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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5316 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 5316
To amend the Federal Food, Drug, and Cosmetic Act to ensure patients
have access to certain shortage and urgent-use compounded medications,
and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 11, 2025
Mrs. Harshbarger (for herself and Mr. Carter of Georgia) 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 shortage and 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 ``Drug Shortage Compounding Patient
Access Act of 2025''.
SEC. 2. PHARMACY COMPOUNDING.
(a) Compounding for Urgent Administration to Patients.--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:
``(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 drug product appeared on the drug
shortage list in effect under section 506E at any time
during the 60-day period ending on the date of the
compounding, distribution, or dispensing of the drug
product.
``(B) 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 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.
``(C) The compounded drug product is labeled with a
beyond-use-date in accordance with applicable United
States Pharmacopeia standards.
``(D) 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.
``(E) Upon receipt of records requested pursuant to
subparagraph (D)(ii), the licensed pharmacist or
licensed physician ensures that the patient information
in such records is linked with the respective order.
``(F) The licensed pharmacist or licensed physician
reports adverse events associated with the compounded
drug product as soon as possible but not 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).''.
(b) Definition.--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 any time during the 60-day period
ending on the date of the compounding,
distribution, or dispensing, the drug product
appeared on the drug shortage list in effect
under section 506E.
``(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), the drug product--
``(I) is labeled in accordance
subparagraphs (C) and (D) of subsection
(a)(3); and
``(II) is documented by the
compounding pharmacist or physician in
accordance with subparagraphs (E) and
(F) of subsection (a)(3).''.
SEC. 3. MITIGATING DRUG SHORTAGES THROUGH IMPROVED REPORTING.
Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356c) is amended--
(1) in the section heading, by inserting ``or surge in
demand for'' after ``production of'';
(2) in subsection (a), in the matter following paragraph
(2)--
(A) by striking ``or an interruption of the
manufacture of the drug'' and inserting ``, an
interruption of the manufacture of the drug, or a surge
in demand for the drug'';
(B) by striking ``such discontinuance or
interruption'' and inserting ``such discontinuance,
interruption, or surge in demand'';
(C) by striking ``the discontinuation or
interruption'' and inserting ``the discontinuation,
interruption, or surge in demand'';
(D) by striking ``such discontinuation or
interruption, the source'' and inserting ``such
discontinuation, interruption, or surge in demand, the
source''; and
(E) by striking ``such discontinuation or
interruption; the expected duration of the
interruption;'' and inserting ``such discontinuation,
interruption, or surge in demand; the expected duration
of the interruption or surge in demand'';
(3) in subsection (b), by striking paragraphs (1) and (2)
and inserting the following:
``(1) in the case of a notice of a discontinuance or
interruption in the manufacture of a drug--
``(A) at least 6 months prior to the date of the
discontinuance or interruption; or
``(B) if compliance with subparagraph (A) is not
possible, as soon as practicable; or
``(2) in the case of a notice of a surge in demand for a
drug, as soon as practicable.'';
(4) in subsection (c)--
(A) by striking ``discontinuance or interruption''
and inserting ``discontinuance, interruption, or surge
in demand''; and
(B) by inserting ``and outsourcing facilities (as
defined in section 503B(d))'' after ``patient
organizations''; and
(5) in subsection (h)--
(A) in paragraph (1), by striking ``and that is
subject to section 503(b)(1)'' and inserting ``or the
active pharmaceutical ingredient of such a drug'';
(B) by amending paragraph (2) to read as follows:
``(2) the term `drug shortage' or `shortage', with respect
to a drug, means a period of time with the demand or projected
demand for the drug within the United States exceeds the supply
of the drug, taking into consideration--
``(A) how the drug is prepared or dispensed,
including the route of administration and dosage form;
and
``(B) information reported by manufacturers, health
care professionals, and patients;''.
(C) in paragraph (3)(B), by striking the period at
the end and inserting ``; and''; and
(D) by adding at the end the following:
``(4) the term `surge' means an increase in demand or
projected demand for a drug that the manufacturer likely will
be unable to meet without meaningful shortfall or delay.''.
SEC. 4. OUTSOURCING FACILITY COMPOUNDING.
Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353b) is amended--
(1) in subsection (a)(2)(A)(ii)--
(A) by striking ``appears'' and inserting
``appeared''; and
(B) by striking ``at the time of'' and inserting
``at any time during the 180-day period ending on the
date of'';
(2) in subsection (a)(10)(A)(iii)--
(A) in subclause (VIII), by striking the semicolon
at the end and inserting ``; and'';
(B) by striking subclause (IX); and
(C) by redesignating subclause (X) as subclause
(IX);
(3) by redesignating the 2 subsections (d) (relating to
definitions and relating to obligation to pay fees) as
subsections (e) and (f), respectively; and
(4) by inserting after subsection (c) the following:
``(d) List of Identified Bulk Drug Substances.--The Secretary shall
make publicly available annual updates on the evaluation of bulk drug
substances for purposes of the list maintained under subsection
(a)(2)(A)(i).'';
SEC. 5. CLARIFYING PROVISIONS; LABELING REQUIREMENT.
Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353a) is amended--
(1) by striking subsection (b)(3)(B) and the matter
following such subsection and inserting the following:
``(B) such drug product is labeled as follows:
`This medication has been compounded for dispensing to
an individual patient and has not been approved by the
Food and Drug Administration'.''; and
(2) in subsection (b)(1)(A)(i)(I) by striking ``National
Formulary monograph'' and inserting ``National Formulary drug
or dietary supplement monograph''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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