I 

109TH CONGRESS 

2D SESSION H. R. 4769 

To amend the Federal Food, Drug, and Cosmetic Act, the Controlled Substances Import and Export Act, and the Public Health Service Act 

to impose requirements respecting Internet pharmacies, to require manufacturers to implement chain-of-custody procedures, to restrict an exemption respecting the importation of controlled substances for personal 

use, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 16, 2006 

Mr. NORWOOD (for himself and Mr. STRICKLAND) 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, the 

Controlled Substances Import and Export Act, and the 

Public Health Service Act to impose requirements respecting Internet pharmacies, to require manufacturers 

to implement chain-of-custody procedures, to restrict an 

exemption respecting the importation of controlled substances for personal use, and for other purposes. 

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 ‘‘Prescription Drug 

3 Abuse Elimination Act of 2006’’. 

4 SEC. 2. INTERNET PHARMACIES. 

5 (a) IN GENERAL.—Chapter V of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend7 ed by inserting after section 503A the following: 

8 ‘‘SEC. 503B. INTERNET SALE OF PRESCRIPTION DRUGS. 

9 ‘‘(a) IN GENERAL.— 

10 ‘‘(1) PROHIBITIONS.—Subject to paragraph (2), 

11 it is a violation of this section— 

12 ‘‘(A) for any person to sell a prescription 

13 drug in interstate commerce through an Inter14 net site— 

15 ‘‘(i) if the Internet site is an illegal 

16 Internet pharmacy under subsection (b); 

17 ‘‘(ii) if the person fails to comply with 

18 the treating provider verification require19 ments of subsection (c); or 

20 ‘‘(iii) if the person fails to submit the 

21 notices required by subsection (d); or 

22 ‘‘(B) for any person to own or operate an 

23 illegal Internet pharmacy in interstate com24 merce. 

25 ‘‘(2) EXCEPTION.—Any person who sells a pre26 scription drug through an Internet site, or who owns 
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1 or operates an Internet pharmacy, is deemed to meet 

2 the requirements of this section for purposes of such 

3 sale, ownership, or operation if the Internet site or 

4 Internet pharmacy is certified by the National Asso5 ciation of Boards of Pharmacy’s Verified Internet 

6 Pharmacy Practice Sites program. 

7 ‘‘(b) INTERNET PHARMACY REQUIREMENTS.— 

8 ‘‘(1) IN GENERAL.—For purposes of this sec9 tion: 

10 ‘‘(A) The term ‘Internet pharmacy’ means 

11 an Internet site, inside or outside the State in12 volved, that— 

13 ‘‘(i) is used or attempted to be used 

14 to communicate with, or obtain informa15 tion from, a person for the purpose of fill16 ing or refilling a prescription; or 

17 ‘‘(ii) is otherwise used in the practice 

18 of pharmacy, including dispensing, distrib19 uting or delivery of, or aiding in the deliv20 ery of, a prescription drug to a person. 

21 ‘‘(B) The term ‘illegal Internet pharmacy’ 

22 means an Internet pharmacy that fails to com23 ply with this subsection. 
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1 ‘‘(2) REQUIREMENTS.—An Internet pharmacy 

2 shall provide to any individual who accesses the 

3 pharmacy the following information: 

4 ‘‘(A) The street address and telephone 

5 number of— 

6 ‘‘(i) the Internet pharmacy’s place of 

7 business; and 

8 ‘‘(ii) the Internet pharmacy’s super9 vising pharmacist. 

10 ‘‘(B) All States in which the Internet phar11 macy is licensed or otherwise authorized to dis12 pense prescription drugs. 

13 ‘‘(C) If the Internet pharmacy makes re14 ferrals to, or solicits on behalf of, a practitioner 

15 or a group of practitioners for prescription serv16 ices— 

17 ‘‘(i) the name, street address, and 

18 telephone number of such practitioner or 

19 group; and 

20 ‘‘(ii) each State in which each practi21 tioner involved is licensed or otherwise au22 thorized to prescribe drugs. 

23 ‘‘(D) A statement that the Internet phar24 macy will dispense prescription drugs only upon 

25 a showing of a prescription. 
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1 ‘‘(c) TREATING PROVIDER VERIFICATION REQUIRE2 MENTS.—The treating provider verification requirements 

3 of this subsection are as follows: 

4 ‘‘(1) IN GENERAL.—Subject to paragraph (2), a 

5 person may sell a prescription drug in interstate 

6 commerce through an Internet site only if— 

7 ‘‘(A) the sale is in accordance with a pre8 scription of the treating provider of the patient 

9 involved; 

10 ‘‘(B) the seller verifies the prescription in 

11 accordance with paragraph (3); 

12 ‘‘(C) the seller maintains a record of direct 

13 communications in accordance with paragraph 

14 (4); and 

15 ‘‘(D) the seller complies with the prohibi16 tion of paragraph (5) against alteration of the 

17 prescription. 

18 ‘‘(2) LIMITATION.—The treating provider 

19 verification requirements of this subsection apply 

20 with respect to a prescription drug only if— 

21 ‘‘(A) the prescription drug is included in 

22 schedule II, III, or IV of section 202(c) of the 

23 Controlled Substances Act; or 

24 ‘‘(B) the Secretary for purposes of this 

25 section identifies the prescription drug as po-
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1 tentially subject to abuse, diversion, and mis2 use. 

3 ‘‘(3) VERIFICATION REQUIREMENT.— 

4 ‘‘(A) REQUIREMENT.—A seller verifies a 

5 prescription in accordance with this paragraph 

6 if— 

7 ‘‘(i) the patient involved or the pa8 tient’s treating provider presents the pre9 scription, directly or by facsimile or elec10 tronic mail, to the seller; or 

11 ‘‘(ii) the seller verifies the prescription 

12 by direct communication with the treating 

13 provider involved. 

14 ‘‘(B) INFORMATION.—When seeking 

15 verification of a prescription under subpara16 graph (A)(ii), a seller shall provide to the treat17 ing provider the following information: 

18 ‘‘(i) Patient’s full name and address. 

19 ‘‘(ii) Identification of the drug by a 

20 national drug code number. 

21 ‘‘(iii) Quantity to be dispensed. 

22 ‘‘(iv) Date of patient request. 

23 ‘‘(v) Date and time of verification re24 quest. 
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1 ‘‘(vi) Name of contact person at sell2 er’s company, including facsimile and tele3 phone number. 

4 ‘‘(C) VERIFICATION EVENTS.—A prescrip5 tion is verified under subparagraph (A)(ii) only 

6 if one of the following occurs: 

7 ‘‘(i) The treating provider confirms 

8 the prescription is accurate by direct com9 munication with the seller. 

10 ‘‘(ii) The treating provider informs 

11 the seller that the prescription is inac12 curate and provides the accurate prescrip13 tion. 

14 ‘‘(iii) The treating provider fails to 

15 communicate with the seller within 48 

16 hours, or a similar time as defined by the 

17 Commissioner of Food and Drugs, after 

18 receiving from the seller the information 

19 described in subparagraph (B). 

20 ‘‘(D) INVALID PRESCRIPTION.—If a treat21 ing provider informs a seller before the deadline 

22 under subparagraph (C)(iii) that the prescrip23 tion is inaccurate or expired, the seller shall not 

24 fill the prescription. The treating provider shall 

25 specify the basis for the inaccuracy or invalidity 
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1 of the prescription. If the prescription commu2 nicated by the seller to the treating provider is 

3 inaccurate, the treating provider shall correct it. 

4 ‘‘(4) RECORD REQUIREMENT.—A seller shall 

5 maintain for at least 2 years a record of all direct 

6 communications with a treating provider regarding 

7 the sale of a prescription drug, including verification 

8 of the prescription involved. 

9 ‘‘(5) NO ALTERATION.— 

10 ‘‘(A) IN GENERAL.—A seller may not alter 

11 a prescription for a prescription drug. 

12 ‘‘(B) EXCEPTIONS.—Notwithstanding sub13 paragraph (A)— 

14 ‘‘(i) if the same prescription drug is 

15 manufactured by the same company and 

16 sold under multiple labels to individual 

17 providers, the seller may fill the prescrip18 tion with a prescription drug manufactured 

19 by that company under another label; and 

20 ‘‘(ii) the seller may fill the prescrip21 tion with a generic version of the prescrip22 tion drug. 

23 ‘‘(6) DEFINITIONS.—In this subsection: 
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1 ‘‘(A) The term ‘direct communication’ in2 cludes communication by telephone, facsimile, 

3 or electronic mail. 

4 ‘‘(B) The term ‘generic version of the pre5 scription drug’ means, with respect to a pre6 scription drug, a drug for which an application 

7 is approved under section 505(j) and for which 

8 the relevant listed drug described in section 

9 505(j)(2) is such prescription drug. 

10 ‘‘(C) The term ‘seller’ means a person that 

11 sells a prescription drug in interstate commerce 

12 through an Internet site. 

13 ‘‘(D) The term ‘treating provider’ means a 

14 health care provider (including a nurse) licensed 

15 by law to administer the prescription drug in16 volved who— 

17 ‘‘(i) has performed a documented pa18 tient evaluation of the individual involved 

19 (including a patient history and physical 

20 examination) to establish the diagnosis for 

21 which the prescription drug involved is pre22 scribed, has discussed with the individual 

23 his or her treatment options and the risks 

24 and benefits of treatment, and maintains 
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1 contemporaneous medical records on the 

2 individual; 

3 ‘‘(ii) is providing care in consultation 

4 with a health care provider described in 

5 clause (i) and who has access to the med6 ical records of the patient involved; or 

7 ‘‘(iii) is providing care as part of an 

8 on-call or cross-coverage arrangement with 

9 a health care provider described in clause 

10 (i). 

11 ‘‘(d) STATE NOTICE REQUIREMENTS.—A person that 

12 sells a prescription drug in interstate commerce through 

13 an Internet site shall provide to each State authority that 

14 licenses or otherwise authorizes the person to dispense the 

15 prescription drug the following information: 

16 ‘‘(1) A statement that the person is selling pre17 scription drugs through an Internet site. 

18 ‘‘(2) The name, Internet address, street ad19 dress, and telephone number of the person’s busi20 ness for selling such drugs. 

21 ‘‘(e) DEFINITION.—In this section, the term ‘pre22 scription drug’ means a drug subject to section 503(b).’’. 

23 (b) INCLUSION AS PROHIBITED ACT.—Section 301 of 

24 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
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1 331) is amended by inserting after paragraph (k) the fol2 lowing: 

3 ‘‘(l) The sale of a prescription drug, or the ownership 

4 or operation of an illegal Internet pharmacy, in violation 

5 of section 503B.’’. 

6 (c) LINKS TO ILLEGAL INTERNET PHARMACY.—Sec7 tion 302 of the Federal Food, Drug, and Cosmetic Act 

8 (21 U.S.C. 332) is amended by adding at the end the fol9 lowing: 

10 ‘‘(c) In the case of a violation of section 503B relat11 ing to an illegal Internet pharmacy, the district courts of 

12 the United States and the United States courts of the Ter13 ritories shall have jurisdiction to order a provider of an 

14 interactive computer service to remove, or disable access 

15 to, a site violating such section, or a link to a site violating 

16 such section, that resides on a computer server that such 

17 provider controls or operates. Such relief shall— 

18 ‘‘(1) be available only after provision to the pro19 vider of notice and an opportunity to appear; 

20 ‘‘(2) not impose any obligation on the provider 

21 to monitor its service or to affirmatively seek facts 

22 indicating activity violating section 503B; 

23 ‘‘(3) specify the provider to which the relief ap24 plies; and 
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1 ‘‘(4) specifically identify the location of the site 

2 or link to be removed, or to which access is to be 

3 disabled.’’. 

4 SEC. 3. DISTRIBUTION AND LABELING OF DRUGS. 

5 (a) DRUG PEDIGREES.—With respect to any State 

6 that imposes a requirement on the manufacturer or dis7 tributor of a drug to provide information to persons receiv8 ing the drug regarding prior sales, purchases, or trades 

9 of the drug, the Secretary of Health and Human Services 

10 shall— 

11 (1) encourage the State to allow the manufac12 turer or distributor to take advantage of techno13 logical advances, including by providing such infor14 mation electronically; and 

15 (2) at the request of the State, provide tech16 nical assistance in implementing the requirement. 

17 (b) CHAIN-OF-CUSTODY REQUIREMENTS.—Chapter 

18 V of the Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 351 et seq.) (as amended by section 2) is amend20 ed— 

21 (1) in section 502, by adding at the end the fol22 lowing: 

23 ‘‘(x) If it is a drug with respect to which the manufac24 turer, importer, distributor, or retailer fails to comply with 

25 the chain-of-custody requirements of section 503C.’’; and 
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1 (2) by inserting after section 503B (as added 

2 by section 2) the following: 

3 ‘‘SEC. 503C. CHAIN-OF-CUSTODY REQUIREMENTS. 

4 ‘‘(a) IN GENERAL.—Not later than January 1, 2007, 

5 the Secretary shall promulgate chain-of-custody require6 ments applicable to each manufacturer, importer, dis7 tributor, and retailer of a prescription drug. 

8 ‘‘(b) MANUFACTURERS.—The chain-of-custody re9 quirements promulgated under this section shall require 

10 each manufacturer of a prescription drug— 

11 ‘‘(1) to incorporate a unique identifier into the 

12 packaging or labeling of the drug; 

13 ‘‘(2) to track the drug through the point of de14 livery to the retailer of the drug; and 

15 ‘‘(3) to maintain, either directly or through a 

16 contractor, a database on the movement of the drug. 

17 ‘‘(c) IMPORTERS, DISTRIBUTORS, AND RETAILERS.— 

18 The chain-of-custody requirements promulgated under 

19 this section shall require each importer, distributor, and 

20 retailer of a prescription drug to assist in the tracking 

21 of the drug under this section by reporting the receipt of 

22 the drug to the manufacturer. 

23 ‘‘(d) PRESCRIPTION DRUG.—In this section, the term 

24 ‘prescription drug’ means a drug subject to section 503(b). 
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1 ‘‘(e) EFFECTIVE DATE.—The chain-of-custody re2 quirements promulgated by the Secretary under this sec3 tion shall take effect on January 1, 2009.’’. 

4 (c) GRANTS FOR COMMUNITY PHARMACISTS.—The 

5 Secretary of Health and Human Services may make 

6 grants to community pharmacists to assist such phar7 macists to comply with tracking requirements imposed on 

8 such pharmacists by drug manufacturers, importers, or 

9 distributors as a result of the amendments made by sub10 section (b). 

11 SEC. 4. RESTRICTION ON PERSONAL USE EXEMPTION FOR 

12 IMPORTING CONTROLLED SUBSTANCES. 

13 Paragraph (2) of section 1006(a) of the Controlled 

14 Substances Import and Export Act (21 U.S.C. 956(a)) is 

15 amended by striking ‘‘may not import the controlled sub16 stance’’ and all that follows and inserting: ‘‘may not im17 port the controlled substance into the United States— 

18 ‘‘(1) in an amount that exceeds 50 dosage units 

19 of the controlled substance; or 

20 ‘‘(2) in the case of a controlled substance in 

21 schedule II, III, or IV, more than 1 time during any 

22 30-day period.’’. 
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1 SEC. 5. WORKING GROUP ON PHARMACEUTICAL COUNTER2 FEITING. 

3 (a) ESTABLISHMENT.—The Secretary of Health and 

4 Human Services (in this section referred to as the ‘‘Sec5 retary’’), acting through the Commissioner of Food and 

6 Drugs, shall convene a working group (in this section re7 ferred to as the ‘‘working group’’) to conduct a study and 

8 submit a report on pharmaceutical counterfeiting. 

9 (b) MEMBERS.—The Secretary shall invite to serve 

10 as members of the working group representatives of the 

11 following: 

12 (1) Domestic regulatory agencies. 

13 (2) Domestic and international law enforcement 

14 officials. 

15 (3) Multinational organizations, such as the 

16 World Trade Organization and the World Health 

17 Organization. 

18 (4) The United States Trade Representative. 

19 (5) The pharmaceutical industry. 

20 (6) Trade associations, including associations 

21 representing each step of the pharmaceutical deliv22 ery system (including representatives of drug manu23 facturers and pharmacists). 

24 (c) STUDY.—The study conducted by the working 

25 group on pharmaceutical counterfeiting shall consider the 

26 following: 
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1 (1) How to enhance supply-chain security. 

2 (2) Consumer education on counterfeiting 

3 issues. 

4 (3) Employing technology designed to frustrate 

5 organized and sophisticated criminals intent on com6 promising the world’s drug supply. 

7 (4) How industry could assist law enforcement 

8 by analyzing suspected counterfeit drugs to deter9 mine authenticity. 

10 (5) How industry can collaborate on issues re11 lated to pharmaceutical counterfeiting without re12 vealing trade secrets or other confidential informa13 tion. 

14 (d) REPORT.—Not later than 2 years after the date 

15 of the enactment of this Act, the working group shall sub16 mit a report to the Congress on the results of the study 

17 conducted under this section, including recommendations 

18 on measures to reduce or eliminate problems associated 

19 with pharmaceutical counterfeiting. 

20 SEC. 6. STUDY ON UNUSED CONTROLLED SUBSTANCES. 

21 (a) STUDY.—The Secretary of Health and Human 

22 Services (in this section referred to as the ‘‘Secretary’’), 

23 acting through the Commissioner of Food and Drugs, 

24 shall conduct a study to determine the best methods to 
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1 ensure that unused controlled substances are not diverted 

2 for unlawful use. 

3 (b) CONSULTATION.—In conducting the study re4 quired by this section, the Secretary shall consult with the 

5 Administrator of the Drug Enforcement Administration, 

6 appropriate law enforcement representatives, the Adminis7 trator of the Environmental Protection Agency, States 

8 and municipalities (including State boards of pharmacy), 

9 and representatives of the pharmaceutical industry. 

10 (c) REPORT.—Not later than 2 years after the date 

11 of the enactment of this Act, the Secretary shall submit 

12 a report to the Congress on the results of the study con13 ducted under this section. 

14 SEC. 7. BASELINE RESEARCH ON PRESCRIPTION DRUG 

15 ABUSE. 

16 (a) RESEARCH.—The Secretary of Health and 

17 Human Services shall conduct research on issues related 

18 to prescription drug abuse, including the following: 

19 (1) Enhancing existing public use surveys and 

20 other sources so as to provide appropriate baseline 

21 data and data on the natural history and context of 

22 prescription drug use in order to evaluate the extent 

23 and nature of potential problems and guide correc24 tive actions which reduce the problems without unin25 tentionally hindering patient access. 
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1 (2) The phenomenon of iatrogenic addiction, in2 cluding the actual incidence and prevalence of iatro3 genic addiction, the factors that modulate the risk of 

4 such addiction, and the extent to which concern 

5 about iatrogenic addiction impacts health care deliv6 ery. 

7 (3) Development of postapproval surveillance 

8 approaches that can detect and address potential 

9 risks of abuse and misuse, including risks in diverse 

10 patient populations that did not previously appear at 

11 risk for diversion or abuse, and in geographic re12 gions that have been relatively absent from risk. 

13 (4) Methods to better translate new ideas about 

14 terminology, diagnosis, and management of addic15 tion diseases into clinical practice at the primary 

16 care and specialist levels. 

17 (5) Reliable, useful assessment tools for addic18 tion in the clinical setting of initial and ongoing 

19 treatment of conditions requiring the use of con20 trolled substances. 

21 (6) Development of better methods of ensuring 

22 patient adherence to prescribed drug regimens. 

23 (7) Relative contributions of genetic, psycho24 social, environmental, and behavioral factors to ad25 diction to prescription opioids. 
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1 (b) REPORT.—Not later than 2 years after the date 

2 of the enactment of this Act, the Secretary of Health and 

3 Human Services shall submit to the Congress a report on 

4 the results of the research conducted under this section. 

5 SEC. 8. DATABASE FOR DRUG ABUSE MORTALITY REPORT6 ING. 

7 Section 505 of the Public Health Service Act (42 

8 U.S.C. 290aa–4) is amended— 

9 (1) in subparagraph (B) of subsection (c)(1), by 

10 striking ‘‘, as indicated in reports by coroners’’; and 

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

12 ‘‘(e) With respect to the activities of the Adminis13 trator under subsections (a) and (c)(1)(B) relating to the 

14 collection of data on the number of deaths occurring as 

15 a result of substance abuse, the Administrator— 

16 ‘‘(1) shall expand and intensify collection activi17 ties to maintain a comprehensive, national database 

18 on such deaths; and 

19 ‘‘(2) shall require medical examiners, coroners, 

20 and other appropriate persons to report to the Ad21 ministrator for purposes of collecting data on such 

22 deaths.’’. 

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