I 

108TH CONGRESS 

1ST SESSION H. R. 2769

To permit commercial importation of prescription drugs from Canada, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 17, 2003

Mrs. EMERSON 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 ‘‘Save Our Seniors Act 

5 of 2003’’. 

6 SEC. 2. IMPORTATION OF PRESCRIPTION DRUGS. 

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

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

9 is amended by striking section 804 and inserting the fol10 lowing: 
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1 ‘‘SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS. 

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

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

4 pharmacist or wholesaler. 

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

6 means a person licensed by a State to practice phar7 macy, including the dispensing and selling of pre8 scription drugs. 

9 ‘‘(3) PRESCRIPTION DRUG.—The term ‘pre10 scription drug’ means a drug subject to section 

11 503(b), other than—

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

13 section 102 of the Controlled Substances Act 

14 (21 U.S.C. 802)); 

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

16 section 351 of the Public Health Service Act 

17 (42 U.S.C. 262)); 

18 ‘‘(C) an infused drug (including a peri19 toneal dialysis solution); 

20 ‘‘(D) an intravenously injected drug; 

21 ‘‘(E) a drug that is inhaled during surgery; 

22 or 

23 ‘‘(F) a drug that is a parenteral drug, the 

24 importation of which pursuant to subsection (b) 

25 is determined by the Secretary to pose a threat 
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1 to the public health, in which case section 

2 801(d)(1) shall continue to apply. 

3 ‘‘(4) QUALIFYING LABORATORY.—The term 

4 ‘qualifying laboratory’ means a laboratory in the 

5 United States that has been approved by the Sec6 retary for the purposes of this section. 

7 ‘‘(5) WHOLESALER.—

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

9 means a person licensed as a wholesaler or dis10 tributor of prescription drugs in the United 

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

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

13 does not include a person authorized to import 

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

15 ‘‘(b) REGULATIONS.—

16 ‘‘(1) IMPORTATION FROM CANADA.—The Sec17 retary shall promulgate regulations permitting phar18 macists and wholesalers to import prescription drugs 

19 from Canada into the United States. 

20 ‘‘(2) IMPORTATION FROM EUROPEAN UNION.—

21 Not sooner than 3 years after the date of the enact22 ment of the Save Our Seniors Act of 2003, if the 

23 Secretary finds that drugs imported from Canada 

24 into the United States under this section have 

25 proved safe and effective, the Secretary may expand 
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1 the application of regulations promulgated under 

2 this section to permit pharmacists and wholesalers 

3 to import prescription drugs from any member of 

4 the European Union into the United States. 

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

6 (b)—

7 ‘‘(1) shall require that safeguards be in place to 

8 ensure that each prescription drug imported under 

9 the regulations complies with section 505 (including 

10 with respect to being safe and effective for the in11 tended use of the prescription drug), with sections 

12 501 and 502, and with other applicable require13 ments of this Act; 

14 ‘‘(2) shall require that an importer of a pre15 scription drug under the regulations comply with 

16 subsections (d)(1) and (e); 

17 ‘‘(3) may require the incorporation of—

18 ‘‘(A) overt optically variable counterfeit re19 sistant packaging technologies that—

20 ‘‘(i) are visible to the naked eye; 

21 ‘‘(ii) are similar to the technologies 

22 used by the Bureau of Engraving and 

23 Printing to secure United States currency; 
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1 ‘‘(iii) are manufactured and distrib2 uted in a highly secure, tightly controlled 

3 environment; and 

4 ‘‘(iv) incorporate any additional visible 

5 and non-visible security features deter6 mined to be appropriate by the Secretary; 

7 or 

8 ‘‘(B) technologies that are determined by 

9 the Secretary to have a function of security 

10 equivalent to such optically variable counterfeit 

11 resistant packaging technologies; and 

12 ‘‘(4) may contain any additional provisions de13 termined by the Secretary to be appropriate as a 

14 safeguard to protect the public health or as a means 

15 to facilitate the importation of prescription drugs. 

16 ‘‘(d) INFORMATION AND RECORDS.—

17 ‘‘(1) IN GENERAL.—The regulations under sub18 section (b) shall require an importer of a prescrip19 tion drug under subsection (b) to submit to the Sec20 retary the following information and documentation: 

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

22 ingredient of the prescription drug. 

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

24 the prescription drug. 
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1 ‘‘(C) The date on which the prescription 

2 drug is shipped. 

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

4 that is shipped. 

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

6 the prescription drug. 

7 ‘‘(F) The price paid by the importer for 

8 the prescription drug. 

9 ‘‘(G) Documentation from the foreign sell10 er specifying—

11 ‘‘(i) the manufacturer or the original 

12 source of the prescription drug; and 

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

14 prescription drug originally received by the 

15 seller from that source. 

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

17 to the prescription drug by the manufacturer of 

18 the prescription drug. 

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

20 and professional license number (if any) of the 

21 importer. 

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

23 that is shipped directly from the first foreign 

24 recipient of the prescription drug from the 

25 manufacturer, documentation demonstrating 
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1 that the prescription drug was received by the 

2 recipient from the manufacturer and subse3 quently shipped by the recipient to the im4 porter. 

5 ‘‘(ii) In the case of any subsequent ship6 ment, documentation identifying each prior 

7 sale, purchase, or trade of the prescription drug 

8 (including the date of the transaction and the 

9 names and addresses of all parties to the trans10 action). 

11 ‘‘(iii) Documentation of the quantity of 

12 each lot of the prescription drug received by the 

13 first foreign recipient demonstrating that the 

14 quantity being imported into the United States 

15 is not more than the quantity that was received 

16 by the first foreign recipient. 

17 ‘‘(iv)(I) In the case of an initial imported 

18 shipment from the recipient involved, docu19 mentation demonstrating that each batch of the 

20 prescription drug in the shipment was statis21 tically sampled and tested for authenticity and 

22 degradation. 

23 ‘‘(II) In the case of any subsequent ship24 ment, documentation demonstrating that a sta-
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1 tistically valid sample of the shipment was test2 ed for authenticity and degradation. 

3 ‘‘(K) Certification from the importer of the 

4 prescription drug that the prescription drug—

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

6 United States; and 

7 ‘‘(ii) meets all labeling requirements 

8 under this Act. 

9 ‘‘(L) Laboratory records, including com10 plete data derived from all tests necessary to 

11 ensure that the prescription drug is in compli12 ance with established specifications and stand13 ards. 

14 ‘‘(M) Documentation demonstrating that 

15 the testing required by subparagraphs (J) and 

16 (L) was conducted at a qualifying laboratory. 

17 ‘‘(N) Any other information that the Sec18 retary determines is necessary to ensure the 

19 protection of the public health. 

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

21 Secretary shall maintain information and docu22 mentation submitted under paragraph (1) for such 

23 period of time as the Secretary determines to be nec24 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 (or within any member of the 

5 European Union with respect to which the Secretary pro6 mulgates regulations under subsection (b)(2)) engaged in 

7 the distribution of a prescription drug that is imported 

8 or offered for importation into the United States shall reg9 ister with the Secretary the name and place of business 

10 of the establishment. 

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

12 shall require that importations of a specific prescription 

13 drug or importations by a specific importer under sub14 section (b) be immediately suspended on discovery of a 

15 pattern of importation of the prescription drugs or by the 

16 importer that is counterfeit or in violation of any require17 ment under this section, until an investigation is com18 pleted and the Secretary determines that the public is ade19 quately protected from counterfeit and violative prescrip20 tion drugs being imported under subsection (b). 

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

22 prescription drug shall provide an importer written au23 thorization for the importer to use, at no cost, the ap24 proved labeling for the prescription drug. 

25 ‘‘(i) OPEN MARKET ACCESS.—
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1 ‘‘(1) IN GENERAL.—It shall be unlawful for a 

2 manufacturer of a prescription drug to discriminate 

3 against, or cause any other person to discriminate 

4 against, a pharmacist or wholesaler that purchases 

5 or offers to purchase a prescription drug from the 

6 manufacturer or from any person that distributes a 

7 prescription drug manufactured by the drug manu8 facturer. 

9 ‘‘(2) APPLICATION.—For the purposes of para10 graph (1), a manufacturer of a prescription drug 

11 shall be considered to discriminate against a phar12 macist or wholesaler if the manufacturer enters into 

13 a contract for sale of a prescription drug, places a 

14 limit on supply, or employs any other measure, that 

15 has the effect of—

16 ‘‘(A) providing pharmacists or wholesalers 

17 access to prescription drugs on terms or condi18 tions that are less favorable than the terms or 

19 conditions provided to a foreign purchaser 

20 (other than a charitable or humanitarian orga21 nization) of the prescription drug; or 

22 ‘‘(B) restricting the access of pharmacists 

23 or wholesalers to a prescription drug that is 

24 permitted to be imported into the United States 

25 under this section. 
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1 ‘‘(j) CHARITABLE CONTRIBUTIONS.—Notwith2 standing any other provision of this section, section 

3 801(d)(1) continues to apply to a prescription drug that 

4 is donated or otherwise supplied at no charge by the man5 ufacturer of the drug to a charitable or humanitarian or6 ganization (including the United Nations and affiliates) 

7 or to a government of a foreign country. 

8 ‘‘(k) WAIVER AUTHORITY FOR IMPORTATION BY IN9 DIVIDUALS.—

10 ‘‘(1) DECLARATIONS.—The Congress declares 

11 that in the enforcement against individuals of the 

12 prohibition of importation of prescription drugs and 

13 devices, the Secretary should—

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

15 the importation by an individual poses a signifi16 cant threat to public health; and 

17 ‘‘(B) exercise discretion to permit individ18 uals to make such importations in cir19 cumstances in which—

20 ‘‘(i) the importation is clearly for per21 sonal use; and 

22 ‘‘(ii) the prescription drug or device 

23 imported does not appear to present an 

24 unreasonable risk to the individual. 

25 ‘‘(2) WAIVER AUTHORITY.—
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1 ‘‘(A) IN GENERAL.—The Secretary may 

2 grant to individuals, by regulation or on a case3 by-case basis, a waiver of the prohibition of im4 portation of a prescription drug or device or 

5 class of prescription drugs or devices, under 

6 such conditions as the Secretary determines to 

7 be appropriate. 

8 ‘‘(B) GUIDANCE ON CASE-BY-CASE WAIV9 ERS.—The Secretary shall publish, and update 

10 as necessary, guidance that accurately describes 

11 circumstances in which the Secretary will con12 sistently grant waivers on a case-by-case basis 

13 under subparagraph (A), so that individuals 

14 may know with the greatest practicable degree 

15 of certainty whether a particular importation 

16 for personal use will be permitted. 

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

18 particular, the Secretary shall by regulation grant 

19 individuals a waiver to permit individuals to import 

20 into the United States a prescription drug that—

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

22 for personal use by an individual, with a valid 

23 prescription, not for resale, in quantities that 

24 do not exceed a 90-day supply; 
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1 ‘‘(B) is imported from Canada, or from 

2 any member of the European Union with re3 spect to which the Secretary promulgates regu4 lations under subsection (b)(2), from a seller 

5 registered with the Secretary; 

6 ‘‘(C) is a prescription drug approved by 

7 the Secretary under chapter V; 

8 ‘‘(D) is in the form of a final finished dos9 age that was manufactured in an establishment 

10 registered under section 510; and 

11 ‘‘(E) is imported under such other condi12 tions as the Secretary determines to be nec13 essary to ensure public safety. 

14 ‘‘(l) STUDIES; REPORTS.—

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

16 NATIONAL ACADEMY OF SCIENCES.—

17 ‘‘(A) STUDY.—

18 ‘‘(i) IN GENERAL.—The Secretary 

19 shall request that the Institute of Medicine 

20 of the National Academy of Sciences con21 duct a study of—

22 ‘‘(I) importations of prescription 

23 drugs made under the regulations 

24 under subsection (b); and 
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1 ‘‘(II) information and docu2 mentation submitted under subsection 

3 (d). 

4 ‘‘(ii) REQUIREMENTS.—In conducting 

5 the study, the Institute of Medicine shall—

6 ‘‘(I) evaluate the compliance of 

7 importers with the regulations under 

8 subsection (b); 

9 ‘‘(II) compare the number of 

10 shipments under the regulations 

11 under subsection (b) during the study 

12 period that are determined to be 

13 counterfeit, misbranded, or adulter14 ated, and compare that number with 

15 the number of shipments made during 

16 the study period within the United 

17 States that are determined to be 

18 counterfeit, misbranded, or adulter19 ated; and 

20 ‘‘(III) consult with the Secretary 

21 to evaluate the effect of importations 

22 under the regulations under sub23 section (b) on trade and patent rights 

24 under Federal law. 
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1 ‘‘(B) REPORT.—Not later than 2 years 

2 after the effective date of the regulations under 

3 subsection (b), the Institute of Medicine shall 

4 submit to the Congress a report describing the 

5 findings of the study under subparagraph (A). 

6 ‘‘(2) BY THE COMPTROLLER GENERAL.—

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

8 the United States shall conduct a study to de9 termine the effect of this section on the price of 

10 prescription drugs sold to consumers at retail. 

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

12 after the effective date of the regulations under 

13 subsection (b), the Comptroller General of the 

14 United States shall submit to the Congress a 

15 report describing the findings of the study 

16 under subparagraph (A). 

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

18 the authority of the Secretary relating to the importation 

19 of prescription drugs, other than with respect to section 

20 801(d)(1) as provided in this section. 

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

22 are authorized to be appropriated such sums as are nec23 essary to carry out this section.’’. 

24 (b) CONFORMING AMENDMENTS.—The Federal 

25 Food, Drug, and Cosmetic Act is amended—
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1 (1) in section 301(aa) (21 U.S.C. 331(aa)), by 

2 striking ‘‘covered product in violation of section 

3 804’’ and inserting ‘‘prescription drug in violation of 

4 section 804’’; and 

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

6 by striking ‘‘covered product pursuant to section 

7 804(a)’’ and inserting ‘‘prescription drug under sec8 tion 804(b)’’.

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