I 

118TH CONGRESS 

1ST SESSION H. R. 4988 

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

methods of authenticating controlled substances in the pharmaceutical 

distribution supply chain, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 27, 2023 

Mr. DAVIS of North Carolina (for himself, Mr. RUTHERFORD, and Ms. 

PETTERSEN) introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

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

modernize the methods of authenticating controlled substances in the pharmaceutical distribution supply chain, 

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 ‘‘Modern Authentication 

5 of Pharmaceuticals Act of 2023’’. 


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•HR 4988 IH

1 SEC. 2. MODERNIZING THE AUTHENTICATION OF CON2 TROLLED SUBSTANCES IN THE PHARMA3 CEUTICAL DISTRIBUTION SUPPLY CHAIN. 

4 (a) IN GENERAL.—Section 582(a)(9) of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 360eee– 

6 1(a)(9)) is amended— 

7 (1) in subparagraph (A)(ii), by striking ‘‘and’’ 

8 at the end; 

9 (2) by redesignating subparagraph (B) as sub10 paragraph (C); and 

11 (3) by inserting after subparagraph (A) the fol12 lowing: 

13 ‘‘(B) a physical chemical identifier shall be 

14 included in or on each dose of a product that 

15 is— 

16 ‘‘(i) a controlled substance (as defined 

17 in section 102 of the Controlled Sub18 stances Act); 

19 ‘‘(ii) in solid oral dosage form; and 

20 ‘‘(iii) manufactured on or after the 

21 date that is five years after the date of en22 actment of the Modern Authentication of 

23 Pharmaceuticals Act of 2023; and’’. 

24 (b) CONFORMING CHANGES.— 


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•HR 4988 IH

1 (1) Section 581(14) of the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 360eee(14)) is amend3 ed to read as follows: 

4 ‘‘(14) PRODUCT IDENTIFIER.—The term ‘prod5 uct identifier’ means— 

6 ‘‘(A) a standardized graphic that includes, 

7 in both human-readable form and on a ma8 chine-readable data carrier that conforms to the 

9 standards developed by a widely recognized 

10 international standards development organiza11 tion, the standardized numerical identifier, lot 

12 number, and expiration date of the product; or 

13 ‘‘(B) a physical chemical identifier, pos14 sessing a unique physical or chemical substance 

15 or combination of substances, that— 

16 ‘‘(i) is in or on a product; 

17 ‘‘(ii) is machine readable; and 

18 ‘‘(iii) is intended to authenticate the 

19 product or a dosage form thereof.’’. 

20 (2) Section 581(28) of the Federal Food, Drug, 

21 and Cosmetic Act (21 U.S.C. 360eee(28)) is amend22 ed to read as follows: 

23 ‘‘(28) VERIFICATION OR VERIFY.—The term 

24 ‘verification’ or ‘verify’ means— 


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•HR 4988 IH

1 ‘‘(A) determining whether the product 

2 identifier affixed to, or imprinted upon, a pack3 age or homogeneous case corresponds to the 

4 standardized numerical identifier or lot number 

5 and expiration date assigned to the product by 

6 the manufacturer or the repackager, as applica7 ble in accordance with section 582; or 

8 ‘‘(B) determining whether a product or a 

9 dosage form thereof is authentic using a phys10 ical chemical identifier described in paragraph 

11 (14)(B).’’. 

Æ 


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