I
119THCONGRESS
1
STSESSION H. R. 1060
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
FEBRUARY6, 2025
Mr. D
AVISof North Carolina (for himself, Mr. RUTHERFORD, and Mr.
B
ACON) introduced the following bill; which was referred to the Com-
mittee 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-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Modern Authentication 4
of Pharmaceuticals Act of 2025’’. 5
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SEC. 2. MODERNIZING THE AUTHENTICATION OF CON-1
TROLLED SUBSTANCES IN THE PHARMA-2
CEUTICAL DISTRIBUTION SUPPLY CHAIN. 3
(a) I
NGENERAL.—Section 582(a)(9) of the Federal 4
Food, Drug, and Cosmetic Act (21 U.S.C. 360eee– 5
1(a)(9)) is amended— 6
(1) in subparagraph (A)(ii), by striking ‘‘and’’ 7
at the end; 8
(2) by redesignating subparagraph (B) as sub-9
paragraph (C); and 10
(3) by inserting after subparagraph (A) the fol-11
lowing: 12
‘‘(B) a physical chemical identifier shall be 13
included in or on each dose of a product that 14
is— 15
‘‘(i) a controlled substance (as defined 16
in section 102 of the Controlled Sub-17
stances Act); 18
‘‘(ii) in solid oral dosage form; and 19
‘‘(iii) manufactured on or after the 20
date that is five years after the date of en-21
actment of the Modern Authentication of 22
Pharmaceuticals Act of 2025; and’’. 23
(b) C
ONFORMINGCHANGES.— 24
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(1) Section 581(14) of the Federal Food, Drug, 1
and Cosmetic Act (21 U.S.C. 360eee(14)) is amend-2
ed to read as follows: 3
‘‘(14) P
RODUCT IDENTIFIER.—The term ‘prod-4
uct identifier’ means— 5
‘‘(A) a standardized graphic that includes, 6
in both human-readable form and on a ma-7
chine-readable data carrier that conforms to the 8
standards developed by a widely recognized 9
international standards development organiza-10
tion, the standardized numerical identifier, lot 11
number, and expiration date of the product; or 12
‘‘(B) a physical chemical identifier, pos-13
sessing a unique physical or chemical substance 14
or combination of substances, that— 15
‘‘(i) is in or on a product; 16
‘‘(ii) is machine readable; and 17
‘‘(iii) is intended to authenticate the 18
product or a dosage form thereof.’’. 19
(2) Section 581(28) of the Federal Food, Drug, 20
and Cosmetic Act (21 U.S.C. 360eee(28)) is amend-21
ed to read as follows: 22
‘‘(28) V
ERIFICATION OR VERIFY .—The term 23
‘verification’ or ‘verify’ means— 24
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‘‘(A) determining whether the product 1
identifier affixed to, or imprinted upon, a pack-2
age or homogeneous case corresponds to the 3
standardized numerical identifier or lot number 4
and expiration date assigned to the product by 5
the manufacturer or the repackager, as applica-6
ble in accordance with section 582; or 7
‘‘(B) determining whether a product or a 8
dosage form thereof is authentic using a phys-9
ical chemical identifier described in paragraph 10
(14)(B).’’. 11
Æ
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