I 

110TH CONGRESS 

2D SESSION S. 980 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 2, 2008 

Referred to the Committee on Energy and Commerce, and in addition to the 

Committee on the Judiciary, for a period to be subsequently determined 

by the Speaker, in each case for consideration of such provisions as fall 

within the jurisdiction of the committee concerned 

AN ACT 

To amend the Controlled Substances Act to address online 

pharmacies. 

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


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Ryan Haight Online 

3 Pharmacy Consumer Protection Act of 2008’’. 

4 SEC. 2. REQUIREMENT OF A VALID PRESCRIPTION FOR 

5 CONTROLLED SUBSTANCES DISPENSED BY 

6 MEANS OF THE INTERNET. 

7 Section 309 of the Controlled Substances Act (21 

8 U.S.C. 829) is amended by adding at the end the fol9 lowing: 

10 ‘‘(e) CONTROLLED SUBSTANCES DISPENSED BY

11 MEANS OF THE INTERNET.— 

12 ‘‘(1) No controlled substance may be delivered, 

13 distributed, or dispensed by means of the Internet 

14 without a valid prescription. 

15 ‘‘(2) As used in this subsection: 

16 ‘‘(A) The term ‘valid prescription’ means a 

17 prescription that is issued for a legitimate med18 ical purpose in the usual course of professional 

19 practice by— 

20 ‘‘(i) a practitioner who has conducted 

21 at least 1 in-person medical evaluation of 

22 the patient; or 

23 ‘‘(ii) a covering practitioner. 

24 ‘‘(B)(i) The term ‘in-person medical eval25 uation’ means a medical evaluation that is con26 ducted with the patient in the physical presence 


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1 of the practitioner, without regard to whether 

2 portions of the evaluation are conducted by 

3 other health professionals. 

4 ‘‘(ii) Nothing in clause (i) shall be con5 strued to imply that 1 in-person medical evalua6 tion demonstrates that a prescription has been 

7 issued for a legitimate medical purpose within 

8 the usual course of professional practice. 

9 ‘‘(C) The term ‘covering practitioner’ 

10 means, with respect to a patient, a practitioner 

11 who conducts a medical evaluation (other than 

12 an in-person medical evaluation) at the request 

13 of a practitioner who— 

14 ‘‘(i) has conducted at least 1 in-per15 son medical evaluation of the patient or an 

16 evaluation of the patient through the prac17 tice of telemedicine, within the previous 24 

18 months; and 

19 ‘‘(ii) is temporarily unavailable to con20 duct the evaluation of the patient. 

21 ‘‘(3) Nothing in this subsection shall apply to— 

22 ‘‘(A) the delivery, distribution, or dis23 pensing of a controlled substance by a practi24 tioner engaged in the practice of telemedicine; 

25 or 


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1 ‘‘(B) the dispensing or selling of a con2 trolled substance pursuant to practices as deter3 mined by the Attorney General by regulation, 

4 which shall be consistent with effective controls 

5 against diversion.’’. 

6 SEC. 3. AMENDMENTS TO THE CONTROLLED SUBSTANCES 

7 ACT RELATING TO THE DELIVERY OF CON8 TROLLED SUBSTANCES BY MEANS OF THE 

9 INTERNET. 

10 (a) IN GENERAL.—Section 102 of the Controlled 

11 Substances Act (21 U.S.C. 802) is amended by adding at 

12 the end the following: 

13 ‘‘(50) The term ‘Internet’ means collectively the 

14 myriad of computer and telecommunications facili15 ties, including equipment and operating software, 

16 which comprise the interconnected worldwide net17 work of networks that employ the Transmission 

18 Control Protocol/Internet Protocol, or any prede19 cessor or successor protocol to such protocol, to com20 municate information of all kinds by wire or radio. 

21 ‘‘(51) The term ‘deliver, distribute, or dispense 

22 by means of the Internet’ refers, respectively, to any 

23 delivery, distribution, or dispensing of a controlled 

24 substance that is caused or facilitated by means of 

25 the Internet. 


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1 ‘‘(52) The term ‘online pharmacy’— 

2 ‘‘(A) means a person, entity, or Internet 

3 site, whether in the United States or abroad, 

4 that knowingly or intentionally delivers, distrib5 utes, or dispenses, or offers or attempts to de6 liver, distribute, or dispense, a controlled sub7 stance by means of the Internet; and 

8 ‘‘(B) does not include— 

9 ‘‘(i) manufacturers or distributors 

10 registered under subsection (a), (b), (c), or 

11 (d) of section 303 who do not dispense 

12 controlled substances to an unregistered 

13 individual or entity; 

14 ‘‘(ii) nonpharmacy practitioners who 

15 are registered under section 303(f) and 

16 whose activities are authorized by that reg17 istration; 

18 ‘‘(iii) any hospital or other medical fa19 cility that is operated by an agency of the 

20 United States (including the Armed 

21 Forces), provided such hospital or other fa22 cility is registered under section 303(f); 

23 ‘‘(iv) a health care facility owned or 

24 operated by an Indian tribe or tribal orga25 nization, only to the extent such facility is 


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1 carrying out a contract or compact under 

2 the Indian Self-Determination and Edu3 cation Assistance Act (25 U.S.C. 450 et 

4 seq.); 

5 ‘‘(v) any agent or employee of any 

6 hospital or facility referred to in clause (iii) 

7 or (iv), provided such agent or employee is 

8 lawfully acting in the usual course of busi9 ness or employment, and within the scope 

10 of the official duties of such agent or em11 ployee, with such hospital or facility, and, 

12 with respect to agents or employees of 

13 health care facilities specified in clause 

14 (iv), only to the extent such individuals are 

15 furnishing services pursuant to the con16 tracts or compacts described in such 

17 clause; 

18 ‘‘(vi) mere advertisements that do not 

19 attempt to facilitate an actual transaction 

20 involving a controlled substance; 

21 ‘‘(vii) a person, entity, or Internet site 

22 that is not in the United States and does 

23 not facilitate the delivery, distribution, or 

24 dispensing of a controlled substance by 


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1 means of the Internet to any person in the 

2 United States; 

3 ‘‘(viii) a pharmacy registered under 

4 section 303(f) whose dispensing of con5 trolled substances via the Internet consists 

6 solely of— 

7 ‘‘(I) ‘refilling prescriptions for 

8 controlled substances in schedule III, 

9 IV, or V’, as defined in paragraph 

10 (55); or 

11 ‘‘(II) ‘filling new prescriptions for 

12 controlled substances in schedule III, 

13 IV, or V’, as defined in paragraph 

14 (56); or 

15 ‘‘(ix) any other persons for whom the 

16 Attorney General and the Secretary have 

17 jointly, by regulation, found it to be con18 sistent with effective controls against diver19 sion and otherwise consistent with the pub20 lic health and safety to exempt from the 

21 definition of an ‘online pharmacy’. 

22 ‘‘(53) The term ‘homepage’ means the opening 

23 or main page or screen of the website of an online 

24 pharmacy that is viewable on the Internet. 


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1 ‘‘(54) The term ‘practice of telemedicine’ 

2 means, for purposes of this title, the practice of 

3 medicine in accordance with applicable Federal and 

4 State laws by a practitioner (other than a phar5 macist) who is at a location remote from the patient 

6 and is communicating with the patient, or health 

7 care professional who is treating the patient, using 

8 a telecommunications system referred to in section 

9 1834(m) of the Social Security Act (42 U.S.C. 

10 1395m(m)), and that— 

11 ‘‘(A) is being conducted— 

12 ‘‘(i) while the patient is being treated 

13 by, and physically located in, a hospital or 

14 clinic registered under section 303(f); and 

15 ‘‘(ii) by a practitioner— 

16 ‘‘(I) acting in the usual course of 

17 professional practice; 

18 ‘‘(II) acting in accordance with 

19 applicable State law; and 

20 ‘‘(III) registered under section 

21 303(f) in the State in which the pa22 tient is located, unless the practi23 tioner— 


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1 ‘‘(aa) is exempted from such 

2 registration in all States under 

3 section 302(d); or 

4 ‘‘(bb) is— 

5 ‘‘(AA) an employee or 

6 contractor of the Depart7 ment of Veterans Affairs 

8 who is acting in the scope of 

9 such employment or con10 tract; and 

11 ‘‘(BB) registered under 

12 section 303(f) in any State 

13 or is utilizing the registra14 tion of a hospital or clinic 

15 operated by the Department 

16 of Veterans Affairs reg17 istered under section 303(f); 

18 ‘‘(B) is being conducted while the patient 

19 is being treated by, and in the physical presence 

20 of, a practitioner— 

21 ‘‘(i) acting in the usual course of pro22 fessional practice; 

23 ‘‘(ii) acting in accordance with appli24 cable State law; and 


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1 ‘‘(iii) registered under section 303(f) 

2 in the State in which the patient is located, 

3 unless the practitioner— 

4 ‘‘(I) is exempted from such reg5 istration in all States under section 

6 302(d); or 

7 ‘‘(II) is— 

8 ‘‘(aa) an employee or con9 tractor of the Department of Vet10 erans Affairs who is acting in the 

11 scope of such employment or con12 tract; and 

13 ‘‘(bb) registered under sec14 tion 303(f) in any State or is 

15 using the registration of a hos16 pital or clinic operated by the 

17 Department of Veterans Affairs 

18 registered under section 303(f); 

19 ‘‘(C) is being conducted by a practi20 tioner— 

21 ‘‘(i) who is an employee or contractor 

22 of the Indian Health Service, or is working 

23 for an Indian tribe or tribal organization 

24 under its contract or compact with the In25 dian Health Service under the Indian SelfVerDate Aug 31 2005 00:41 Apr 04, 2008 Jkt 069200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S980.RFH S980

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1 Determination and Education Assistance 

2 Act (25 U.S.C. 450 et seq.); 

3 ‘‘(ii) acting within the scope of the 

4 employment, contract, or compact de5 scribed in clause (i); and 

6 ‘‘(iii) who is designated as an Internet 

7 Eligible Controlled Substances Provider by 

8 the Secretary under section 311(g)(2); 

9 ‘‘(D)(i) is being conducted during a public 

10 health emergency declared by the Secretary 

11 under section 319 of the Public Health Service 

12 Act (42 U.S.C. 247d); and 

13 ‘‘(ii) involves patients located in such 

14 areas, and such controlled substances, as the 

15 Secretary, with the concurrence of the Attorney 

16 General, designates, provided that such designa17 tion shall not be subject to the procedures pre18 scribed by subchapter II of chapter 5 of title 5, 

19 United States Code; 

20 ‘‘(E) is being conducted by a practitioner 

21 who has obtained from the Attorney General a 

22 special registration under section 311(h); 

23 ‘‘(F) is being conducted— 

24 ‘‘(i) in a medical emergency situa25 tion— 


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1 ‘‘(I) that prevents the patient 

2 from being in the physical presence of 

3 a practitioner registered under section 

4 303(f) who is an employee or con5 tractor of the Veterans Health Admin6 istration acting in the usual course of 

7 business and employment and within 

8 the scope of the official duties or con9 tract of that employee or contractor; 

10 ‘‘(II) that prevents the patient 

11 from being physically present at a 

12 hospital or clinic operated by the De13 partment of Veterans Affairs reg14 istered under section 303(f); 

15 ‘‘(III) during which the primary 

16 care practitioner of the patient or a 

17 practitioner otherwise practicing tele18 medicine within the meaning of this 

19 paragraph is unable to provide care or 

20 consultation; and 

21 ‘‘(IV) that requires immediate 

22 intervention by a health care practi23 tioner using controlled substances to 

24 prevent what the practitioner reason25 ably believes in good faith will be imVerDate Aug 31 2005 00:41 Apr 04, 2008 Jkt 069200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S980.RFH S980

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1 minent and serious clinical con2 sequences, such as further injury or 

3 death; and 

4 ‘‘(ii) by a practitioner that— 

5 ‘‘(I) is an employee or contractor 

6 of the Veterans Health Administration 

7 acting within the scope of that em8 ployment or contract; 

9 ‘‘(II) is registered under section 

10 303(f) in any State or is utilizing the 

11 registration of a hospital or clinic op12 erated by the Department of Veterans 

13 Affairs registered under section 

14 303(f); and 

15 ‘‘(III) issues a controlled sub16 stance prescription in this emergency 

17 context that is limited to a maximum 

18 of a 5-day supply which may not be 

19 extended or refilled; or 

20 ‘‘(G) is being conducted under any other 

21 circumstances that the Attorney General and 

22 the Secretary have jointly, by regulation, deter23 mined to be consistent with effective controls 

24 against diversion and otherwise consistent with 

25 the public health and safety. 


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1 ‘‘(55) The term ‘refilling prescriptions for con2 trolled substances in schedule III, IV, or V’— 

3 ‘‘(A) means the dispensing of a controlled 

4 substance in schedule III, IV, or V in accord5 ance with refill instructions issued by a practi6 tioner as part of a valid prescription that meets 

7 the requirements of subsection (b) or (c) of sec8 tion 309, as appropriate; and 

9 ‘‘(B) does not include the issuance of a 

10 new prescription to an individual for a con11 trolled substance that individual was previously 

12 prescribed. 

13 ‘‘(56) The term ‘filling new prescriptions for 

14 controlled substances in schedule III, IV, or V’ 

15 means a prescription for an individual for a con16 trolled substance in schedule III, IV, or V, if— 

17 ‘‘(A) the pharmacy dispensing that pre18 scription has previously dispensed to the patient 

19 that same controlled substance other than by 

20 means of the Internet and pursuant to the valid 

21 prescription of a practitioner that meets the ap22 plicable requirements of sections 309(b) or (c) 

23 (in this paragraph referred to as the ‘original 

24 prescription’); 


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1 ‘‘(B) the pharmacy contacts the practi2 tioner who issued the original prescription at 

3 the request of that individual to determine 

4 whether the practitioner will authorize the 

5 issuance of a new prescription for that indi6 vidual for the controlled substance described in 

7 subparagraph (A); and 

8 ‘‘(C) the practitioner, acting in the usual 

9 course of professional practice, determines there 

10 is a legitimate medical purpose for the issuance 

11 of the new prescription.’’. 

12 (b) REGISTRATION REQUIREMENTS.—Section 303(f) 

13 of the Controlled Substances Act (21 U.S.C. 823(f)) is 

14 amended in the matter preceding paragraph (1)— 

15 (1) in the first sentence, by adding after 

16 ‘‘schedule II, III, IV, or V’’ the following: ‘‘and shall 

17 modify the registrations of pharmacies so registered 

18 to authorize them to dispense controlled substances 

19 by means of the Internet’’; and 

20 (2) in the second sentence, by striking ‘‘if he 

21 determines that the issuance of such registration’’ 

22 and inserting ‘‘or such modification of registration if 

23 the Attorney General determines that the issuance of 

24 such registration or modification’’. 


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1 (c) REPORTING REQUIREMENTS.—Section 307(d) of 

2 the Controlled Substances Act (21 U.S.C. 827(d)) is 

3 amended by— 

4 (1) designating the text as paragraph (1); and 

5 (2) inserting after paragraph (1), as so des6 ignated by this Act, the following: 

7 ‘‘(2) Each pharmacy with a modified registra8 tion under section 303(f) that authorizes the dis9 pensing of controlled substances by means of the 

10 Internet shall report to the Attorney General the 

11 controlled substances it dispenses, in the amount 

12 specified, and in such time and manner as the Attor13 ney General by regulation shall require, except that 

14 the Attorney General, under this paragraph, may 

15 not require any pharmacy to report any information 

16 other than the total quantity of each controlled sub17 stance that the pharmacy has dispensed each month. 

18 For purposes of this subsection, no reporting shall 

19 be required unless the pharmacy has met 1 of the 

20 following thresholds in the month for which the re21 porting is required: 

22 ‘‘(A) 100 or more prescriptions dispensed. 

23 ‘‘(B) 5,000 or more dosage units of all 

24 controlled substances combined.’’. 

25 (d) ONLINE PRESCRIPTION REQUIREMENTS.— 


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1 (1) IN GENERAL.—The Controlled Substances 

2 Act is amended by inserting after section 310 (21 

3 U.S.C. 830) the following: 

4 ‘‘ADDITIONAL REQUIREMENTS RELATING TO ONLINE

5 PHARMACIES AND TELEMEDICINE

6 ‘‘SEC. 311. (a) IN GENERAL.—An online pharmacy 

7 shall display in a visible and clear manner on its homepage 

8 a statement that it complies with the requirements of this 

9 section with respect to the delivery or sale or offer for sale 

10 of controlled substances and shall at all times display on 

11 the homepage of its Internet site a declaration of compli12 ance in accordance with this section. 

13 ‘‘(b) LICENSURE.—Each online pharmacy shall com14 ply with the requirements of State law concerning the li15 censure of pharmacies in each State from which it, and 

16 in each State to which it, delivers, distributes, or dispenses 

17 or offers to deliver, distribute, or dispense controlled sub18 stances by means of the Internet, pursuant to applicable 

19 licensure requirements, as determined by each such State. 

20 ‘‘(c) INTERNET PHARMACY SITE DISCLOSURE IN21 FORMATION.—Each online pharmacy shall post in a visible 

22 and clear manner on the homepage of each Internet site 

23 it operates, or on a page directly linked thereto in which 

24 the hyperlink is also visible and clear on the homepage, 

25 the following information for each pharmacy that delivers, 


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1 distributes, or dispenses controlled substances pursuant to 

2 orders made on, through, or on behalf of, that website: 

3 ‘‘(1) The name and address of the pharmacy as 

4 it appears on the pharmacy’s Drug Enforcement Ad5 ministration certificate of registration. 

6 ‘‘(2) The pharmacy’s telephone number and 

7 email address. 

8 ‘‘(3) The name, professional degree, and States 

9 of licensure of the pharmacist-in-charge, and a tele10 phone number at which the pharmacist-in-charge 

11 can be contacted. 

12 ‘‘(4) A list of the States in which the pharmacy 

13 is licensed to dispense controlled substances. 

14 ‘‘(5) A certification that the pharmacy is reg15 istered under this part to deliver, distribute, or dis16 pense by means of the Internet controlled sub17 stances. 

18 ‘‘(6) The name, address, telephone number, 

19 professional degree, and States of licensure of any 

20 practitioner who has a contractual relationship to 

21 provide medical evaluations or issue prescriptions for 

22 controlled substances, through referrals from the 

23 website or at the request of the owner or operator 

24 of the website, or any employee or agent thereof. 


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1 ‘‘(7) The following statement, unless revised by 

2 the Attorney General by regulation: ‘This online 

3 pharmacy will only dispense a controlled substance 

4 to a person who has a valid prescription issued for 

5 a legitimate medical purpose based upon a medical 

6 relationship with a prescribing practitioner. This in7 cludes at least one prior in-person medical evalua8 tion or medical evaluation via telemedicine in accord9 ance with applicable requirements of section 309 of 

10 the Controlled Substances Act (21 U.S.C. 829).’. 

11 ‘‘(d) NOTIFICATION.—(1) Thirty days prior to offer12 ing a controlled substance for sale, delivery, distribution, 

13 or dispensing, the online pharmacy shall notify the Attor14 ney General, in the form and manner as the Attorney Gen15 eral shall determine, and the State boards of pharmacy 

16 in any States in which the online pharmacy offers to sell, 

17 deliver, distribute, or dispense controlled substances. 

18 ‘‘(2) The notification required under paragraph (1) 

19 shall include— 

20 ‘‘(A) the information required to be posted on 

21 the online pharmacy’s Internet site under subsection 

22 (c) and shall notify the Attorney General and the 

23 applicable State boards of pharmacy, under penalty 

24 of perjury, that the information disclosed on its 


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1 Internet site under subsection (c) is true and accu2 rate; 

3 ‘‘(B) the online pharmacy’s Internet site ad4 dress and a certification that the online pharmacy 

5 shall notify the Attorney General of any change in 

6 the address at least 30 days in advance; and 

7 ‘‘(C) the Drug Enforcement Administration 

8 registration numbers of any pharmacies and practi9 tioners referred to in subsection (c), as applicable. 

10 ‘‘(3) An online pharmacy that is already operational 

11 as of the effective date of this section, shall notify the At12 torney General and applicable State boards of pharmacy 

13 in accordance with this subsection not later than 30 days 

14 after the effective date of this section. 

15 ‘‘(e) DECLARATION OF COMPLIANCE.—On and after 

16 the date on which it makes the notification under sub17 section (d), each online pharmacy shall display on the 

18 homepage of its Internet site, in such form as the Attorney 

19 General shall by regulation require, a declaration that it 

20 has made such notification to the Attorney General. 

21 ‘‘(f) REPORTS.—Any statement, declaration, notifica22 tion, or disclosure required under this section shall be con23 sidered a report required to be kept under this part. 

24 ‘‘(g) NOTICE AND DESIGNATIONS CONCERNING IN25 DIAN TRIBES.— 


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1 ‘‘(1) IN GENERAL.—For purposes of sections 

2 102(52) and 512(c)(6)(B), the Secretary shall notify 

3 the Attorney General, at such times and in such 

4 manner as the Secretary and the Attorney General 

5 determine appropriate, of the Indian tribes or tribal 

6 organizations with which the Secretary has con7 tracted or compacted under the Indian Self-Deter8 mination and Education Assistance Act (25 U.S.C. 

9 450 et seq.) for the tribes or tribal organizations to 

10 provide pharmacy services. 

11 ‘‘(2) DESIGNATIONS.— 

12 ‘‘(A) IN GENERAL.—The Secretary may 

13 designate a practitioner described in subpara14 graph (B) as an Internet Eligible Controlled 

15 Substances Provider. Such designations shall be 

16 made only in cases where the Secretary has 

17 found that there is a legitimate need for the 

18 practitioner to be so designated because the 

19 population served by the practitioner is in a 

20 sufficiently remote location that access to med21 ical services is limited. 

22 ‘‘(B) PRACTITIONERS.—A practitioner de23 scribed in this subparagraph is a practitioner 

24 who is an employee or contractor of the Indian 

25 Health Service, or is working for an Indian 


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1 tribe or tribal organization under its contract or 

2 compact under the Indian Self-Determination 

3 and Education Assistance Act (25 U.S.C. 450 

4 et seq.) with the Indian Health Service. 

5 ‘‘(h) SPECIAL REGISTRATION FOR TELEMEDICINE.— 

6 ‘‘(1) IN GENERAL.—The Attorney General may 

7 issue to a practitioner a special registration to en8 gage in the practice of telemedicine for purposes of 

9 section 102(54)(E) if the practitioner, upon applica10 tion for such special registration— 

11 ‘‘(A) demonstrates a legitimate need for 

12 the special registration; and 

13 ‘‘(B) is registered under section 303(f) in 

14 the State in which the patient will be located 

15 when receiving the telemedicine treatment, un16 less the practitioner— 

17 ‘‘(i) is exempted from such registra18 tion in all States under section 302(d); or 

19 ‘‘(ii) is an employee or contractor of 

20 the Department of Veterans Affairs who is 

21 acting in the scope of such employment or 

22 contract and is registered under section 

23 303(f) in any State or is utilizing the reg24 istration of a hospital or clinic operated by 


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1 the Department of Veterans Affairs reg2 istered under section 303(f). 

3 ‘‘(2) REGULATIONS.—The Attorney General 

4 shall, with the concurrence of the Secretary, promul5 gate regulations specifying the limited circumstances 

6 in which a special registration under this subsection 

7 may be issued and the procedures for obtaining such 

8 a special registration. 

9 ‘‘(3) DENIALS.—Proceedings to deny an appli10 cation for registration under this subsection shall be 

11 conducted in accordance with section 304(c). 

12 ‘‘(i) REPORTING OF TELEMEDICINE BY VHA DUR13 ING MEDICAL EMERGENCY SITUATIONS.— 

14 ‘‘(1) IN GENERAL.—Any practitioner issuing a 

15 prescription for a controlled substance under the au16 thorization to conduct telemedicine during a medical 

17 emergency situation described in section 102(54)(F) 

18 shall report to the Secretary of Veterans Affairs the 

19 authorization of that emergency prescription, in ac20 cordance with such requirements as the Secretary of 

21 Veterans Affairs shall, by regulation, establish. 

22 ‘‘(2) TO ATTORNEY GENERAL.—Not later than 

23 30 days after the date that a prescription described 

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1 erans Affairs shall report to the Attorney General 

2 the authorization of that emergency prescription. 

3 ‘‘(j) CLARIFICATION CONCERNING PRESCRIPTION

4 TRANSFERS.—Any transfer between pharmacies of infor5 mation relating to a prescription for a controlled substance 

6 shall meet the applicable requirements under regulations 

7 promulgated by the Attorney General under this Act.’’. 

8 (2) TECHNICAL AND CONFORMING AMEND9 MENTS.—The table of contents for the Comprehen10 sive Drug Abuse Prevention and Control Act of 

11 1970 (Public Law 91–513; 84 Stat. 1236) is amend12 ed by inserting after the item relating to section 310 

13 the following: 

‘‘Sec. 311. Additional requirements relating to online pharmacies and telemedicine.’’. 

14 (e) OFFENSES INVOLVING CONTROLLED SUB15 STANCES IN SCHEDULES III, IV, AND V.—Section 401(b) 

16 of the Controlled Substances Act (21 U.S.C. 841(b)) is 

17 amended— 

18 (1) in paragraph (1)— 

19 (A) in subparagraph (C), by striking ‘‘1 

20 gram of’’ before ‘‘flunitrazepam’’; 

21 (B) in subparagraph (D), by striking ‘‘or 

22 in the case of any controlled substance in 

23 schedule III (other than gamma hydroxybutyric 

24 acid), or 30 milligrams of flunitrazepam’’; and 


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1 (C) by adding at the end the following: 

2 ‘‘(E)(i) In the case of any controlled sub3 stance in schedule III, such person shall be sen4 tenced to a term of imprisonment of not more 

5 than 10 years and if death or serious bodily in6 jury results from the use of such substance 

7 shall be sentenced to a term of imprisonment of 

8 not more than 20 years, a fine not to exceed 

9 the greater of that authorized in accordance 

10 with the provisions of title 18, United States 

11 Code, or $500,000 if the defendant is an indi12 vidual or $2,500,000 if the defendant is other 

13 than an individual, or both. 

14 ‘‘(ii) If any person commits such a viola15 tion after a prior conviction for a felony drug 

16 offense has become final, such person shall be 

17 sentenced to a term of imprisonment of not 

18 more than 20 years and if death or serious bod19 ily injury results from the use of such substance 

20 shall be sentenced to a term of imprisonment of 

21 not more than 30 years, a fine not to exceed 

22 the greater of twice that authorized in accord23 ance with the provisions of title 18, United 

24 States Code, or $1,000,000 if the defendant is 


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1 an individual or $5,000,000 if the defendant is 

2 other than an individual, or both. 

3 ‘‘(iii) Any sentence imposing a term of im4 prisonment under this subparagraph shall, in 

5 the absence of such a prior conviction, impose 

6 a term of supervised release of at least 2 years 

7 in addition to such term of imprisonment and 

8 shall, if there was such a prior conviction, im9 pose a term of supervised release of at least 4 

10 years in addition to such term of imprison11 ment.’’; 

12 (2) in paragraph (2)— 

13 (A) by striking ‘‘3 years’’ and inserting ‘‘5 

14 years’’; 

15 (B) by striking ‘‘6 years’’ and inserting 

16 ‘‘10 years’’; 

17 (C) by striking ‘‘after one or more prior 

18 convictions’’ and all that follows through ‘‘have 

19 become final,’’ and inserting ‘‘after a prior con20 viction for a felony drug offense has become 

21 final,’’; and 

22 (3) in paragraph (3)— 

23 (A) by striking ‘‘2 years’’ and inserting ‘‘6 

24 years’’; 


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1 (B) by striking ‘‘after one or more convic2 tions’’ and all that follows through ‘‘have be3 come final,’’ and inserting ‘‘after a prior convic4 tion for a felony drug offense has become 

5 final,’’; and 

6 (C) by adding at the end the following 

7 ‘‘Any sentence imposing a term of imprison8 ment under this paragraph may, if there was a 

9 prior conviction, impose a term of supervised 

10 release of not more than 1 year, in addition to 

11 such term of imprisonment.’’. 

12 (f) OFFENSES INVOLVING DISPENSING OF CON13 TROLLED SUBSTANCES BY MEANS OF THE INTERNET.— 

14 Section 401 of the Controlled Substances Act (21 U.S.C. 

15 841) is amended by adding at the end the following: 

16 ‘‘(g) OFFENSES INVOLVING DISPENSING OF CON17 TROLLED SUBSTANCES BY MEANS OF THE INTERNET.— 

18 (1) It shall be unlawful for any person to knowingly or 

19 intentionally— 

20 ‘‘(A) deliver, distribute, or dispense a controlled 

21 substance by means of the Internet, except as au22 thorized by this title; or 

23 ‘‘(B) aid or abet (as such terms are used in sec24 tion 2 of title 18, United States Code) any activity 


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1 described in subparagraph (A) that is not authorized 

2 by this title. 

3 ‘‘(2) Examples of activities that violate paragraph (1) 

4 include, but are not limited to, knowingly or inten5 tionally— 

6 ‘‘(A) delivering, distributing, or dispensing a 

7 controlled substance by means of the Internet by an 

8 online pharmacy that is not validly registered with 

9 a modification authorizing such activity as required 

10 by section 303(f) (unless exempt from such registra11 tion); 

12 ‘‘(B) writing a prescription for a controlled sub13 stance for the purpose of delivery, distribution, or 

14 dispensation by means of the Internet in violation of 

15 section 309(e); 

16 ‘‘(C) serving as an agent, intermediary, or other 

17 entity that causes the Internet to be used to bring 

18 together a buyer and seller to engage in the dis19 pensing of a controlled substance in a manner not 

20 authorized by sections 303(f) or 309(e); 

21 ‘‘(D) offering to fill a prescription for a con22 trolled substance based solely on a consumer’s com23 pletion of an online medical questionnaire; and 


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1 ‘‘(E) making a material false, fictitious, or 

2 fraudulent statement or representation in the sub3 mission to the Attorney General under section 311. 

4 ‘‘(3)(A) This subsection does not apply to— 

5 ‘‘(i) the delivery, distribution, or dispensation of 

6 controlled substances by nonpractitioners to the ex7 tent authorized by their registration under this title; 

8 ‘‘(ii) the placement on the Internet of material 

9 that merely advocates the use of a controlled sub10 stance or includes pricing information without at11 tempting to propose or facilitate an actual trans12 action involving a controlled substance; or 

13 ‘‘(iii) except as provided in subparagraph (B), 

14 any activity that is limited to— 

15 ‘‘(I) the provision of a telecommunications 

16 service, or of an Internet access service or 

17 Internet information location tool (as those 

18 terms are defined in section 231 of the Commu19 nications Act of 1934 (47 U.S.C. 231)); or 

20 ‘‘(II) the transmission, storage, retrieval, 

21 hosting, formatting, or translation (or any com22 bination thereof) of a communication, without 

23 selection or alteration of the content of the 

24 communication, except that deletion of a par25 ticular communication or material made by anVerDate Aug 31 2005 00:41 Apr 04, 2008 Jkt 069200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\S980.RFH S980

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1 other person in a manner consistent with sec2 tion 230(c) of the Communications Act of 1934 

3 (47 U.S.C. 230(c)) shall not constitute such se4 lection or alteration of the content of the com5 munication. 

6 ‘‘(B) The exceptions under subclauses (I) and (II) of 

7 subparagraph (A)(iii) shall not apply to a person acting 

8 in concert with a person who violates paragraph (1). 

9 ‘‘(4) Any person who knowingly or intentionally vio10 lates this subsection shall be sentenced in accordance with 

11 subsection (b) of this section.’’. 

12 (g) PUBLICATION.—Section 403(c) of the Controlled 

13 Substances Act (21 U.S.C. 843(c)) is amended by— 

14 (1) designating the text as paragraph (1); and 

15 (2) adding at the end the following: 

16 ‘‘(2)(A) Except as authorized by this title, it shall be 

17 unlawful for any person by means of the Internet to know18 ingly advertise the sale or distribution of, or to offer to 

19 sell, distribute, or dispense, a controlled substance. 

20 ‘‘(B) Examples of activities that violate subparagraph 

21 (A) include, but are not limited to, knowingly or inten22 tionally causing the placement on the Internet of an adver23 tisement that refers to or directs prospective buyers to 

24 Internet sellers of controlled substances who are not reg25 istered with a modification under section 303(f). 


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1 ‘‘(C) Subparagraph (A) does not apply to material 

2 that either— 

3 ‘‘(i) merely advertises the distribution of con4 trolled substances by nonpractitioners to the extent 

5 authorized by their registration under this title; or 

6 ‘‘(ii) merely advocates the use of a controlled 

7 substance or includes pricing information without at8 tempting to facilitate an actual transaction involving 

9 a controlled substance.’’. 

10 (h) INJUNCTIVE RELIEF.—Section 512 of the Con11 trolled Substances Act (21 U.S.C. 882) is amended by 

12 adding at the end the following: 

13 ‘‘(c) STATE CAUSE OF ACTION PERTAINING TO ON14 LINE PHARMACIES.—(1) In any case in which the State 

15 has reason to believe that an interest of the residents of 

16 that State has been or is being threatened or adversely 

17 affected by the action of a person, entity, or Internet site 

18 that violates the provisions of section 303(f), 309(e), or 

19 311, the State may bring a civil action on behalf of such 

20 residents in a district court of the United States with ap21 propriate jurisdiction— 

22 ‘‘(A) to enjoin the conduct which violates this 

23 section; 

24 ‘‘(B) to enforce compliance with this section; 


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1 ‘‘(C) to obtain damages, restitution, or other 

2 compensation, including civil penalties under section 

3 402(b); and 

4 ‘‘(D) to obtain such other legal or equitable re5 lief as the court may find appropriate. 

6 ‘‘(2)(A) Prior to filing a complaint under paragraph 

7 (1), the State shall serve a copy of the complaint upon 

8 the Attorney General and upon the United States Attor9 ney for the judicial district in which the complaint is to 

10 be filed. In any case where such prior service is not fea11 sible, the State shall serve the complaint on the Attorney 

12 General and the appropriate United States Attorney on 

13 the same day that the State’s complaint is filed in Federal 

14 district court of the United States. Such proceedings shall 

15 be independent of, and not in lieu of, criminal prosecutions 

16 or any other proceedings under this title or any other laws 

17 of the United States. 

18 ‘‘(B) Upon receiving notice respecting a civil action 

19 pursuant to this section, the United States shall have the 

20 right to intervene in such action, upon so intervening, to 

21 be heard on all matters arising therein, and to file peti22 tions for appeal. 

23 ‘‘(C) Service of a State’s complaint on the United 

24 States as required in this paragraph shall be made in acVerDate Aug 31 2005 00:41 Apr 04, 2008 Jkt 069200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6201 E:\BILLS\S980.RFH S980

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1 cord with the requirements of rule 4(i)(1) of the Federal 

2 Rule of Civil Procedure. 

3 ‘‘(3) For purposes of bringing any civil action under 

4 paragraph (1), nothing in this Act shall prevent an attor5 ney general of a State from exercising the powers con6 ferred on the attorney general of a State by the laws of 

7 such State to conduct investigations or to administer oaths 

8 or affirmations or to compel the attendance of witnesses 

9 of or the production of documentary or other evidence. 

10 ‘‘(4) Any civil action brought under paragraph (1) in 

11 a district court of the United States may be brought in 

12 the district in which the defendant is found, is an inhab13 itant, or transacts business or wherever venue is proper 

14 under section 1391 of title 28, United States Code. Proc15 ess in such action may be served in any district in which 

16 the defendant is an inhabitant or in which the defendant 

17 may be found. 

18 ‘‘(5) No private right of action is created under this 

19 subsection. 

20 ‘‘(6) No civil action may be brought under paragraph 

21 (1) against— 

22 ‘‘(A) the United States; 

23 ‘‘(B) an Indian Tribe or tribal organization, to 

24 the extent such tribe or tribal organization is law25 fully carrying out a contract or compact under the 


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1 Indian Self-Determination and Education Assistance 

2 Act; or 

3 ‘‘(C) any employee of the United States or such 

4 Indian tribe or tribal organization, provided such 

5 agent or employee is acting in the usual course of 

6 business or employment, and within the scope of the 

7 official duties of such agent or employee therewith.’’. 

8 (i) FORFEITURE OF FACILITATING PROPERTY IN

9 DRUG CASES.—Section 511(a)(4) of the Controlled Sub10 stances Act (21 U.S.C. 881(a)(4)) is amended to read as 

11 follows: 

12 ‘‘(4) Any property, real or personal, tangible or 

13 intangible, used or intended to be used to commit, 

14 or to facilitate the commission, of a violation of this 

15 title or title III, and any property traceable there16 to.’’. 

17 (j) IMPORT AND EXPORT ACT.—Section 1010(b) of 

18 the Controlled Substances Import and Export Act (21 

19 U.S.C. 960(b)) is amended— 

20 (1) in paragraph (4)— 

21 (A) by striking ‘‘or any quantity of a con22 trolled substance in schedule III, IV, or V, (ex23 cept a violation involving flunitrazepam and ex24 cept a violation involving gamma hydroxy25 butyric acid)’’; 


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1 (B) by inserting ‘‘, or’’ before ‘‘less than 

2 one kilogram of hashish oil’’; and 

3 (C) striking ‘‘imprisoned’’ and all that fol4 lows through the end of the paragraph and in5 serting ‘‘sentenced in accordance with section 

6 401(b)(1)(D) of this title (21 U.S.C. 

7 841(b)(1)(E)).’’; 

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

9 ‘‘(5) In the case of a violation of subsection (a) 

10 of this section involving a controlled substance in 

11 schedule III, such person shall be sentenced in ac12 cordance with section 401(b)(1)(E). 

13 ‘‘(6) In the case of a violation of subsection (a) 

14 of this section involving a controlled substance in 

15 schedule IV (except a violation involving 

16 flunitrazepam), such person shall be sentenced in ac17 cordance with section 401(b)(2). 

18 ‘‘(7) In the case of a violation of subsection (a) 

19 of this section involving a controlled substance in 

20 schedule V, such person shall be sentenced in ac21 cordance with section 401(b)(3).’’; and 

22 (3) in paragraph (3), by striking ‘‘, nor shall a 

23 person so sentenced be eligible for parole during the 

24 term of such a sentence’’ in the final sentence. 

25 (k) EFFECTIVE DATE.— 


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1 (1) IN GENERAL.—Except as provided in para2 graph (2), the amendments made by this Act shall 

3 take effect 180 days after the date of enactment of 

4 this Act. 

5 (2) DEFINITION OF PRACTICE OF TELEMEDI6 CINE.— 

7 (A) IN GENERAL.—Until the earlier of 3 

8 months after the date on which regulations are 

9 promulgated to carry out section 311(h) of the 

10 Controlled Substances Act, as amended by this 

11 Act, or 15 months after the date of enactment 

12 of this Act— 

13 (i) the definition of the term ‘‘practice 

14 of telemedicine’’ in subparagraph (B) of 

15 this paragraph shall apply for purposes of 

16 the Controlled Substances Act; and 

17 (ii) the definition of the term ‘‘prac18 tice of telemedicine’’ in section 102(54) of 

19 the Controlled Substances Act, as amended 

20 by this Act, shall not apply. 

21 (B) TEMPORARY PHASE-IN OF TELEMEDI22 CINE REGULATION.—During the period speci23 fied in subparagraph (A), the term ‘‘practice of 

24 telemedicine’’ means the practice of medicine in 

25 accordance with applicable Federal and State 


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1 laws by a practitioner (as that term is defined 

2 in section 102 of the Controlled Substances Act 

3 (21 U.S.C. 802)) (other than a pharmacist) 

4 who is at a location remote from the patient 

5 and is communicating with the patient, or 

6 health care professional who is treating the pa7 tient, using a telecommunications system re8 ferred to in section 1834(m) of the Social Secu9 rity Act (42 U.S.C. 1395m(m)), if the practi10 tioner is using an interactive telecommuni11 cations system that satisfies the requirements 

12 of section 410.78(a)(3) of title 42, Code of Fed13 eral Regulations. 

14 (C) RULE OF CONSTRUCTION.—Nothing in 

15 this subsection may be construed to create a 

16 precedent that any specific course of conduct 

17 constitutes the ‘‘practice of telemedicine’’ (as 

18 that term is defined in section 102(54) of the 

19 Controlled Substances Act, as amended by this 

20 Act) after the end of the period specified in 

21 subparagraph (A). 

22 (l) GUIDELINES AND REGULATIONS.— 

23 (1) IN GENERAL.—The Attorney General may 

24 promulgate and enforce any rules, regulations, and 

25 procedures which may be necessary and appropriate 


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1 for the efficient execution of functions under this 

2 Act or the amendments made by this Act, and, with 

3 the concurrence of the Secretary of Health and 

4 Human Services where this Act or the amendments 

5 made by this Act so provides, promulgate any in6 terim rules necessary for the implementation of this 

7 Act or the amendments made by this Act, prior to 

8 its effective date. 

9 (2) SENTENCING GUIDELINES.—The United 

10 States Sentencing Commission, in determining 

11 whether to amend, or establish new, guidelines or 

12 policy statements, to conform the Federal sentencing 

13 guidelines and policy statements to this Act and the 

14 amendments made by this Act— 

15 (A) shall consult with the Department of 

16 Justice, experts and other affected parties con17 cerning which penalties for scheduled sub18 stances amended by this Act should be reflected 

19 in the Federal sentencing guidelines; and 

20 (B) should not construe any change in the 

21 maximum penalty for a violation involving a 

22 controlled substance in a particular schedule as 

23 being the sole reason to amend a, or establish 

24 a new, guideline or policy statement. 


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1 (m) ANNUAL REPORT.—Not later than 180 days 

2 after the date of enactment of this Act, and annually for 

3 2 years after the initial report, the Drug Enforcement Ad4 ministration, in consultation with the Department of 

5 State, shall submit to Congress a report describing— 

6 (1) the foreign supply chains and sources of 

7 controlled substances offered for sale without a valid 

8 prescription on the Internet; 

9 (2) the efforts and strategy of the Drug En10 forcement Administration to decrease the foreign 

11 supply chain and sources of controlled substances of12 fered for sale without a valid prescription on the 

13 Internet; and 

14 (3) the efforts of the Drug Enforcement Ad15 ministration to work with domestic and multi16 national pharmaceutical companies and others to 

17 build international cooperation and a commitment to 

18 fight on a global scale the problem of distribution of 

19 controlled substances over the Internet without a 

20 valid prescription. 

21 SEC. 4. RULE OF CONSTRUCTION. 

22 Nothing in this Act or the amendments made by this 

23 Act shall be construed as authorizing, prohibiting, or limVerDate Aug 31 2005 00:41 Apr 04, 2008 Jkt 069200 PO 00000 Frm 00039 Fmt 6652 Sfmt 6201 E:\BILLS\S980.RFH S980

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1 iting the use of electronic prescriptions for controlled sub2 stances. 

Passed the Senate April 1 (legislative day, March 

13), 2008. 

Attest: NANCY ERICKSON, 

Secretary. 


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