I 

109TH CONGRESS 

2D SESSION H. R. 4829 

To direct the Secretary of Health and Human Services to require the incorporation of counterfeit-resistant technologies into the packaging of prescription drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 1, 2006 

Mr. BURTON of Indiana (for himself, Mr. GUTKNECHT, Mr. SANDERS, Mr. 

EMANUEL, Ms. HERSETH, Mrs. NORTHUP, Mr. JONES of North Carolina, 

Mr. DEFAZIO, and Mr. SOUDER) introduced the following bill; which was 

referred to the Committee on Energy and Commerce 

A BILL 

To direct the Secretary of Health and Human Services to 

require the incorporation of counterfeit-resistant technologies into the packaging 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 ‘‘Reducing Fraudulent 

5 and Imitation Drugs Act of 2006’’. 
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1 SEC. 2. COUNTERFEIT-RESISTANT TECHNOLOGIES FOR 

2 PRESCRIPTION DRUGS. 

3 (a) REQUIRED TECHNOLOGIES.—The Secretary of 

4 Health and Human Services shall require that the pack5 aging of any prescription drug incorporate— 

6 (1) radio frequency identification (RFID) tag7 ging technology, or similar trace and track tech8 nologies that have an equivalent function; 

9 (2) tamper-indicating technologies; and 

10 (3) blister security packaging when possible. 

11 (b) USE OF TECHNOLOGIES.— 

12 (1) AUTHORIZED USES.—The Secretary shall 

13 require that technologies described in subsection 

14 (a)(1) be used exclusively to authenticate the pedi15 gree of prescription drugs, including by— 

16 (A) implementing inventory control; 

17 (B) tracking and tracing prescription 

18 drugs; 

19 (C) verifying shipment or receipt of pre20 scription drugs; 

21 (D) authenticating finished prescription 

22 drugs; and 

23 (E) electronically authenticating the pedi24 gree of prescription drugs. 

25 (2) PRIVACY PROTECTION.—The Secretary shall 

26 prohibit technologies required by subsection (a)(1) 
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1 from containing or transmitting any information 

2 that may be used to identify a health care practi3 tioner or the prescription drug consumer. 

4 (3) PROHIBITION AGAINST ADVERTISING.—The 

5 Secretary shall prohibit technologies required by 

6 subsection (a)(1) from containing or transmitting 

7 any advertisement or information about prescription 

8 drug indications or off-label prescription drug uses. 

9 (c) RECOMMENDED TECHNOLOGIES.—The Secretary 

10 shall encourage the manufacturers and distributors of pre11 scription drugs to incorporate into the packaging of such 

12 drugs, in addition to the technologies required under sub13 section (a), overt optically variable counterfeit-resistant 

14 technologies that— 

15 (1) are visible to the naked eye, providing for 

16 visual identification of prescription drug authenticity 

17 without the need for readers, microscopes, lighting 

18 devices, or scanners; 

19 (2) are similar to technologies used by the Bu20 reau of Engraving and Printing to secure United 

21 States currency; 

22 (3) are manufactured and distributed in a high23 ly secure, tightly controlled environment; and 
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1 (4) incorporate additional layers of non-visible 

2 covert security features up to and including forensic 

3 capability. 

4 (d) STANDARDS FOR PACKAGING.— 

5 (1) MULTIPLE ELEMENTS.—For the purpose of 

6 making it more difficult to counterfeit the packaging 

7 of prescription drugs, the Secretary shall require 

8 manufacturers of prescription drugs to incorporate 

9 the technologies described in paragraphs (1), (2), 

10 and (3) of subsection (a), and shall encourage manu11 facturers and distributors of prescription drugs to 

12 incorporate the technologies described in subsection 

13 (c), into multiple elements of the physical packaging 

14 of the drugs, including— 

15 (A) blister packs, shrink wrap, package la16 bels, package seals, bottles, and boxes; and 

17 (B) at the item level. 

18 (2) LABELING OF SHIPPING CONTAINER.— 

19 Shipments of prescription drugs shall include a label 

20 on the shipping container that incorporates the tech21 nologies described in subsection (a)(1), so that mem22 bers of the supply chain inspecting the packages will 

23 be able to determine the authenticity of the ship24 ment. Chain of custody procedures shall apply to 

25 such labels and shall include procedures applicable 
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1 to contractual agreements for the use and distribu2 tion of the labels, methods to audit the use of the 

3 labels, and database access for the relevant govern4 mental agencies for audit or verification of the use 

5 and distribution of the labels. 

6 (e) PENALTY.—A prescription drug is deemed to be 

7 misbranded for purposes of the Federal Food, Drug, and 

8 Cosmetic Act (21 U.S.C. 301 et seq.) if the packaging or 

9 labeling of the drug is in violation of a requirement or 

10 prohibition applicable to the drug under subsection (a), 

11 (b), or (d). 

12 (f) TRANSITIONAL PROVISIONS; EFFECTIVE

13 DATES.— 

14 (1) NATIONAL SPECIFIED LIST OF SUSCEP15 TIBLE PRESCRIPTION DRUGS.— 

16 (A) INITIAL PUBLICATION.—Not later than 

17 180 days after the date of the enactment of this 

18 Act, the Secretary of Health and Human Serv19 ices shall publish in the Federal Register a list, 

20 to be known as the National Specified List of 

21 Susceptible Prescription Drugs, consisting of 

22 not less than 30 of the prescription drugs that 

23 are most frequently subject to counterfeiting in 

24 the United States (as determined by the Sec25 retary). 
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1 (B) REVISION.—Not less than annually 

2 through the end of calendar year 2009, the Sec3 retary shall review and, as appropriate, revise 

4 the National Specified List of Susceptible Pre5 scription Drugs. The Secretary may not revise 

6 the List to include fewer than 30 prescription 

7 drugs. 

8 (2) EFFECTIVE DATES.—The Secretary shall 

9 implement the requirements and prohibitions of sub10 sections (a), (b), and (d)— 

11 (A) with respect to prescription drugs on 

12 the National Specified List of Susceptible Pre13 scription Drugs, beginning not later than the 

14 earlier of— 

15 (i) 1 year after the initial publication 

16 of such List; or 

17 (ii) December 31, 2007; and 

18 (B) with respect to all prescription drugs, 

19 beginning not later than December 31, 2010. 

20 (3) AUTHORIZED USES DURING TRANSITIONAL

21 PERIOD.—In lieu of the requirements specified in 

22 subsection (b)(1), for the period beginning on the ef23 fective date applicable under paragraph (2)(A) and 

24 ending on the commencement of the effective date 

25 applicable under paragraph (2)(B), the Secretary 
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1 shall require that technologies described in sub2 section (a)(1) be used exclusively to verify the au3 thenticity of prescription drugs. 

4 (g) DEFINITIONS.—In this Act: 

5 (1) The term ‘‘pedigree’’— 

6 (A) means the history of each prior sale, 

7 purchase, or trade of the prescription drug in8 volved to a distributor or retailer of the drug 

9 (including the date of the transaction and the 

10 names and addresses of all parties to the trans11 action); and 

12 (B) excludes information about the sale, 

13 purchase, or trade of the drug to the drug con14 sumer. 

15 (2) The term ‘‘prescription drug’’ means a drug 

16 subject to section 503(b)(1) of the Federal Food, 

17 Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)). 

18 (3) The term ‘‘Secretary’’ means the Secretary 

19 of Health and Human Services. 

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