I 

108TH CONGRESS 

1ST SESSION H. R. 616

To amend the Internal Revenue Code of 1986 with respect to the purchase 

of prescription drugs by individuals who have attained retirement age, 

and to amend the Federal Food, Drug, and Cosmetic Act with respect 

to the importation of prescription drugs and the sale of such drugs 

through Internet sites. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 5, 2003

Mr. PAUL introduced the following bill; which was referred to the Committee 

on Energy and Commerce, and in addition to the Committee on Ways 

and Means, for a period to be subsequently determined by the Speaker, 

in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL

To amend the Internal Revenue Code of 1986 with respect 

to the purchase of prescription drugs by individuals who 

have attained retirement age, and to amend the Federal 

Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs and the sale of such drugs 

through Internet sites.

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 ‘‘Prescription Drug Af3 fordability Act’’. 

4 TITLE I—AMENDMENTS TO IN5 TERNAL REVENUE CODE OF 

6 1986

7 SEC. 101. INCOME TAX CREDIT FOR PRESCRIPTION DRUGS 

8 PURCHASED BY INDIVIDUALS WHO HAVE AT9 TAINED RETIREMENT AGE. 

10 (a) IN GENERAL.—Subpart A of part IV of sub11 chapter A of chapter 1 of the Internal Revenue Code of 

12 1986 (relating to nonrefundable personal credits) is 

13 amended by inserting after section 25B the following new 

14 section: 

15 ‘‘SEC. 25C. PRESCRIPTION DRUGS PURCHASED BY INDIVID16 UALS WHO HAVE ATTAINED SOCIAL SECU17 RITY RETIREMENT AGE. 

18 ‘‘(a) IN GENERAL.—In the case of an individual who 

19 has attained social security retirement age, there shall be 

20 allowed as a credit against the tax imposed by this chapter 

21 for the taxable year an amount equal to 80 percent of the 

22 amount paid by the taxpayer during the taxable year (and 

23 not compensated for by insurance or otherwise) for any 

24 prescribed drug (as defined in section 213(d)(3)) for use 

25 by such individual. 
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1 ‘‘(b) SOCIAL SECURITY RETIREMENT AGE.—For 

2 purposes of this section, the term ‘social security retire3 ment age’ means retirement age (as defined in section 

4 216(l)(1) of the Social Security Act). 

5 ‘‘(c) DENIAL OF DOUBLE BENEFIT.—

6 ‘‘(1) COORDINATION WITH MEDICAL EXPENSE

7 DEDUCTION.—The amount which would (but for this 

8 subsection) be taken into account by the taxpayer 

9 under section 213 for the taxable year shall be re10 duced by the credit (if any) allowed by this section 

11 to the taxpayer for such year. 

12 ‘‘(2) COORDINATION WITH MEDICAL SAVINGS

13 ACCOUNTS.—No credit shall be allowed under this 

14 section for amounts paid from any medical savings 

15 account (as defined in section 220(d)). 

16 ‘‘(d) ELECTION NOT TO HAVE CREDIT APPLY.—

17 This section shall not apply to a taxpayer for a taxable 

18 year if the taxpayer elects not to have this section apply 

19 for such year.’’

20 (b) CLERICAL AMENDMENT.—The table of sections 

21 for subpart A of part IV of subchapter A of chapter 1 

22 of such Code is amended by inserting after the item relat23 ing to section 25B the following new item:

‘‘Sec. 25C. Prescription drugs purchased by individuals who have 

attained social security retirement age.’’
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1 (c) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply to taxable years beginning more 

3 than 1 year after the date of the enactment of this Act. 

4 TITLE II—AMENDMENTS TO FED5 ERAL FOOD, DRUG, AND COS6 METIC ACT 

7 SEC. 201. FACILITATION OF IMPORTATION OF DRUGS AP8 PROVED BY FOOD AND DRUG ADMINISTRA9 TION. 

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

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

12 is amended—

13 (1) by striking section 804; and 

14 (2) in section 801(d)—

15 (A) by striking paragraph (2); and 

16 (B) by striking ‘‘(d)(1)’’ and all that fol17 lows through the end of paragraph (1) and in18 serting the following: 

19 ‘‘(d)(1)(A) A person who meets applicable legal re20 quirements to be an importer of drugs described in sub21 paragraph (B) may import such a drug (without regard 

22 to whether the person is a manufacturer of the drug) if 

23 the person submits to the Secretary an application to im24 port the drug and the Secretary approves the application. 
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1 ‘‘(B) For purposes of subparagraph (A), the drugs 

2 described in this subparagraph are drugs that are subject 

3 to section 503(b)(1) or that are composed wholly or partly 

4 of insulin. 

5 ‘‘(C) The Secretary shall approve an application 

6 under subparagraph (A) if the application demonstrates 

7 that the drug to be imported meets all requirements under 

8 this Act for the admission of the drug into the United 

9 States, including demonstrating that—

10 ‘‘(i) an application for the drug has been ap11 proved under section 505, or as applicable, under 

12 section 351 of the Public Health Service Act; and 

13 ‘‘(ii) the drug is not adulterated or misbranded. 

14 ‘‘(D) Not later than 60 days after the date on which 

15 an application under subparagraph (A) is submitted to the 

16 Secretary, the Secretary shall—

17 ‘‘(i) approve the application; or 

18 ‘‘(ii) refuse to approve the application and pro19 vide to the person who submitted the application the 

20 reason for such refusal. 

21 ‘‘(E) This paragraph may not be construed as affect22 ing any right secured by patent.’’. 

23 (b) CONFORMING AMENDMENTS.—Section 801(d) of 

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

25 381(d)) is amended—
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1 (1) by redesignating paragraphs (3) and (4) as 

2 paragraphs (2) and (3), respectively; and 

3 (2) in paragraph (3) (as so redesignated) by 

4 striking ‘‘paragraph (3)’’ each place such term ap5 pears and inserting ‘‘paragraph (2)’’. 

6 SEC. 202. INTERNET SALES OF PRESCRIPTION DRUGS. 

7 Section 503(b) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 353(b)) is amended by adding at 

9 the end the following paragraph: 

10 ‘‘(6)(A) With respect to the interstate sale of a pre11 scription drug through an Internet site, the Secretary may 

12 not with respect to such sale take any action under this 

13 Act against any of the persons involved if—

14 ‘‘(i) the sale was made in compliance with this 

15 Act and with State laws that are applicable to the 

16 sale of the drug; and 

17 ‘‘(ii) accurate information regarding compliance 

18 with this Act and such State laws is posted on the 

19 Internet site. 

20 ‘‘(B) For purposes of subparagraph (A), the sale of 

21 a prescription drug by a person shall be considered to be 

22 an interstate sale of the drug through an Internet site if—

23 ‘‘(i) the purchaser of the drug submits the pur24 chase order for the drug, or conducts any other part 
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1 of the sales transaction for the drug, through an 

2 Internet site; and 

3 ‘‘(ii) pursuant to such sale, the person intro4 duces the drug into interstate commerce or delivers 

5 the drug for introduction into such commerce. 

6 ‘‘(C) Subparagraph (A) may not be construed as au7 thorizing the Secretary to enforce any violation of State 

8 law. 

9 ‘‘(D) For purposes of this paragraph, the term ‘pre10 scription drug’ means a drug that is subject to paragraph 

11 (1).’’. 

12 SEC. 203. REGULATIONS OF SECRETARY OF HEALTH AND 

13 HUMAN SERVICES; EFFECTIVE DATE. 

14 (a) REGULATIONS.—Before the expiration of the pe15 riod specified in subsection (b), the Secretary of Health 

16 and Human Services shall promulgate regulations to carry 

17 out the amendments to the Federal Food, Drug, and Cos18 metic Act that are made by sections 201 and 202. 

19 (b) EFFECTIVE DATE.—The amendments to the Fed20 eral Food, Drug, and Cosmetic Act that are made by sec21 tions 201 and 202 take effect upon the expiration of the 

22 one-year period beginning on the date of the enactment 

23 of this Act, without regard to whether the regulations re24 quired in subsection (a) have been promulgated.

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