I 

108TH CONGRESS 

1ST SESSION H. R. 2497

To permit commercial importation of prescription drugs from Canada, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 17, 2003

Mr. SANDERS (for himself, Mr. BROWN of Ohio, Mr. OLVER, Mrs. 

NAPOLITANO, Mr. SERRANO, Ms. LEE, Ms. CORRINE BROWN of Florida, 

Mr. MURTHA, Mr. HOLDEN, Mr. PALLONE, Mr. PAUL, Mr. LANTOS, Mr. 

FILNER, Mr. FROST, Ms. BALDWIN, Mr. FRANK of Massachusetts, Mr. 

CONYERS, Mr. HINCHEY, Mr. TIERNEY, Mr. ABERCROMBIE, Mr. WYNN, 

Ms. SLAUGHTER, Mr. NADLER, Ms. NORTON, Mr. COSTELLO, Mr. 

OWENS, Mr. CROWLEY, Mr. KLECZKA, Mr. KUCINICH, Mr. CASE, Mr. 

DEFAZIO, Ms. WOOLSEY, and Mr. DAVIS of Illinois) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL

To permit commercial importation of prescription drugs from 

Canada, 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,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prescription Drug Par5 ity for Americans Act’’. 
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1 SEC. 2. IMPORTATION OF PRESCRIPTION DRUGS. 

2 (a) IN GENERAL.—Chapter VIII of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 

4 is amended by striking section 804 and inserting the fol5 lowing: 

6 ‘‘SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS. 

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

8 ‘‘(1) IMPORTER.—The term ‘importer’ means a 

9 pharmacist or wholesaler. 

10 ‘‘(2) PHARMACIST.—The term ‘pharmacist’ 

11 means a person licensed by a State to practice phar12 macy, including the dispensing and selling of pre13 scription drugs. 

14 ‘‘(3) PRESCRIPTION DRUG.—The term ‘pre15 scription drug’ means a drug subject to section 

16 503(b), other than—

17 ‘‘(A) a controlled substance (as defined in 

18 section 102 of the Controlled Substances Act 

19 (21 U.S.C. 802)); 

20 ‘‘(B) a biological product (as defined in 

21 section 351 of the Public Health Service Act 

22 (42 U.S.C. 262)); 

23 ‘‘(C) an infused drug (including a peri24 toneal dialysis solution); 

25 ‘‘(D) an intravenously injected drug; or 

26 ‘‘(E) a drug that is inhaled during surgery. 
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1 ‘‘(4) QUALIFYING LABORATORY.—The term 

2 ‘qualifying laboratory’ means a laboratory in the 

3 United States that has been approved by the Sec4 retary for the purposes of this section. 

5 ‘‘(5) WHOLESALER.—

6 ‘‘(A) IN GENERAL.—The term ‘wholesaler’ 

7 means a person licensed as a wholesaler or dis8 tributor of prescription drugs in the United 

9 States under section 503(e)(2)(A). 

10 ‘‘(B) EXCLUSION.—The term ‘wholesaler’ 

11 does not include a person authorized to import 

12 drugs under section 801(d)(1). 

13 ‘‘(b) REGULATIONS.—The Secretary, after consulta14 tion with the United States Trade Representative and the 

15 Commissioner of Customs, shall promulgate regulations 

16 permitting pharmacists and wholesalers to import pre17 scription drugs from Canada into the United States. 

18 ‘‘(c) LIMITATION.—The regulations under subsection 

19 (b) shall—

20 ‘‘(1) require that safeguards be in place to en21 sure that each prescription drug imported under the 

22 regulations complies with section 505 (including 

23 with respect to being safe and effective for the in24 tended use of the prescription drug), with sections 
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1 501 and 502, and with other applicable require2 ments of this Act; 

3 ‘‘(2) require that an importer of a prescription 

4 drug under the regulations comply with subsections 

5 (d)(1) and (e); and 

6 ‘‘(3) contain any additional provisions deter7 mined by the Secretary to be appropriate as a safe8 guard to protect the public health or as a means to 

9 facilitate the importation of prescription drugs. 

10 ‘‘(d) INFORMATION AND RECORDS.—

11 ‘‘(1) IN GENERAL.—The regulations under sub12 section (b) shall require an importer of a prescrip13 tion drug under subsection (b) to submit to the Sec14 retary the following information and documentation: 

15 ‘‘(A) The name and quantity of the active 

16 ingredient of the prescription drug. 

17 ‘‘(B) A description of the dosage form of 

18 the prescription drug. 

19 ‘‘(C) The date on which the prescription 

20 drug is shipped. 

21 ‘‘(D) The quantity of the prescription drug 

22 that is shipped. 

23 ‘‘(E) The point of origin and destination of 

24 the prescription drug. 
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1 ‘‘(F) The price paid by the importer for 

2 the prescription drug. 

3 ‘‘(G) Documentation from the foreign sell4 er specifying—

5 ‘‘(i) the original source of the pre6 scription drug; and 

7 ‘‘(ii) the quantity of each lot of the 

8 prescription drug originally received by the 

9 seller from that source. 

10 ‘‘(H) The lot or control number assigned 

11 to the prescription drug by the manufacturer of 

12 the prescription drug. 

13 ‘‘(I) The name, address, telephone number, 

14 and professional license number (if any) of the 

15 importer. 

16 ‘‘(J)(i) In the case of a prescription drug 

17 that is shipped directly from the first foreign 

18 recipient of the prescription drug from the 

19 manufacturer: 

20 ‘‘(I) Documentation demonstrating 

21 that the prescription drug was received by 

22 the recipient from the manufacturer and 

23 subsequently shipped by the first foreign 

24 recipient to the importer. 
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1 ‘‘(II) Documentation of the quantity 

2 of each lot of the prescription drug re3 ceived by the first foreign recipient dem4 onstrating that the quantity being im5 ported into the United States is not more 

6 than the quantity that was received by the 

7 first foreign recipient. 

8 ‘‘(III)(aa) In the case of an initial im9 ported shipment, documentation dem10 onstrating that each batch of the prescrip11 tion drug in the shipment was statistically 

12 sampled and tested for authenticity and 

13 degradation. 

14 ‘‘(bb) In the case of any subsequent 

15 shipment, documentation demonstrating 

16 that a statistically valid sample of the ship17 ment was tested for authenticity and deg18 radation. 

19 ‘‘(ii) In the case of a prescription drug 

20 that is not shipped directly from the first for21 eign recipient of the prescription drug from the 

22 manufacturer, documentation demonstrating 

23 that each batch in each shipment offered for 

24 importation into the United States was statis-
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1 tically sampled and tested for authenticity and 

2 degradation. 

3 ‘‘(K) Certification from the importer or 

4 manufacturer of the prescription drug that the 

5 prescription drug—

6 ‘‘(i) is approved for marketing in the 

7 United States; and 

8 ‘‘(ii) meets all labeling requirements 

9 under this Act. 

10 ‘‘(L) Laboratory records, including com11 plete data derived from all tests necessary to 

12 ensure that the prescription drug is in compli13 ance with established specifications and stand14 ards. 

15 ‘‘(M) Documentation demonstrating that 

16 the testing required by subparagraphs (J) and 

17 (L) was conducted at a qualifying laboratory. 

18 ‘‘(N) Any other information that the Sec19 retary determines is necessary to ensure the 

20 protection of the public health. 

21 ‘‘(2) MAINTENANCE BY THE SECRETARY.—The 

22 Secretary shall maintain information and docu23 mentation submitted under paragraph (1) for such 

24 period of time as the Secretary determines to be nec25 essary. 
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1 ‘‘(e) TESTING.—The regulations under subsection (b) 

2 shall require—

3 ‘‘(1) that testing described in subparagraphs 

4 (J) and (L) of subsection (d)(1) be conducted by the 

5 importer or by the manufacturer of the prescription 

6 drug at a qualified laboratory; 

7 ‘‘(2) if the tests are conducted by the im8 porter—

9 ‘‘(A) that information needed to—

10 ‘‘(i) authenticate the prescription drug 

11 being tested; and 

12 ‘‘(ii) confirm that the labeling of the 

13 prescription drug complies with labeling re14 quirements under this Act; 

15 be supplied by the manufacturer of the pre16 scription drug to the pharmacist or wholesaler; 

17 and 

18 ‘‘(B) that the information supplied under 

19 subparagraph (A) be kept in strict confidence 

20 and used only for purposes of testing or other21 wise complying with this Act; and 

22 ‘‘(3) may include such additional provisions as 

23 the Secretary determines to be appropriate to pro24 vide for the protection of trade secrets and commer-
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1 cial or financial information that is privileged or 

2 confidential. 

3 ‘‘(f) REGISTRATION OF FOREIGN SELLERS.—Any es4 tablishment within Canada engaged in the distribution of 

5 a prescription drug that is imported or offered for impor6 tation into the United States shall register with the Sec7 retary the name and place of business of the establish8 ment. 

9 ‘‘(g) SUSPENSION OF IMPORTATION.—The Secretary 

10 shall require that importations of a specific prescription 

11 drug or importations by a specific importer under sub12 section (b) be immediately suspended on discovery of a 

13 pattern of importation of the prescription drugs or by the 

14 importer that is counterfeit or in violation of any require15 ment under this section, until an investigation is com16 pleted and the Secretary determines that the public is ade17 quately protected from counterfeit and violative prescrip18 tion drugs being imported under subsection (b). 

19 ‘‘(h) APPROVED LABELING.—The manufacturer of a 

20 prescription drug shall provide an importer written au21 thorization for the importer to use, at no cost, the ap22 proved labeling for the prescription drug. 

23 ‘‘(i) PROHIBITION OF DISCRIMINATION.—

24 ‘‘(1) IN GENERAL.—It shall be unlawful for a 

25 manufacturer of a prescription drug to discriminate 
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1 against, or cause any other person to discriminate 

2 against, a pharmacist or wholesaler that purchases 

3 or offers to purchase a prescription drug from the 

4 manufacturer or from any person that distributes a 

5 prescription drug manufactured by the drug manu6 facturer. 

7 ‘‘(2) DISCRIMINATION.—For the purposes of 

8 paragraph (1), a manufacturer of a prescription 

9 drug shall be considered to discriminate against a 

10 pharmacist or wholesaler if the manufacturer enters 

11 into a contract for sale of a prescription drug, places 

12 a limit on supply, or employs any other measure, 

13 that has the effect of—

14 ‘‘(A) providing pharmacists or wholesalers 

15 access to prescription drugs on terms or condi16 tions that are less favorable than the terms or 

17 conditions provided to a foreign purchaser 

18 (other than a charitable or humanitarian orga19 nization) of the prescription drug; or 

20 ‘‘(B) restricting the access of pharmacists 

21 or wholesalers to a prescription drug that is 

22 permitted to be imported into the United States 

23 under this section. 

24 ‘‘(j) CHARITABLE CONTRIBUTIONS.—Notwith25 standing any other provision of this section, section 
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1 801(d)(1) continues to apply to a prescription drug that 

2 is donated or otherwise supplied at no charge by the man3 ufacturer of the drug to a charitable or humanitarian or4 ganization (including the United Nations and affiliates) 

5 or to a government of a foreign country. 

6 ‘‘(k) WAIVER AUTHORITY FOR IMPORTATION BY IN7 DIVIDUALS.—

8 ‘‘(1) DECLARATIONS.—Congress declares that 

9 in the enforcement against individuals of the prohi10 bition of importation of prescription drugs and de11 vices, the Secretary should—

12 ‘‘(A) focus enforcement on cases in which 

13 the importation by an individual poses a signifi14 cant threat to public health; and 

15 ‘‘(B) exercise discretion to permit individ16 uals to make such importations in cir17 cumstances in which—

18 ‘‘(i) the importation is clearly for per19 sonal use; and 

20 ‘‘(ii) the prescription drug or device 

21 imported does not appear to present an 

22 unreasonable risk to the individual. 

23 ‘‘(2) WAIVER AUTHORITY.—

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

25 grant to individuals, by regulation or on a case-
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1 by-case basis, a waiver of the prohibition of im2 portation of a prescription drug or device or 

3 class of prescription drugs or devices, under 

4 such conditions as the Secretary determines to 

5 be appropriate. 

6 ‘‘(B) GUIDANCE ON CASE-BY-CASE WAIV7 ERS.—The Secretary shall publish, and update 

8 as necessary, guidance that accurately describes 

9 circumstances in which the Secretary will con10 sistently grant waivers on a case-by-case basis 

11 under subparagraph (A), so that individuals 

12 may know with the greatest practicable degree 

13 of certainty whether a particular importation 

14 for personal use will be permitted. 

15 ‘‘(3) DRUGS IMPORTED FROM CANADA.—In 

16 particular, the Secretary shall by regulation grant 

17 individuals a waiver to permit individuals to import 

18 into the United States a prescription drug that—

19 ‘‘(A) is imported from a licensed pharmacy 

20 for personal use by an individual, not for resale, 

21 in quantities that do not exceed a 90-day sup22 ply; 

23 ‘‘(B) is accompanied by a copy of a valid 

24 prescription; 
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1 ‘‘(C) is imported from Canada, from a sell2 er registered with the Secretary; 

3 ‘‘(D) is a prescription drug approved by 

4 the Secretary under chapter V; 

5 ‘‘(E) is in the form of a final finished dos6 age that was manufactured in an establishment 

7 registered under section 510; and 

8 ‘‘(F) is imported under such other condi9 tions as the Secretary determines to be nec10 essary to ensure public safety. 

11 ‘‘(l) STUDIES; REPORTS.—

12 ‘‘(1) BY THE INSTITUTE OF MEDICINE OF THE

13 NATIONAL ACADEMY OF SCIENCES.—

14 ‘‘(A) STUDY.—

15 ‘‘(i) IN GENERAL.—The Secretary 

16 shall request that the Institute of Medicine 

17 of the National Academy of Sciences con18 duct a study of—

19 ‘‘(I) importations of prescription 

20 drugs made under the regulations 

21 under subsection (b); and 

22 ‘‘(II) information and docu23 mentation submitted under subsection 

24 (d). 
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1 ‘‘(ii) REQUIREMENTS.—In conducting 

2 the study, the Institute of Medicine shall—

3 ‘‘(I) evaluate the compliance of 

4 importers with the regulations under 

5 subsection (b); 

6 ‘‘(II) compare the number of 

7 shipments under the regulations 

8 under subsection (b) during the study 

9 period that are determined to be 

10 counterfeit, misbranded, or adulter11 ated, and compare that number with 

12 the number of shipments made during 

13 the study period within the United 

14 States that are determined to be 

15 counterfeit, misbranded, or adulter16 ated; and 

17 ‘‘(III) consult with the Secretary, 

18 the United States Trade Representa19 tive, and the Commissioner of Patents 

20 and Trademarks to evaluate the effect 

21 of importations under the regulations 

22 under subsection (b) on trade and 

23 patent rights under Federal law. 

24 ‘‘(B) REPORT.—Not later than 2 years 

25 after the effective date of the regulations under 
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1 subsection (b), the Institute of Medicine shall 

2 submit to Congress a report describing the find3 ings of the study under subparagraph (A). 

4 ‘‘(2) BY THE COMPTROLLER GENERAL.—

5 ‘‘(A) STUDY.—The Comptroller General of 

6 the United States shall conduct a study to de7 termine the effect of this section on the price of 

8 prescription drugs sold to consumers at retail. 

9 ‘‘(B) REPORT.—Not later than 18 months 

10 after the effective date of the regulations under 

11 subsection (b), the Comptroller General of the 

12 United States shall submit to Congress a report 

13 describing the findings of the study under sub14 paragraph (A). 

15 ‘‘(m) CONSTRUCTION.—Nothing in this section limits 

16 the authority of the Secretary relating to the importation 

17 of prescription drugs, other than with respect to section 

18 801(d)(1) as provided in this section. 

19 ‘‘(n) AUTHORIZATION OF APPROPRIATIONS.—There 

20 are authorized to be appropriated such sums as are nec21 essary to carry out this section.’’. 

22 (b) CONFORMING AMENDMENTS.—The Federal 

23 Food, Drug, and Cosmetic Act is amended—

24 (1) in section 301(aa) (21 U.S.C. 331(aa)), by 

25 striking ‘‘covered product in violation of section 
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1 804’’ and inserting ‘‘prescription drug in violation of 

2 section 804’’; 

3 (2) in section 303(a)(6) (21 U.S.C. 333(a)(6), 

4 by striking ‘‘covered product pursuant to section 

5 804(a)’’ and inserting ‘‘prescription drug under sec6 tion 804(b)’’.

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