I 

108TH CONGRESS 

2D SESSION H. R. 3870

To amend the Public Health Service Act, the Federal Food, Drug, and 

Cosmetic Act, and the Controlled Substances Import and Export Act 

to provide grants to States to establish prescription drug monitoring 

programs, 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 

MARCH 2, 2004

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 Public Health Service Act, the Federal Food, 

Drug, and Cosmetic Act, and the Controlled Substances 

Import and Export Act to provide grants to States to 

establish prescription drug monitoring programs, 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,
2

•HR 3870 IH 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Prescription Drug 

3 Abuse Elimination Act of 2004’’. 

4 SEC. 2. PRESCRIPTION DRUG MONITORING PROGRAM. 

5 Part P of title III of the Public Health Service Act 

6 (42 U.S.C. 280g et seq.) is amended by adding after sec7 tion 399N the following: 

8 ‘‘SEC. 399O. PRESCRIPTION DRUG MONITORING PROGRAM. 

9 ‘‘(a) PRESCRIPTION DRUG.—For purposes of this 

10 section, the term ‘prescription drug’ means—

11 ‘‘(1) a drug that is included in schedule II, III, 

12 or IV of section 202(c) of the Controlled Substances 

13 Act; or 

14 ‘‘(2) a drug that is—

15 ‘‘(A) subject to section 503(b) of the Fed16 eral Food, Drug, and Cosmetic Act; and 

17 ‘‘(B) identified for purposes of this section 

18 by the Secretary as potentially subject to abuse, 

19 diversion, and misuse. 

20 ‘‘(b) GRANTS.—The Secretary shall make a grant to 

21 each State that submits an application in accordance with 

22 subsection (k) for the purpose of establishing a prescrip23 tion drug monitoring program described in this section. 

24 ‘‘(c) REPORTING REQUIREMENTS.—A funding agree25 ment for a grant under this section is that the State in26 volved shall comply with the following: 
3

•HR 3870 IH 

1 ‘‘(1) The State shall require dispensers to re2 port each dispensing in the State of a prescription 

3 drug to an ultimate user or research subject. 

4 ‘‘(2) A State may exclude from the reporting 

5 requirement of this section—

6 ‘‘(A) the direct application of a prescrip7 tion drug to the body of an ultimate user or re8 search subject; 

9 ‘‘(B) the dispensing of a prescription drug 

10 in a quantity limited to an amount adequate to 

11 treat the ultimate user or research subject in12 volved for 48 hours or less; or 

13 ‘‘(C) the application or dispensing of a pre14 scription drug in accordance with an exclusion 

15 identified by the Secretary under subsection 

16 (i)(2). 

17 ‘‘(3) Subject to paragraph (5), the information 

18 to be reported under this section with respect to the 

19 dispensing of a prescription drug shall include the 

20 following: 

21 ‘‘(A) Drug Enforcement Administration 

22 Registration Number of the dispenser. 

23 ‘‘(B) Drug Enforcement Administration 

24 Registration Number and name of the practi25 tioner who prescribed the drug. 
4

•HR 3870 IH 

1 ‘‘(C) Name, address, and telephone num2 ber of the ultimate user or research subject. 

3 ‘‘(D) Identification of the drug by a na4 tional drug code number. 

5 ‘‘(E) Quantity dispensed. 

6 ‘‘(F) Estimated number of days for which 

7 such quantity should last. 

8 ‘‘(G) Number of refills ordered. 

9 ‘‘(H) Whether the drug was dispensed as 

10 a refill of a prescription or as a first-time re11 quest. 

12 ‘‘(I) Date of the dispensing. 

13 ‘‘(J) Date of origin of the prescription. 

14 ‘‘(4) The State shall specify an electronic for15 mat for the reporting of information under this sec16 tion and may waive the requirement of such format 

17 with respect to an individual dispenser. 

18 ‘‘(5) The State may meet the requirements of 

19 paragraphs (3) and (4) by requiring that informa20 tion be reported under this section in accordance 

21 with the current version of the telecommunications 

22 format for controlled substances of the American So23 ciety for Automation in Pharmacy. 
5

•HR 3870 IH 

1 ‘‘(d) DATABASE.—A funding agreement for a grant 

2 under this section is that the State involved shall comply 

3 with the following: 

4 ‘‘(1) The State shall establish and maintain an 

5 electronic database containing the information re6 ported to the State under this section. 

7 ‘‘(2) The database must be searchable by any 

8 field or combination of fields. 

9 ‘‘(3) The State shall include reported informa10 tion in the database in a timely and efficient man11 ner, with appropriate safeguards for ensuring the 

12 accuracy and completeness of the database. 

13 ‘‘(4) The State shall take appropriate security 

14 measures to protect the integrity of, and access to, 

15 the database. 

16 ‘‘(e) REQUIRED AVAILABILITY OF INFORMATION.—

17 Subject to subsection (g), a funding agreement for a grant 

18 under this section is that the State involved, with respect 

19 to the database established by the State under subsection 

20 (d), shall comply with the following: 

21 ‘‘(1) The State, taking into consideration the 

22 criteria established by the Secretary under sub23 section (i)(1), shall notify appropriate authorities re24 sponsible for drug diversion investigation if informa-
6

•HR 3870 IH 

1 tion in the database indicates a potential unlawful 

2 diversion or misuse of a prescription drug. 

3 ‘‘(2) The State shall provide for sharing of in4 formation on a specific individual in the database 

5 with each State that—

6 ‘‘(A) maintains a database established 

7 under subsection (d); and 

8 ‘‘(B) agrees to use the information in ac9 cordance with the requirements of this section. 

10 ‘‘(3) The State shall automatically share infor11 mation reported to the State under this section with 

12 another State if—

13 ‘‘(A) such other State maintains a data14 base under subsection (d); and 

15 ‘‘(B) the information concerns—

16 ‘‘(i) the dispensing of a prescription 

17 drug to an ultimate consumer or research 

18 subject who resides in such other State; or 

19 ‘‘(ii) the dispensing of a prescription 

20 drug prescribed by a practitioner whose 

21 principal place of business is located in 

22 such other State. 

23 ‘‘(f) OPTIONAL AVAILABILITY OF INFORMATION.—

24 Subject to subsection (g), a funding agreement for a grant 

25 under this section is that the State involved, with respect 
7

•HR 3870 IH 

1 to the database established by the State under subsection 

2 (d), may choose to comply with any of the following: 

3 ‘‘(1) On request, the State may make available 

4 information on a specific individual from the data5 base to any dispenser or practitioner who certifies 

6 that the requested information is for the purpose of 

7 providing pharmaceutical or medical treatment, or 

8 evaluating the need for such treatment, with respect 

9 to a bona fide patient. 

10 ‘‘(2) On request, the State may make available 

11 information on a specific individual from the data12 base to any local, State, or Federal law enforcement 

13 authority responsible for prescription drug diversion 

14 investigation that requests the information and cer15 tifies that—

16 ‘‘(A) the requested information relates to 

17 an active criminal investigation or proceeding 

18 involving the unlawful diversion or misuse of a 

19 prescription drug; and 

20 ‘‘(B) the authority has reasonable cause to 

21 conclude that such information will further the 

22 purpose of the investigation or assist in the pro23 ceeding. 

24 ‘‘(3) On request, the State may make available 

25 information on a specific individual from the data-
8

•HR 3870 IH 

1 base to any health care professional licensing au2 thority that requests the information and certifies 

3 that the requested information relates to an active 

4 investigation or proceeding involving the unlawful di5 version or misuse of a prescription drug, and the au6 thority has reasonable cause to conclude that such 

7 information will further the purpose of the investiga8 tion or assist in the proceeding. Information made 

9 available to a health care professional licensing au10 thority under this paragraph shall be limited to 

11 those individuals licensed, regulated, or disciplined 

12 by the authority. 

13 ‘‘(4) The State may make available information 

14 on a specific individual from the database to dis15 pensers, practitioners, law enforcement authorities 

16 responsible for prescription drug diversion investiga17 tion, and health care professional licensing authori18 ties in accordance with paragraphs (1), (2), and (3), 

19 irrespective of whether such dispensers, practi20 tioners, or authorities are from another State. 

21 ‘‘(5) On request, the State may make available 

22 information on a specific individual from the data23 base to that specific individual with appropriate 

24 identification and procedures. 
9

•HR 3870 IH 

1 ‘‘(g) LIMITATION.—With respect to information in a 

2 database established under subsection (d), a funding 

3 agreement for a grant under this section is that—

4 ‘‘(1) the State involved shall limit the release of 

5 information pursuant to subsections (e) and (f) to 

6 the minimum necessary to accomplish the intended 

7 purpose of such release; 

8 ‘‘(2) after the passage of 18 months from the 

9 date of the dispensing of a drug, the State involved 

10 will make information on such dispensing available 

11 only to the extent required by court order; and 

12 ‘‘(3) except as inconsistent with the provisions 

13 of this section, the State involved will comply with 

14 section 264(c) of the Health Insurance Portability 

15 and Accountability Act of 1996 (Public Law 104–

16 191; 110 Stat. 2033) (concerning the confidentiality 

17 of individually identifiable health information) and 

18 any regulation promulgated under such section. 

19 ‘‘(h) QUALITY IMPROVEMENT PROGRAM.—A funding 

20 agreement for a grant under this section is that the State 

21 involved shall operate a continuous quality improvement 

22 program to ensure the State’s compliance with this section 

23 and to improve the State’s prescription drug monitoring 

24 program. 

25 ‘‘(i) AUTHORITY OF SECRETARY.—
10

•HR 3870 IH 

1 ‘‘(1) NATIONAL CRITERIA.—The Secretary shall 

2 establish criteria for determining whether informa3 tion in a database established under subsection (d) 

4 indicates a potential unlawful diversion or misuse of 

5 a prescription drug. 

6 ‘‘(2) EXCLUSIONS.—The Secretary may identify 

7 instances (in addition to those described in subpara8 graphs (A) and (B) of subsection (c)(2)) in which a 

9 State may exclude from the reporting requirement of 

10 this section the application or dispensing of a pre11 scription drug. 

12 ‘‘(j) ADVISORY COUNCIL.—A funding agreement for 

13 a grant under this section is that the State involved shall 

14 comply with the following: 

15 ‘‘(1) The State shall establish an advisory coun16 cil to assist in the establishment and implementation 

17 of a prescription drug monitoring program under 

18 this section. 

19 ‘‘(2) The State shall ensure that the member20 ship of the advisory council includes the following: 

21 ‘‘(A) A representative of the primary State 

22 agency responsible for law enforcement. 

23 ‘‘(B) A representative of the primary State 

24 agency responsible for health care. 
11

•HR 3870 IH 

1 ‘‘(C) A health care practitioner with a spe2 cialty in pain medicine licensed in the State to 

3 prescribe drugs. 

4 ‘‘(D) A pharmacist licensed in the State. 

5 ‘‘(E) A prosecutor experienced in criminal 

6 prosecution of drug diversion cases. 

7 ‘‘(F) A member representing the public at 

8 large. 

9 ‘‘(k) APPLICATION.—For purposes of subsection (b), 

10 an application is in accordance with this subsection if—

11 ‘‘(1) the application contains each funding 

12 agreement in this section; 

13 ‘‘(2) with respect to such funding agreements, 

14 the application provides assurances of compliance 

15 satisfactory to the Secretary; and 

16 ‘‘(3) the application is in such form, is made in 

17 such manner, and contains such information as the 

18 Secretary determines to be necessary to carry out 

19 this section. 

20 ‘‘(l) DEFINITIONS.—For purposes of this section: 

21 ‘‘(1) The term ‘bona fide patient’ means an in22 dividual who is a patient of the dispenser or practi23 tioner involved. 

24 ‘‘(2) The term ‘dispense’ means to deliver a 

25 prescription drug to an ultimate user or research 
12

•HR 3870 IH 

1 subject by, or pursuant to the lawful order of, a 

2 practitioner, irrespective of whether the dispenser 

3 uses the Internet or other means to effect such deliv4 ery. 

5 ‘‘(3) The term ‘dispenser’ means a physician, 

6 pharmacist, or other individual who dispenses a pre7 scription drug to an ultimate user or research sub8 ject. 

9 ‘‘(4) The term ‘ultimate user’ means a person 

10 who has lawfully obtained, and who possesses, a pre11 scription drug for his or her own use, for the use of 

12 a member of his or her household, or for the use of 

13 an animal owned by him or her or by a member of 

14 his or her household. 

15 ‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—

16 ‘‘(1) IN GENERAL.—There is authorized to be 

17 appropriated to carry out this section $10,000,000 

18 for fiscal year 2005 and each subsequent fiscal year. 

19 ‘‘(2) STARTUP GRANTS.—For the purpose of 

20 awarding grants under this section to assist with the 

21 initial costs of establishing a prescription drug moni22 toring program, there is authorized to be appro23 priated $25,000,000 for the period of fiscal years 

24 2005 through 2009. Such authorization of appro-
13

•HR 3870 IH 

1 priations is in addition to the authorization of ap2 propriations in paragraph (1).’’. 

3 SEC. 3. INTERNET PHARMACIES. 

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

5 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend6 ed by inserting after section 503A the following: 

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

8 ‘‘(a) IN GENERAL.—

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

10 it is a violation of this section—

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

12 drug in interstate commerce through an Inter13 net site—

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

15 Internet pharmacy under subsection (b); 

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

17 the treating provider verification require18 ments of subsection (c); 

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

20 notices required by subsection (d); or 

21 ‘‘(iv) if the person fails to comply with 

22 the reporting requirements applicable to 

23 the person under a State prescription drug 

24 monitoring program established with a 
14

•HR 3870 IH 

1 grant under section 399O of the Public 

2 Health Service Act; or 

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

4 illegal Internet pharmacy in interstate com5 merce. 

6 ‘‘(2) EXCEPTION.—Any person who sells a pre7 scription drug through an Internet site, or who owns 

8 or operates an Internet pharmacy, is deemed to meet 

9 the requirements of this section for purposes of such 

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

11 Internet pharmacy is certified by the National Asso12 ciation of Boards of Pharmacy’s Verified Internet 

13 Pharmacy Practice Sites program. 

14 ‘‘(b) INTERNET PHARMACY REQUIREMENTS.—

15 ‘‘(1) IN GENERAL.—For purposes of this sec16 tion: 

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

18 an Internet site that is used primarily to sell 

19 prescription drugs in interstate commerce. 

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

21 means an Internet pharmacy that fails to com22 ply with this subsection. 

23 ‘‘(2) REQUIREMENTS.—An Internet pharmacy 

24 shall provide to any individual who accesses the 

25 pharmacy the following information: 
15

•HR 3870 IH 

1 ‘‘(A) The street address and telephone 

2 number of—

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

4 business; and 

5 ‘‘(ii) the Internet pharmacy’s super6 vising pharmacist. 

7 ‘‘(B) All States in which the Internet phar8 macy is licensed or otherwise authorized to dis9 pense prescription drugs. 

10 ‘‘(C) If the Internet pharmacy makes re11 ferrals to, or solicits on behalf of, a practitioner 

12 or a group of practitioners for prescription serv13 ices—

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

15 telephone number of such practitioner or 

16 group; and 

17 ‘‘(ii) each State in which each practi18 tioner involved is licensed or otherwise au19 thorized to prescribe drugs. 

20 ‘‘(D) A statement that the Internet phar21 macy will dispense prescription drugs only upon 

22 a showing of a prescription. 

23 ‘‘(c) TREATING PROVIDER VERIFICATION REQUIRE24 MENTS.—The treating provider verification requirements 

25 of this subsection are as follows: 
16

•HR 3870 IH 

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

2 person may sell a prescription drug in interstate 

3 commerce through an Internet site only if—

4 ‘‘(A) the sale is in accordance with a pre5 scription of the treating provider of the patient 

6 involved; 

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

8 accordance with paragraph (3); 

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

10 communications in accordance with paragraph 

11 (4); and 

12 ‘‘(D) the seller complies with the prohibi13 tion of paragraph (5) against alteration of the 

14 prescription. 

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

16 verification requirements of this subsection apply 

17 with respect to a prescription drug only if—

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

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

20 Controlled Substances Act; or 

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

22 section identifies the prescription drug as po23 tentially subject to abuse, diversion, and mis24 use. 

25 ‘‘(3) VERIFICATION REQUIREMENT.—
17

•HR 3870 IH 

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

2 prescription in accordance with this paragraph 

3 if—

4 ‘‘(i) the patient involved or the pa5 tient’s treating provider presents the pre6 scription, directly or by facsimile or elec7 tronic mail, to the seller; or 

8 ‘‘(ii) the seller verifies the prescription 

9 by direct communication with the treating 

10 provider involved. 

11 ‘‘(B) INFORMATION.—When seeking 

12 verification of a prescription under subpara13 graph (A)(ii), a seller shall provide to the treat14 ing provider the following information: 

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

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

17 national drug code number. 

18 ‘‘(iii) Quantity to be dispensed. 

19 ‘‘(iv) Date of patient request. 

20 ‘‘(v) Date and time of verification re21 quest. 

22 ‘‘(vi) Name of contact person at sell23 er’s company, including facsimile and tele24 phone number. 
18

•HR 3870 IH 

1 ‘‘(C) VERIFICATION EVENTS.—A prescrip2 tion is verified under subparagraph (A)(ii) only 

3 if one of the following occurs: 

4 ‘‘(i) The treating provider confirms 

5 the prescription is accurate by direct com6 munication with the seller. 

7 ‘‘(ii) The treating provider informs 

8 the seller that the prescription is inac9 curate and provides the accurate prescrip10 tion. 

11 ‘‘(iii) The treating provider fails to 

12 communicate with the seller within 48 

13 hours, or a similar time as defined by the 

14 Commissioner of Food and Drugs, after 

15 receiving from the seller the information 

16 described in subparagraph (B). 

17 ‘‘(D) INVALID PRESCRIPTION.—If a treat18 ing provider informs a seller before the deadline 

19 under subparagraph (C)(iii) that the prescrip20 tion is inaccurate or expired, the seller shall not 

21 fill the prescription. The treating provider shall 

22 specify the basis for the inaccuracy or invalidity 

23 of the prescription. If the prescription commu24 nicated by the seller to the treating provider is 

25 inaccurate, the treating provider shall correct it. 
19

•HR 3870 IH 

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

2 maintain a record of all direct communications with 

3 a treating provider regarding the sale of a prescrip4 tion drug, including verification of the prescription 

5 involved. 

6 ‘‘(5) NO ALTERATION.—A seller may not alter 

7 a prescription for a prescription drug. Notwith8 standing the preceding sentence, if the same pre9 scription drug is manufactured by the same com10 pany and sold under multiple labels to individual 

11 providers, the seller may fill the prescription with a 

12 prescription drug manufactured by that company 

13 under another label. 

14 ‘‘(6) DEFINITIONS.—In this subsection: 

15 ‘‘(A) The term ‘direct communication’ in16 cludes communication by telephone, facsimile, 

17 or electronic mail. 

18 ‘‘(B) The term ‘seller’ means a person that 

19 sells a prescription drug in interstate commerce 

20 through an Internet site. 

21 ‘‘(C) The term ‘treating provider’ means—

22 ‘‘(i) a health care provider who has 

23 performed a documented patient evaluation 

24 of the individual involved (including a pa25 tient history and physical examination) to 
20

•HR 3870 IH 

1 establish the diagnosis for which the pre2 scription drug involved is prescribed, has 

3 discussed with the individual his or her 

4 treatment options and the risks and bene5 fits of treatment, and maintains contem6 poraneous medical records on the indi7 vidual; 

8 ‘‘(ii) a health care provider who is 

9 providing care in consultation with a 

10 health care provider described in clause (i) 

11 and who has access to the medical records 

12 of the patient involved; or 

13 ‘‘(iii) a health care provider who is 

14 providing care as part of an on-call or 

15 cross-coverage arrangement with a health 

16 care provider described in clause (i). 

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

18 sells a prescription drug in interstate commerce through 

19 an Internet site shall provide to each State authority that 

20 licenses or otherwise authorizes the person to dispense the 

21 prescription drug the following information: 

22 ‘‘(1) A statement that the person is selling pre23 scription drugs through an Internet site. 
21

•HR 3870 IH 

1 ‘‘(2) The name, Internet address, street ad2 dress, and telephone number of the person’s busi3 ness for selling such drugs. 

4 ‘‘(e) DEFINITION.—In this section, the term ‘pre5 scription drug’ means a drug subject to section 503(b).’’. 

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

7 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 331) is amended by inserting after paragraph (k) the fol9 lowing: 

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

11 or operation of an illegal Internet pharmacy, in violation 

12 of section 503B.’’. 

13 (c) LINKS TO ILLEGAL INTERNET PHARMACY.—Sec14 tion 302 of the Federal Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 332) is amended by adding at the end the fol16 lowing: 

17 ‘‘(c) In the case of a violation of section 503B relat18 ing to an illegal Internet pharmacy, the district courts of 

19 the United States and the United States courts of the Ter20 ritories shall have jurisdiction to order a provider of an 

21 interactive computer service to remove, or disable access 

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

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

24 provider controls or operates. Such relief shall—
22

•HR 3870 IH 

1 ‘‘(1) be available only after provision to the pro2 vider of notice and an opportunity to appear; 

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

4 to monitor its service or to affirmatively seek facts 

5 indicating activity violating section 503B; 

6 ‘‘(3) specify the provider to which the relief ap7 plies; and 

8 ‘‘(4) specifically identify the location of the site 

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

10 disabled.’’. 

11 SEC. 4. DISTRIBUTION AND LABELING OF DRUGS. 

12 (a) DRUG PEDIGREE AMENDMENTS.—Paragraph (1) 

13 of section 503(e) of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 353(e)) is amended—

15 (1) in subparagraph (A), by striking ‘‘Each per16 son who is engaged in the wholesale distribution of 

17 a drug subject to subsection (b) and who is not the 

18 manufacturer or an authorized distributor of record 

19 of such drug shall’’ and inserting ‘‘Subject to sub20 paragraph (C), each person who is engaged in the 

21 wholesale distribution of a drug subject to subsection 

22 (b) shall’’; and 

23 (2) by adding after subparagraph (B) the fol24 lowing: 
23

•HR 3870 IH 

1 ‘‘(C) Subparagraph (A) applies to the manufacturer 

2 of a drug or the authorized distributor of record of a drug 

3 only if—

4 ‘‘(i) the drug is included in schedule II of sec5 tion 202(c) of the Controlled Substances Act; or 

6 ‘‘(ii) the Secretary designates the drug for pur7 poses of this subparagraph, taking into consideration 

8 the impact to public health that would result from 

9 counterfeiting or diversion of the drug, the price of 

10 the drug, the volume of the drug, the dosage form 

11 of the drug, the clinical uses of the drug, the history 

12 of counterfeiting or diversion of the drug, and 

13 whether products similar to the drug have a history 

14 of counterfeiting or diversion.’’. 

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

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

17 U.S.C. 351 et seq.) (as amended by section 3) is amend18 ed—

19 (1) in section 502, by adding at the end the fol20 lowing: 

21 ‘‘(w) If it is a drug with respect to which the manu22 facturer, importer, distributor, or retailer fails to comply 

23 with the chain-of-custody requirements of section 503C.’’; 

24 and 
24

•HR 3870 IH 

1 (2) by inserting after section 503B the fol2 lowing: 

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

4 ‘‘(a) IN GENERAL.—Not later than January 1, 2006, 

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). 
25

•HR 3870 IH 

1 ‘‘(e) EFFECTIVE DATE.—The chain-of-custody re2 quirements promulgated by the Secretary under this sec3 tion shall take effect on January 1, 2008.’’. 

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. 5. 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 import 

17 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.’’. 
26

•HR 3870 IH 

1 SEC. 6. 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. 

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

22 group on pharmaceutical counterfeiting shall consider the 

23 following: 

24 (1) How to enhance supply-chain security. 

25 (2) Consumer education on counterfeiting 

26 issues. 
27

•HR 3870 IH 

1 (3) Employing technology designed to frustrate 

2 organized and sophisticated criminals intent on com3 promising the world’s drug supply. 

4 (4) How industry could assist law enforcement 

5 by analyzing suspected counterfeit drugs to deter6 mine authenticity. 

7 (5) How industry can collaborate on issues re8 lated to pharmaceutical counterfeiting without re9 vealing trade secrets or other confidential informa10 tion. 

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

12 of the enactment of this Act, the working group shall sub13 mit a report to the Congress on the results of the study 

14 conducted under this section, including recommendations 

15 on measures to reduce or eliminate problems associated 

16 with pharmaceutical counterfeiting. 

17 SEC. 7. BASELINE RESEARCH ON PRESCRIPTION DRUG 

18 ABUSE. 

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

20 Human Services shall conduct research on issues related 

21 to prescription drug abuse, including the following: 

22 (1) Enhancing existing public use surveys and 

23 other sources so as to provide appropriate baseline 

24 data and data on the natural history and context of 

25 prescription drug use in order to evaluate the extent 
28

•HR 3870 IH 

1 and nature of potential problems and guide correc2 tive actions which reduce the problems without unin3 tentionally hindering patient access. 

4 (2) The phenomenon of iatrogenic addiction, in5 cluding the actual incidence and prevalence of iatro6 genic addiction, the factors that modulate the risk of 

7 such addiction, and the extent to which concern 

8 about iatrogenic addiction impacts health care deliv9 ery. 

10 (3) Development of postapproval surveillance 

11 approaches that can detect and address potential 

12 risks of abuse and misuse, including risks in diverse 

13 patient populations that did not previously appear at 

14 risk for diversion or abuse, and in geographic re15 gions that have been relatively absent from risk. 

16 (4) Methods to better translate new ideas about 

17 terminology, diagnosis, and management of addic18 tion diseases into clinical practice at the primary 

19 care and specialist levels. 

20 (5) Reliable, useful assessment tools for addic21 tion in the clinical setting of initial and ongoing 

22 treatment of conditions requiring the use of con23 trolled substances. 

24 (6) Development of better methods of ensuring 

25 patient adherence to prescribed drug regimens. 
29

•HR 3870 IH 

1 (7) Relative contributions of genetic, psycho2 social, environmental, and behavioral factors to ad3 diction to prescription opioids. 

4 (b) REPORT.—Not later than 2 years after the date 

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

6 Human Services shall submit to the Congress a report on 

7 the results of the research conducted under this section. 

8 SEC. 8. DATABASE FOR DRUG ABUSE MORTALITY REPORT9 ING. 

10 Section 505 of the Public Health Service Act (42 

11 U.S.C. 290aa–4) is amended—

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

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

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

15 ‘‘(e) With respect to the activities of the Adminis16 trator under subsections (a) and (c)(1)(B) relating to the 

17 collection of data on the number of deaths occurring as 

18 a result of substance abuse, the Administrator—

19 ‘‘(1) shall expand and intensify collection activi20 ties to maintain a comprehensive, national database 

21 on such deaths; and 

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

23 and other appropriate persons to report to the Ad-
30

•HR 3870 IH 

1 ministrator for purposes of collecting data on such 

2 deaths.’’

Æ