Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes). FDA's therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the active section of the "Approved Drug Products With Therapeutic Equivalence Evaluations" (commonly known as the Orange Book). These therapeutic equivalence evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. This guidance finalizes the draft guidance of the same title issued in July 2022.

Full Text

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<title>Federal Register, Volume 91 Issue 162 (Monday, August 24, 2026)</title>
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[Federal Register Volume 91, Number 162 (Monday, August 24, 2026)]
[Notices]
[Pages 54721-54722]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17215]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0528]


Evaluation of Therapeutic Equivalence; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry titled ``Evaluation 
of Therapeutic Equivalence.'' This guidance explains FDA's thinking on 
therapeutic equivalence evaluations and therapeutic equivalence codes 
(TE codes). FDA's therapeutic equivalence evaluations are listed for 
multisource prescription drug products approved under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) in the active section of the 
``Approved Drug Products With Therapeutic Equivalence Evaluations'' 
(commonly known as the Orange Book). These therapeutic equivalence 
evaluations have been prepared to serve as public information and 
advice to state health agencies, prescribers, and pharmacists to 
promote public education in the area of drug product selection and to 
foster containment of health care costs. This guidance finalizes the 
draft guidance of the same title issued in July 2022.

DATES: The announcement of the guidance is published in the Federal 
Register on August 24, 2026.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2022-D-0528 for ``Evaluation of Therapeutic Equivalence.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information

[[Page 54722]]

redacted/blacked out, will be available for public viewing and posted 
on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets 
Management Staff. If you do not wish your name and contact information 
to be made publicly available, you can provide this information on the 
cover sheet and not in the body of your comments and you must identify 
this information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan Hughes, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, 240-702-3970, <a href="/cdn-cgi/l/email-protection#753f1a1b14011d141b5b3d00121d1006351311145b1d1d065b121a03"><span class="__cf_email__" data-cfemail="a4eecbcac5d0ccc5ca8aecd1c3ccc1d7e4c2c0c58accccd78ac3cbd2">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
titled ``Evaluation of Therapeutic Equivalence.'' This guidance 
explains FDA's current thinking on therapeutic equivalence evaluations, 
including the assignment of TE codes, and addresses frequently asked 
questions regarding therapeutic equivalence. FDA's therapeutic 
equivalence evaluations are listed for multisource prescription drug 
products approved under the FD&C Act in the Active section of the 
Orange Book. As FDA explained when it first proposed to make available 
a list of all approved drug products, together with therapeutic 
evaluations of listed products that are available from more than one 
manufacturer, therapeutic equivalence evaluations have been prepared to 
serve as public information and advice to state health agencies, 
prescribers, and pharmacists to promote public education in the area of 
drug product selection and to foster containment of health care costs 
(see, e.g., 44 FR 2932 (January 12, 1979) and 45 FR 72582 (October 31, 
1980)).
    This guidance finalizes the draft guidance titled ``Evaluation of 
Therapeutic Equivalence'' issued on July 21, 2022 (87 FR 43529). FDA 
considered comments received on the draft guidance as the guidance was 
finalized. Changes from the draft to the final guidance include 
revisions to reflect an additional process by which applicants of 
certain 505(b)(2) applications may request TE codes. In addition, minor 
changes were made to improve clarity and to update the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Evaluation of Therapeutic Equivalence.'' 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR 10.30 relating to the submission of a citizen petition have 
been approved under OMB control number 0910-0191. The collections of 
information in 21 CFR 201.56 and 201.57 relating to the content and 
format requirements of labeling for prescription drug products have 
been approved under OMB control number 0910-0572. The collections of 
information in 21 CFR part 314 relating to the content and format of 
new drug applications and abbreviated new drug applications, including 
the results of safety and effectiveness studies, have been approved 
under OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17215 Filed 8-21-26; 8:45 am]
BILLING CODE 4164-01-P


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