Page 18 - COMMUNITY PHARMACY PRACTICE
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02/04/2024
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Development and Regulation of OTC
(Nonprescription) Drug Products
• Over-the-counter (OTC) drugs are developed under the
OTC Monograph Process or through the New Drug
Application (NDA) Process
• FDA's monograph process
• New OTC drug process
• to ensure that they are properly labeled and that their
benefits outweigh their risks.
• They are regulated by the center for drug evaluation and
research (division of FDA)
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By
Prof Alyaa A Ramadan, PhD
Department of Pharmaceutics,
Faculty of Pharmacy
Alexandria University
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