I 

108TH CONGRESS 

1ST SESSION H. R. 2717

To amend the Federal Food, Drug, and Cosmetic Act to establish a program 

to provide for the voluntary certification of Internet and mail-order 

pharmacies, to amend such Act to authorize, subject to certain conditions, 

the importation by individuals of prescription drugs from Canada for 

personal use, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 14, 2003

Mr. BROWN of Ohio (for himself, Mr. STARK, and Mr. HINCHEY) introduced 

the following bill; which was referred to the Committee on Energy and 

Commerce 

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to 

establish a program to provide for the voluntary certification of Internet and mail-order pharmacies, to amend 

such Act to authorize, subject to certain conditions, the 

importation by individuals of prescription drugs from 

Canada 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 ‘‘Affordable Medicine 

3 Safety and Access Act’’. 

4 TITLE I—INTERNET AND MAIL5 ORDER PHARMACIES 

6 SEC. 101. VOLUNTARY CERTIFICATIONS REGARDING 

7 INTERNET AND MAIL-ORDER PHARMACIES. 

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

9 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend10 ed by inserting after section 503A the following section: 

11 ‘‘SEC. 503B. VOLUNTARY CERTIFICATIONS REGARDING 

12 INTERNET AND MAIL-ORDER PHARMACIES. 

13 ‘‘(a) IN GENERAL.—The Secretary, directly or 

14 through contract with one or more public or nonprofit pri15 vate entities, shall establish a program under which Inter16 net and mail-order pharmacies, on a voluntary basis, are 

17 certified by the Secretary as meeting the requirements of 

18 this section for certification. 

19 ‘‘(b) SEAL.—The Secretary shall provide for a seal 

20 that Internet and mail-order pharmacies certified under 

21 subsection (a) are authorized to display for purposes of 

22 indicating to the public the fact of such certification. 

23 ‘‘(c) CONDITIONS FOR CERTIFICATION.—As a condi24 tion of certifying an Internet or mail-order pharmacy 

25 under subsection (a), the Secretary shall require the fol26 lowing with respect to such pharmacy: 
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1 ‘‘(1) Verification that, in each State in which 

2 the pharmacy engages in pharmaceutical activities, 

3 the pharmacy, and all the employees and agents of 

4 the pharmacy, are in compliance with applicable 

5 laws regarding—

6 ‘‘(A) the practice of pharmacy, including 

7 licensing laws; and 

8 ‘‘(B) the manufacturing and distribution of 

9 controlled substances, including with respect to 

10 mailing or shipping such substances to con11 sumers. 

12 ‘‘(2) Controls to ensure that a prescription drug 

13 is dispensed by the pharmacy only pursuant to a 

14 valid prescription, including circumstance in which 

15 the drug is shipped or mailed from a country under 

16 whose laws the drug is not a prescription drug. 

17 ‘‘(3) The prominent display of contact informa18 tion for the pharmacy, including a telephone num19 ber, an electronic mail address, a mailing address, 

20 and (if different from the mailing address) the ad21 dress for the physical location of the principal place 

22 of business of the pharmacy. 

23 ‘‘(4) The prominent display of complete and ac24 curate information concerning the ownership and 
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1 management of the pharmacy, including addresses 

2 and contact information. 

3 ‘‘(5) A certification from the person who owns 

4 or manages the pharmacy that a certification under 

5 subsection (a) for the pharmacy has not previously 

6 been terminated by the Secretary, and that no other 

7 Internet or mail-order pharmacy owned or managed 

8 by such person has received a certification under 

9 subsection (a) that has been terminated by the Sec10 retary. 

11 ‘‘(6) An agreement by the pharmacy that, upon 

12 certification under subsection (a), the facilities and 

13 business practices of the pharmacy will be subject to 

14 inspection by the Secretary to the extent appropriate 

15 to determine whether the pharmacy is in compliance 

16 with conditions under this subsection. 

17 ‘‘(7) Meaningful and accessible opportunities 

18 for a consumer to consult with a licensed pharmacist 

19 regarding a drug prior to the time at which the 

20 pharmacy dispenses the drug to the consumer. 

21 ‘‘(8) Controls to ensure that, prior to dis22 pensing a drug to a consumer, a prospective review 

23 of the use of the drug by the consumer is completed, 

24 based on accurate information about the consumer 
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1 and the medication profiles of the consumer and 

2 other pertinent medical information. 

3 ‘‘(9) Effective, accessible systems for commu4 nication with consumers, including systems for con5 sumer reporting of adverse drug reactions and er6 rors, systems by which consumers can effectively 

7 track and report problems with unfulfilled orders, 

8 systems for the investigation and redress of con9 sumer complaints, and systems facilitating effective 

10 communication between the pharmacy and con11 sumers concerning drug recalls. 

12 ‘‘(10) Controls to ensure the protection of pa13 tient privacy and confidentiality, including but not 

14 limited to the prevention of unauthorized internal 

15 and external use of personally-identifiable patient in16 formation. 

17 ‘‘(11) An agreement by the pharmacy that the 

18 pharmacy will notify the Secretary within 10 days 

19 concerning any change in information submitted 

20 under this subsection as a condition of certification 

21 under subsection (a). 

22 ‘‘(12) Such additional criteria as the Secretary 

23 determines, after notice and opportunity for com24 ment, to be appropriate for the sound operation of 

25 certified pharmacies or the protection of consumers.
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1 ‘‘(d) ANNUAL APPLICATION; DURATION OF CERTIFI2 CATION.—

3 ‘‘(1) IN GENERAL.—The Secretary may certify 

4 an Internet or mail-order pharmacy under sub5 section (a) only if the pharmacy submits to the Sec6 retary an application for such certification that dem7 onstrates compliance with the conditions under sub8 section (c) and is in such form, and is made in such 

9 manner, as the Secretary may require. The Sec10 retary shall establish an application form for pur11 poses of the preceding sentence, including an elec12 tronic application form. 

13 ‘‘(2) DURATION OF CERTIFICATION; RE14 NEWAL.—

15 ‘‘(A) IN GENERAL.—A certification under 

16 subsection (a) is effective for the one-year pe17 riod beginning on the date on which the appli18 cation under paragraph (1) for such certifi19 cation is approved by the Secretary. The Sec20 retary may renew the certification, pursuant to 

21 the submission of an additional application 

22 under paragraph (1), and the number of renew23 als of the certification is not limited. The Sec24 retary may establish an abbreviated process for 

25 such renewal applications. 
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1 ‘‘(B) RENEWAL EVALUATION.—Before re2 newing a certification under subsection (a), the 

3 Secretary shall conduct an evaluation to deter4 mine whether the pharmacy involved is in com5 pliance with the conditions under subsection 

6 (c). The evaluation, at the Secretary’s discre7 tion and as applicable, may include testing of 

8 the Internet site of the pharmacy or other sys9 tems through which the pharmacy commu10 nicates with consumers, and may include phys11 ical inspection of the records and premises of 

12 the pharmacy pursuant to subsection (c)(6). 

13 ‘‘(e) FEES.—The Secretary may impose a fee on the 

14 submission of an application under subsection (d). Any 

15 such fee is due upon the submission of the application. 

16 To the extent provided in appropriations Acts, such fees 

17 are available to the Secretary for carrying out this section. 

18 ‘‘(f) INFORMATION CAMPAIGN.—The Secretary shall 

19 carry out activities to inform the public of the program 

20 under subsection (a), including information on the signifi21 cance of the seal under subsection (b) when displayed by 

22 an Internet or mail-order pharmacy, and including infor23 mation on the benefits of doing business with a pharmacy 

24 certified under subsection (a) as compared to a pharmacy 

25 that is not so certified. 
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1 ‘‘(g) TERMINATION OF CERTIFICATION.—The Sec2 retary, upon the own initiative of the Secretary or a peti3 tion by an interested person, may terminate a certification 

4 under subsection (a), after notice to the Internet or mail5 order pharmacy involved and an opportunity for a hearing. 

6 ‘‘(h) CONTRACT FOR OPERATION OF PROGRAM.—

7 ‘‘(1) DETERMINATION REGARDING USE OF CON8 TRACT AUTHORITY.—The Secretary may award a 

9 contract under subsection (a) for the operation of 

10 the program under such subsection only if the Sec11 retary determines that the administration by the 

12 contractor of such program would be as protective or 

13 more protective of the public than direct administra14 tion of the program by the Secretary. 

15 ‘‘(2) CERTAIN REQUIREMENTS.—With respect 

16 to a contract under subsection (a): 

17 ‘‘(A) The duration of the contract may not 

18 exceed two years. 

19 ‘‘(B) The Secretary may renew the con20 tract, subject to compliance with subparagraph 

21 (A). 

22 ‘‘(C) The Secretary shall annually review 

23 performance under the contract. 
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1 ‘‘(D) The contract shall specify that the 

2 Secretary may terminate the contract for unsat3 isfactory performance under the contract. 

4 ‘‘(i) DEFINITIONS.—For purposes of this section: 

5 ‘‘(1) The term ‘Internet pharmacy’ means a 

6 pharmacy that, by shipping, mailing, or transporting 

7 a prescription drug, dispenses such drug pursuant to 

8 a sale of the drug by the pharmacy in circumstances 

9 in which the purchaser of the drug submitted the 

10 purchase order for the drug, or conducted any other 

11 part of the sales transaction for the drug, through 

12 an Internet site. 

13 ‘‘(2) The term ‘mail-order pharmacy’ means a 

14 pharmacy that, by shipping, mailing, or transporting 

15 a prescription drug, dispenses such drug pursuant to 

16 a sale of the drug by the pharmacy in circumstances 

17 in which the purchaser of the drug submitted the 

18 purchase order for the drug, or conducted any other 

19 part of the sales transaction for the drug, through 

20 the mail or through any telecommunications means 

21 other than an Internet site. 

22 ‘‘(3)(A) Subject to subparagraph (B), the term 

23 ‘pharmacy’ means an organization licensed by a 

24 State to practice pharmacy, including the dispensing 

25 and selling of prescription drugs. 
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1 ‘‘(B) The Secretary shall consider an organiza2 tion as meeting the definition established in sub3 paragraph (A) if the Secretary determines that the 

4 organization would qualify for licensure in at least 

5 one of the States but for a policy of such State that 

6 denies licensure as a pharmacy on the basis that the 

7 organization dispenses prescription drugs from loca8 tions in Canada or dispenses prescription drugs ob9 tained by such organization from an entity in Can10 ada. 

11 ‘‘(4) The term ‘prescription drug’ means a drug 

12 subject to section 503(b).’’. 

13 (b) UNAUTHORIZED DISPLAY OF SEAL; FALSE

14 CLAIMS.—Section 301 of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 331) is amended by adding at 

16 the end the following: 

17 ‘‘(hh) The display by an Internet or mail-order phar18 macy of the seal under section 503B without a certifi19 cation in effect under such section for the pharmacy, or 

20 the making by such a pharmacy of a false claim that such 

21 a certification is in effect for the pharmacy.’’.
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1 TITLE II—PERSONAL IMPORTA2 TION OF PRESCRIPTION 

3 DRUGS FROM CANADA 

4 Subtitle A—Waiver Requirement 

5 SEC. 201. WAIVER REQUIREMENT FOR PERSONAL IMPOR6 TATION OF PRESCRIPTION DRUGS FROM 

7 CANADA. 

8 Chapter VIII of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 381 et seq.) is amended by adding 

10 at the end the following section: 

11 ‘‘WAIVER REQUIREMENT FOR PERSONAL IMPORTATION

12 OF PRESCRIPTION DRUGS FROM CANADA

13 ‘‘SEC. 805. With respect to the importation by indi14 viduals of prescription drugs from Canada, the Secretary 

15 shall in accordance with this section establish by regula16 tion a waiver of prohibitions under this Act that apply to 

17 the importation of drugs. Such a waiver shall permit an 

18 individual to import into the United States any prescrip19 tion drug that—

20 ‘‘(1) is imported from Canada for personal use 

21 by the individual (not for resale); 

22 ‘‘(2) is approved by the Secretary under section 

23 505, is manufactured in an establishment registered 

24 with the Secretary under section 510, and is not a 
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1 controlled substance in schedule I, II, or III under 

2 section 202(c) of the Controlled Substances Act; 

3 ‘‘(3) is imported from a Canadian pharmacy 

4 that has submitted to the Secretary a registration 

5 that identifies the pharmacy and provides docu6 mentation that the pharmacy is licensed in Canada; 

7 ‘‘(4) is imported in a quantity that does not 

8 (for that instance of importation) exceed a 90-day 

9 supply; 

10 ‘‘(5) at the time of importation, is accompanied 

11 by a copy of a valid prescription for the drug for the 

12 individual, issued in the United States by a practi13 tioner in accordance with section 503(b), or is ac14 companied by documentation that verifies the 

15 issuance of such a prescription for the individual; 

16 ‘‘(6) is in the form of a final finished dosage; 

17 and 

18 ‘‘(7) is imported under such other conditions as 

19 the Secretary determines to be necessary to ensure 

20 public safety.’’. 

21 Subtitle B—Studies 

22 SEC. 211. STUDY REGARDING IN-PERSON PERSONAL IM23 PORTATION FROM CANADA. 

24 (a) IN GENERAL.—The Secretary of Health and 

25 Human Services (referred to in this subtitle as the ‘‘Sec-
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1 retary’’), acting through the Commissioner of Food and 

2 Drugs, shall conduct a study for the purpose of developing 

3 recommendations regarding any legislative or administra4 tive changes that may be necessary to provide reasonable 

5 assurance concerning the safety and effectiveness of pre6 scription drugs that are purchased in-person at a licensed 

7 pharmacy in Canada and imported from Canada into the 

8 United States for personal use by individuals who are not 

9 in the business of importing such drugs (referred to in 

10 this section with respect to such drugs as ‘‘in-person per11 sonal importation’’). Not later than 18 months after the 

12 date of the enactment of this Act, the Secretary shall sub13 mit to the Congress a report describing the findings of 

14 such study. 

15 (b) CERTAIN REQUIREMENTS.—The activities of the 

16 Secretary in carrying out the study under subsection (a) 

17 shall include the following: 

18 (1) With respect to prescription drugs that are 

19 commonly purchased from Canadian pharmacies for 

20 in-person personal importation, the purchase of a 

21 representative sample of such drugs at randomly-se22 lected Canadian pharmacies that are representative 

23 of Canadian pharmacies from which prescription 

24 drugs are purchased for personal importation. 
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1 (2) Determining, for purposes of laws and regu2 lations administered by the Food and Drug Adminis3 tration, the safety and effectiveness of the prescrip4 tion drugs that are purchased under paragraph (1). 

5 (3) Making a comparison of laws and regula6 tions referred to in paragraph (2) with the Canadian 

7 system for the regulation of the safety and effective8 ness of prescription drugs. 

9 (c) ADVISORY BOARD.—The Secretary shall establish 

10 an advisory board for the purpose of providing advice to 

11 the Secretary regarding the design of the study under sub12 section (a) and regarding the development of recommenda13 tions in the study. The membership of the advisory board 

14 shall include representatives of the Directorate of Border 

15 and Transportation Security (Department of Homeland 

16 Security); the comparable agency or agencies of the Cana17 dian government; health officials of State and local gov18 ernments; pharmacists in the United States; and physi19 cians and patients in the United States. 

20 SEC. 212. STUDY REGARDING INTERNET AND MAIL-ORDER 

21 PHARMACIES CLAIMING CANADIAN SOURCES 

22 FOR PRESCRIPTION DRUGS. 

23 With respect to prescription drugs that are commonly 

24 prescribed in the United States, the Secretary, acting 
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1 through the Commissioner of Food and Drugs, shall con2 duct a study through which the Secretary—

3 (1) makes purchases of such drugs from Inter4 net pharmacies and mail-order pharmacies that 

5 make sales to consumers in the United States and 

6 claim such drugs are obtained from Canadian phar7 macies or wholesalers, which purchases are a rep8 resentative sample of such drugs purchased from 

9 such pharmacies; and 

10 (2) determines whether the drugs purchased 

11 under paragraph (1) are approved for commercial 

12 distribution in Canada and are obtained from Cana13 dian pharmacies or wholesalers. 

14 The Secretary shall seek the cooperation of the Govern15 ment of Canada in making the determination under para16 graph (2). Not later than 18 months after the date of the 

17 enactment of this Act, the Secretary shall submit to the 

18 Congress a report describing the findings of such study.

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