Notice2025-10252
Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs
Primary source
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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) (OTC000038) entitled "Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs." This proposed order, if finalized, will permit minor dosage form changes, i.e., from tablets or capsules to chewable tablets, orally disintegrating tablets, or films, of over-the-counter (OTC) monograph drugs that are in conformity with the requirements of the order, the Federal Food, Drug, and Cosmetic Act (FD&C Act), and other applicable requirements, without the issuance of a separate order amending an applicable OTC monograph to add the new dosage form or otherwise finding the new dosage form to be generally recognized as safe and effective (GRASE).
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 23940-23941]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10252]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1360]
Over-the-Counter Monograph Procedure for Minor Changes C001:
Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter
Monograph Drugs
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) (OTC000038) entitled ``Over-the-Counter Monograph
Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage
Forms for Certain Over-the-Counter Monograph Drugs.'' This proposed
order, if finalized, will permit minor dosage form changes, i.e., from
tablets or capsules to chewable tablets, orally disintegrating tablets,
or films, of over-the-counter (OTC) monograph drugs that are in
conformity with the requirements of the order, the Federal Food, Drug,
and Cosmetic Act (FD&C Act), and other applicable requirements, without
the issuance of a separate order amending an applicable OTC monograph
to add the new dosage form or otherwise finding the new dosage form to
be generally recognized as safe and effective (GRASE).
DATES: Submit electronic comments on the proposed administrative order
by October 3, 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
October 3, 2025. Please note that late, untimely filed comments will
not be considered. Instructions for submitting comments are contained
in the proposed order OTC000038, 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 announcing the availability of the proposed order OTC000038
pursuant to section 505G(c) of the FD&C Act (21 U.S.C. 355h(c)), which
specifies FDA's proposed requirements for making a minor change in the
dosage form of certain OTC monograph drugs, without the issuance of a
separate order under section 505G(b) of the FD&C Act amending an
applicable monograph to add the new dosage form or otherwise finding
the new dosage form to be GRASE. Section 505G(c) of the FD&C Act
applies to drugs described in section 505G(a)(1) or (a)(2) of the FD&C
Act or that are otherwise the subject of an order under section
505G(b). More specifically, section 505G(c)(3) of the FD&C Act directs
FDA to issue one or more administrative orders specifying the
requirements for determining whether a minor dosage form change to a
drug made by a sponsor pursuant to section 505G(c) of the FD&C Act will
affect the safety or effectiveness of the drug or materially affect the
extent of absorption or other exposure to an active ingredient in the
drug in comparison to a suitable reference product.
This proposed order also fulfills a commitment made by FDA under
the terms of the ``Over-the-Counter Monograph User Fee Program
Performance Goals and Procedures,'' commonly referred to as the OMUFA
commitment letter (the document can be accessed at <a href="https://www.fda.gov/media/106407/download">https://www.fda.gov/media/106407/download</a> and the document with the updated goal dates for
fiscal years 2021 to 2025 can be accessed at <a href="https://www.fda.gov/media/146283/download">https://www.fda.gov/media/146283/download</a>). The OMUFA commitment letter specifies goals and
timelines mutually agreed upon by FDA and industry with respect to
various OTC monograph drug activities conducted by FDA. FDA committed
to issuing a proposed order outlining key requirements to clarify which
types of minor changes to solid oral dosage forms are permissible
without the issuance of an order finding the new dosage forms to be
GRASE (when the applicable OTC monograph does not already provide for
these types of changes), together with related draft guidance (FDA is
publishing notice of the draft guidance for industry ``Recommendations
for Complying With Over-the-Counter Monograph Procedure for Minor
Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain
Over-the-Counter Monograph Drugs'' elsewhere in this issue of the
Federal Register).
Consistent with section 505G(c)(3) of the FD&C Act, FDA proposes to
specify the requirements for determining whether a particular minor
dosage form change to a drug made by a sponsor
[[Page 23941]]
pursuant to section 505G(c) will affect the safety or effectiveness of
the drug or materially affect the extent of absorption or other
exposure to an active ingredient in the drug product in comparison to a
suitable reference product. This proposed order specifies these
requirements for when the minor dosage form change is from a tablet or
capsule dosage form to one of the following dosage forms: chewable
tablet, ODT, or film. The proposed order, if finalized, will permit
these minor changes in the dosage form of OTC monograph drugs that are
both highly soluble and highly permeable and in conformity with the
requirements of the order, section 505G(c) of the FD&C Act, and other
applicable requirements, without the issuance of a separate order under
section 505G(b) of the FD&C Act to amend the applicable OTC monograph
to add the new dosage form or otherwise find the new dosage form to be
GRASE.
FDA plans to separately consider minor changes in dosage form under
section 505G(c) of the FD&C Act from tablets or capsules to chewable
tablets, ODTs, or films for OTC monograph drugs with active ingredients
that are not both highly soluble and highly permeable (i.e., drugs that
have: (1) low solubility and high permeability; (2) high solubility and
low permeability; and (3) low solubility and low permeability). In the
future, FDA plans to issue a separate notice announcing a request for
information that would seek comments on minor changes in dosage form
under section 505G(c) of the FD&C Act for these types of drugs. Any
comments on minor changes in solid oral dosage forms under section
505G(c) for OTC monograph drugs that are not both highly soluble and
highly permeable that are submitted to the docket for this proposed
order (OTC000038) will be considered outside the scope of this proposed
order and will not be considered as part of a finalization of proposed
order OTC000038.
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
This proposed order contains no collections of information that are
subject to clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The
proposed order is issued under section 505G(c) of the FD&C Act. Under
section 505G(o) of the FD&C Act, the PRA does not apply to collections
of information made under section 505G of the FD&C Act. Moreover, the
labeling changes proposed in this order are excluded from the
definition of ``collection of information'' under the PRA by 5 CFR
1320.3(c)(2), which states that ``The public disclosure of information
originally supplied by the Federal government to the recipient for the
purpose of disclosure to the public is not included within this
definition.'' 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. 2025-10252 Filed 6-4-25; 8:45 am]
BILLING CODE 4164-01-P
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