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 sub-
stances in the pharmaceutical distribution supply chain, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Modern Authentication 
of Pharmaceuticals Act of 2023’’. 
VerDate Sep 11 2014 
05:40 Aug 18, 2023
Jkt 039200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H4988.IH
H4988
pbinns on DSKJLVW7X2PROD with $$_JOB
SEC. 2. MODERNIZING THE AUTHENTICATION OF CON-
TROLLED SUBSTANCES IN THE PHARMA-
CEUTICAL DISTRIBUTION SUPPLY CHAIN. 
(a) IN GENERAL.—Section 582(a)(9) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360eee– 
1(a)(9)) is amended— 
(1) in subparagraph (A)(ii), by striking ‘‘and’’ 
at the end; 
(2) by redesignating subparagraph (B) as sub-
paragraph (C); and 
(3) by inserting after subparagraph (A) the fol-
lowing: 
‘‘(B) a physical chemical identifier shall be 
included in or on each dose of a product that 
is— 
‘‘(i) a controlled substance (as defined 
in section 102 of the Controlled Sub-
stances Act); 
‘‘(ii) in solid oral dosage form; and 
‘‘(iii) manufactured on or after the 
date that is five years after the date of en-
actment of the Modern Authentication of 
Pharmaceuticals Act of 2023; and’’. 
(b) CONFORMING CHANGES.— 
VerDate Sep 11 2014 
05:40 Aug 18, 2023
Jkt 039200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4988.IH
H4988
pbinns on DSKJLVW7X2PROD with $$_JOB
(1) Section 581(14) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360eee(14)) is amend-
ed to read as follows: 
‘‘(14) PRODUCT IDENTIFIER.—The term ‘prod-
uct identifier’ means— 
‘‘(A) a standardized graphic that includes, 
in both human-readable form and on a ma-
chine-readable data carrier that conforms to the 
standards developed by a widely recognized 
international standards development organiza-
tion, the standardized numerical identifier, lot 
number, and expiration date of the product; or 
‘‘(B) a physical chemical identifier, pos-
sessing a unique physical or chemical substance 
or combination of substances, that— 
‘‘(i) is in or on a product; 
‘‘(ii) is machine readable; and 
‘‘(iii) is intended to authenticate the 
product or a dosage form thereof.’’. 
(2) Section 581(28) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360eee(28)) is amend-
ed to read as follows: 
‘‘(28) VERIFICATION
OR
VERIFY.—The term 
‘verification’ or ‘verify’ means— 
VerDate Sep 11 2014 
05:40 Aug 18, 2023
Jkt 039200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H4988.IH
H4988
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(A) determining whether the product 
identifier affixed to, or imprinted upon, a pack-
age or homogeneous case corresponds to the 
standardized numerical identifier or lot number 
and expiration date assigned to the product by 
the manufacturer or the repackager, as applica-
ble in accordance with section 582; or 
‘‘(B) determining whether a product or a 
dosage form thereof is authentic using a phys-
ical chemical identifier described in paragraph 
(14)(B).’’. 
Æ 
VerDate Sep 11 2014 
05:40 Aug 18, 2023
Jkt 039200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6301
E:\BILLS\H4988.IH
H4988
pbinns on DSKJLVW7X2PROD with $$_JOB