Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB641 Compare Versions

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

Old	New	Differences
1	1	II
2	2	119THCONGRESS
3	3	1
4	4	STSESSION S. 641
5	5	To amend the Federal Food, Drug, and Cosmetic Act to allow for the
6	6	personal importation of safe and affordable drugs from approved phar-
7	7	macies in Canada.
8	8	IN THE SENATE OF THE UNITED STATES
9	9	FEBRUARY19, 2025
10	10	Ms. K
11	11	LOBUCHAR(for herself, Mr. GRASSLEY, Ms. BALDWIN, Mr. KING, Mr.
12	12	M
13	13	ERKLEY, Mrs. SHAHEEN, Mr. WHITEHOUSE, and Mr. WELCH) intro-
14	14	duced the following bill; which was read twice and referred to the Com-
15	15	mittee on Health, Education, Labor, and Pensions
16	16	A BILL
17	17	To amend the Federal Food, Drug, and Cosmetic Act to
18	18	allow for the personal importation of safe and affordable
19	19	drugs from approved pharmacies in Canada.
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 ‘‘Safe and Affordable 4
24	24	Drugs from Canada Act of 2025’’. 5
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27	27	•S 641 IS
28	28	SEC. 2. SAFE AND AFFORDABLE DRUGS FROM CANADA. 1
29	29	Chapter VIII of the Federal Food, Drug, and Cos-2
30	30	metic Act (21 U.S.C. 381 et seq.) is amended by adding 3
31	31	at the end the following: 4
32	32	‘‘SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIP-5
33	33	TION DRUGS FROM CANADA. 6
34	34	‘‘(a) I
35	35	NGENERAL.—Notwithstanding any other pro-7
36	36	vision of this Act, not later than 180 days after the date 8
37	37	of enactment of this section, the Secretary shall promul-9
38	38	gate regulations permitting individuals to safely import 10
39	39	into the United States a prescription drug described in 11
40	40	subsection (b). 12
41	41	‘‘(b) P
42	42	RESCRIPTIONDRUG.—A prescription drug de-13
43	43	scribed in this subsection— 14
44	44	‘‘(1) is a prescription drug that— 15
45	45	‘‘(A) is purchased from an approved Cana-16
46	46	dian pharmacy; 17
47	47	‘‘(B) is dispensed by a pharmacist licensed 18
48	48	to practice pharmacy and dispense prescription 19
49	49	drugs in Canada; 20
50	50	‘‘(C) is purchased for personal use by the 21
51	51	individual, not for resale, in quantities that do 22
52	52	not exceed a 90-day supply; 23
53	53	‘‘(D) is filled using a valid prescription 24
54	54	issued by a physician licensed to practice in a 25
55	55	State in the United States; and 26
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59	59	‘‘(E) has the same active ingredient or in-1
60	60	gredients, route of administration, dosage form, 2
61	61	and strength as a prescription drug approved 3
62	62	by the Secretary under chapter V; and 4
63	63	‘‘(2) does not include— 5
64	64	‘‘(A) a controlled substance (as defined in 6
65	65	section 102 of the Controlled Substances Act); 7
66	66	‘‘(B) a biological product (as defined in 8
67	67	section 351 of the Public Health Service Act); 9
68	68	‘‘(C) an infused drug (including a peri-10
69	69	toneal dialysis solution); 11
70	70	‘‘(D) an intravenously injected drug; 12
71	71	‘‘(E) a drug that is inhaled during surgery; 13
72	72	‘‘(F) a parenteral drug; 14
73	73	‘‘(G) a drug manufactured through one or 15
74	74	more biotechnology processes, including— 16
75	75	‘‘(i) a therapeutic DNA plasmid prod-17
76	76	uct; 18
77	77	‘‘(ii) a therapeutic synthetic peptide 19
78	78	product of not more than 40 amino acids; 20
79	79	‘‘(iii) a monoclonal antibody product 21
80	80	for in vivo use; and 22
81	81	‘‘(iv) a therapeutic recombinant DNA- 23
82	82	derived product; 24
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85	85	•S 641 IS
86	86	‘‘(H) a drug required to be refrigerated at 1
87	87	any time during manufacturing, packing, proc-2
88	88	essing, or holding; or 3
89	89	‘‘(I) a photoreactive drug. 4
90	90	‘‘(c) A
91	91	PPROVEDCANADIANPHARMACY.— 5
92	92	‘‘(1) I
93	93	N GENERAL.—In this section, an ap-6
94	94	proved Canadian pharmacy is a pharmacy that— 7
95	95	‘‘(A) is physically located in Canada; and 8
96	96	‘‘(B) the Secretary certifies— 9
97	97	‘‘(i) is licensed to operate and dis-10
98	98	pense prescription drugs to individuals in 11
99	99	Canada; and 12
100	100	‘‘(ii) meets the criteria under para-13
101	101	graph (3). 14
102	102	‘‘(2) P
103	103	UBLICATION OF APPROVED CANADIAN 15
104	104	PHARMACIES.—The Secretary shall publish on the 16
105	105	website of the Food and Drug Administration a list 17
106	106	of approved Canadian pharmacies, including the 18
107	107	website address of each such approved Canadian 19
108	108	pharmacy, from which individuals may purchase pre-20
109	109	scription drugs in accordance with subsection (a). 21
110	110	‘‘(3) A
111	111	DDITIONAL CRITERIA.—To be an ap-22
112	112	proved Canadian pharmacy, the Secretary shall cer-23
113	113	tify that the pharmacy— 24
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117	117	‘‘(A) has been in existence for a period of 1
118	118	at least 5 years preceding the date of such cer-2
119	119	tification and has a purpose other than to par-3
120	120	ticipate in the program established under this 4
121	121	section; 5
122	122	‘‘(B) operates in accordance with phar-6
123	123	macy standards set forth by the provincial 7
124	124	pharmacy rules and regulations enacted in Can-8
125	125	ada; 9
126	126	‘‘(C) has processes established by the phar-10
127	127	macy, or participates in another established 11
128	128	process, to certify that the physical premises 12
129	129	and data reporting procedures and licenses are 13
130	130	in compliance with all applicable laws and regu-14
131	131	lations, and has implemented policies designed 15
132	132	to monitor ongoing compliance with such laws 16
133	133	and regulations; 17
134	134	‘‘(D) conducts or commits to participate in 18
135	135	ongoing and comprehensive quality assurance 19
136	136	programs and implements such quality assur-20
137	137	ance measures, including blind testing, to en-21
138	138	sure the veracity and reliability of the findings 22
139	139	of the quality assurance program; 23
140	140	‘‘(E) agrees that laboratories approved by 24
141	141	the Secretary shall be used to conduct product 25
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144	144	•S 641 IS
145	145	testing to determine the safety and efficacy of 1
146	146	sample pharmaceutical products; 2
147	147	‘‘(F) has established, or will establish or 3
148	148	participate in, a process for resolving grievances 4
149	149	and will be held accountable for violations of es-5
150	150	tablished guidelines and rules; 6
151	151	‘‘(G) does not resell products from online 7
152	152	pharmacies located outside Canada to cus-8
153	153	tomers in the United States; and 9
154	154	‘‘(H) meets any other criteria established 10
155	155	by the Secretary.’’. 11
156	156	Æ
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