Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 13553-13554 [2025-04978]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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 [www.gpo.gov]
[FR Doc No: 2025-04978]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

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.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

========================================================================


Federal Register / Vol. 90, No. 56 / Tuesday, March 25, 2025 / Rules 
and Regulations

[[Page 13553]]



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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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 
https://www.ofr.gov and the Government Publishing Office's website at 
https://www.gpo.gov.

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.
---------------------------------------------------------------------------

    \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