Prescription-to-over-the-Counter Switch Criteria


This paper traces the evolution of prescription-to-over-the-counter (OTC) switch criteria and assesses the impact of new developments in this and related areas, as a means to create a conceptual framework for considering the future of prescription-to-OTC switch. Over the past two decades, switch criteria have evolved from the foundational definitions of safety, effectiveness, and labeling in the OTC Review through the pharmacological interpretations of OTCness in Peck’s Principles, to the modern day focus in DeLap’s Principles on the consumer as the focal point for studying endpoints of self-care. Today’s switch criteria represent a solid regulatory/scientific foundation for the next evolution of OTC drugs: to treat chronic conditions and diseases, which are not being adequately treated with current health care options. Further dialogue on the potential for OTC access to enhance collaborative self-care should be actively considered.

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Correspondence to R. William Soller PhD.

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Soller, R.W. Prescription-to-over-the-Counter Switch Criteria. Ther Innov Regul Sci 36, 309–317 (2002).

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Key Words

  • Prescription
  • OTC
  • Switch criteria
  • Self-care