HR 5316
Drug Shortage Compounding Patient Access Act of 2025
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Bill overview
This bill, the Drug Shortage Compounding Patient Access Act of 2025, aims to improve access to compounded medications during drug shortages. It allows licensed pharmacists and physicians to compound medications for urgent administration to patients in hospitals and clinics, even if a commercially available alternative isn't immediately available. The bill also clarifies labeling requirements for these compounded drugs and strengthens reporting requirements for drug shortages to help manufacturers anticipate and mitigate supply issues.
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119th CONGRESS — 1st Session
H. R. 5316
IN THE HOUSE OF REPRESENTATIVES
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.
This Act may be cited as the Drug Shortage Compounding Patient Access Act of 2025
.
orat the end;
in paragraph (2)(B)(ii)(II), by striking the period at the end and inserting ; or
; and
by adding at the end the following:
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.
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.
The compounded drug product is labeled with a beyond-use-date in accordance with applicable United States Pharmacopeia standards.
The licensed pharmacist or licensed physician marks the packaging of the compounded drug product with text—
indicating that the drug product is provided to the hospital or other clinical setting only for urgent administration to a patient; and
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—
7 days of each such patient receiving such medication; or
7 days of each such patient being discharged.
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.
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).
essentially a copy of a commercially available drug productdoes not include—
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
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—
is labeled in accordance subparagraphs (C) and (D) of subsection (a)(3); and
is documented by the compounding pharmacist or physician in accordance with subparagraphs (E) and (F) of subsection (a)(3).
Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amended—
in the section heading, by inserting OR SURGE IN DEMAND FOR
after PRODUCTION OF
;
in subsection (a), in the matter following paragraph (2)—
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
;
by striking such discontinuance or interruption
and inserting such discontinuance, interruption, or surge in demand
;
by striking the discontinuation or interruption
and inserting the discontinuation, interruption, or surge in demand
;
such discontinuation or interruption, the sourceand inserting
such discontinuation, interruption, or surge in demand, the source; and
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
;
in subsection (b), by striking paragraphs (1) and (2) and inserting the following:
at least 6 months prior to the date of the discontinuance or interruption; or
if compliance with subparagraph (A) is not possible, as soon as practicable; or
in the case of a notice of a surge in demand for a drug, as soon as practicable.
in subsection (c)—
by striking discontinuance or interruption
and inserting discontinuance, interruption, or surge in demand
; and
by inserting and outsourcing facilities (as defined in section 503B(d))
after patient organizations
; and
in subsection (h)—
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
;
by amending paragraph (2) to read as follows:
drug shortageor
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—
how the drug is prepared or dispensed, including the route of administration and dosage form; and
information reported by manufacturers, health care professionals, and patients;
in paragraph (3)(B), by striking the period at the end and inserting ; and
; and
by adding at the end the following:
surgemeans an increase in demand or projected demand for a drug that the manufacturer likely will be unable to meet without meaningful shortfall or delay.
Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b) is amended—
by striking appears
and inserting appeared
; and
by striking at the time of
and inserting at any time during the 180-day period ending on the date of
;
in subsection (a)(10)(A)(iii)—
in subclause (VIII), by striking the semicolon at the end and inserting ; and
;
by striking subclause (IX); and
by redesignating subclause (X) as subclause (IX);
by redesignating the 2 subsections (d) (relating to definitions and relating to obligation to pay fees) as subsections (e) and (f), respectively; and
by inserting after subsection (c) the following:
Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a) is amended—
This medication has been compounded for dispensing to an individual patient and has not been approved by the Food and Drug Administration.
National Formulary monographand inserting
National Formulary drug or dietary supplement monograph.