OTC drug filing and review process in the US

  • Priyal Nayi K.B. Institute of Pharmaceutical Education and Research, Kadi Sarva Vishwa Vidyalaya, Gandhinagar, Gujarat
  • Maitreyi Zaveri
  • Dhaval Sheth US Head - Regulatory Affairs, Neoplus Translation and Neocubes Pharma
  • Niranjan Kanaki


The Over-the-Counter (OTC) Drug Monograph System in the United States (US) serves as a vital regulatory framework for non-prescription medications. Through the monograph review process there is a low regulatory burden for industry to market OTC drugs and that helps to keep OTC drug costs low to consumers. As, this process is applicable only in the US the OTC drug filing and review process becomes streamline and due to its limited time exposure this process is not time consuming.

There are mainly two pathways to bring a OTC drug in the US: (a) NDA, (b) OTC drug review process. By comparing both the procedures NDA submission is time consuming process and as of that for OTC review process, if drugs meet the conditions specified in the monograph OTC drug can be marketed in a more streamline process. Administrative order process provides sponsor or requestors and the FDA to issue an order. As, the three phase rulemaking process is removed after the enactment of CARES act, the OTC monograph reform encountered several challenges and is beneficial. OTC Monograph System, serves as a cornerstone for ensuring the accessibility, safety, and efficacy of a diverse range of OTC drugs.

The proposed study is based on review process for various OTC monograph drugs. This research is focused on the regulatory pathway that facilitates the approval of non-prescription medications, the study explores the historical evolution and current functioning of the OTC Monograph System.

Keywords: Over the counter (OTC) drug review process, OTC Monograph Order Request (OMOR), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)


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1. Understanding Over-the-Counter Medicines [Internet]. FDA; 2018 May 16 [cited 2024 Jan 05]. Available from:
2. Drug Application Process for Nonprescription Drugs [Internet]. FDA; 2022 Jun 28 [cited 2023 Dec 26]. Available from:
3. OTC Monograph Reform in the CARES Act [Internet]. FDA; 2023 Oct 04 [cited 2024 Feb 05]. Available from:
4. Lumanity. NDA Versus OTC Monograph: Which Pathway is Right for You? [Internet]. Lumanity; 2004 [cited 2024 Jan 22]. Available from:
5. OTC Monographs @ FDA [Internet]. FDA; 2020 Oct [cited 2024 Feb 03]. Available from:
6. OTC Drug Review Process [Internet]. FDA; 2023 Oct 10 [cited 2024 Jan 18]. Available from:
7. Over-The-Counter Monograph Drug User Fee Program (OMUFA) [Internet]. FDA; 2024 Mar 28 [cited 2024 Apr 16]. Available from:
8. Over-the-Counter Monograph Order Requests: Format and Content: Guidance [Internet]. FDA; 2023 Apr [cited 2024 May 12]. Available from:
9. Providing Over-the-Counter Monograph Submissions in Electronic Format: Guidance [Internet]. FDA; 2023 Sept [cited 2024 Mar 27]. Available from:
10. Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2024 [Internet]. Federal Register; 2024 Mar 29 [cited 2024 Apr 11]. Available from:
11. Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program: Guidance [Internet]. FDA; 2022 Nov [cited 2024 Mar 03]. Available from:
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How to Cite
Nayi, P., M. Zaveri, D. Sheth, and N. Kanaki. “OTC Drug Filing and Review Process in the US”. International Journal of Drug Regulatory Affairs, Vol. 12, no. 2, June 2024, pp. 73-79, doi:10.22270/ijdra.v12i2.677.

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