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May 2, 2007, 12:00 am ET - Amendment SA 993 proposed by Senator Gregg.
May 3, 2007, 12:00 am ET - Considered by Senate.
May 7, 2007, 12:00 am ET - Considered by Senate.
May 8, 2007, 12:00 am ET - Considered by Senate.
May 8, 2007, 12:00 am ET - Proposed amendment SA 993 withdrawn in Senate.

Full Text of this Amendment

SA 993. Mr. GREGG submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:
TITLE X--INTERNET PHARMACIES


SEC. X01. SHORT TITLE.
This title may be cited as the ``Safe Internet Pharmacy Act of 2007''.
SEC. X02. INTERNET PHARMACIES.
(a) Internet Pharmacies.--Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 510 the following:
``SEC. 511. INTERNET PHARMACIES.
``(a) Definitions.--In this section:
``(1) ADVERTISING SERVICE PROVIDER.--The term `advertising service provider' means an advertising company that contracts with a provider of an interactive computer service (as defined in section 230(f) of the Communications Act of 1934 (47 U.S.C. 230(f)) to provide advertising on the Internet.
``(2) DESIGNATED PAYMENT SYSTEM.--
``(A) IN GENERAL.--The term `designated payment system' means a system used by a person described in subparagraph (B) to effect a credit transaction, electronic fund transfer, or money transmitting service that the Board determines, by regulation or order, is regularly used in connection with, or to facilitate restricted transactions.
``(B) PERSONS DESCRIBED.--A person referred to in subparagraph (A) is--
``(i) a creditor;
``(ii) a credit card issuer;
``(iii) a financial institution;
``(iv) an operator of a terminal at which an electronic fund transfer may be initiated;
``(v) a money transmitting business; or
``(vi) a participant in an international, national, regional, or local network constructed primarily to effect a credit transaction, electronic fund transfer, or money transmitting service.
``(3) FEDERAL FUNCTIONAL REGULATOR.--The term `Federal functional regulator' has the meaning given the term in section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809).
``(4) INTERNET PHARMACY.--The term `Internet pharmacy' means a person that offers to dispense or dispenses in the United States a prescription drug through an Internet website in interstate commerce, regardless of whether the physical location of the principal place of business of the Internet pharmacy is in the United States or in another country.
``(5) PRESCRIPTION DRUG.--The term `prescription drug' means a drug described in section 503(b) that is approved by the Secretary under section 505.
``(6) RESTRICTED TRANSACTION.--The term `restricted transaction' means a transaction or transmittal, on behalf of a individual who places an unlawful Internet pharmacy request to any person engaged in the operation of an unlicensed Internet pharmacy, of--
``(A) credit, or the proceeds of credit, extended to or on behalf of the individual for the purpose of the unlawful Internet request (including credit extended through the use of a credit card);
``(B) an electronic fund transfer or funds transmitted by or through a money transmitting business, or the proceeds of an electronic fund transfer or money transmitting service, from or on behalf of the individual for the purpose of the unlawful Internet request;
``(C) a check, draft, or similar instrument which is drawn by or on behalf of the individual for the purpose of the unlawful Internet request and is drawn on or payable at or through any financial institution; or
``(D) the proceeds of any other form of financial transaction (identified by the Board by regulation) that involves a financial institution as a payor or financial intermediary on behalf of or for the benefit of the individual for the purpose of the unlawful Internet request.
``(7) TREATING PROVIDER.--The term `treating provider' means a health care provider licensed in the United States who is authorized to prescribe medications and who--
``(A)(i) performs a documented patient evaluation (including a patient history and physical examination) of an individual, portions of which may be conducted by other health professionals;
``(ii) discusses with the individual the treatment options of the individual and the risks and benefits of treatment; and
``(iii) maintains contemporaneous medical records concerning the individual; or
``(B) provides care to an individual as part of an on-call or cross-coverage arrangement with a health care provider described in subparagraph (A).
``(8) UNLAWFUL INTERNET PHARMACY REQUEST.--The term `unlawful Internet pharmacy request' means the request, or transmittal of a request, made to an unlicensed Internet pharmacy for a prescription drug by mail (including a private carrier), facsimile, telephone, or electronic mail, or by a means that involves the use, in whole or in part, of the Internet.
``(9) UNLICENSED INTERNET PHARMACY.--The term `unlicensed Internet pharmacy' means an Internet pharmacy that is not licensed under this section.
``(10) OTHER DEFINITIONS.--
``(A) BOARD.--The term `Board' means the Board of Governors of the Federal Reserve System.
``(B) CREDIT; CREDITOR; CREDIT CARD.--The terms `credit', `creditor', and `credit card' have the meanings given the terms in section 103 of the Truth in Lending Act (15 U.S.C. 1602).
``(C) ELECTRONIC FUND TRANSFER.--The term `electronic fund transfer'--
``(i) has the meaning given the term in section 903 of the Electronic Fund Transfer Act (15 U.S.C. 1693a); and
``(ii) includes any fund transfer covered under article 4A of the Uniform Commercial Code, as in effect in any State.
``(D) FINANCIAL INSTITUTION.--The term `financial institution'--
``(i) has the meaning given the term in section 903 of the Electronic Transfer Fund Act (15 U.S.C. 1693a); and
``(ii) includes a financial institution (as defined in section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
``(E) MONEY TRANSMITTING BUSINESS; MONEY TRANSMITTING SERVICE.--The terms `money transmitting business' and `money transmitting service' have the meanings given the terms in section 5330(d) of title 31, United States Code.
``(b) In General.--An Internet pharmacy may only dispense or offer to dispense a prescription drug to a person in the United States in accordance with this section.
``(c) Licensing of Internet Pharmacies.--
``(1) IN GENERAL.--An Internet pharmacy shall be licensed by the Secretary in accordance with this section prior to offering to dispense or dispensing a prescription drug to an individual.
``(2) CONDITIONS FOR LICENSING.--
``(A) APPLICATION REQUIREMENTS.--An Internet pharmacy shall submit to the Secretary an application that includes--
``(i)(I) in the case of an Internet pharmacy located in the United States, verification that, in each State in which the Internet pharmacy engages in dispensing or offering to dispense prescription drugs, the Internet pharmacy, and all employees and agents of the Internet pharmacy, is in compliance with applicable Federal and State laws regarding--
``(aa) the practice of pharmacy, including licensing laws and inspection requirements; and
``(bb) the manufacturing and distribution of controlled substances, including with respect to mailing or shipping controlled substances to consumers; or
``(II) in the case of an Internet pharmacy whose principal place of business is located outside the United States, verification that--
``(aa) all employees and agents of the Internet pharmacy are in compliance with applicable Federal and State laws regarding the practice of pharmacy, including licensing laws and inspection requirements;
``(bb) the Internet pharmacy is in compliance with applicable Federal and State laws regarding the practice of pharmacy, including licensing laws and inspection requirements;
``(cc) the Internet pharmacy expressly and affirmatively agrees to provide and maintain an agent for service of process in the United States;
``(dd) the Internet pharmacy expressly and affirmatively agrees to be subject to the jurisdiction of the United States and any of its States or territories where it engages in commerce; and
``(ee) the Internet pharmacy agrees to affix to each shipping container of drugs to be shipped in the United States such markings as the Secretary determines to be necessary to identify that the shipment is from a licensed Internet pharmacy, which may include anticounterfeiting or track-and-trace technologies;
``(ii) verification that the person that owns the Internet pharmacy has not had a license for an Internet pharmacy terminated by the Secretary, and that no other Internet pharmacy owned by the person has had a license under this subsection that has been terminated by the Secretary;
``(iii) verification from the person that owns the Internet pharmacy that the person will permit inspection of the facilities and business practices of the Internet pharmacy by the Secretary to the extent necessary to determine whether the Internet pharmacy is in compliance with this subsection;
``(iv) in the case of an agreement between a patient and an Internet pharmacy that releases the Internet pharmacy, and any employee or agent of the Internet pharmacy, from liability for damages arising out of the negligence of the Internet pharmacy, an assurance that such a limitation of liability shall be null and void;
``(v) verification that the Internet pharmacy expressly and affirmatively agrees to provide the Secretary with the identity of any providers of interactive computer services that provide host services or advertising services for the Internet pharmacy; and
``(vi) assurance that the Internet pharmacy will comply with the requirements under subparagraphs (B) and (C).
``(B) IDENTIFICATION REQUIREMENTS.--An Internet pharmacy shall post in a clear and visible manner, on each page of the website of the Internet pharmacy or by a link to a separate page, the following information:
``(i) The street address, city, ZIP Code or comparable mail code, State (or comparable entity), country, and telephone number of--
``(I) each place of business of the Internet pharmacy; and
``(II) the name of the supervising pharmacist of the Internet pharmacy and each individual who serves as a pharmacist for purposes of the Internet pharmacy website.
``(ii) The names of all States in which the Internet pharmacy and the pharmacists employed by the Internet pharmacy are licensed or otherwise authorized to dispense prescription drugs.
``(iii) If the Internet pharmacy makes referrals to, or solicits on behalf of, a health care practitioner or group of practitioners in the United States for prescription services--
``(I) the name, street address, city, ZIP Code or comparable mail code, State, and telephone number of the practitioner or group; and
``(II) the name of each State in which each practitioner is licensed or otherwise authorized to prescribe drugs.
``(iv) A statement that the Internet pharmacy will dispense prescription drugs only after receipt of a valid prescription from a treating provider.
``(v) A distinctive tamper resistant seal to identify that the Internet pharmacy is licensed.
``(C) PROFESSIONAL SERVICES REQUIREMENTS.--An Internet pharmacy shall carry out the following:
``(i) Maintain patient medication profiles and other related data in a readily accessible format organized to facilitate consultation with treating providers, caregivers, and patients.
``(ii) Conduct prospective drug use reviews before dispensing medications or medical devices.
``(iii) Ensure patient confidentiality and the protection of patient identity and patient-specific information, in accordance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996.
``(iv) Offer interactive and meaningful consultation by a licensed pharmacist to the caregiver or patient before and after the time at which the Internet pharmacy dispenses the drug.
``(v)(I) Establish a mechanism for patients to report errors and suspected adverse drug reactions.
``(II) Document in the reporting mechanism the response of the Internet pharmacy to those reports.
``(III) Submit those reports within 3 days of receipt and the response of the Internet pharmacy to the Food and Drug Administration in a manner determined appropriate by the Secretary.
``(vi) Develop a system to inform caregivers and patients about drug recalls.
``(vii) Educate caregivers and patients about the appropriate means of disposing of expired, damaged, or unusable medications.
``(viii) Assure that the sale of a prescription drug is in accordance with a valid prescription from the treating provider of the individual.
``(ix)(I) Verify the validity of the prescription of an individual by using 1 of the following methods:
``(aa) If the prescription for any drug other than a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) is received from an individual or the treating provider of the individual by mail (including a private carrier), or from the treating provider of the individual by electronic mail, the validity of the prescription shall be confirmed in accordance with all applicable Federal and State laws.
``(bb) If the prescription is for a controlled substance (as defined in section 102 of the Controlled Substances Act), the validity of the prescription shall be confirmed with the treating provider as described in subclause (II).
``(II) When seeking verification of a prescription of an individual under subclause (I)(bb), an Internet pharmacy shall provide to the treating provider the following information:
``(aa) The full name and address of the individual.
``(bb) Identification of the prescription drug.
``(cc) The quantity of the prescription drug to be dispensed.
``(dd) The date on which the individual presented the prescription to the Internet pharmacy.
``(ee) The date and time of the verification request.
``(ff) The name of a contact person at the Internet pharmacy, including a voice telephone number, electronic mail address, and facsimile telephone number.
``(III) A prescription is verified under subclause (I)(bb) only if 1 of the following occurs:
``(aa) The treating provider confirms, by direct communication with the Internet pharmacy, that the prescription is accurate.
``(bb) The treating provider informs the Internet pharmacy that the prescription is inaccurate and provides the accurate prescription.
``(IV) An Internet pharmacy shall not fill a prescription if--
``(aa) a treating provider informs the Internet pharmacy within 72 hours after receipt of a communication under subclause (I)(bb) that the prescription is inaccurate or expired; or
``(bb) the treating provider does not respond within that time.
``(x) Maintain, for such period of time as the Secretary shall prescribe by regulation, a record of all direct communications with a treating provider regarding the dispensing of a prescription drug, including verification of the prescription.
``(3) LICENSURE PROCEDURE.--
``(A) ACTION BY SECRETARY.--On receipt of a complete licensing application from an Internet pharmacy under paragraph (2), the Secretary shall--
``(i) assign an identification number to the Internet pharmacy;
``(ii) notify the applicant of the receipt of the licensing application; and
``(iii) if the Internet pharmacy is in compliance with the conditions under paragraph (2), issue a license not later than 60 days after receipt of a licensing application from the Internet pharmacy.
``(B) ELECTRONIC FILING.--
``(i) IN GENERAL.--For the purpose of reducing paperwork and reporting burdens, the Secretary shall require the use of electronic methods of submitting to the Secretary a licensing application required under this section and provide for electronic methods of receiving the applications.
``(ii) AUTHENTICATION.--In providing for the electronic submission of such licensing applications under this section, the Secretary shall ensure that adequate authentication protocols are used to allow identification of the Internet pharmacy and validation of the data as appropriate.
``(4) DATABASE.--
``(A) IN GENERAL.--The Secretary shall compile, maintain, and periodically update a database of the Internet pharmacies licensed under this section.
``(B) AVAILABILITY.--The Secretary shall make the database described under subparagraph (A) and information submitted by the licensee under paragraph (2)(B) available to the public on an Internet website and through a toll-free telephone number.
``(5) FEES.--
``(A) IN GENERAL.--
``(i) LICENSING APPLICATION FEE.--The Secretary shall establish a licensing application fee to be paid by all applicants.
``(ii) RENEWAL FEE.--The Secretary shall establish a yearly renewal fee to be paid by all Internet pharmacies licensed under this section.
``(B) COLLECTION.--
``(i) COLLECTION OF LICENSING APPLICATION FEE.--A licensing application fee payable for the fiscal year in which the Internet pharmacy submits a licensing application, as established under subparagraph (C), shall be payable upon the submission to the Secretary of such licensing application.
``(ii) COLLECTION OF RENEWAL FEES.--After the licensing application fee is paid for the first fiscal year of licensure, the yearly renewal fee, as established under subparagraph (C), shall be payable on or before October 1 of each subsequent fiscal year.
``(iii) ONE FEE PER INTERNET PHARMACY.--The licensing application fee and yearly renewal fee shall be paid only once for each Internet pharmacy for a fiscal year in which the fee is payable.
``(C) FEE AMOUNT.--The amount of the licensing application fee and the yearly renewal fee for an Internet pharmacy shall be determined each year by the Secretary based on the anticipated costs to the Secretary of enforcing the requirements of this section in the subsequent fiscal year.
``(D) ANNUAL FEE DETERMINATION.--
``(i) IN GENERAL.--Not later than 60 days before the beginning of each fiscal year beginning after September 30, 2007, the Secretary shall determine the amount of the licensing application fee and the yearly renewal fee for that fiscal year.
``(ii) PUBLICATION OF FEE AMOUNT.--Not later than 60 days before each fiscal year, the Secretary shall publish the amount of the licensing application fee and the yearly renewal fee under this section for that fiscal year and provide for a period of 30 days for the public to provide written comments on the fees.
``(E) USE OF FEES.--The fees collected under this section shall be used, without further appropriation, to carry out this section.
``(F) FAILURE TO PAY FEE.--
``(i) DUE DATE.--A fee payable under this section shall be paid by the date that is 30 days after the date on which the fee is due.
``(ii) FAILURE TO PAY.--If an Internet pharmacy subject to a fee under this section fails to pay the fee by the date specified under clause (i), the Secretary shall not permit the Internet pharmacy to engage in the dispensing of drugs as described under this section until all such fees owed by the Internet pharmacy are paid.
``(G) REPORTS.--Beginning with fiscal year 2008, not later than 60 days after the end of each fiscal year during which licensing application fees are collected under this section, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that describes--
``(i) implementation of the licensing fee authority during the fiscal year; and
``(ii) the use by the Secretary of the licensing fees collected during the fiscal year for which the report is made.
``(6) SUSPENSION.--
``(A) IN GENERAL.--If the Secretary determines that an Internet pharmacy is engaged in a pattern of violations of any of the requirements of this Act, the Secretary may immediately order the suspension of the license of the Internet pharmacy.
``(B) APPEAL OF SUSPENSION ORDER.--An Internet pharmacy subject to a suspension order under subparagraph (A) may appeal the suspension order to the Secretary. Not later than 30 days after an appeal is filed, the Secretary, after providing opportunity for an informal hearing, shall affirm or terminate the order.
``(C) FAILURE TO ACT.--If, during the 30-day period specified in subparagraph (B), the Secretary fails to provide an opportunity for a hearing or to affirm or terminate the order, the order shall be deemed to be terminated.
``(D) NO JUDICIAL REVIEW.--An order under this paragraph shall not be subject to judicial review.
``(7) TERMINATION OF LICENSE.--The Secretary may terminate a license issued under this subsection, after notice to the Internet pharmacy and an opportunity for a hearing, and if the Secretary determines that the Internet pharmacy--
``(A) has demonstrated a pattern of noncompliance with this section;
``(B) has made an untrue statement of material fact in its licensing application; or
``(C) is in violation of any applicable Federal or State law relating to the dispensing of a prescription drug.
``(8) RENEWAL EVALUATION.--
``(A) IN GENERAL.--Before renewing a license of an Internet pharmacy under this subsection, the Secretary shall conduct an evaluation to determine whether the Internet pharmacy is in compliance with this section.
``(B) EVALUATION OF INTERNET PHARMACIES.--At the discretion of the Secretary and as applicable, an evaluation under subparagraph (A) may include testing of the Internet pharmacy website or other systems through which the Internet pharmacy communicates with consumers, and a physical inspection of the records and premises of the pharmacy.
``(9) CONTRACT FOR OPERATION OF PROGRAM.--
``(A) IN GENERAL.--The Secretary may award a contract under this subsection for the operation of the licensing program.
``(B) TERM.--The duration of a contract under subparagraph (A) shall not exceed 5 years and may be renewable.
``(C) PERFORMANCE REVIEW.--The Secretary shall annually review performance under a contract under subparagraph (A).
``(d) Providers of Interactive Computer Services or Advertising Services.--No provider of interactive computer services (as defined in section 230(f) of the Communications Act of 1934 (47 U.S.C. 230(f)) or an advertising service provider shall be liable under this section on account of another person's selling or dispensing of a prescription drug, so long as the provider of the interactive computer service or the advertising service provider does not own or exercise corporate control
over such person.
``(e) Policies and Procedures Required To Prevent Payments for Unlawful Internet Pharmacy Requests.--
``(1) REGULATIONS.--Not later than 180 days after designating a system under subsection (a)(2), the Board shall promulgate regulations that require--
``(A) an operator of a credit card system that is a designated payment system, an operator of an international, national, or local network used to effect a credit transaction, electronic fund transfer, or money transmitting service that is a designated payment system, and an operator of any other designated payment system specified by the Board that is centrally managed and is primarily engaged in the transmission and settlement of credit transactions, electronic transfers, or money transmitting
services where at least 1 party to the transaction or transfer is an individual; and
``(B) in the case of a designated payment system, other than a designated payment system described in subparagraph (A), a person described in subsection (a)(2)(B);

to establish policies and procedures that are reasonably designed to prevent the introduction of restricted transactions into a designated payment system or the completion of restricted transactions using a designated payment system.
``(2) REQUIREMENTS FOR POLICIES AND PROCEDURES.--In promulgating regulations under paragraph (1), the Board shall--
``(A) identify types of policies and procedures, including nonexclusive examples, that shall be considered to be reasonably designed to identify and reasonably designed to prevent the introduction of a restricted transaction in a designated payment or the completion of restricted transactions using a designated payment system; and
``(B) to the extent practicable, permit any designated payment system, or person described in subsection (a)(2)(B), as applicable, to choose among alternative means of preventing the introduction or completion of restricted transactions.
``(3) NO LIABILITY FOR BLOCKING OR REFUSING TO HONOR RESTRICTED TRANSACTION.--
``(A) IN GENERAL.--A designated payment system, or a person described in subsection (a)(2)(B), that is subject to a regulation or an order issued under this subsection, and any participant in such payment system, that--
``(i) prevents or otherwise refuses to honor restricted transactions, in an effort to implement the policies and procedures required under this subsection or to otherwise comply with this section, shall not be liable to any party for such action; and
``(ii) prevents or otherwise refuses to honor a nonrestricted transaction in an effort to implement the policies and procedures under this subsection or to otherwise comply with this section, shall not be liable to any party for such action.
``(B) COMPLIANCE WITH THIS SUBSECTION.--A person described in subsection (a)(2)(B) meets the requirements of this subsection, if any, if the person relies on and complies with the policies and procedures of a designated payment system of which the person is a member or in which the person is a participant, and such policies and procedures of the designated payment system comply with the requirements of the regulations under paragraph (1)(B).
``(4) ENFORCEMENT.--
``(A) IN GENERAL.--This subsection shall be enforced by the Federal functional regulators and the Federal Trade Commission under applicable law in the manner provided in section 505(a) of the Gramm-Leach-Bliley Act (21 U.S.C. 6805(a)).
``(B) FACTORS TO BE CONSIDERED.--In considering any enforcement action under this subsection against a payment system or person described in subsection (a)(2)(B), the Federal functional regulators and the Federal Trade Commission shall consider the following factors:
``(i) The extent to which the payment system or person knowingly permits restricted transactions.
``(ii) The history of the payment system or person in connection with permitting restricted transactions.
``(iii) The extent to which the payment system or person has established and is maintaining policies and procedures in compliance with regulations prescribed under this subsection.
``(iv) The feasibility that any specific remedy prescribed can be implemented by the payment system or person without substantial deviation from normal business practice.
``(v) The costs and burdens the specific remedy will have on the payment system or person.
``(f) Reports Regarding Internet-Related Violations of Federal and State Laws on Dispensing of Drugs.--The Secretary shall, pursuant to the submission of an application meeting criteria prescribed by the Secretary, make an award of a grant or contract to an entity with experience in developing and maintaining systems for the purpose of--
``(1) identifying Internet pharmacy websites that are not licensed or that appear to be operating in violation of Federal or State laws concerning the dispensing of drugs;
``(2) reporting such Internet pharmacy websites to State medical licensing boards and State pharmacy licensing boards, and to the Attorney General and the Secretary, for further investigation; and
``(3) submitting, for each fiscal year for which the award under this subsection is made, a report to the Secretary describing investigations undertaken with respect to violations described in paragraph (1).
``(g) Transactions Permitted.--A designated payment system or person subject to a regulation or an order issued under subsection (e) may engage in transactions with licensed and unlicensed Internet pharmacies in connection with investigating violations or potential violations of any rule or requirement adopted by the payment system or person in connection with complying with subsection (e). A person subject to a regulation or an order issued under subsection (e) and the agents and employees
of that person shall not be found to be in violation of, or liable under, any Federal, State, or other law for engaging in any such transaction.
``(h) Relation to State Laws.--No requirement, prohibition, or liability may be imposed on a designated payment system or person subject to a regulation or an order issued under subsection (e) under the laws of any State with respect to any payment transaction by an individual because the payment transaction involves a payment to an Internet pharmacy.
``(i) Timing of Requirements.--A designated payment system or a person subject to a regulation under subsection (e) shall adopt policies and procedures reasonably designed to comply with any regulations required under subsection (e) not later than 180 days after the date on which such final regulations are issued.''.
(b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:
``(hh)(1) The sale, under section 511, of a drug that is not a prescription drug, the sale of such a prescription drug without a valid prescription from a treating provider, or the ownership or operation of an Internet pharmacy, in violation of section 511.
``(2) The representation by advertisement, sales presentation, direct communication (including telephone, facsimile, or electronic mail), or otherwise by an Internet pharmacy, that a prescription drug may be obtained from the Internet pharmacy without a prescription, in violation of section 511.
``(3) The advertisement related to a prescription drug through any media including sales presentation, direct communication (including telephone, facsimile, or electronic mail), by an unlicensed Internet pharmacy.
``(4) The provision of an untrue statement of material fact in the licensing application of an Internet pharmacy.
``(5) For purposes of this subsection, any term used in this subsection that is also used in section 511 shall have the meaning given that term in section 511.''.
(c) Links to Unlicensed Internet Pharmacies.--Section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) is amended by adding at the end the following:
``(c)(1) In the case of a violation of section 511 relating to an unlicensed Internet pharmacy (as defined in such section 511), the district courts of the United States and the United States courts of the territories shall have jurisdiction to order a provider of an interactive computer service to remove, or disable access to, links to a website violating that section that resides on a computer server that the provider controls or operates.
``(2) Relief under paragraph (1)--
``(A) shall be available only after provision to the provider of notice and an opportunity to appear;
``(B) shall not impose any obligation on the provider to monitor its service or to affirmatively seek facts indicating activity violating section 511;
``(C) shall specify the provider to which the relief applies; and
``(D) shall specifically identify the location of the website to be removed or to which access is to be disabled.''.
(d) Regulations.--
(1) IN GENERAL.--Not later than 1 year after the date of enactment of this title, the Secretary of Health and Human Services shall promulgate interim final regulations to carry out the amendments made by this section.
(2) EFFECTIVE DATE.--The requirement of licensure under section 511 of the Federal Food, Drug, and Cosmetic Act (as added by this section) shall take effect on the date determined by the Secretary of Health and Human Services but in no event later than 90 days after the effective date of the interim final regulations under paragraph (1).
(e) Penalties.--Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following:
``(g) Notwithstanding subsection (a), any person who knowingly violates paragraph (1), (2), (3), or (4) of section 301(hh) shall be imprisoned for not more than 10 years or fined in accordance with title 18, United States Code, or both.''.


(As printed in the Congressional Record for the Senate on May 1, 2007.)