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# OTC Drug Dispute Resolution Guidance
- URL: https://www.fdaweb.com/otc-drug-dispute-resolution-guidance/
- Published: 2023-06-22T12:00:00.000Z
- Updated: 2026-09-14T18:40:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154741

FDA has published a draft guidance, *Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act*, with recommendations on the formal dispute resolution and administrative hearings procedures for resolving scientific and medical disputes between CDER and requestors and sponsors of drugs that will be subject to a final administrative order under Section 505G of the Federal Food, Drug, and Cosmetic Act. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-dispute-resolution-and-administrative-hearings-final-administrative-orders-under-section-505g?utm%5Fmedium=email&utm%5Fsource=govdelivery) covers nonprescription drugs without approved NDAs that are governed by the provisions of Section 505G (over-the-counter monograph drugs).

Specifically, the guidance describes the CDER formal dispute resolution procedures for eligible requestors or sponsors that want to appeal a scientific and/or medical issue related to a final order. It also outlines the procedures for an administrative hearing related to a final order. And it describes the procedures for consolidated proceedings for formal dispute resolution and hearings to resolve scientific and/or medical disputes related to final orders.