I 
117TH CONGRESS 
1ST SESSION H. R. 3662 
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 
JUNE 1, 2021 
Mr. GRIFFITH (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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Patient Access to Ur-
gent-Use Pharmacy Compounding Act of 2021’’. 
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SEC. 2. URGENT-USE COMPOUNDING FOR ADMINISTRA-
TION IN HOSPITALS OR OTHER CLINICAL 
SETTINGS. 
Section 503A(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353a(a)) is amended— 
(1) in paragraph (1), by striking ‘‘or’’ at the 
end; 
(2) in paragraph (2)(B)(ii)(II), by striking the 
period at the end and inserting ‘‘; or’’; and 
(3) by adding at the end the following new 
paragraph: 
‘‘(3) notwithstanding the requirement in the 
matter preceding paragraph (1) that the drug prod-
uct is compounded for an identified individual pa-
tient based on a valid prescription order or notation 
described in such matter, is by a licensed pharmacist 
or licensed physician and the compounded drug 
product is compounded for distribution in limited 
quantities to a licensed prescriber for urgent admin-
istration to a patient in a hospital or other clinical 
setting, provided that all of the following are met: 
‘‘(A) The licensed prescriber certifies by 
notation on the order to the compounding phar-
macist or physician that the licensed prescriber 
has made reasonable attempts to obtain, and 
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has not been able to obtain, to address the ur-
gent medical need— 
‘‘(i) a drug product that is approved 
or authorized by the Food and Drug Ad-
ministration with the same active ingre-
dient and the same route of administra-
tion; or 
‘‘(ii) a drug product that is com-
pounded by an outsourcing facility in ac-
cordance with section 503B with the same 
active ingredient and the same route of ad-
ministration. 
‘‘(B) The compounded drug product is la-
beled with a beyond-use-date in accordance with 
applicable United States Pharmacopeia stand-
ards. 
‘‘(C) The licensed pharmacist or licensed 
physician marks the packaging of the com-
pounded drug product with text— 
‘‘(i) indicating that the drug product 
is provided to the hospital or other clinical 
setting only for urgent administration to a 
patient; and 
‘‘(ii) requesting that the hospital or 
other clinical setting provide to the com-
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pounding pharmacist or physician the 
records that identify the patient or pa-
tients to whom the drug products were ad-
ministered within— 
‘‘(I) 7 days of each such patient 
receiving such medication; or 
‘‘(II) 7 days of each such patient 
being discharged. 
‘‘(D) Upon receipt of records requested 
pursuant to subparagraph (C)(ii), the licensed 
pharmacist or licensed physician ensures that 
the patient information in such records is 
linked with the respective order. 
‘‘(E) The licensed pharmacist or licensed 
physician reports adverse events associated with 
the compounded drug product as soon as pos-
sible but no later than 15 days after becoming 
aware of such events to the MedWatch Adverse 
Event Reporting program of the Food and 
Drug Administration (or any successor pro-
gram).’’. 
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SEC. 3. COMPOUNDING FOR SHORTAGES FOR ADMINISTRA-
TION IN HOSPITALS OR OTHER CLINICAL 
SETTINGS. 
Paragraph (2) of section 503A(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 353a(b)(2)) is 
amended to read as follows: 
‘‘(2) DEFINITION.—For purposes of paragraph 
(1)(D), the term ‘essentially a copy of a commer-
cially available drug product’ does not include— 
‘‘(A) a drug product in which there is a 
change, made for an identified individual pa-
tient, which produces for that patient a signifi-
cant difference, as determined by the pre-
scribing practitioner, between the compounded 
drug and the comparable commercially available 
drug product; or 
‘‘(B) a drug product that meets each of 
the following conditions: 
‘‘(i) At the time of compounding, dis-
tribution, or dispensing, the drug product 
appears on— 
‘‘(I) the drug shortage list in ef-
fect under section 506E; or 
‘‘(II) the drug shortage list main-
tained by the American Society of 
Hospital Pharmacists. 
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‘‘(ii) If the drug product is not com-
pounded for an identified individual patient 
based on a valid prescription order or nota-
tion, notwithstanding such requirement in 
the matter preceding paragraph (1) of sub-
section (a), then the drug product— 
‘‘(I) is labeled in accordance sub-
paragraphs (B) and (C) of subsection 
(a)(3); and 
‘‘(II) is documented by the 
compounding pharmacist or physician 
in accordance with subparagraphs (D) 
and (E) of subsection (a)(3).’’. 
Æ 
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