Rule2025-04978
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
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
March 25, 2025
Effective
December 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule, entitled "Nonprescription Drug Product With an Additional Condition for Nonprescription Use," (ACNU) was delayed until March 21, 2025. Additional time is needed for review; therefore, the delay is extended for an additional 60 days.
Full Text
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<title>Federal Register, Volume 90 Issue 56 (Tuesday, March 25, 2025)</title>
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[Federal Register Volume 90, Number 56 (Tuesday, March 25, 2025)]
[Rules and Regulations]
[Pages 13553-13554]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04978]
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Rules and Regulations
Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
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Federal Register / Vol. 90, No. 56 / Tuesday, March 25, 2025 / Rules
and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201 and 314
[Docket No. FDA-2021-N-0862]
RIN 0910-AH62
Nonprescription Drug Product With an Additional Condition for
Nonprescription Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; delay of effective date.
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SUMMARY: In accordance with the memorandum of January 20, 2025, from
the President, entitled ``Regulatory Freeze Pending Review,'' the
effective date of the final rule, entitled ``Nonprescription Drug
Product With an Additional Condition for Nonprescription Use,'' (ACNU)
was delayed until March 21, 2025. Additional time is needed for review;
therefore, the delay is extended for an additional 60 days.
DATES: As of March 21, 2025, the effective date for the final rule
published December 26, 2024, (89 FR 105288), is further delayed to a
new effective date of May 27, 2025.
FOR FURTHER INFORMATION CONTACT: Myla Dellupac, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Silver Spring, MD 20993-0002, 301-837-7461.
SUPPLEMENTARY INFORMATION:
I. Electronic Access and Filing
A copy of the notice of proposed rulemaking (87 FR 38313, June 28,
2022), all comments received, the final rule (89 FR 105288, December
26, 2024), and all background material may be viewed online at <a href="http://www.regulations.gov">http://www.regulations.gov</a> using the docket number listed above. A copy of
this document will be placed in the docket. Electronic retrieval help
and guidelines are available on the website. It is available 24 hours
each day, 365 days each year. An electronic copy of this document may
also be downloaded from the Office of the Federal Register's website at
<a href="http://www.ofr.gov">http://www.ofr.gov</a> and the Government Publishing Office's website at
<a href="http://www.gpo.gov">http://www.gpo.gov</a>.
II. Background
FDA published a final rule, titled ``Nonprescription Drug Product
With an Additional Condition for Nonprescription Use,'' in the Federal
Register on December 26, 2024 (89 FR 105288). That rule was published
with an effective date of January 27, 2025. On January 20, 2025, the
President issued a memorandum titled, ``Regulatory Freeze Pending
Review.'' With respect to rules that have been published in the Federal
Register, but have not taken effect, the memorandum orders agencies
consider postponing the rules' effective dates for 60 days from the
date of the memorandum (i.e., until March 21, 2025) for the purpose of
reviewing any questions of fact, law, and policy the rules may raise.
In accordance with this direction, FDA delayed the effective date
of the final rule, ``Nonprescription Drug Product With an Additional
Condition for Nonprescription Use'' (89 FR 105288), until March 21,
2025. Given that more time is needed to review the rule, FDA is
delaying the effective date an additional 60 days. The final rule
establishes requirements for a nonprescription drug product with an
ACNU, including application, labeling, and postmarketing reporting
requirements. In addition to applicable existing application
requirements, the final rule establishes the specific requirements for
a new drug application (NDA) or abbreviated new drug application (ANDA)
for a nonprescription drug product with an ACNU. In circumstances where
a prescription drug product is already approved, the rule requires an
applicant to submit a separate application for the approval of a
nonprescription drug product with an ACNU, rather than a supplement to
the existing application for the approved prescription drug product.
The final rule establishes specific labeling requirements, including
the content and format of specific labeling statements. Additionally,
the rule requires that an applicant submit a postmarketing report of an
ACNU failure. The final rule clarifies that an ACNU constitutes a
meaningful difference between a prescription drug product and a
nonprescription drug product that makes the nonprescription drug
product safe and effective for use without the supervision of a
practitioner licensed by law to administer such drug; therefore, a
prescription drug product and a nonprescription drug product with an
ACNU with the same active ingredient may be simultaneously marketed
even if they do not have meaningful differences other than the ACNU,
such as different indications or strengths. The final rule specifies
that FDA will refuse to approve an application for a nonprescription
drug product with an ACNU if the application fails to meet applicable
requirements. The final rule exempts a nonprescription drug product
with an ACNU from the requirement to be labeled with adequate
directions for use, provided that certain labeling conditions are met
and the ACNU is implemented by the applicant as approved by FDA.
Finally, the final rule explains certain circumstances in which a
nonprescription drug product with an ACNU would be misbranded.
To the extent that 5 U.S.C. 553 applies to this action, it is
exempt from notice and comment because it constitutes a rule of
procedure under 5 U.S.C. 553(b)(A). Alternatively, FDA's implementation
of this action without opportunity for public comment, effective
immediately, is based on the good cause exceptions in 5 U.S.C.
553(b)(B) and (d)(3). Seeking public comment is impracticable,
unnecessary, and contrary to the public interest. The temporary delay
in the effective date until May 27, 2025, is necessary to give Agency
officials the opportunity for further review and consideration of the
new regulation, consistent with the memorandum described previously.
Given the imminence of the effective date and the brief length of the
extension of the effective date, seeking prior public comment on this
temporary delay would have been impracticable, as well as contrary to
the public interest in the orderly promulgation and
[[Page 13554]]
implementation of regulations.\1\ FDA also believes that affected
entities need to be informed as soon as possible of the extension and
its length in order to plan and adjust their implementation process
accordingly.
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\1\ In the event that this rule does not publish on or before
March 21, 2025, good cause similarly exists to stay the
effectiveness of the rule published December 26, 2024, and revise
its effective date until May 27, 2025.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-04978 Filed 3-21-25; 8:45 am]
BILLING CODE 4164-01-P
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