[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4095 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 4095

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
                        of Internet pharmacies.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 28, 2012

   Mr. Cassidy (for himself and Mr. Ross of Arkansas) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
                        of Internet pharmacies.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Online Pharmacy Safety Act''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) consumers in the United States are targeted by 
        organized international crime networks that use Internet 
        websites to sell illegal and often dangerous drugs under the 
        guise of being legitimate online pharmacies;
            (2) illegal online drug sellers offer products that do not 
        meet the safety standards established by United States laws, 
        and recent reports from the National Association of Boards of 
        Pharmacy show that 92 to 95 percent of Internet websites 
        offering to sell prescription medications online are 
        illegitimate and operate in clear violation of United States 
        laws enacted to protect patients;
            (3) criminals are attracted to the high profit margin of 
        business through illegitimate online drug sales, as counterfeit 
        drug sales alone are estimated to have generated 
        $75,000,000,000 in 2010, an increase of 92 percent from 2005;
            (4) the World Health Organization estimates that 50 percent 
        of the prescription medicines sold online by Internet websites 
        that hide their physical address are counterfeit;
            (5) research by The Partnership at Drugfree.org found that 
        1 in 6 consumers in the United States, a total of about 
        36,000,000 Americans, has bought or currently buys prescription 
        medication online without a valid prescription;
            (6) the prevalence of illegal online drug sellers, and 
        their sale of counterfeit or otherwise illegitimate medicines, 
        is a growing public health threat;
            (7) people have been seriously injured or killed by 
        products sold by illegal online drug sellers;
            (8) the accessibility of controlled substances and other 
        drugs without a valid prescription by illegal online drug 
        sellers contributes to a growing prescription drug abuse 
        problem in the United States that is endangering teenagers and 
        public health;
            (9) the anonymous and unregulated nature of the Internet 
        contributes to the counterfeit drug trade and enables 
        counterfeit medicines to reach United States consumers through 
        illegitimate online drug sellers posing as legitimate 
        pharmacies;
            (10) counterfeit drugs that are sold through illegal online 
        drug sellers are manufactured by criminals who deliberately and 
        fraudulently misrepresent the product in order to trick 
        consumers into thinking they are purchasing a legitimate and 
        safe medicine;
            (11) these counterfeit drugs are frequently manufactured in 
        unsanitary conditions and may contain the wrong ingredients, 
        lack active ingredients, have insufficient or contaminated 
        active ingredients, or contain too many active ingredients;
            (12) counterfeit drugs obtained from illegal online drug 
        sellers have been found to contain harmful ingredients 
        including arsenic, boric acid, brick dust, cement powder, chalk 
        dust, floor polish, leaded road paint, nickel, shoe polish, and 
        talcum powder;
            (13) United States citizens deserve access to safe and 
        legitimate online pharmacies and protection from illegal 
        Internet websites that sell counterfeit or otherwise 
        illegitimate medication;
            (14) while the Ryan Haight Online Pharmacy Consumer 
        Protection Act of 2008 (Public Law 110-425) has helped to 
        prevent illegitimate online sales of prescribed controlled 
        substances, illegal online sellers continue to sell other types 
        of prescription drugs and stronger laws are needed to stop 
        them; and
            (15) greater education and awareness regarding illegal 
        online drug sellers will help to protect the United States drug 
        supply chain from infiltration by unregulated and counterfeit 
        products.

SEC. 3. VALID PRESCRIPTIONS.

    Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(b)) is amended--
            (1) in paragraph (1), in the matter following subparagraph 
        (B), by striking ``shall be dispensed'' and all that follows 
        through the end of paragraph (1) and inserting the following: 
        ``shall be dispensed only pursuant to a valid prescription that 
        is (i) a written prescription of a practitioner licensed by law 
        to administer such drug, (ii) an oral prescription of such 
        practitioner which is reduced promptly to writing by the 
        pharmacist, (iii) an electronic or facsimile prescription 
        issued by a practitioner licensed by law to administer such 
        drug, or (iv) the refill of any such written, oral, facsimile, 
        or electronic prescription if such refilling is authorized by 
        the prescriber either in the original prescription, in the 
        electronic or facsimile prescription, or by oral order which is 
        reduced promptly to writing by the pharmacist. The act of 
        dispensing a drug contrary to the provisions of this paragraph 
        shall be deemed to be an act which results in the drug being 
        misbranded while held for sale. In applying this paragraph, 
        dispensing pursuant to a prescription is deemed to be pursuant 
        to a valid prescription if the dispensing occurs in good faith 
        based on a reasonable belief that the prescription is a valid 
        prescription.''; and
            (2) by adding at the end the following:
            ``(6) For purposes of paragraph (1), the term `valid 
        prescription' means a prescription that is issued for a 
        legitimate medical purpose in the usual course of professional 
        practice by--
                    ``(A) a licensed practitioner who has conducted at 
                least 1 in-person medical evaluation of the patient, 
                subject to paragraph (7);
                    ``(B) a covering practitioner; or
                    ``(C) a practitioner engaged in the practice of 
                telemedicine.
            ``(7) For purposes of paragraph (6) and this paragraph:
                    ``(A)(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.
                    ``(B) The term `covering practitioner' means, with 
                respect to a patient, a licensed practitioner who 
                conducts a medical evaluation (other than an in-person 
                medical evaluation) at the request of a licensed 
                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
                            ``(ii) is temporarily unavailable to 
                        conduct the evaluation of the patient.
                    ``(C) The term `practice of telemedicine' has the 
                meaning given that term in section 102 of the 
                Controlled Substances Act.
            ``(8) For purposes of paragraphs (6) and (7), an in-person 
        medical evaluation of the patient is not required if--
                    ``(A) the prescribing practitioner is issuing a 
                prescription or dispensing a legend drug in accordance 
                with the Expedited Partner Therapy in the Management of 
                Sexually Transmitted Diseases guidance document issued 
                by the Centers for Disease Control and Prevention; or
                    ``(B) the prescription, administration, or 
                dispensing is through a public health clinic or other 
                distribution mechanism approved by the State health 
                authority in order to prevent, mitigate, or treat a 
                pandemic illness, infectious disease outbreak, or 
                intentional or accidental release of a biological, 
                chemical, or radiological agent.
            ``(9) The Secretary may by regulation establish exceptions 
        to the requirements described in paragraphs (6) through (8) 
        with respect to a drug, based on criteria established by the 
        Secretary.''.

SEC. 4. REGISTRY OF LEGITIMATE ONLINE PHARMACY WEBSITES.

    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. 510A. REGISTRY OF LEGITIMATE ONLINE PHARMACY WEBSITES.

    ``(a) Definitions.--In this section:
            ``(1) Dispensing pharmacy.--The term `dispensing pharmacy' 
        means a pharmacy that dispenses, distributes, or supplies 
        prescription drugs pursuant to orders made on, through, or on 
        behalf of, an online pharmacy website.
            ``(2) Domain name.--The term `domain name' has the meaning 
        given that term in section 45 of the Lanham Act (15 U.S.C. 
        1127).
            ``(3) Financial transaction provider.--The term `financial 
        transaction provider' has the meaning given that term in 
        section 5362(4) of title 31, United States Code.
            ``(4) Internet website.--The term `Internet website' means 
        the collection of digital assets, including links, indexes, or 
        pointers to digital assets, accessible through the Internet 
        that are addressed relative to a common domain name.
            ``(5) Legitimate online pharmacy website.--The term 
        `legitimate online pharmacy website' means an online pharmacy 
        website that is included in the Registry pursuant to a 
        designation by the Secretary under this section.
            ``(6) Online pharmacy website.--The term `online pharmacy 
        website' means an Internet website that offers, sells, 
        dispenses, or distributes, or facilitates the offering, sale, 
        dispensing, or distribution of, prescription drugs to 
        consumers, except that an Internet website shall not be 
        considered an online pharmacy website if the website does not--
                    ``(A) have the capability to accept payment;
                    ``(B) refer consumers to a separate website to 
                conduct or facilitate online payment for the purpose of 
                receiving a prescription drug without a valid 
                prescription; or
                    ``(C) otherwise engage in a financial transaction 
                for prescription drugs by means of the Internet.
            ``(7) Prescription drug.--The term `prescription drug' 
        means a drug that is subject to section 503(b)(1).
    ``(b) Establishment of Registry.--The Secretary shall establish a 
Registry of Legitimate Online Pharmacy Websites (referred to in this 
section as the `Registry') for the purpose of educating consumers and 
promoting public health and safety.
    ``(c) Criteria.--The Secretary shall designate an online pharmacy 
website as a legitimate online pharmacy website, and include such 
legitimate online pharmacy website on the Registry, if the Secretary 
determines that--
            ``(1) the online pharmacy website is accredited by the 
        United States National Association of Boards of Pharmacy 
        Verified Internet Pharmacy Practice Sites program; or
            ``(2) the online pharmacy website meets each of the 
        following requirements:
                    ``(A) Prescription drugs ordered, sold, dispensed, 
                distributed, supplied, or provided through or by the 
                online pharmacy website are sold, dispensed, 
                distributed, supplied, or provided solely by dispensing 
                pharmacies that are domiciled in the United States and 
                that maintain pharmacy licensure, a permit, or 
                registration in good standing in all United States 
                jurisdictions where such dispensing pharmacies provide 
                services or are required to maintain such licensure, 
                permit, or registration.
                    ``(B) Each dispensing pharmacy affiliated with, or 
                that dispenses, distributes, supplies, or provides 
                prescription or other drugs on behalf of the online 
                pharmacy website, maintains a valid Drug Enforcement 
                Administration registration, unless such registration 
                is not required by Drug Enforcement Administration 
                regulations.
                    ``(C) Each dispensing pharmacy affiliated with, or 
                that dispenses, distributes, supplies, or provides 
                prescription drugs on behalf of the online pharmacy 
                website, dispenses, distributes, supplies, provides, or 
                offers or attempts to dispense, distribute, supply, or 
                provide, prescription drugs only pursuant to a valid 
                prescription (as defined in section 503(b)).
                    ``(D) Each dispensing pharmacy affiliated with, or 
                that dispenses, distributes, supplies, or provides 
                prescription drugs on behalf of the online pharmacy 
                website, complies with applicable Federal and State 
                laws and regulations applicable to pharmacy practice.
                    ``(E) The online pharmacy website prominently 
                displays the following information:
                            ``(i) An accurate United States street 
                        address of each dispensing pharmacy or the 
                        corporate or other legal business entity 
                        headquarters of each dispensing pharmacy.
                            ``(ii) An accurate, readily accessible, and 
                        responsive telephone number or other secure 
                        accurate means that allows the consumer to 
                        contact or consult with the pharmacist about 
                        his or her prescription drug.
                    ``(F) The online pharmacy website does not make any 
                statements, regarding the nature of any dispensing 
                pharmacy or product offered via the website, that are 
                materially misleading or fraudulent.
                    ``(G) The domain name registration information 
                applicable to the online pharmacy website is accurate, 
                not anonymous, and has a logical nexus to a dispensing 
                pharmacy located in the United States or the corporate 
                or other legal business headquarters thereof.
                    ``(H) The online pharmacy website, including any 
                operator, content owner, or domain name registrant of 
                the online pharmacy website, is not affiliated with, 
                and does not own or control any other online pharmacy 
                website that violates the requirements under this 
                paragraph.
                    ``(I) The online pharmacy website, including any 
                operator, content owner, or domain name registrant of 
                the online pharmacy website, is not affiliated with, 
                and does not own or control, any other online pharmacy 
                website that violates Federal or State laws and 
                regulations applicable to pharmacy practice.
                    ``(J) Information that would be considered 
                protected health information under the regulations 
                promulgated under section 264(c) of the Health 
                Insurance Portability and Accountability Act of 1996 
                (commonly referred to as the `HIPAA Privacy Rule') is 
                transmitted by the online pharmacy website and each 
                dispensing pharmacy affiliated with, or that dispenses, 
                distributes, supplies, or provides prescription drugs 
                on behalf of the online pharmacy website, in accordance 
                with the requirements of such Act, including the use of 
                Secure-Socket Layer or equivalent technology for the 
                transmission of protected health information, and the 
                online pharmacy website displays its privacy policy and 
                that such policy complies with the requirements of the 
                HIPAA Privacy Rule.
                    ``(K) The online pharmacy website complies with 
                other requirements as determined appropriate by the 
                Secretary, in consultation with other Federal and State 
                agencies responsible for regulating the practice of 
                pharmacy, for purposes of implementing subparagraphs 
                (A) through (J).
    ``(d) Process.--
            ``(1) Application.--The Secretary shall develop an 
        application process through which an interested operator, 
        content owner, or domain name registrant of an online pharmacy 
        website may apply for inclusion on the Registry. Such an 
        application shall be submitted in such form and manner as 
        required by the Secretary and shall include, at a minimum, 
        information to determine whether the online pharmacy website 
        satisfies the criteria described under subsection (c). Neither 
        the Secretary nor any private entity with whom a contract is 
        entered into under subsection (e) shall charge a fee for 
        submission of an application for listing on the Registry.
            ``(2) Identification without application.--
                    ``(A) In general.--The Secretary shall take 
                reasonable steps to identify online pharmacy websites 
                for which no application has been submitted under 
                paragraph (1) and evaluate whether these online 
                pharmacy websites satisfy the criteria described under 
                subsection (c).
                    ``(B) Compliance confirmed.--In cases where 
                satisfaction of the criteria described under subsection 
                (c) can be verified without the receipt of an 
                application, an online pharmacy website that the 
                Secretary determines to satisfy such criteria may be 
                designated as a legitimate online pharmacy website and 
                included on the Registry and the operator, content 
                owner, or domain name registrant of such online 
                pharmacy website shall be notified of such placement.
                    ``(C) Additional information required.--In cases 
                where satisfaction of the criteria described under 
                subsection (c) cannot be verified without additional 
                information or some corrective action by the online 
                pharmacy website operator, content owner, or domain 
                name registrant, the online pharmacy website shall not 
                be designated as a legitimate online pharmacy website 
                or placed on the Registry until the additional 
                information is received by the Secretary and the 
                Secretary determines that all applicable and necessary 
                corrective actions have been taken.
            ``(3) Regulations regarding application process.--
                    ``(A) In general.--Not later than 180 days after 
                the date of the enactment of this section, the 
                Secretary shall promulgate regulations--
                            ``(i) to establish the timeframes 
                        applicable to informing online pharmacy website 
                        operators, content owners, or domain name 
                        registrants that submit an application under 
                        paragraph (1) of the acceptance or denial of 
                        such application;
                            ``(ii) to address what information may be 
                        shared with or withheld from online pharmacy 
                        website operators, content owners, or domain 
                        name registrants that submit such an 
                        application regarding corrective actions that 
                        would need to be taken to establish compliance 
                        with the Registry requirements;
                            ``(iii) to establish an appeal process 
                        giving online pharmacy website operators, 
                        content owners, or domain name registrants that 
                        submit such an application the ability to 
                        request a second review of the application to 
                        determine compliance with the Registry 
                        requirements;
                            ``(iv) to establish a process giving a 
                        licensed pharmacy domiciled in the United 
                        States the ability to request a determination 
                        as to whether such pharmacy is an `online 
                        pharmacy website' for purposes of the Registry; 
                        and
                            ``(v) to address other procedural matters 
                        regarding the receipt and evaluation of 
                        applications submitted under paragraph (1) as 
                        the Secretary determines necessary.
                    ``(B) Limitation regarding appeals process.--The 
                appeals process established under subparagraph (A)(iii) 
                shall in no case require the Secretary--
                            ``(i) to disclose information that may 
                        impede an ongoing or potential criminal or 
                        regulatory investigation; or
                            ``(ii) to provide an opportunity for appeal 
                        in cases where the Secretary determines, in the 
                        Secretary's sole discretion, that the violation 
                        of a Registry requirement is materially 
                        significant, such a violation is not likely to 
                        be curable, or the applicant has engaged in a 
                        pattern of violations of Federal or State law.
            ``(4) Authority and process for removal from registry.--
                    ``(A) In general.--The Secretary shall have the 
                authority to remove an online pharmacy website from the 
                Registry--
                            ``(i) upon determination that the online 
                        pharmacy website is not in compliance with the 
                        criteria as established by this section;
                            ``(ii) upon determination that the online 
                        pharmacy website was mistakenly included in the 
                        Registry; or
                            ``(iii) for good cause as determined by the 
                        Secretary based on credible evidence.
                    ``(B) Process.--If the Secretary determines that an 
                online pharmacy website shall be removed from the 
                Registry under subparagraph (A), the Secretary shall 
                provide notice to the operator, content owner, or 
                domain name registrant of the online pharmacy website 
                of the determination, the date of the removal of the 
                website from the Registry, and the reasons for removal.
                    ``(C) Regulations for appeal process.--
                            ``(i) In general.--The Secretary shall 
                        promulgate regulations that provide the 
                        operator, content owner, or domain name 
                        registrant of an online pharmacy website 
                        removed from the Registry the ability to appeal 
                        the removal and to provide information to 
                        correct matters that served as basis for 
                        removal from the Registry. Such regulations 
                        shall provide a reasonable time period to 
                        correct the grounds for removal.
                            ``(ii) Limitation regarding appeals 
                        process.--The appeals process established under 
                        clause (i) shall in no case require the 
                        Secretary--
                                    ``(I) to disclose information that 
                                may impede an ongoing or potential 
                                criminal or regulatory investigation; 
                                or
                                    ``(II) to provide an opportunity 
                                for appeal in cases where the Secretary 
                                determines, in the Secretary's sole 
                                discretion, that the violation of a 
                                Registry requirement is materially 
                                significant, such a violation is not 
                                likely to be curable, or the applicant 
                                has engaged in a pattern of violations 
                                of Federal or State law.
            ``(5) Re-inclusion on registry.--Nothing in this section 
        prohibits an interested operator, content owner, or domain name 
        registrant of an online pharmacy website from applying under 
        paragraph (1) for re-inclusion of the website on the Registry 
        subsequent to the website's removal from the Registry.
    ``(e) Contracts With Private Entities.--
            ``(1) In general.--The Secretary may enter into contracts 
        with the United States National Association of Boards of 
        Pharmacy or other private entities to--
                    ``(A) review applications submitted under 
                subsection (d)(1) and evaluate whether the online 
                pharmacy website satisfies the criteria described under 
                subsection (c);
                    ``(B) on an ongoing basis, review and identify 
                online pharmacy websites for which no application has 
                been submitted under subsection (d)(1) and evaluate 
                whether these online pharmacies satisfy the criteria 
                described under subsection (c);
                    ``(C) make recommendations to the Secretary as to 
                whether an online pharmacy website, either through 
                application or through identification under 
                subparagraph (B), satisfies the criteria under 
                subsection (c);
                    ``(D) notify the Food and Drug Administration of 
                online pharmacy websites that do not satisfy such 
                criteria; and
                    ``(E) provide services to maintain the Registry.
            ``(2) Contracting.--In contracting with entities under this 
        subsection, the Secretary--
                    ``(A) may waive such provisions of the Federal 
                Acquisition Regulation, except for provisions relating 
                to confidentiality of information, as necessary for the 
                efficient implementation of this subsection and for 
                selecting such entities; and
                    ``(B) shall select entities that have demonstrated 
                a history of competency in reviewing, evaluating, and 
                determining the legitimacy of online pharmacy websites, 
                based on standards approved by the United States 
                National Association of Boards of Pharmacy.
            ``(3) Terms of contract.--A contract with an entity under 
        this subsection shall include such terms and conditions as 
        specified by the Secretary, including the following:
                    ``(A) The entity shall monitor the Internet on an 
                ongoing basis in order to sufficiently maintain a 
                current list of legitimate online pharmacy websites for 
                consideration by the Secretary.
                    ``(B) On at least a monthly basis, the entity shall 
                submit to the Secretary an updated list of legitimate 
                online pharmacy websites recommended for inclusion on 
                the Registry.
    ``(f) Use of Registry.--
            ``(1) Public availability.--The Secretary shall--
                    ``(A) make the Registry available to Internet 
                advertising services, financial transaction providers, 
                domain name registries, domain name registrars, other 
                domain name authorities, information location tool 
                service providers, and others as determined necessary 
                and appropriate by the Secretary to promote public 
                health and safety;
                    ``(B) make the Registry available to consumers and 
                other interested persons through publication on the 
                Internet website of the Food and Drug Administration; 
                and
                    ``(C) specify the Registry criteria used to 
                designate legitimate online pharmacy websites on the 
                Internet website of the Food and Drug Administration.
            ``(2) Consumer education.--The Secretary shall--
                    ``(A) engage in a campaign to educate consumers on 
                the availability and use of the Registry to promote 
                public health and safety through means as determined 
                appropriate and necessary by the Secretary, which may 
                include radio, television, print media, and Internet 
                public service announcements; and
                    ``(B) make consumer education materials available, 
                on the Internet website of the Food and Drug 
                Administration and in a consumer-friendly form and 
                manner, regarding how to safely purchase drugs over the 
                Internet.
    ``(g) Refusal of Service; Immunity.--
            ``(1) Refusal of service.--A domain name registry, domain 
        name registrar, other domain name authority, financial 
        transaction provider, information location tool service 
        provider, or Internet advertising service, acting in good faith 
        based on the Registry, may cease or refuse to provide services 
        to an online pharmacy website that is not included on the 
        Registry.
            ``(2) Immunity from liability.--If an entity described in 
        paragraph (1), including the directors, officers, employees, or 
        agents of the entity, acting in good faith, ceases or refuses 
        to provide services to an online pharmacy website that is not 
        included on the Registry--
                    ``(A) no cause of action may be brought under any 
                Federal or State law against the entity for such 
                cessation or refusal; and
                    ``(B) no administrative proceeding may be 
                instituted against the entity for such cessation or 
                refusal.''.

SEC. 5. EFFECTIVE DATE.

    This Act (and the amendments made by this Act) shall take effect on 
the date that is 180 days after the date of enactment of this Act.
                                 <all>