OTCS 2000: Achievements and Challenges

Drug information journal : DIJ / Drug Information Association volume 34, pages693–701(2000)Cite this article

Abstract

The last 30 years has brought significant changes to self care through responsible self medication. From being essentially unregulated in the 1960s, over-the-counter (OTC) medicines have been transformed by the evolving statutory and regulatory initiatives into a mature market with a high level of consumer confidence in their safety and expected benefits. This paper reviews the legislative/regulatory achievements that have modernized self care with OTCs, including the statutory and regulatory basis for OTCness, the criteria and studies used as a basis for permitting OTC availability, and the paradigm for interaction between regulators and sponsors, as well as the challenges still facing the industry.

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Affiliations

  1. Senior Vice President and Director of Science & Technology, Consumer Healthcare Products Association, 1150 Connecticut Ave. NW, Washington, District of Columbia, 20006, USA

    R. William Soller PhD

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  1. R. William Soller PhD
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Correspondence to R. William Soller PhD.

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Soller, R.W. OTCS 2000: Achievements and Challenges. Ther Innov Regul Sci 34, 693–701 (2000). https://doi.org/10.1177/009286150003400305

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Key Words

  • Over-the-counter medicines
  • Self care