Over-the-Counter (OTC) Applications

What is an Over-the-Counter Application? The Over-the-Counter Application is the documentation submitted to the FDA to gain approval to manufacture and market non-prescription or OTC medications. This documentation can either be an NDA or an ANDA based on the chosen marketing pathway.

Pathways for Marketing Approval of OTC drugs.

Direct-to-OTC pathway is used for drugs that have not previously received approval as a prescription drug and requires the submission of an NDA. These drugs are often already approved in foreign markets, and the FDA has post-marketing data available to them.

Prescription-to-OTC switch is used for drugs that have previously been granted NDA or ANDA approval. There are two types of prescription-to-nonprescription switches.

  • Full switch requires the submission of an efficacy supplement by the sponsor. On approval, the drug will only be available as a non-prescription drug. 
  • Partial switch, during which the sponsor only switches some indications to non-prescription status. This requires the submission of a new NDA.

Additional requirements for OTC drug approvals

  • Compliance with the OTC drug monograph system.
  • Consumer studies demonstrating label comprehension, the ability of consumers to decide if the drug is appropriate for them, and prevention of use-related hazards.
  • Efficacy and safety data, and post-marketing safety data for prescription-to-OTC switches.

Source: Center for Drug Evaluation and Research. (2022b, June 28). Drug Application Process for Nonprescription Drugs. U.S. Food and Drug Administration. Retrieved August 22, 2022, from https://www.fda.gov/drugs/types-applications/drug-application-process-nonprescription-drugs