II

106TH CONGRESS

1ST SESSION S. 1462

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

in personal baggage and through mail order of certain covered products

for personal use from Canada, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JULY 29, 1999

Mr. JEFFORDS introduced the following bill; which was read twice and

referred to the Committee on Finance

A BILL

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

permit importation in personal baggage and through mail

order of certain covered products for personal use 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. IMPORTATION OF COVERED PRODUCTS FOR

4 PERSONAL USE.

5 Chapter VIII of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 381 et seq.) is amended—

7 (1) in section 801(d)(1), by inserting ‘‘and sec8 tion 804’’ after ‘‘paragraph (2)’’; and
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1 (2) by adding at the end the following:

2 ‘‘SEC. 804. IMPORTATION OF COVERED PRODUCTS FOR

3 PERSONAL USE.

4 ‘‘(a) GENERAL AUTHORITY WITH RESPECT TO PER5 SONAL BAGGAGE.—

6 ‘‘(1) REGULATIONS.—

7 ‘‘(A) IN GENERAL.—Notwithstanding sec8 tions 301(d), 301(t), and 801(a), the Secretary

9 shall promulgate regulations permitting individ10 uals to import into the United States from Can11 ada, in personal baggage, a covered product

12 that meets—

13 ‘‘(i) the conditions described in sub14 paragraph (B); and

15 ‘‘(ii) such additional criteria as the

16 Secretary may specify in order to ensure

17 the safety of patients in the United States.

18 ‘‘(B) CONDITIONS.—A covered product

19 may be imported under such regulations if—

20 ‘‘(i) the intended use of the product is

21 appropriately identified;

22 ‘‘(ii) the product is not considered to

23 represent a significant health risk (as de24 termined by the Secretary without any con25 sideration given to the cost or availability
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1 of such a product in the United States);

2 and

3 ‘‘(iii) the individual seeking to import

4 the product—

5 ‘‘(I) affirms in writing that the

6 product is for the personal use of the

7 individual;

8 ‘‘(II) seeks to import an amount

9 of the product appropriate for per10 sonal use, such as a 3-month supply;

11 and

12 ‘‘(III) provides the name and ad13 dress of a health professional licensed

14 to prescribe drugs in the United

15 States that is responsible for treat16 ment with the product or provides evi17 dence that the product is for the con18 tinuation of a treatment begun in a

19 foreign country.

20 ‘‘(IV) provides a detailed descrip21 tion of the covered product being im22 ported, including the name, amount,

23 and market value of the product;
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1 ‘‘(V) provides the time when and

2 the place where the covered product is

3 purchased;

4 ‘‘(VI) provides the port of entry

5 to which the covered product is des6 tined;

7 ‘‘(VII) provides the name, ad8 dress, and telephone number of the

9 individual who is importing the cov10 ered product; and

11 ‘‘(VIII) provides any other infor12 mation that the Secretary determines

13 to be necessary, including such infor14 mation as the Secretary determines to

15 be appropriate to identify the facility

16 in which the product was manufac17 tured.

18 ‘‘(2) PROMULGATION.—In promulgating regula19 tions under paragraph (1), the Secretary shall con20 sult with the United States Trade Representative

21 and the Commissioner of Customs.

22 ‘‘(b) GENERAL AUTHORITY WITH RESPECT TO MAIL

23 ORDER.—

24 ‘‘(1) REGULATIONS.—Notwithstanding sections

25 301(d), 301(t), and 801(a), the Secretary shall pro-
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1 mulgate regulations permitting individuals to import

2 into the United States from Canada, by mail order,

3 a covered product that meets such criteria as the

4 Secretary specifies to ensure the safety of patients

5 in the United States. The Secretary shall refer to

6 the criteria described in subsection (a)(1), and, to

7 the extent practicable, use such criteria as a guide

8 in promulgating such regulations.

9 ‘‘(2) PROMULGATION.—In promulgating regula10 tions under paragraph (1), the Secretary shall con11 sult with the United States Trade Representative

12 and the Commissioner of Customs.

13 ‘‘(3) RECORDS.—Any information documenting

14 the importation of a covered product under the regu15 lations described in paragraph (1) shall be gathered

16 and maintained by the Secretary for such period as

17 the Secretary determines to be appropriate.

18 ‘‘(c) STUDY AND REPORT.—

19 ‘‘(1) STUDY.—The Secretary shall conduct a

20 study on the imports permitted under this section,

21 taking into consideration the information received

22 under subsections (a)(4) and (b)(3). In conducting

23 the study, the Secretary shall evaluate the safety

24 and purity of the products imported, and other pat-
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1 ent and trade issues that may have an effect on the

2 safety or availability of such products.

3 ‘‘(2) REPORT.—Not later than 5 years after the

4 date of enactment of this section, the Secretary shall

5 prepare and submit to Congress a report containing

6 the study described in paragraph (1).

7 ‘‘(d) CONSTRUCTION.—Nothing in this section shall

8 be construed to limit the statutory, regulatory, or enforce9 ment authority of the Secretary relating to importation

10 of covered products, other than the importation described

11 in subsections (a) and (b).

12 ‘‘(e) LIMITATION.—Information collected pursuant to

13 this section shall be subject to the provisions of section

14 522a of title 5, United States Code (commonly known as

15 the ‘Privacy Act of 1974’).

16 ‘‘(f) DEFINITIONS.—In this section:

17 ‘‘(1) COVERED PRODUCT.—The term ‘covered

18 product’ means a prescription drug under section

19 503(b)(1).

20 ‘‘(2) MARKET VALUE.—The term ‘market

21 value’ means the price actually paid for the covered

22 product in Canada or, in the case of a gift, the price

23 at which the covered product is being sold in Can24 ada.’’.

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