Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 8173-8174 [2025-01840]

Agencies

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

[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 [www.gpo.gov]
[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 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 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