Dextromethorphan serves as a safe, effective antitussive ingredient in many critical OTC cough and cold formulations. While reasonable age restrictions may curb adolescent misuse without limiting adult access, lawmakers should refrain from unnecessary additional barriers. Targeted age controls strike the right balance between safety and availability.
The advertising of nonprescription, over-the-counter medicines helps acquaint the public with these products and must be truthful, not misleading, and must meet high standards reflecting the nature of the product advertised.
This proposed safety administrative order addresses the GRASE status of OTC oral health care drug products containing benzocaine alone or with phenol preparations labeled for anesthetic/analgesic indications (21 CFR 356).
While VOCs can have environmental impacts in aggregate, existing alternatives don’t always provide the consistent therapeutic results needed for OTC products relied upon by millions for. As such, any legislation aimed at further restricting pharmaceutical VOCs must carefully weigh potential unintended consequences on public health.
This white paper provides guidance for the evaluation and reporting of impurities in OTC monograph drug products formulated as topicals and topical rinses. This document serves as CHPA's member company consensus on this complex issue.
CHPA supports a review of existing rules and coordination efforts to identify opportunities that could mitigate shortage risks during times of peak need.
The Health in Hand Foundation is dedicated to helping consumers lead happier, healthier lives by providing information and guidance on how to safely use, store, and dispose of OTC medicines, dietary supplements, and consumer medical devices.
