View Rule

This would repeal a requirement that any drug sterilized by irradiation is considered a new drug” and subject to the approval requirements of a new drug and not to be produced under an OTC monograph. This would mean that FDA pre-approval would no longer be required for over-the-counter drugs sterilized by irradiation that otherwise could be marketed legally without an approved new drug application or abbreviated new drug application. FDA is taking this action because the irradiation regulation is out of date and unnecessary. The technology of controlled nuclear radiation is better understood. Other FDA regulations require drugs marketed pursuant to an OTC drug monograph be manufactured in compliance with current good manufacturing practices (CGMPs). Appropriate and effective sterilization, including irradiation, is adequately addressed by the CGMP requirements.