II

107TH CONGRESS

1ST SESSION S. 1229

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

to import prescription drugs in limited circumstances.

IN THE SENATE OF THE UNITED STATES

JULY 24, 2001

Mr. WELLSTONE (for himself and Ms. STABENOW) introduced the following

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

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

permit individuals to import prescription drugs in limited

circumstances.

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 ‘‘Personal Prescription

5 Drug Import Fairness Act’’.
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1 SEC. 2. IMPORTATION OF PRESCRIPTION DRUGS BY INDI2 VIDUALS.

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

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

5 is amended by adding at the end the following:

6 ‘‘SEC. 805. IMPORTATION OF PRESCRIPTION DRUGS BY IN7 DIVIDUALS.

8 ‘‘(a) DEFINITIONS.—In this section:

9 ‘‘(1) IMPORT FORM.—The term ‘import form’

10 means a form prescribed by the Secretary, in con11 sultation with the Secretary of the Treasury, that

12 discloses—

13 ‘‘(A) the name, address, and telephone

14 number of an individual who imports a pre15 scription drug;

16 ‘‘(B) the name, address, and telephone

17 number of the pharmacy or other entity that

18 dispensed the prescription drug to the indi19 vidual or ships the prescription drug to the in20 dividual in the United States;

21 ‘‘(C)(i) the name, address, and telephone

22 number of the health care practitioner licensed

23 to prescribe drugs in the United States who is

24 responsible for the individual’s treatment with

25 the prescription drug; or
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1 ‘‘(ii) evidence that the prescription drug is

2 for the continuation of treatment begun outside

3 the United States;

4 ‘‘(D) the location of the establishment that

5 manufactured the prescription drug, to the ex6 tent known; and

7 ‘‘(E) such other information as the Sec8 retary may require.

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

11 503(b), other than a controlled substance (as de12 fined in section 102 of the Controlled Substances

13 Act (21 U.S.C. 802)) or a biological product (as de14 fined in section 351(i) of the Public Health Service

15 Act (42 U.S.C. 262(i))).

16 ‘‘(b) REGULATIONS.—The Secretary, after consulta17 tion with the United States Trade Representative and the

18 Commissioner of Customs, shall promulgate regulations

19 permitting individuals to import into the United States in

20 personal baggage or by mail (or by other approved delivery

21 service) a prescription drug that—

22 ‘‘(1) is imported for personal use by an indi23 vidual, not for resale, at intervals of not less than

24 approximately 90 days in quantities that do not ex25 ceed a 90-day supply;
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1 ‘‘(2) is imported from a country, union, or eco2 nomic area referred to in section 802(b)(1)(A) and

3 is a legally dispensed drug in that country, union, or

4 economic area;

5 ‘‘(3) is a prescription drug approved by the Sec6 retary under chapter V;

7 ‘‘(4) is in the form of a final finished dosage

8 that was manufactured in an establishment reg9 istered under section 510;

10 ‘‘(5) is accompanied by an import form; and

11 ‘‘(6) is imported under such other conditions as

12 the Secretary determines to be necessary to ensure

13 public safety.

14 ‘‘(c) RECORDS.—The Secretary shall collect, and

15 maintain for a period of time that the Secretary deter16 mines to be necessary, records of imports of prescription

17 drugs under this section.

18 ‘‘(d) LIST OF DRUGS MANUFACTURED OUTSIDE THE

19 UNITED STATES.—

20 ‘‘(1) IN GENERAL.—The Secretary shall main21 tain and make readily available to the public a list

22 of drugs approved under chapter V that—

23 ‘‘(A) are manufactured in establishments

24 outside the United States that are registered

25 under section 510; or
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1 ‘‘(B) are manufactured in establishments

2 inside the United States that are registered

3 under section 510 and are exported to a coun4 try, union, or economic area referred to in sec5 tion 802(b)(1)(A).

6 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—

7 There is authorized to be appropriated to carry out

8 this subsection $1,000,000.’’.

9 (b) CONFORMING AMENDMENT.—Section 801(d)(1)

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

11 821(d)(1)) is amended by striking ‘‘section 804’’ and in12 serting ‘‘sections 804 and 805’’.

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