Notice2025-10253
Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 5, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000037) entitled "Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the- Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms." This proposed order, if finalized, will require over-the- counter (OTC) monograph drugs in an orally disintegrating tablet (ODT) or film dosage form that are subject to specified OTC monographs to be packaged in single-unit or unit-dose containers.
Full Text
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<title>Federal Register, Volume 90 Issue 107 (Thursday, June 5, 2025)</title>
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[Federal Register Volume 90, Number 107 (Thursday, June 5, 2025)]
[Notices]
[Pages 23941-23942]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10253]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1359]
Over-the-Counter Monograph Condition B001: Single-Unit or Unit-
Dose Containers for Over-the-Counter Monograph Drugs in Orally
Disintegrating Tablet and Film Dosage Forms
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability on its website of the proposed administrative order
(proposed order) (OTC000037) entitled ``Over-the-Counter Monograph
Condition B001: Single-Unit or Unit-Dose Containers for Over-the-
Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage
Forms.'' This proposed order, if finalized, will require over-the-
counter (OTC) monograph drugs in an orally disintegrating tablet (ODT)
or film dosage form that are subject to specified OTC monographs to be
packaged in single-unit or unit-dose containers.
DATES: Submit electronic comments on the proposed administrative order
by August 4, 2025.
ADDRESSES: The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of August
4, 2025. Please note that late, untimely filed comments will not be
considered. Instructions for submitting comments are contained in the
proposed order OTC000037, which can be viewed in the OTC Monographs@FDA
portal at <a href="https://dps.fda.gov/omuf">https://dps.fda.gov/omuf</a>. Comments must be submitted
electronically.
FOR FURTHER INFORMATION CONTACT: Shannon Liu, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-2484.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing the proposed order OTC000037 pursuant to section
505G(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355h(b)(2)), which permits the Agency to issue an administrative
order at its initiative. Section 505G(b)(7) of the FD&C Act (21 U.S.C.
355h(b)(7)) explicitly permits an administrative order issued under
section 505G(b)(2) to include requirements for the packaging of a drug
to encourage use in accordance with labeling, such as through
requirements for unit-dose packaging, requirements for products
intended for use by pediatric populations, and requirements to reduce
risk of harm from unsupervised ingestion.
This proposed order, if finalized, establishes packaging
requirements for OTC monograph drugs in an ODT or film dosage form that
are subject to an OTC monograph listed in the proposed order. In
addition to meeting the applicable OTC monograph conditions and other
applicable requirements under section 505G of the FD&C Act, these OTC
monograph drugs in ODT or film dosage forms would, if the proposed
order is finalized, be explicitly required to be packaged in single-
unit or unit-dose containers in order to be
[[Page 23942]]
considered generally recognized as safe and effective and not
misbranded.
As we develop any final order on this topic, FDA will consider
comments on the applicability of Executive Order 14192, in particular,
on any costs or cost savings.
The proposed order can be viewed in the OTC Monographs@FDA portal
at <a href="https://dps.fda.gov/omuf">https://dps.fda.gov/omuf</a>. The proposed order contains instructions
for commenting on the proposed order. Comments to the proposed order
must be submitted electronically to the Federal eRulemaking Portal
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
OTC Monographs@FDA provides a resource for the public to view
administrative orders (proposed, final, and interim final orders) for
OTC Monograph Drugs and view OTC Monographs. In the future, OTC
Monographs@FDA will facilitate the public's ability to submit, search,
and view comments and data for proposed, final, and interim final
orders.
II. Paperwork Reduction Act of 1995
The proposed order is issued under section 505G(b)(2) of the FD&C
Act. Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501-3521) does not apply to collections of
information made under section 505G of the FD&C Act. Therefore,
clearance by the Office of Management and Budget under the PRA is not
required for collections of information, if any, in a final order
issued under section 505G of the FD&C Act that results from this
proposed order.
Dated: June 2, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10253 Filed 6-4-25; 8:45 am]
BILLING CODE 4164-01-P
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