S 980 ESRFHCommentsClose CommentsPermalink

To amend the Controlled Substances Act to address online pharmacies.CommentsClose CommentsPermalink

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

SECTION 1. SHORT TITLE.

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

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:CommentsClose CommentsPermalink





`(e) Controlled Substances Dispensed by Means of the Internet-CommentsClose CommentsPermalink





`(1) No controlled substance may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.CommentsClose CommentsPermalink





`(2) As used in this subsection:CommentsClose CommentsPermalink





`(A) The term `valid prescription' means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by--CommentsClose CommentsPermalink





`(i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; orCommentsClose CommentsPermalink





`(ii) a covering practitioner.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(ii) is temporarily unavailable to conduct the evaluation of the patient.CommentsClose CommentsPermalink





`(3) Nothing in this subsection shall apply to--CommentsClose CommentsPermalink





`(A) the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine; orCommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(52) The term `online pharmacy'--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(B) does not include--CommentsClose CommentsPermalink





`(i) manufacturers or distributors registered under subsection (a), (b), (c), or (d) of section 303 who do not dispense controlled substances to an unregistered individual or entity;CommentsClose CommentsPermalink





`(ii) nonpharmacy practitioners who are registered under section 303(f) and whose activities are authorized by that registration;CommentsClose CommentsPermalink





`(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);CommentsClose CommentsPermalink





`(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 (25 U.S.C. 450 et seq.);CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(vi) mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance;CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(viii) a pharmacy registered under section 303(f) whose dispensing of controlled substances via the Internet consists solely of--CommentsClose CommentsPermalink





`(I) `refilling prescriptions for controlled substances in schedule III, IV, or V', as defined in paragraph (55); orCommentsClose CommentsPermalink





`(II) `filling new prescriptions for controlled substances in schedule III, IV, or V', as defined in paragraph (56); orCommentsClose CommentsPermalink





`(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'.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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 (42 U.S.C. 1395m(m)), and that--CommentsClose CommentsPermalink





`(A) is being conducted--CommentsClose CommentsPermalink





`(i) while the patient is being treated by, and physically located in, a hospital or clinic registered under section 303(f); andCommentsClose CommentsPermalink





`(ii) by a practitioner--CommentsClose CommentsPermalink





`(I) acting in the usual course of professional practice;CommentsClose CommentsPermalink





`(II) acting in accordance with applicable State law; andCommentsClose CommentsPermalink





`(III) registered under section 303(f) in the State in which the patient is located, unless the practitioner--CommentsClose CommentsPermalink

`(aa) is exempted from such registration in all States under section 302(d); orCommentsClose CommentsPermalink

`(bb) is--CommentsClose CommentsPermalink

`(AA) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; andCommentsClose CommentsPermalink

`(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);CommentsClose CommentsPermalink

`(B) is being conducted while the patient is being treated by, and in the physical presence of, a practitioner--CommentsClose CommentsPermalink





`(i) acting in the usual course of professional practice;CommentsClose CommentsPermalink





`(ii) acting in accordance with applicable State law; andCommentsClose CommentsPermalink





`(iii) registered under section 303(f) in the State in which the patient is located, unless the practitioner--CommentsClose CommentsPermalink





`(I) is exempted from such registration in all States under section 302(d); orCommentsClose CommentsPermalink





`(II) is--CommentsClose CommentsPermalink

`(aa) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; andCommentsClose CommentsPermalink

`(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);CommentsClose CommentsPermalink

`(C) is being conducted by a practitioner--CommentsClose CommentsPermalink





`(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 (25 U.S.C. 450 et seq.);CommentsClose CommentsPermalink





`(ii) acting within the scope of the employment, contract, or compact described in clause (i); andCommentsClose CommentsPermalink





`(iii) who is designated as an Internet Eligible Controlled Substances Provider by the Secretary under section 311(g)(2);CommentsClose CommentsPermalink





`(D)(i) is being conducted during a public health emergency declared by the Secretary under section 319 of the Public Health Service Act (42 U.S.C. 247d); andCommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(E) is being conducted by a practitioner who has obtained from the Attorney General a special registration under section 311(h);CommentsClose CommentsPermalink





`(F) is being conducted--CommentsClose CommentsPermalink





`(i) in a medical emergency situation--CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(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);CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(ii) by a practitioner that--CommentsClose CommentsPermalink





`(I) is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;CommentsClose CommentsPermalink





`(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); andCommentsClose CommentsPermalink





`(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; orCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(55) The term `refilling prescriptions for controlled substances in schedule III, IV, or V'--CommentsClose CommentsPermalink





`(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 subsection (b) or (c) of section 309, as appropriate; andCommentsClose CommentsPermalink





`(B) does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed.CommentsClose CommentsPermalink





`(56) The term `filling new prescriptions for controlled substances in schedule III, IV, or V' means a prescription for an individual for a controlled substance in schedule III, IV, or V, if--CommentsClose CommentsPermalink





`(A) the pharmacy dispensing that prescription has previously dispensed to the patient that same controlled substance other than by means of the Internet and pursuant to the valid prescription of a practitioner that meets the applicable requirements of sections 309(b) or (c) (in this paragraph referred to as the `original prescription');CommentsClose CommentsPermalink





`(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); andCommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(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)--CommentsClose CommentsPermalink





(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'; andCommentsClose CommentsPermalink





(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'.CommentsClose CommentsPermalink





(c) Reporting Requirements- Section 307(d) of the Controlled Substances Act (21 U.S.C. 827(d)) is amended by--CommentsClose CommentsPermalink





(1) designating the text as paragraph (1); andCommentsClose CommentsPermalink





(2) inserting after paragraph (1), as so designated by this Act, the following:CommentsClose CommentsPermalink





`(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 subsection, no reporting shall be required unless the pharmacy has met 1 of the following thresholds in the month for which the reporting is required:CommentsClose CommentsPermalink





`(A) 100 or more prescriptions dispensed.CommentsClose CommentsPermalink





`(B) 5,000 or more dosage units of all controlled substances combined.'.CommentsClose CommentsPermalink





(d) Online Prescription Requirements-CommentsClose CommentsPermalink





(1) IN GENERAL- The Controlled Substances Act is amended by inserting after section 310 (21 U.S.C. 830) the following:CommentsClose CommentsPermalink

`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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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:CommentsClose CommentsPermalink





`(1) The name and address of the pharmacy as it appears on the pharmacy's Drug Enforcement Administration certificate of registration.CommentsClose CommentsPermalink





`(2) The pharmacy's telephone number and email address.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(4) A list of the States in which the pharmacy is licensed to dispense controlled substances.CommentsClose CommentsPermalink





`(5) A certification that the pharmacy is registered under this part to deliver, distribute, or dispense by means of the Internet controlled substances.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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 of the Controlled Substances Act (21 U.S.C. 829).'.CommentsClose CommentsPermalink





`(d) Notification- (1) Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing, the online pharmacy shall notify the Attorney General, in the form and manner as the Attorney General shall determine, and the State boards of pharmacy in any States in which the online pharmacy offers to sell, deliver, distribute, or dispense controlled substances.CommentsClose CommentsPermalink





`(2) The notification required under paragraph (1) shall include--CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(C) the Drug Enforcement Administration registration numbers of any pharmacies and practitioners referred to in subsection (c), as applicable.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(f) Reports- Any statement, declaration, notification, or disclosure required under this section shall be considered a report required to be kept under this part.CommentsClose CommentsPermalink





`(g) Notice and Designations Concerning Indian Tribes-CommentsClose CommentsPermalink





`(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 (25 U.S.C. 450 et seq.) for the tribes or tribal organizations to provide pharmacy services.CommentsClose CommentsPermalink





`(2) DESIGNATIONS-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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 (25 U.S.C. 450 et seq.) with the Indian Health Service.CommentsClose CommentsPermalink





`(h) Special Registration for Telemedicine-CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(A) demonstrates a legitimate need for the special registration; andCommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(i) is exempted from such registration in all States under section 302(d); orCommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(3) DENIALS- Proceedings to deny an application for registration under this subsection shall be conducted in accordance with section 304(c).CommentsClose CommentsPermalink





`(i) Reporting of Telemedicine by VHA During Medical Emergency Situations-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





`Sec. 311. Additional requirements relating to online pharmacies and telemedicine.'.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(1) in paragraph (1)--CommentsClose CommentsPermalink





(A) in subparagraph (C), by striking `1 gram of' before `flunitrazepam';CommentsClose CommentsPermalink





(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'; andCommentsClose CommentsPermalink





(C) by adding at the end the following:CommentsClose CommentsPermalink





`(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, 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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.';CommentsClose CommentsPermalink





(2) in paragraph (2)--CommentsClose CommentsPermalink





(A) by striking `3 years' and inserting `5 years';CommentsClose CommentsPermalink





(B) by striking `6 years' and inserting `10 years';CommentsClose CommentsPermalink





(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,'; andCommentsClose CommentsPermalink





(3) in paragraph (3)--CommentsClose CommentsPermalink





(A) by striking `2 years' and inserting `6 years';CommentsClose CommentsPermalink





(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,'; andCommentsClose CommentsPermalink





(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.'.CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





`(g) Offenses Involving Dispensing of Controlled Substances by Means of the Internet- (1) It shall be unlawful for any person to knowingly or intentionally--CommentsClose CommentsPermalink





`(A) deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by this title; orCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) Examples of activities that violate paragraph (1) include, but are not limited to, knowingly or intentionally--CommentsClose CommentsPermalink





`(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);CommentsClose CommentsPermalink





`(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);CommentsClose CommentsPermalink





`(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);CommentsClose CommentsPermalink





`(D) offering to fill a prescription for a controlled substance based solely on a consumer's completion of an online medical questionnaire; andCommentsClose CommentsPermalink





`(E) making a material false, fictitious, or fraudulent statement or representation in the submission to the Attorney General under section 311.CommentsClose CommentsPermalink





`(3)(A) This subsection does not apply to--CommentsClose CommentsPermalink





`(i) the delivery, distribution, or dispensation of controlled substances by nonpractitioners to the extent authorized by their registration under this title;CommentsClose CommentsPermalink





`(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; orCommentsClose CommentsPermalink





`(iii) except as provided in subparagraph (B), any activity that is limited to--CommentsClose CommentsPermalink





`(I) the provision of a telecommunications service, or of an Internet access service or Internet information location tool (as those terms are defined in section 231 of the Communications Act of 1934 (47 U.S.C. 231)); orCommentsClose CommentsPermalink





`(II) the transmission, storage, retrieval, hosting, formatting, or translation (or any combination thereof) of a communication, without selection or alteration of the content of the communication, except that deletion of a particular communication or material made by another person in a manner consistent with section 230(c) of the Communications Act of 1934 (47 U.S.C. 230(c)) shall not constitute such selection or alteration of the content of the communication.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(4) Any person who knowingly or intentionally violates this subsection shall be sentenced in accordance with subsection (b) of this section.'.CommentsClose CommentsPermalink





(g) Publication- Section 403(c) of the Controlled Substances Act (21 U.S.C. 843(c)) is amended by--CommentsClose CommentsPermalink





(1) designating the text as paragraph (1); andCommentsClose CommentsPermalink





(2) adding at the end the following:CommentsClose CommentsPermalink





`(2)(A) Except as authorized by this title, it shall be unlawful for any person by means of the Internet to knowingly advertise the sale or distribution of, or to offer to sell, distribute, or dispense, a controlled substance.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(C) Subparagraph (A) does not apply to material that either--CommentsClose CommentsPermalink





`(i) merely advertises the distribution of controlled substances by nonpractitioners to the extent authorized by their registration under this title; orCommentsClose CommentsPermalink





`(ii) merely advocates the use of a controlled substance or includes pricing information without attempting to facilitate an actual transaction involving a controlled substance.'.CommentsClose CommentsPermalink





(h) Injunctive Relief- Section 512 of the Controlled Substances Act (21 U.S.C. 882) is amended by adding at the end the following:CommentsClose CommentsPermalink





`(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(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--CommentsClose CommentsPermalink





`(A) to enjoin the conduct which violates this section;CommentsClose CommentsPermalink





`(B) to enforce compliance with this section;CommentsClose CommentsPermalink





`(C) to obtain damages, restitution, or other compensation, including civil penalties under section 402(b); andCommentsClose CommentsPermalink





`(D) to obtain such other legal or equitable relief as the court may find appropriate.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(B) Upon receiving notice respecting a civil action pursuant to this section, the United States shall have the right to intervene in such action, upon so intervening, to be heard on all matters arising therein, and to file petitions for appeal.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(5) No private right of action is created under this subsection.CommentsClose CommentsPermalink





`(6) No civil action may be brought under paragraph (1) against--CommentsClose CommentsPermalink





`(A) the United States;CommentsClose CommentsPermalink





`(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; orCommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(i) Forfeiture of Facilitating Property in Drug Cases- Section 511(a)(4) of the Controlled Substances Act (21 U.S.C. 881(a)(4)) is amended to read as follows:CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(j) Import and Export Act- Section 1010(b) of the Controlled Substances Import and Export Act (21 U.S.C. 960(b)) is amended--CommentsClose CommentsPermalink





(1) in paragraph (4)--CommentsClose CommentsPermalink





(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)';CommentsClose CommentsPermalink





(B) by inserting `, or' before `less than one kilogram of hashish oil'; andCommentsClose CommentsPermalink





(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)).';CommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(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).'; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(k) Effective Date-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(2) DEFINITION OF PRACTICE OF TELEMEDICINE-CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(i) the definition of the term `practice of telemedicine' in subparagraph (B) of this paragraph shall apply for purposes of the Controlled Substances Act; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(l) Guidelines and Regulations-CommentsClose CommentsPermalink





(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 provides, promulgate any interim rules necessary for the implementation of this Act or the amendments made by this Act, prior to its effective date.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) shall consult with the Department of Justice, experts and other affected parties concerning which penalties for scheduled substances amended by this Act should be reflected in the Federal sentencing guidelines; andCommentsClose CommentsPermalink





(B) should not construe any change in the maximum penalty for a violation involving a controlled substance in a particular schedule as being the sole reason to amend a, or establish a new, guideline or policy statement.CommentsClose CommentsPermalink





(m) Annual Report- Not later than 180 days after the date of enactment of this Act, and annually for 2 years after the initial report, the Drug Enforcement Administration, in consultation with the Department of State, shall submit to Congress a report describing--CommentsClose CommentsPermalink





(1) the foreign supply chains and sources of controlled substances offered for sale without a valid prescription on the Internet;CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

Passed the Senate April 1 (legislative day, March 13), 2008.CommentsClose CommentsPermalink

Attest:CommentsClose CommentsPermalink

Secretary.