.
  The Drug Enforcement Administration estimates that as many as 7 
million Americans are addicted to prescription drugs--more than the 
number of cocaine and heroin addicts combined.
  Today, prescription painkillers cause a higher number of overdose-
related deaths than cocaine or heroin. And large quantities of these 
drugs are just a few mouse clicks away. The dangers posed by illegal 
online pharmacies are real. The National Center on Addiction and 
Substance Abuse reports a 542-percent increase in abuse of prescription 
opiates among 12- to 17-year olds between 1992 and 2002.
  Hundreds of rogue online pharmacies peddle these highly-addictive 
painkillers to adults and teenagers without a valid prescription. The 
most popular of these drugs is commonly known as Vicodin.
  Teenagers are fast becoming addicted to prescription painkillers, in 
large part because of their availability on the Internet. The 
Partnership for a Drug Free America reports that every day, 2,500 
teenagers use a prescription drug to get high for the first time. 
Teenagers are abusing prescription drugs at a higher rate because they 
perceive them as less dangerous than illegal drugs.
  Today, the House has the opportunity to put a stop to illegal online 
pharmacies. I am pleased to join Congressman Bart Stupak and 
Congresswoman Mary Bono Mack as an original sponsor of H.R. 6353, the 
Ryan Haight Online Pharmacy Consumer Protection Act of 2008.
  On February 12, 2001, Ryan Haight died of an overdose of Vicodin. He 
was just 18. An investigation into his death revealed that Ryan ordered 
the drugs from a doctor he had never seen and who had never examined 
him. The drugs were shipped directly to his home by an online pharmacy.
  This legislation amends the Controlled Substances Act to address the 
growing sale of prescription drugs by these so-called online 
pharmacies. The bill prohibits the sale or distribution of all 
controlled substances via the Internet without a valid prescription and 
requires online pharmacies to display information identifying the 
business and any pharmacy and doctor associated with the Web site. The 
bill also provides tough penalties for the illegal sale of prescription 
drugs.
  Legislation sponsored by Senators Feinstein and Sessions unanimously 
passed the Senate in April. It is time for the House to do the same.
  This legislation represents months of hard work and bipartisan 
negotiations by House and Senate Republicans and Democrats. I wish to 
thank my House colleagues, Mr. Stupak and Mrs. Bono Mack and my Senate 
colleagues, Senators Feinstein and Sessions, for their efforts to 
complete this legislation.
  I urge my colleagues to join me in supporting this important bill.
  Mrs. BACHMANN. Mr. Speaker, the House considered and passed H.R. 
6353, the Ryan Haight Online Pharmacy Consumer Protection Act. This 
legislation will ensure that purchasers of potentially dangerous 
prescription drugs are evaluated face-to-face by a physician, removing 
the potentially dangerous anonymity inherent in the current federal 
regulations which allow prescriptions to be written based on a 
telephone call or online questionnaire.
  To be sure, online pharmaceuticals makes it possible for millions of 
Americans to conveniently and affordably access the prescription 
medications on which they rely. However, the online system of 
prescribing and dispensing

[[Page 20312]]

medication has been accompanied by a disturbing increase in the level 
of harm and death due to prescription drugs. This increase is, in large 
part, a result of the current federal guidelines that allow online 
pharmacies to write prescriptions for patients based on a telephone 
conversation with a physician or a simple online questionnaire, 
empowering patients to diagnose and prescribe for themselves virtually 
any drug and dosage they desire. Without the necessary information for 
adequate oversight by a qualified physician, many people have been 
exposed to dangerous and, all too often, deadly medications.
  In response, many states have enacted laws requiring that individuals 
seeking access to powerful medications such as Vicoden and Xanax be 
evaluated in person before being prescribed a controlled substance. For 
example, in my state of Minnesota, the legislature and governor have 
recently worked together to establish Justin's Law. Named for a vibrant 
young man whose bright future was cut short by an overdose of 
prescription painkillers obtained through an internet pharmacy without 
a physician visit, Justin's Law has already been implemented to hold 
illicit online pharmacies accountable.
  That said, the lives affected by online pharmacies are not limited to 
a particular state, and moreover, the interstate nature of the commerce 
conducted via the internet warrants that legislation be enacted at the 
federal level to help protect online consumers. As a result, I applaud 
my colleague, Congressman Stupak for introducing H.R. 6353. This 
legislation, of which I am a cosponsor, will help stem the dangerous 
tide of controlled substances being dispensed without adequate 
supervision.
  Mr. PALLONE. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 6353, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________