I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Online Pharmacy Safe5 ty Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds that— 

8 (1) consumers in the United States are targeted 

9 by organized international crime networks that use 

10 Internet websites to sell illegal and often dangerous 


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1 drugs under the guise of being legitimate online 

2 pharmacies; 

3 (2) illegal online drug sellers offer products that 

4 do not meet the safety standards established by 

5 United States laws, and recent reports from the Na6 tional Association of Boards of Pharmacy show that 

7 92 to 95 percent of Internet websites offering to sell 

8 prescription medications online are illegitimate and 

9 operate in clear violation of United States laws en10 acted to protect patients; 

11 (3) criminals are attracted to the high profit 

12 margin of business through illegitimate online drug 

13 sales, as counterfeit drug sales alone are estimated 

14 to have generated $75,000,000,000 in 2010, an in15 crease of 92 percent from 2005; 

16 (4) the World Health Organization estimates 

17 that 50 percent of the prescription medicines sold 

18 online by Internet websites that hide their physical 

19 address are counterfeit; 

20 (5) research by The Partnership at 

21 Drugfree.org found that 1 in 6 consumers in the 

22 United States, a total of about 36,000,000 Ameri23 cans, has bought or currently buys prescription 

24 medication online without a valid prescription; 


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1 (6) the prevalence of illegal online drug sellers, 

2 and their sale of counterfeit or otherwise illegitimate 

3 medicines, is a growing public health threat; 

4 (7) people have been seriously injured or killed 

5 by products sold by illegal online drug sellers; 

6 (8) the accessibility of controlled substances 

7 and other drugs without a valid prescription by ille8 gal online drug sellers contributes to a growing pre9 scription drug abuse problem in the United States 

10 that is endangering teenagers and public health; 

11 (9) the anonymous and unregulated nature of 

12 the Internet contributes to the counterfeit drug 

13 trade and enables counterfeit medicines to reach 

14 United States consumers through illegitimate online 

15 drug sellers posing as legitimate pharmacies; 

16 (10) counterfeit drugs that are sold through il17 legal online drug sellers are manufactured by crimi18 nals who deliberately and fraudulently misrepresent 

19 the product in order to trick consumers into think20 ing they are purchasing a legitimate and safe medi21 cine; 

22 (11) these counterfeit drugs are frequently 

23 manufactured in unsanitary conditions and may con24 tain the wrong ingredients, lack active ingredients, 


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1 have insufficient or contaminated active ingredients, 

2 or contain too many active ingredients; 

3 (12) counterfeit drugs obtained from illegal on4 line drug sellers have been found to contain harmful 

5 ingredients including arsenic, boric acid, brick dust, 

6 cement powder, chalk dust, floor polish, leaded road 

7 paint, nickel, shoe polish, and talcum powder; 

8 (13) United States citizens deserve access to 

9 safe and legitimate online pharmacies and protection 

10 from illegal Internet websites that sell counterfeit or 

11 otherwise illegitimate medication; 

12 (14) while the Ryan Haight Online Pharmacy 

13 Consumer Protection Act of 2008 (Public Law 110– 

14 425) has helped to prevent illegitimate online sales 

15 of prescribed controlled substances, illegal online 

16 sellers continue to sell other types of prescription 

17 drugs and stronger laws are needed to stop them; 

18 and 

19 (15) greater education and awareness regarding 

20 illegal online drug sellers will help to protect the 

21 United States drug supply chain from infiltration by 

22 unregulated and counterfeit products. 

23 SEC. 3. VALID PRESCRIPTIONS. 

24 Section 503(b) of the Federal Food, Drug, and Cos25 metic Act (21 U.S.C. 353(b)) is amended— 


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1 (1) in paragraph (1), in the matter following 

2 subparagraph (B), by striking ‘‘shall be dispensed’’ 

3 and all that follows through the end of paragraph 

4 (1) and inserting the following: ‘‘shall be dispensed 

5 only pursuant to a valid prescription that is (i) a 

6 written prescription of a practitioner licensed by law 

7 to administer such drug, (ii) an oral prescription of 

8 such practitioner which is reduced promptly to writ9 ing by the pharmacist, (iii) an electronic or facsimile 

10 prescription issued by a practitioner licensed by law 

11 to administer such drug, or (iv) the refill of any 

12 such written, oral, facsimile, or electronic prescrip13 tion if such refilling is authorized by the prescriber 

14 either in the original prescription, in the electronic 

15 or facsimile prescription, or by oral order which is 

16 reduced promptly to writing by the pharmacist. The 

17 act of dispensing a drug contrary to the provisions 

18 of this paragraph shall be deemed to be an act which 

19 results in the drug being misbranded while held for 

20 sale. In applying this paragraph, dispensing pursu21 ant to a prescription is deemed to be pursuant to a 

22 valid prescription if the dispensing occurs in good 

23 faith based on a reasonable belief that the prescrip24 tion is a valid prescription.’’; and 

25 (2) by adding at the end the following: 


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1 ‘‘(6) For purposes of paragraph (1), the term 

2 ‘valid prescription’ means a prescription that is 

3 issued for a legitimate medical purpose in the usual 

4 course of professional practice by— 

5 ‘‘(A) a licensed practitioner who has con6 ducted at least 1 in-person medical evaluation 

7 of the patient, subject to paragraph (7); 

8 ‘‘(B) a covering practitioner; or 

9 ‘‘(C) a practitioner engaged in the practice 

10 of telemedicine. 

11 ‘‘(7) For purposes of paragraph (6) and this 

12 paragraph: 

13 ‘‘(A)(i) The term ‘in-person medical eval14 uation’ means a medical evaluation that is con15 ducted with the patient in the physical presence 

16 of the practitioner, without regard to whether 

17 portions of the evaluation are conducted by 

18 other health professionals. 

19 ‘‘(ii) Nothing in clause (i) shall be con20 strued to imply that 1 in-person medical evalua21 tion demonstrates that a prescription has been 

22 issued for a legitimate medical purpose within 

23 the usual course of professional practice. 

24 ‘‘(B) The term ‘covering practitioner’ 

25 means, with respect to a patient, a licensed 


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1 practitioner who conducts a medical evaluation 

2 (other than an in-person medical evaluation) at 

3 the request of a licensed practitioner who— 

4 ‘‘(i) has conducted at least 1 in-per5 son medical evaluation of the patient or an 

6 evaluation of the patient through the prac7 tice of telemedicine, within the previous 24 

8 months; and 

9 ‘‘(ii) is temporarily unavailable to con10 duct the evaluation of the patient. 

11 ‘‘(C) The term ‘practice of telemedicine’ 

12 has the meaning given that term in section 102 

13 of the Controlled Substances Act. 

14 ‘‘(8) For purposes of paragraphs (6) and (7), 

15 an in-person medical evaluation of the patient is not 

16 required if— 

17 ‘‘(A) the prescribing practitioner is issuing 

18 a prescription or dispensing a legend drug in 

19 accordance with the Expedited Partner Therapy 

20 in the Management of Sexually Transmitted 

21 Diseases guidance document issued by the Cen22 ters for Disease Control and Prevention; or 

23 ‘‘(B) the prescription, administration, or 

24 dispensing is through a public health clinic or 

25 other distribution mechanism approved by the 


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1 State health authority in order to prevent, miti2 gate, or treat a pandemic illness, infectious dis3 ease outbreak, or intentional or accidental re4 lease of a biological, chemical, or radiological 

5 agent. 

6 ‘‘(9) The Secretary may by regulation establish 

7 exceptions to the requirements described in para8 graphs (6) through (8) with respect to a drug, based 

9 on criteria established by the Secretary.’’. 

10 SEC. 4. REGISTRY OF LEGITIMATE ONLINE PHARMACY 

11 WEBSITES. 

12 Chapter V of the Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

14 section 510 the following: 

15 ‘‘SEC. 510A. REGISTRY OF LEGITIMATE ONLINE PHARMACY 

16 WEBSITES. 

17 ‘‘(a) DEFINITIONS.—In this section: 

18 ‘‘(1) DISPENSING PHARMACY.—The term ‘dis19 pensing pharmacy’ means a pharmacy that dis20 penses, distributes, or supplies prescription drugs 

21 pursuant to orders made on, through, or on behalf 

22 of, an online pharmacy website. 

23 ‘‘(2) DOMAIN NAME.—The term ‘domain name’ 

24 has the meaning given that term in section 45 of the 

25 Lanham Act (15 U.S.C. 1127). 


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1 ‘‘(3) FINANCIAL TRANSACTION PROVIDER.— 

2 The term ‘financial transaction provider’ has the 

3 meaning given that term in section 5362(4) of title 

4 31, United States Code. 

5 ‘‘(4) INTERNET WEBSITE.—The term ‘Internet 

6 website’ means the collection of digital assets, in7 cluding links, indexes, or pointers to digital assets, 

8 accessible through the Internet that are addressed 

9 relative to a common domain name. 

10 ‘‘(5) LEGITIMATE ONLINE PHARMACY

11 WEBSITE.—The term ‘legitimate online pharmacy 

12 website’ means an online pharmacy website that is 

13 included in the Registry pursuant to a designation 

14 by the Secretary under this section. 

15 ‘‘(6) ONLINE PHARMACY WEBSITE.—The term 

16 ‘online pharmacy website’ means an Internet website 

17 that offers, sells, dispenses, or distributes, or facili18 tates the offering, sale, dispensing, or distribution 

19 of, prescription drugs to consumers, except that an 

20 Internet website shall not be considered an online 

21 pharmacy website if the website does not— 

22 ‘‘(A) have the capability to accept pay23 ment; 

24 ‘‘(B) refer consumers to a separate website 

25 to conduct or facilitate online payment for the 


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1 purpose of receiving a prescription drug without 

2 a valid prescription; or 

3 ‘‘(C) otherwise engage in a financial trans4 action for prescription drugs by means of the 

5 Internet. 

6 ‘‘(7) PRESCRIPTION DRUG.—The term ‘pre7 scription drug’ means a drug that is subject to sec8 tion 503(b)(1). 

9 ‘‘(b) ESTABLISHMENT OF REGISTRY.—The Secretary 

10 shall establish a Registry of Legitimate Online Pharmacy 

11 Websites (referred to in this section as the ‘Registry’) for 

12 the purpose of educating consumers and promoting public 

13 health and safety. 

14 ‘‘(c) CRITERIA.—The Secretary shall designate an 

15 online pharmacy website as a legitimate online pharmacy 

16 website, and include such legitimate online pharmacy 

17 website on the Registry, if the Secretary determines 

18 that— 

19 ‘‘(1) the online pharmacy website is accredited 

20 by the United States National Association of Boards 

21 of Pharmacy Verified Internet Pharmacy Practice 

22 Sites program; or 

23 ‘‘(2) the online pharmacy website meets each of 

24 the following requirements: 


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1 ‘‘(A) Prescription drugs ordered, sold, dis2 pensed, distributed, supplied, or provided 

3 through or by the online pharmacy website are 

4 sold, dispensed, distributed, supplied, or pro5 vided solely by dispensing pharmacies that are 

6 domiciled in the United States and that main7 tain pharmacy licensure, a permit, or registra8 tion in good standing in all United States juris9 dictions where such dispensing pharmacies pro10 vide services or are required to maintain such 

11 licensure, permit, or registration. 

12 ‘‘(B) Each dispensing pharmacy affiliated 

13 with, or that dispenses, distributes, supplies, or 

14 provides prescription or other drugs on behalf 

15 of the online pharmacy website, maintains a 

16 valid Drug Enforcement Administration reg17 istration, unless such registration is not re18 quired by Drug Enforcement Administration 

19 regulations. 

20 ‘‘(C) Each dispensing pharmacy affiliated 

21 with, or that dispenses, distributes, supplies, or 

22 provides prescription drugs on behalf of the on23 line pharmacy website, dispenses, distributes, 

24 supplies, provides, or offers or attempts to dis25 pense, distribute, supply, or provide, prescripVerDate Mar 15 2010 23:42 Feb 28, 2012 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4095.IH H4095

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1 tion drugs only pursuant to a valid prescription 

2 (as defined in section 503(b)). 

3 ‘‘(D) Each dispensing pharmacy affiliated 

4 with, or that dispenses, distributes, supplies, or 

5 provides prescription drugs on behalf of the on6 line pharmacy website, complies with applicable 

7 Federal and State laws and regulations applica8 ble to pharmacy practice. 

9 ‘‘(E) The online pharmacy website promi10 nently displays the following information: 

11 ‘‘(i) An accurate United States street 

12 address of each dispensing pharmacy or 

13 the corporate or other legal business entity 

14 headquarters of each dispensing pharmacy. 

15 ‘‘(ii) An accurate, readily accessible, 

16 and responsive telephone number or other 

17 secure accurate means that allows the con18 sumer to contact or consult with the phar19 macist about his or her prescription drug. 

20 ‘‘(F) The online pharmacy website does 

21 not make any statements, regarding the nature 

22 of any dispensing pharmacy or product offered 

23 via the website, that are materially misleading 

24 or fraudulent. 


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1 ‘‘(G) The domain name registration infor2 mation applicable to the online pharmacy 

3 website is accurate, not anonymous, and has a 

4 logical nexus to a dispensing pharmacy located 

5 in the United States or the corporate or other 

6 legal business headquarters thereof. 

7 ‘‘(H) The online pharmacy website, includ8 ing any operator, content owner, or domain 

9 name registrant of the online pharmacy website, 

10 is not affiliated with, and does not own or con11 trol any other online pharmacy website that vio12 lates the requirements under this paragraph. 

13 ‘‘(I) The online pharmacy website, includ14 ing any operator, content owner, or domain 

15 name registrant of the online pharmacy website, 

16 is not affiliated with, and does not own or con17 trol, any other online pharmacy website that 

18 violates Federal or State laws and regulations 

19 applicable to pharmacy practice. 

20 ‘‘(J) Information that would be considered 

21 protected health information under the regula22 tions promulgated under section 264(c) of the 

23 Health Insurance Portability and Accountability 

24 Act of 1996 (commonly referred to as the 

25 ‘HIPAA Privacy Rule’) is transmitted by the 


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1 online pharmacy website and each dispensing 

2 pharmacy affiliated with, or that dispenses, dis3 tributes, supplies, or provides prescription 

4 drugs on behalf of the online pharmacy website, 

5 in accordance with the requirements of such 

6 Act, including the use of Secure-Socket Layer 

7 or equivalent technology for the transmission of 

8 protected health information, and the online 

9 pharmacy website displays its privacy policy 

10 and that such policy complies with the require11 ments of the HIPAA Privacy Rule. 

12 ‘‘(K) The online pharmacy website com13 plies with other requirements as determined ap14 propriate by the Secretary, in consultation with 

15 other Federal and State agencies responsible 

16 for regulating the practice of pharmacy, for 

17 purposes of implementing subparagraphs (A) 

18 through (J). 

19 ‘‘(d) PROCESS.— 

20 ‘‘(1) APPLICATION.—The Secretary shall de21 velop an application process through which an inter22 ested operator, content owner, or domain name reg23 istrant of an online pharmacy website may apply for 

24 inclusion on the Registry. Such an application shall 

25 be submitted in such form and manner as required 


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1 by the Secretary and shall include, at a minimum, 

2 information to determine whether the online phar3 macy website satisfies the criteria described under 

4 subsection (c). Neither the Secretary nor any private 

5 entity with whom a contract is entered into under 

6 subsection (e) shall charge a fee for submission of 

7 an application for listing on the Registry. 

8 ‘‘(2) IDENTIFICATION WITHOUT APPLICA9 TION.— 

10 ‘‘(A) IN GENERAL.—The Secretary shall 

11 take reasonable steps to identify online phar12 macy websites for which no application has 

13 been submitted under paragraph (1) and evalu14 ate whether these online pharmacy websites sat15 isfy the criteria described under subsection (c). 

16 ‘‘(B) COMPLIANCE CONFIRMED.—In cases 

17 where satisfaction of the criteria described 

18 under subsection (c) can be verified without the 

19 receipt of an application, an online pharmacy 

20 website that the Secretary determines to satisfy 

21 such criteria may be designated as a legitimate 

22 online pharmacy website and included on the 

23 Registry and the operator, content owner, or 

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1 macy website shall be notified of such place2 ment. 

3 ‘‘(C) ADDITIONAL INFORMATION RE4 QUIRED.—In cases where satisfaction of the cri5 teria described under subsection (c) cannot be 

6 verified without additional information or some 

7 corrective action by the online pharmacy 

8 website operator, content owner, or domain 

9 name registrant, the online pharmacy website 

10 shall not be designated as a legitimate online 

11 pharmacy website or placed on the Registry 

12 until the additional information is received by 

13 the Secretary and the Secretary determines that 

14 all applicable and necessary corrective actions 

15 have been taken. 

16 ‘‘(3) REGULATIONS REGARDING APPLICATION

17 PROCESS.— 

18 ‘‘(A) IN GENERAL.—Not later than 180 

19 days after the date of the enactment of this sec20 tion, the Secretary shall promulgate regula21 tions— 

22 ‘‘(i) to establish the timeframes appli23 cable to informing online pharmacy website 

24 operators, content owners, or domain name 

25 registrants that submit an application 


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1 under paragraph (1) of the acceptance or 

2 denial of such application; 

3 ‘‘(ii) to address what information may 

4 be shared with or withheld from online 

5 pharmacy website operators, content own6 ers, or domain name registrants that sub7 mit such an application regarding correc8 tive actions that would need to be taken to 

9 establish compliance with the Registry re10 quirements; 

11 ‘‘(iii) to establish an appeal process 

12 giving online pharmacy website operators, 

13 content owners, or domain name reg14 istrants that submit such an application 

15 the ability to request a second review of 

16 the application to determine compliance 

17 with the Registry requirements; 

18 ‘‘(iv) to establish a process giving a li19 censed pharmacy domiciled in the United 

20 States the ability to request a determina21 tion as to whether such pharmacy is an 

22 ‘online pharmacy website’ for purposes of 

23 the Registry; and 

24 ‘‘(v) to address other procedural mat25 ters regarding the receipt and evaluation of 


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1 applications submitted under paragraph 

2 (1) as the Secretary determines necessary. 

3 ‘‘(B) LIMITATION REGARDING APPEALS

4 PROCESS.—The appeals process established 

5 under subparagraph (A)(iii) shall in no case re6 quire the Secretary— 

7 ‘‘(i) to disclose information that may 

8 impede an ongoing or potential criminal or 

9 regulatory investigation; or 

10 ‘‘(ii) to provide an opportunity for ap11 peal in cases where the Secretary deter12 mines, in the Secretary’s sole discretion, 

13 that the violation of a Registry require14 ment is materially significant, such a viola15 tion is not likely to be curable, or the ap16 plicant has engaged in a pattern of viola17 tions of Federal or State law. 

18 ‘‘(4) AUTHORITY AND PROCESS FOR REMOVAL

19 FROM REGISTRY.— 

20 ‘‘(A) IN GENERAL.—The Secretary shall 

21 have the authority to remove an online phar22 macy website from the Registry— 

23 ‘‘(i) upon determination that the on24 line pharmacy website is not in compliance 


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1 with the criteria as established by this sec2 tion; 

3 ‘‘(ii) upon determination that the on4 line pharmacy website was mistakenly in5 cluded in the Registry; or 

6 ‘‘(iii) for good cause as determined by 

7 the Secretary based on credible evidence. 

8 ‘‘(B) PROCESS.—If the Secretary deter9 mines that an online pharmacy website shall be 

10 removed from the Registry under subparagraph 

11 (A), the Secretary shall provide notice to the 

12 operator, content owner, or domain name reg13 istrant of the online pharmacy website of the 

14 determination, the date of the removal of the 

15 website from the Registry, and the reasons for 

16 removal. 

17 ‘‘(C) REGULATIONS FOR APPEAL PROC18 ESS.— 

19 ‘‘(i) IN GENERAL.—The Secretary 

20 shall promulgate regulations that provide 

21 the operator, content owner, or domain 

22 name registrant of an online pharmacy 

23 website removed from the Registry the 

24 ability to appeal the removal and to pro25 vide information to correct matters that 


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1 served as basis for removal from the Reg2 istry. Such regulations shall provide a rea3 sonable time period to correct the grounds 

4 for removal. 

5 ‘‘(ii) LIMITATION REGARDING AP6 PEALS PROCESS.—The appeals process es7 tablished under clause (i) shall in no case 

8 require the Secretary— 

9 ‘‘(I) to disclose information that 

10 may impede an ongoing or potential 

11 criminal or regulatory investigation; 

12 or 

13 ‘‘(II) to provide an opportunity 

14 for appeal in cases where the Sec15 retary determines, in the Secretary’s 

16 sole discretion, that the violation of a 

17 Registry requirement is materially sig18 nificant, such a violation is not likely 

19 to be curable, or the applicant has en20 gaged in a pattern of violations of 

21 Federal or State law. 

22 ‘‘(5) RE-INCLUSION ON REGISTRY.—Nothing in 

23 this section prohibits an interested operator, content 

24 owner, or domain name registrant of an online phar25 macy website from applying under paragraph (1) for 


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1 re-inclusion of the website on the Registry subse2 quent to the website’s removal from the Registry. 

3 ‘‘(e) CONTRACTS WITH PRIVATE ENTITIES.— 

4 ‘‘(1) IN GENERAL.—The Secretary may enter 

5 into contracts with the United States National Asso6 ciation of Boards of Pharmacy or other private enti7 ties to— 

8 ‘‘(A) review applications submitted under 

9 subsection (d)(1) and evaluate whether the on10 line pharmacy website satisfies the criteria de11 scribed under subsection (c); 

12 ‘‘(B) on an ongoing basis, review and iden13 tify online pharmacy websites for which no ap14 plication has been submitted under subsection 

15 (d)(1) and evaluate whether these online phar16 macies satisfy the criteria described under sub17 section (c); 

18 ‘‘(C) make recommendations to the Sec19 retary as to whether an online pharmacy 

20 website, either through application or through 

21 identification under subparagraph (B), satisfies 

22 the criteria under subsection (c); 

23 ‘‘(D) notify the Food and Drug Adminis24 tration of online pharmacy websites that do not 

25 satisfy such criteria; and 


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1 ‘‘(E) provide services to maintain the Reg2 istry. 

3 ‘‘(2) CONTRACTING.—In contracting with enti4 ties under this subsection, the Secretary— 

5 ‘‘(A) may waive such provisions of the 

6 Federal Acquisition Regulation, except for pro7 visions relating to confidentiality of informa8 tion, as necessary for the efficient implementa9 tion of this subsection and for selecting such 

10 entities; and 

11 ‘‘(B) shall select entities that have dem12 onstrated a history of competency in reviewing, 

13 evaluating, and determining the legitimacy of 

14 online pharmacy websites, based on standards 

15 approved by the United States National Asso16 ciation of Boards of Pharmacy. 

17 ‘‘(3) TERMS OF CONTRACT.—A contract with 

18 an entity under this subsection shall include such 

19 terms and conditions as specified by the Secretary, 

20 including the following: 

21 ‘‘(A) The entity shall monitor the Internet 

22 on an ongoing basis in order to sufficiently 

23 maintain a current list of legitimate online 

24 pharmacy websites for consideration by the Sec25 retary. 


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1 ‘‘(B) On at least a monthly basis, the enti2 ty shall submit to the Secretary an updated list 

3 of legitimate online pharmacy websites rec4 ommended for inclusion on the Registry. 

5 ‘‘(f) USE OF REGISTRY.— 

6 ‘‘(1) PUBLIC AVAILABILITY.—The Secretary 

7 shall— 

8 ‘‘(A) make the Registry available to Inter9 net advertising services, financial transaction 

10 providers, domain name registries, domain 

11 name registrars, other domain name authori12 ties, information location tool service providers, 

13 and others as determined necessary and appro14 priate by the Secretary to promote public health 

15 and safety; 

16 ‘‘(B) make the Registry available to con17 sumers and other interested persons through 

18 publication on the Internet website of the Food 

19 and Drug Administration; and 

20 ‘‘(C) specify the Registry criteria used to 

21 designate legitimate online pharmacy websites 

22 on the Internet website of the Food and Drug 

23 Administration. 

24 ‘‘(2) CONSUMER EDUCATION.—The Secretary 

25 shall— 


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1 ‘‘(A) engage in a campaign to educate con2 sumers on the availability and use of the Reg3 istry to promote public health and safety 

4 through means as determined appropriate and 

5 necessary by the Secretary, which may include 

6 radio, television, print media, and Internet pub7 lic service announcements; and 

8 ‘‘(B) make consumer education materials 

9 available, on the Internet website of the Food 

10 and Drug Administration and in a consumer11 friendly form and manner, regarding how to 

12 safely purchase drugs over the Internet. 

13 ‘‘(g) REFUSAL OF SERVICE; IMMUNITY.— 

14 ‘‘(1) REFUSAL OF SERVICE.—A domain name 

15 registry, domain name registrar, other domain name 

16 authority, financial transaction provider, information 

17 location tool service provider, or Internet advertising 

18 service, acting in good faith based on the Registry, 

19 may cease or refuse to provide services to an online 

20 pharmacy website that is not included on the Reg21 istry. 

22 ‘‘(2) IMMUNITY FROM LIABILITY.—If an entity 

23 described in paragraph (1), including the directors, 

24 officers, employees, or agents of the entity, acting in 

25 good faith, ceases or refuses to provide services to 


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1 an online pharmacy website that is not included on 

2 the Registry— 

3 ‘‘(A) no cause of action may be brought 

4 under any Federal or State law against the en5 tity for such cessation or refusal; and 

6 ‘‘(B) no administrative proceeding may be 

7 instituted against the entity for such cessation 

8 or refusal.’’. 

9 SEC. 5. EFFECTIVE DATE. 

10 This Act (and the amendments made by this Act) 

11 shall take effect on the date that is 180 days after the 

12 date of enactment of this Act. 

Æ 


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