Progress On Adding OTC Drugs To US Market? Room To Move But Label Format Limits Options

Changes for supporting OTC labeling for drugs currently available Rx-only and indicated for chronic, more complicated conditions, aren’t minor and won’t happen within limits of one-dimensional text media printed on OTC drug containers, packages and inserts.

Some problems with OTC Drug Facts labels required in the US are worse than others and some likely can be corrected with minor changes to the format, labeling experts agreed during a recent Food and Drug Administration webinar.

Other changes, notably for supporting OTC labeling for drugs that currently are available Rx-only and are indicated for chronic, more complicated conditions, aren’t minor and won’t happen within the limits of one-dimensional text media

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