Frequently Asked Questions

• Frequently Asked Questions

Recent Communications

• November 19, 2024: From Our Perspective: OMUFA - Past, Current, and Future
• November 7, 2024: FDA Press Release: FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review
• June 14, 2024: CDER Statement: FDA issues agency-initiated proposed order regarding OTC monograph drugs containing acetaminophen
• September 14, 2023: CDER Statement: FDA clarifies results of recent advisory committee meeting on oral phenylephrine
• December 16, 2022: CDER Conversation: An Update on Sunscreen Requirements: The Deemed Final Order and the Proposed Order
• October 3, 2022: CDER Statement: FDA Expands CDER NextGen Portal to Enable Certain Electronic Over-the-Counter (OTC) Monograph Submissions
• September 20, 2021: FDA-in-Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter (OTC) Drugs
• March 25, 2021: FDA-in-Brief: FDA Republishing Fee Rates under the Over-the-Counter Monograph Drug User Fee Program
• August 6, 2020: FDA Voices: AN Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act - Anh's Note: Failed on Live too
• March 30, 2020: FDA Statement: FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation

Catalogue of Pre-OMUFA Documents

• Catalogue of Pre-OMUFA Documents

Presentations

• "The Nonprescription Drug Facts Label in a Changing Consumer Marketplace 2021" webinar presentation from June 9, 2021
• "OTC Monograph Reform in the CARES Act: Safety Orders External Link Disclaimer" webinar presentation from January 27, 2021
• "Monograph reform is here! Learn what to expect and how to prepare" webinar presentation from May 29, 2020

Meetings

• 12/2/2024 FDA and Industry OMUFA Implementation Meeting Minutes
• 8/5/2024 FDA and Industry OMUFA Implementation Meeting Minutes
• 4/24/2024 FDA and Industry OMUFA Implementation Meeting Minutes
• 12/04/2023 FDA and Industry OMUFA Implementation Meeting Minutes
• 8/29/2023 FDA and Industry OMUFA Implementation Meeting Minutes
• 6/6/2023 FDA and Industry OMUFA Implementation Meeting Minutes
• 12/1/2022 FDA and Industry OMUFA Implementation Meeting Minutes
• 9/1/2022 FDA and Industry OMUFA Implementation Meeting Minutes
• 4/19/2022 FDA and Industry OMUFA Implementation Meeting Minutes
• 12/13/2021 FDA and Industry OMUFA Implementation Meeting Minutes
• 8/31/2021 FDA and Industry OMUFA Implementation Meeting Minutes
• 4/13/2021 FDA and Industry OMUFA Implementation Meeting Minutes

Guidance Documents

• 12/22/2025 - FDA issues final guidance for industry "Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug and Cosmetic Act"
• 07/25/2024 - FDA issues final guidance for industry "Providing Over-the-Counter Monograph Submissions in Electronic Format"
• 06/22/2023 - FDA issues draft guidance for industry "Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act"
• 04/12/2023 - FDA issues draft guidance for industry "Over-the-Counter Monograph Order Requests (OMORs): Format and Content"
• 02/01/2022 - FDA posts draft guidance for industry "Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs"
• Search for FDA Guidance Documents

Historical Status of OTC Rulemakings

• Status of OTC Rulemakings Prior to the CARES Act

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