Page 12 - Community pharmcy practice E-book 2025
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31/10/2025, 23:40 Community Pharmacy Practice - Course Materials
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)
Safe Use of Nonprescription Drugs
Adulteration and Misbranding Labeling
Adverse Drug Reaction Reporting Abuse
Adulteration and Misbranding
A nonprescription drug is adulterated if it contains a substance that may make the product
harmful to consumers
A nonprescription medication is considered misbranded if its labeling is false or misleading, if it
does not bear the required labeling information, or if the container is made or filled in a
deceptive manner
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