Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1060 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 1060
5	5	To amend the Federal Food, Drug, and Cosmetic Act to modernize the
6	6	methods of authenticating controlled substances in the pharmaceutical
7	7	distribution supply chain, and for other purposes.
8	8	IN THE HOUSE OF REPRESENTATIVES
9	9	FEBRUARY6, 2025
10	10	Mr. D
11	11	AVISof North Carolina (for himself, Mr. RUTHERFORD, and Mr.
12	12	B
13	13	ACON) introduced the following bill; which was referred to the Com-
14	14	mittee on Energy and Commerce
15	15	A BILL
16	16	To amend the Federal Food, Drug, and Cosmetic Act to
17	17	modernize the methods of authenticating controlled sub-
18	18	stances in the pharmaceutical distribution supply chain,
19	19	and for other purposes.
20	20	Be it enacted by the Senate and House of Representa-1
21	21	tives of the United States of America in Congress assembled, 2
22	22	SECTION 1. SHORT TITLE. 3
23	23	This Act may be cited as the ‘‘Modern Authentication 4
24	24	of Pharmaceuticals Act of 2025’’. 5
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27	27	•HR 1060 IH
28	28	SEC. 2. MODERNIZING THE AUTHENTICATION OF CON-1
29	29	TROLLED SUBSTANCES IN THE PHARMA-2
30	30	CEUTICAL DISTRIBUTION SUPPLY CHAIN. 3
31	31	(a) I
32	32	NGENERAL.—Section 582(a)(9) of the Federal 4
33	33	Food, Drug, and Cosmetic Act (21 U.S.C. 360eee– 5
34	34	1(a)(9)) is amended— 6
35	35	(1) in subparagraph (A)(ii), by striking ‘‘and’’ 7
36	36	at the end; 8
37	37	(2) by redesignating subparagraph (B) as sub-9
38	38	paragraph (C); and 10
39	39	(3) by inserting after subparagraph (A) the fol-11
40	40	lowing: 12
41	41	‘‘(B) a physical chemical identifier shall be 13
42	42	included in or on each dose of a product that 14
43	43	is— 15
44	44	‘‘(i) a controlled substance (as defined 16
45	45	in section 102 of the Controlled Sub-17
46	46	stances Act); 18
47	47	‘‘(ii) in solid oral dosage form; and 19
48	48	‘‘(iii) manufactured on or after the 20
49	49	date that is five years after the date of en-21
50	50	actment of the Modern Authentication of 22
51	51	Pharmaceuticals Act of 2025; and’’. 23
52	52	(b) C
53	53	ONFORMINGCHANGES.— 24
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56	56	•HR 1060 IH
57	57	(1) Section 581(14) of the Federal Food, Drug, 1
58	58	and Cosmetic Act (21 U.S.C. 360eee(14)) is amend-2
59	59	ed to read as follows: 3
60	60	‘‘(14) P
61	61	RODUCT IDENTIFIER.—The term ‘prod-4
62	62	uct identifier’ means— 5
63	63	‘‘(A) a standardized graphic that includes, 6
64	64	in both human-readable form and on a ma-7
65	65	chine-readable data carrier that conforms to the 8
66	66	standards developed by a widely recognized 9
67	67	international standards development organiza-10
68	68	tion, the standardized numerical identifier, lot 11
69	69	number, and expiration date of the product; or 12
70	70	‘‘(B) a physical chemical identifier, pos-13
71	71	sessing a unique physical or chemical substance 14
72	72	or combination of substances, that— 15
73	73	‘‘(i) is in or on a product; 16
74	74	‘‘(ii) is machine readable; and 17
75	75	‘‘(iii) is intended to authenticate the 18
76	76	product or a dosage form thereof.’’. 19
77	77	(2) Section 581(28) of the Federal Food, Drug, 20
78	78	and Cosmetic Act (21 U.S.C. 360eee(28)) is amend-21
79	79	ed to read as follows: 22
80	80	‘‘(28) V
81	81	ERIFICATION OR VERIFY .—The term 23
82	82	‘verification’ or ‘verify’ means— 24
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85	85	•HR 1060 IH
86	86	‘‘(A) determining whether the product 1
87	87	identifier affixed to, or imprinted upon, a pack-2
88	88	age or homogeneous case corresponds to the 3
89	89	standardized numerical identifier or lot number 4
90	90	and expiration date assigned to the product by 5
91	91	the manufacturer or the repackager, as applica-6
92	92	ble in accordance with section 582; or 7
93	93	‘‘(B) determining whether a product or a 8
94	94	dosage form thereof is authentic using a phys-9
95	95	ical chemical identifier described in paragraph 10
96	96	(14)(B).’’. 11
97	97	Æ
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