I
118THCONGRESS
1
STSESSION H. R. 167
To amend the Federal Food, Drug, and Cosmetic Act to ensure patients
have access to certain urgent-use compounded medications, and for other
purposes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY9, 2023
Mr. G
RIFFITH(for himself and Mr. CUELLAR) 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
ensure patients have access to certain urgent-use com-
pounded medications, 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 ‘‘Patient Access to Ur-4
gent-Use Pharmacy Compounding Act of 2023’’. 5
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SEC. 2. URGENT-USE COMPOUNDING FOR ADMINISTRA-1
TION IN HOSPITALS OR OTHER CLINICAL 2
SETTINGS. 3
Section 503A(a) of the Federal Food, Drug, and Cos-4
metic Act (21 U.S.C. 353a(a)) is amended— 5
(1) in paragraph (1), by striking ‘‘or’’ at the 6
end; 7
(2) in paragraph (2)(B)(ii)(II), by striking the 8
period at the end and inserting ‘‘; or’’; and 9
(3) by adding at the end the following new 10
paragraph: 11
‘‘(3) notwithstanding the requirement in the 12
matter preceding paragraph (1) that the drug prod-13
uct is compounded for an identified individual pa-14
tient based on a valid prescription order or notation 15
described in such matter, is by a licensed pharmacist 16
or licensed physician and the compounded drug 17
product is compounded for distribution in limited 18
quantities to a licensed prescriber for urgent admin-19
istration to a patient in a hospital or other clinical 20
setting, provided that all of the following are met: 21
‘‘(A) The licensed prescriber certifies by 22
notation on the order to the compounding phar-23
macist or physician that the licensed prescriber 24
has made reasonable attempts to obtain, and 25
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•HR 167 IH
has not been able to obtain, to address the ur-1
gent medical need— 2
‘‘(i) a drug product that is approved 3
or authorized by the Food and Drug Ad-4
ministration with the same active ingre-5
dient and the same route of administra-6
tion; or 7
‘‘(ii) a drug product that is com-8
pounded by an outsourcing facility in ac-9
cordance with section 503B with the same 10
active ingredient and the same route of ad-11
ministration. 12
‘‘(B) The compounded drug product is la-13
beled with a beyond-use-date in accordance with 14
applicable United States Pharmacopeia stand-15
ards. 16
‘‘(C) The licensed pharmacist or licensed 17
physician marks the packaging of the com-18
pounded drug product with text— 19
‘‘(i) indicating that the drug product 20
is provided to the hospital or other clinical 21
setting only for urgent administration to a 22
patient; and 23
‘‘(ii) requesting that the hospital or 24
other clinical setting provide to the com-25
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pounding pharmacist or physician the 1
records that identify the patient or pa-2
tients to whom the drug products were ad-3
ministered within— 4
‘‘(I) 7 days of each such patient 5
receiving such medication; or 6
‘‘(II) 7 days of each such patient 7
being discharged. 8
‘‘(D) Upon receipt of records requested 9
pursuant to subparagraph (C)(ii), the licensed 10
pharmacist or licensed physician ensures that 11
the patient information in such records is 12
linked with the respective order. 13
‘‘(E) The licensed pharmacist or licensed 14
physician reports adverse events associated with 15
the compounded drug product as soon as pos-16
sible but no later than 15 days after becoming 17
aware of such events to the MedWatch Adverse 18
Event Reporting program of the Food and 19
Drug Administration (or any successor pro-20
gram).’’. 21
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SEC. 3. COMPOUNDING FOR SHORTAGES FOR ADMINISTRA-1
TION IN HOSPITALS OR OTHER CLINICAL 2
SETTINGS. 3
Paragraph (2) of section 503A(b) of the Federal 4
Food, Drug, and Cosmetic Act (21 U.S.C. 353a(b)(2)) is 5
amended to read as follows: 6
‘‘(2) D
EFINITION.—For purposes of paragraph 7
(1)(D), the term ‘essentially a copy of a commer-8
cially available drug product’ does not include— 9
‘‘(A) a drug product in which there is a 10
change, made for an identified individual pa-11
tient, which produces for that patient a signifi-12
cant difference, as determined by the pre-13
scribing practitioner, between the compounded 14
drug and the comparable commercially available 15
drug product; or 16
‘‘(B) a drug product that meets each of 17
the following conditions: 18
‘‘(i) At the time of compounding, dis-19
tribution, or dispensing, the drug product 20
appears on— 21
‘‘(I) the drug shortage list in ef-22
fect under section 506E; or 23
‘‘(II) the drug shortage list main-24
tained by the American Society of 25
Hospital Pharmacists. 26
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‘‘(ii) If the drug product is not com-1
pounded for an identified individual patient 2
based on a valid prescription order or nota-3
tion, notwithstanding such requirement in 4
the matter preceding paragraph (1) of sub-5
section (a), then the drug product— 6
‘‘(I) is labeled in accordance sub-7
paragraphs (B) and (C) of subsection 8
(a)(3); and 9
‘‘(II) is documented by the 10
compounding pharmacist or physician 11
in accordance with subparagraphs (D) 12
and (E) of subsection (a)(3).’’. 13
Æ
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