FDA Finalizes Guidance on Evaluation of Therapeutic Equivalence, Reinforcing Drug Selection Standards

What this means for your practice

This finalized guidance offers critical clarity for all healthcare businesses involved in prescribing or dispensing medications, including telehealth platforms, medspas, and dental practices. Understanding FDA's therapeutic equivalence evaluations and codes (TE codes) is essential for compliant and cost-effective drug product selection. Practices that emphasize generic prescribing or seek to optimize patient costs must ensure their prescribing practitioners and pharmacists are familiar with the Orange Book and the principles outlined in this guidance to confidently select therapeutically equivalent, multisource prescription drugs. Non-adherence to these principles, even if unintentional, could lead to questions regarding drug efficacy, patient safety, and economic stewardship.

The Food and Drug Administration (FDA) has announced the availability of its final guidance for industry titled "Evaluation of Therapeutic Equivalence." This publication, a notice of availability in the Federal Register, signifies a crucial update for stakeholders involved in drug product selection, prescribing, and dispensing across the healthcare sector.

Understanding Therapeutic Equivalence

The core of this guidance lies in explaining the FDA's perspective on therapeutic equivalence evaluations and the associated therapeutic equivalence codes (TE codes). Therapeutic equivalence refers to drug products that are pharmaceutical equivalents and for which the rate and extent of absorption of the active ingredient do not show a significant difference under suitable test conditions. In essence, therapeutically equivalent drug products can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

The Role of the Orange Book

FDA's therapeutic equivalence evaluations are a cornerstone of public information for multisource prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These evaluations are meticulously listed in the active section of the "Approved Drug Products With Therapeutic Equivalence Evaluations," more commonly known as the Orange Book. The Orange Book serves as an indispensable resource for healthcare professionals seeking to identify equivalent drug products.

Purpose and Impact

The FDA emphasizes that these therapeutic equivalence evaluations have been prepared to serve multiple vital functions:

• Public Information and Advice: They provide transparent data and expert advice to state health agencies, prescribers, and pharmacists.
• Public Education: They promote a better understanding among the public regarding drug product selection.
• Cost Containment: By facilitating the appropriate use of therapeutically equivalent generic drugs, the guidance helps to foster the containment of health care costs.

This final guidance formalizes the agency's thinking, finalizing a draft guidance of the same title that was initially issued in July 2022. Its release on August 24, 2026, reinforces the FDA's commitment to ensuring clarity and consistency in the evaluation of drug products.

Submitting Comments on Agency Guidances

The FDA maintains an open channel for feedback on its guidances. Stakeholders may submit either electronic or written comments on agency guidances at any time. For this specific guidance, comments should reference Docket No. FDA-2022-D-0528.

Electronic Submissions

Electronic comments can be submitted via the Federal eRulemaking Portal at www.regulations.gov. It is crucial to follow the instructions for submitting comments. Comments submitted electronically, including any attachments, will be publicly posted to the docket unchanged. Therefore, individuals are solely responsible for ensuring that their comments do not include confidential information such as medical details, Social Security numbers, or confidential business information. If personal identifying information is included in the body of the comments, it will be posted publicly.

Written/Paper Submissions

Written or paper submissions can be mailed or hand-delivered to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written comments, FDA will post the comment and any attachments, with the exception of information explicitly marked and identified as confidential, following specific instructions.

Confidential Submissions

To submit a comment containing confidential information that is not intended for public disclosure, comments must be submitted solely as a written/paper submission. Two copies are required: one original copy clearly marked "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION" and a second copy with the confidential information redacted/blacked out. Both copies should be sent to the Dockets Management Staff. Any information marked as "confidential" will only be disclosed in accordance with 21 CFR 10.20 and other applicable disclosure laws.

Key Facts

| Detail | Value | |---|---| | Agency | Food and Drug Administration (FDA), HHS | | Action | Notice of availability of final guidance | | Guidance Title | Evaluation of Therapeutic Equivalence | | Docket Number | FDA-2022-D-0528 | | Publication Date | August 24, 2026 | | Purpose | Explains FDA's thinking on therapeutic equivalence evaluations and codes; promotes public education in drug product selection; fosters containment of health care costs. |

Frequently Asked Questions

What is the new FDA guidance about?

The guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes) for multisource prescription drug products.

Where can healthcare providers find these therapeutic equivalence evaluations?

They are listed in the active section of the "Approved Drug Products With Therapeutic Equivalence Evaluations," commonly known as the Orange Book.

Who is the primary audience for this guidance?

The guidance is intended to provide public information and advice to state health agencies, prescribers, and pharmacists.

What are the main goals of the FDA's therapeutic equivalence evaluations?

The goals are to promote public education in drug product selection and to foster the containment of health care costs.

Can the public submit comments on this guidance?

Yes, electronic or written comments on Agency guidances may be submitted at any time, referencing Docket No. FDA-2022-D-0528.

Source: FDA — Notice: Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability · 2026-08-24