An OTC drug is considered safe and effective for use by the general public without a prescriber's authorization.
Necessary characteristics for OTC drugs include:
In addition, consumers must be able to self-diagnose, self-select the medication, self-treat, and self-manage the condition for which the OTC drug is intended.
A useful tip for identifying whether the condition(s) for which your product is intended are amenable to OTC use is to check and to see if the condition(s) are addressed under the OTC Drug Review (i.e., the OTC monographs), which is discussed in a later module.
Note that FDA's OTC Drug Review does not cover prescription drug products.
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