Us Congress 2023-2024 Regular Session

Us Congress House Bill HB167 Compare Versions

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

Old	New	Differences
1	1	I
2	2	118THCONGRESS
3	3	1
4	4	STSESSION H. R. 167
5	5	To amend the Federal Food, Drug, and Cosmetic Act to ensure patients
6	6	have access to certain urgent-use compounded medications, and for other
7	7	purposes.
8	8	IN THE HOUSE OF REPRESENTATIVES
9	9	JANUARY9, 2023
10	10	Mr. G
11	11	RIFFITH(for himself and Mr. CUELLAR) introduced the following bill;
12	12	which was referred to the Committee on Energy and Commerce
13	13	A BILL
14	14	To amend the Federal Food, Drug, and Cosmetic Act to
15	15	ensure patients have access to certain urgent-use com-
16	16	pounded medications, and for other purposes.
17	17	Be it enacted by the Senate and House of Representa-1
18	18	tives of the United States of America in Congress assembled, 2
19	19	SECTION 1. SHORT TITLE. 3
20	20	This Act may be cited as the ‘‘Patient Access to Ur-4
21	21	gent-Use Pharmacy Compounding Act of 2023’’. 5
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24	24	•HR 167 IH
25	25	SEC. 2. URGENT-USE COMPOUNDING FOR ADMINISTRA-1
26	26	TION IN HOSPITALS OR OTHER CLINICAL 2
27	27	SETTINGS. 3
28	28	Section 503A(a) of the Federal Food, Drug, and Cos-4
29	29	metic Act (21 U.S.C. 353a(a)) is amended— 5
30	30	(1) in paragraph (1), by striking ‘‘or’’ at the 6
31	31	end; 7
32	32	(2) in paragraph (2)(B)(ii)(II), by striking the 8
33	33	period at the end and inserting ‘‘; or’’; and 9
34	34	(3) by adding at the end the following new 10
35	35	paragraph: 11
36	36	‘‘(3) notwithstanding the requirement in the 12
37	37	matter preceding paragraph (1) that the drug prod-13
38	38	uct is compounded for an identified individual pa-14
39	39	tient based on a valid prescription order or notation 15
40	40	described in such matter, is by a licensed pharmacist 16
41	41	or licensed physician and the compounded drug 17
42	42	product is compounded for distribution in limited 18
43	43	quantities to a licensed prescriber for urgent admin-19
44	44	istration to a patient in a hospital or other clinical 20
45	45	setting, provided that all of the following are met: 21
46	46	‘‘(A) The licensed prescriber certifies by 22
47	47	notation on the order to the compounding phar-23
48	48	macist or physician that the licensed prescriber 24
49	49	has made reasonable attempts to obtain, and 25
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52	52	•HR 167 IH
53	53	has not been able to obtain, to address the ur-1
54	54	gent medical need— 2
55	55	‘‘(i) a drug product that is approved 3
56	56	or authorized by the Food and Drug Ad-4
57	57	ministration with the same active ingre-5
58	58	dient and the same route of administra-6
59	59	tion; or 7
60	60	‘‘(ii) a drug product that is com-8
61	61	pounded by an outsourcing facility in ac-9
62	62	cordance with section 503B with the same 10
63	63	active ingredient and the same route of ad-11
64	64	ministration. 12
65	65	‘‘(B) The compounded drug product is la-13
66	66	beled with a beyond-use-date in accordance with 14
67	67	applicable United States Pharmacopeia stand-15
68	68	ards. 16
69	69	‘‘(C) The licensed pharmacist or licensed 17
70	70	physician marks the packaging of the com-18
71	71	pounded drug product with text— 19
72	72	‘‘(i) indicating that the drug product 20
73	73	is provided to the hospital or other clinical 21
74	74	setting only for urgent administration to a 22
75	75	patient; and 23
76	76	‘‘(ii) requesting that the hospital or 24
77	77	other clinical setting provide to the com-25
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80	80	•HR 167 IH
81	81	pounding pharmacist or physician the 1
82	82	records that identify the patient or pa-2
83	83	tients to whom the drug products were ad-3
84	84	ministered within— 4
85	85	‘‘(I) 7 days of each such patient 5
86	86	receiving such medication; or 6
87	87	‘‘(II) 7 days of each such patient 7
88	88	being discharged. 8
89	89	‘‘(D) Upon receipt of records requested 9
90	90	pursuant to subparagraph (C)(ii), the licensed 10
91	91	pharmacist or licensed physician ensures that 11
92	92	the patient information in such records is 12
93	93	linked with the respective order. 13
94	94	‘‘(E) The licensed pharmacist or licensed 14
95	95	physician reports adverse events associated with 15
96	96	the compounded drug product as soon as pos-16
97	97	sible but no later than 15 days after becoming 17
98	98	aware of such events to the MedWatch Adverse 18
99	99	Event Reporting program of the Food and 19
100	100	Drug Administration (or any successor pro-20
101	101	gram).’’. 21
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104	104	•HR 167 IH
105	105	SEC. 3. COMPOUNDING FOR SHORTAGES FOR ADMINISTRA-1
106	106	TION IN HOSPITALS OR OTHER CLINICAL 2
107	107	SETTINGS. 3
108	108	Paragraph (2) of section 503A(b) of the Federal 4
109	109	Food, Drug, and Cosmetic Act (21 U.S.C. 353a(b)(2)) is 5
110	110	amended to read as follows: 6
111	111	‘‘(2) D
112	112	EFINITION.—For purposes of paragraph 7
113	113	(1)(D), the term ‘essentially a copy of a commer-8
114	114	cially available drug product’ does not include— 9
115	115	‘‘(A) a drug product in which there is a 10
116	116	change, made for an identified individual pa-11
117	117	tient, which produces for that patient a signifi-12
118	118	cant difference, as determined by the pre-13
119	119	scribing practitioner, between the compounded 14
120	120	drug and the comparable commercially available 15
121	121	drug product; or 16
122	122	‘‘(B) a drug product that meets each of 17
123	123	the following conditions: 18
124	124	‘‘(i) At the time of compounding, dis-19
125	125	tribution, or dispensing, the drug product 20
126	126	appears on— 21
127	127	‘‘(I) the drug shortage list in ef-22
128	128	fect under section 506E; or 23
129	129	‘‘(II) the drug shortage list main-24
130	130	tained by the American Society of 25
131	131	Hospital Pharmacists. 26
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134	134	•HR 167 IH
135	135	‘‘(ii) If the drug product is not com-1
136	136	pounded for an identified individual patient 2
137	137	based on a valid prescription order or nota-3
138	138	tion, notwithstanding such requirement in 4
139	139	the matter preceding paragraph (1) of sub-5
140	140	section (a), then the drug product— 6
141	141	‘‘(I) is labeled in accordance sub-7
142	142	paragraphs (B) and (C) of subsection 8
143	143	(a)(3); and 9
144	144	‘‘(II) is documented by the 10
145	145	compounding pharmacist or physician 11
146	146	in accordance with subparagraphs (D) 12
147	147	and (E) of subsection (a)(3).’’. 13
148	148	Æ
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