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GUIDANCE DOCUMENT

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs March 2026

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2022-D-1864
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Regulatory Policy

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.” This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes (referred to as “topical products”). This guidance provides recommendations for physicochemical and structural (collectively, “Q3”) characterizations that can be used to identify the dosage form of a proposed generic (test) topical product, and to describe properties of the drug product that may be critical to its performance (to support a demonstration of bioequivalence (BE)). This guidance finalizes the draft guidance of the same title issued on October 21, 2022.

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All written comments should be identified with this document's docket number: FDA-2022-D-1864.

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