I 

108TH CONGRESS 

1ST SESSION H. R. 2427

To authorize the Secretary of Health and Human Services to promulgate 

regulations for the reimportation of prescription drugs, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 11, 2003

Mr. GUTKNECHT (for himself, Mr. JONES of North Carolina, Mr. SHAYS, Mr. 

JANKLOW, Mr. PETRI, Mr. KINGSTON, Mrs. EMERSON, Mr. BEREUTER, 

Mr. OSBORNE, Mr. HOEKSTRA, Mr. BARTLETT of Maryland, Mr. SMITH

of Michigan, Mr. PAUL, Mr. DUNCAN, Mrs. NORTHUP, Mr. GILCHREST, 

Mr. ROHRABACHER, Mr. BURTON of Indiana, Mr. HENSARLING, Mr. 

EMANUEL, Mr. FRANK of Massachusetts, Mr. PETERSON of Minnesota, 

Mr. RAMSTAD, Mr. REHBERG, Mr. ISTOOK, Mr. BROWN of South Carolina, and Mr. TAYLOR of North Carolina) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL

To authorize the Secretary of Health and Human Services 

to promulgate regulations for the reimportation of prescription drugs, 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 ‘‘Pharmaceutical Mar5 ket Access Act of 2003’’. 
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1 SEC. 2. FINDINGS. 

2 The Congress finds as follows: 

3 (1) Americans unjustly pay up to 1000 percent 

4 more to fill their prescriptions than consumers in 

5 other countries. 

6 (2) The United States is the world’s largest 

7 market for pharmaceuticals yet consumers still pay 

8 the world’s highest prices. 

9 (3) An unaffordable drug is neither safe nor ef10 fective. Allowing and structuring the importation of 

11 prescription drugs ensures access to affordable 

12 drugs, thus providing a level of safety to American 

13 consumers they do not currently enjoy. 

14 (4) According to the Congressional Budget Of15 fice, American seniors alone will spend $1.8 trillion 

16 dollars on pharmaceuticals over the next ten years. 

17 (5) Allowing open pharmaceutical markets 

18 could save American consumers at least $635 billion 

19 of their own money each year. 

20 SEC. 3. PURPOSES. 

21 The purposes of this Act are as follows: 

22 (1) To give all Americans immediate relief from 

23 the outrageously high cost of pharmaceuticals. 

24 (2) To reverse the perverse economics of the 

25 American pharmaceutical markets. 
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1 (3) To allow the importation of drugs only if 

2 the drugs and the facilities where they are manufac3 tured are approved by the Food and Drug Adminis4 tration, and to exclude pharmaceutical narcotics. 

5 (4) To require that imported prescription drugs 

6 be packaged and shipped using counterfeit-resistant 

7 technologies approved by the Bureau of Engraving 

8 and Printing (technologies similar to those used to 

9 secure United States currency). 

10 SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS. 

11 Section 804 of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 384) is amended—

13 (1) in subsection (a)—

14 (A) by striking ‘‘The Secretary’’ and in15 serting ‘‘Not later than 180 days after the date 

16 of the enactment of the Pharmaceutical Market 

17 Access Act of 2003, the Secretary’’; and 

18 (B) by striking ‘‘pharmacists and whole19 salers’’ and inserting ‘‘pharmacists, wholesalers, 

20 and qualifying individuals’’; 

21 (2) in subsection (b)—

22 (A) by amending paragraph (1) to read as 

23 follows: 

24 ‘‘(1) require that each covered product imported 

25 pursuant to such subsection complies with sections 
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1 501, 502, and 505, and other applicable require2 ments of this Act; and’’; 

3 (B) in paragraph (2), by striking ‘‘, includ4 ing subsection (d); and’’ and inserting a period; 

5 and 

6 (C) by striking paragraph (3); 

7 (3) in subsection (c), by inserting ‘‘by phar8 macists and wholesalers (but not qualifying individ9 uals)’’ after ‘‘importation of covered products’’; 

10 (4) in subsection (d)—

11 (A) by striking paragraphs (3) and (10); 

12 (B) in paragraph (5), by striking ‘‘, includ13 ing the professional license number of the im14 porter, if any’’; 

15 (C) in paragraph (6)—

16 (i) in subparagraph (C), by inserting 

17 ‘‘(if required under subsection (e))’’ before 

18 the period; 

19 (ii) in subparagraph (D), by inserting 

20 ‘‘(if required under subsection (e))’’ before 

21 the period; and 

22 (iii) in subparagraph (E), by striking 

23 ‘‘labeling’’; 

24 (D) in paragraph (7)—
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1 (i) in subparagraph (A), by inserting 

2 ‘‘(if required under subsection (e))’’ before 

3 the period; and 

4 (ii) by amending subparagraph (B) to 

5 read as follows: 

6 ‘‘(B) Certification from the importer or 

7 manufacturer of such product that the product 

8 meets all requirements of this Act.’’; and 

9 (E) by redesignating paragraphs (4) 

10 through (9) as paragraphs (3) through (8), re11 spectively; 

12 (5) by amending subsection (e) to read as fol13 lows: 

14 ‘‘(e) TESTING.—

15 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

16 regulations under subsection (a) shall require that 

17 testing referred to in paragraphs (5) through (7) of 

18 subsection (d) be conducted by the importer of the 

19 covered product, unless the covered product is a pre20 scription drug subject to the requirements of section 

21 505B for counterfeit-resistant technologies. 

22 ‘‘(2) EXCEPTION.—The testing requirements of 

23 paragraphs (5) through (7) of subsection (d) shall 

24 not apply to an importer unless the importer is a 

25 wholesaler.’’; 
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1 (6) in subsection (f), by striking ‘‘or designated 

2 by the Secretary, subject to such limitations as the 

3 Secretary determines to be appropriate to protect 

4 the public health’’; 

5 (7) in subsection (g)—

6 (A) by striking ‘‘counterfeit or’’; and 

7 (B) by striking ‘‘and the Secretary deter8 mines that the public is adequately protected 

9 from counterfeit and violative covered products 

10 being imported pursuant to subsection (a)’’; 

11 (8) in subsection (i)(1)—

12 (A) by amending subparagraph (A) to read 

13 as follows: 

14 ‘‘(A) IN GENERAL.—The Secretary shall 

15 conduct, or contract with an entity to conduct, 

16 a study on the imports permitted pursuant to 

17 subsection (a), including consideration of the 

18 information received under subsection (d). In 

19 conducting such study, the Secretary or entity 

20 shall evaluate the compliance of importers with 

21 regulations under subsection (a), and the inci22 dence of shipments pursuant to such sub23 section, if any, that have been determined to be 

24 misbranded or adulterated, and determine how 

25 such compliance contrasts with the incidence of 
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1 shipments of prescription drugs transported 

2 within the United States that have been deter3 mined to be misbranded or adulterated.’’; and 

4 (B) in subparagraph (B), by striking ‘‘Not 

5 later than 2 years after the effective date of 

6 final regulations under subsection (a),’’ and in7 serting ‘‘Not later than 18 months after the 

8 date of the enactment of the Pharmaceutical 

9 Market Access Act of 2003,’’; 

10 (9) in subsection (k)(2)—

11 (A) by redesignating subparagraphs (D) 

12 and (E) as subparagraphs (E) and (F), respec13 tively; and 

14 (B) by inserting after subparagraph (C) 

15 the following: 

16 ‘‘(D) The term ‘qualifying individual’ 

17 means an individual who is not a pharmacist or 

18 a wholesaler. ’’; and 

19 (10) by striking subsections (l) and (m). 

20 SEC. 5. USE OF COUNTERFEIT-RESISTANT TECHNOLOGIES 

21 TO PREVENT COUNTERFEITING. 

22 (a) MISBRANDING.—Section 502 of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 352; deeming 

24 drugs and devices to be misbranded) is amended by adding 

25 at the end the following: 
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1 ‘‘(w) If it is a drug subject to section 503(b), unless 

2 the packaging of such drug complies with the require3 ments of section 505B for counterfeit-resistant tech4 nologies.’’. 

5 (b) REQUIREMENTS.—Title V of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend7 ed by inserting after section 505A the following: 

8 ‘‘SEC. 505B. COUNTERFEIT-RESISTANT TECHNOLOGIES. 

9 ‘‘(a) INCORPORATION OF COUNTERFEIT-RESISTANT

10 TECHNOLOGIES INTO PRESCRIPTION DRUG PACK11 AGING.—The Secretary shall require that the packaging 

12 of any drug subject to section 503(b) incorporate—

13 ‘‘(1) overt optically variable counterfeit-resist14 ant technologies that are described in subsection (b) 

15 and comply with the standards of subsection (c); or 

16 ‘‘(2) technologies that have an equivalent func17 tion of security, as determined by the Secretary. 

18 ‘‘(b) ELIGIBLE TECHNOLOGIES.—Technologies de19 scribed in this subsection—

20 ‘‘(1) shall be visible to the naked eye, providing 

21 for visual identification of product authenticity with22 out the need for readers, microscopes, lighting de23 vices, or scanners; 
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1 ‘‘(2) shall be similar to that used by the Bureau 

2 of Engraving and Printing to secure United States 

3 currency; 

4 ‘‘(3) shall be manufactured and distributed in a 

5 highly secure, tightly controlled environment; and 

6 ‘‘(4) should incorporate additional layers of 

7 non-visible covert security features up to and includ8 ing forensic capability. 

9 ‘‘(c) STANDARDS FOR PACKAGING.—

10 ‘‘(1) MULTIPLE ELEMENTS.—For the purpose 

11 of making it more difficult to counterfeit the pack12 aging of drugs subject to section 503(b), manufac13 turers of the drugs shall incorporate the technologies 

14 described in subsection (b) into multiple elements of 

15 the physical packaging of the drugs, including blister 

16 packs, shrink wrap, package labels, package seals, 

17 bottles, and boxes. 

18 ‘‘(2) LABELING OF SHIPPING CONTAINER.—

19 Shipments of drugs described in subsection (a) shall 

20 include a label on the shipping container that incor21 porates the technologies described in subsection (b), 

22 so that officials inspecting the packages will be able 

23 to determine the authenticity of the shipment. Chain 

24 of custody procedures shall apply to such labels and 

25 shall include procedures applicable to contractual 
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1 agreements for the use and distribution of the labels, 

2 methods to audit the use of the labels, and database 

3 access for the relevant governmental agencies for 

4 audit or verification of the use and distribution of 

5 the labels.’’.

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