Rule2025-01840
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
January 27, 2025
Effective
March 21, 2025
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) is delayed until March 21, 2025.
Full Text
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<title>Federal Register, Volume 90 Issue 16 (Monday, January 27, 2025)</title>
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[Federal Register Volume 90, Number 16 (Monday, January 27, 2025)]
[Rules and Regulations]
[Pages 8173-8174]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-01840]
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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)
is delayed until March 21, 2025.
DATES: The effective date for the final rule published December 26,
2024, (89 FR 105288), is delayed until March 21, 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 has decided to delay the
effective date of the final rule, ``Nonprescription Drug Product With
an Additional Condition for Nonprescription Use'' (89 FR 105288), until
March 21, 2025. 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
[[Page 8174]]
comment is impracticable, unnecessary, and contrary to the public
interest. The temporary delay in the effective date until March 21,
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 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
January 27, 2025, good cause similarly exists to stay the
effectiveness of the rule published December 26, 2024, and revise
its effective date until March 21, 2025.
Dorothy A. Fink,
Acting Secretary.
[FR Doc. 2025-01840 Filed 1-24-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on January 27, 2025.
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