[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 167 Introduced in House (IH)]
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118th CONGRESS
1st Session
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
January 9, 2023
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 compounded medications, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Patient Access to Urgent-Use
Pharmacy Compounding Act of 2023''.
SEC. 2. URGENT-USE COMPOUNDING FOR ADMINISTRATION IN HOSPITALS OR OTHER
CLINICAL SETTINGS.
Section 503A(a) of the Federal Food, Drug, and Cosmetic 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 product is compounded for
an identified individual patient 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 administration 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 pharmacist or physician
that the licensed prescriber has made reasonable
attempts to obtain, and has not been able to obtain, to
address the urgent medical need--
``(i) a drug product that is approved or
authorized by the Food and Drug Administration
with the same active ingredient and the same
route of administration; or
``(ii) a drug product that is compounded by
an outsourcing facility in accordance with
section 503B with the same active ingredient
and the same route of administration.
``(B) The compounded drug product is labeled with a
beyond-use-date in accordance with applicable United
States Pharmacopeia standards.
``(C) The licensed pharmacist or licensed physician
marks the packaging of the compounded 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
compounding pharmacist or physician the records
that identify the patient or patients to whom
the drug products were administered 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 possible 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 program).''.
SEC. 3. COMPOUNDING FOR SHORTAGES FOR ADMINISTRATION 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 commercially available drug
product' does not include--
``(A) a drug product in which there is a change,
made for an identified individual patient, which
produces for that patient a significant difference, as
determined by the prescribing 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,
distribution, or dispensing, the drug product
appears on--
``(I) the drug shortage list in
effect under section 506E; or
``(II) the drug shortage list
maintained by the American Society of
Hospital Pharmacists.
``(ii) If the drug product is not
compounded for an identified individual patient
based on a valid prescription order or
notation, notwithstanding such requirement in
the matter preceding paragraph (1) of
subsection (a), then the drug product--
``(I) is labeled in accordance
subparagraphs (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).''.
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