Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation


The Food and Drug Administration (FDA, the Agency, or we) is proposing to repeal a regulation that requires an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA) for any drug product that is sterilized by irradiation (the irradiation regulation). Repealing the irradiation regulation would mean that over- the-counter (OTC) drug products that are generally recognized as safe and effective, that are not misbranded, and that comply with all applicable regulatory requirements can be marketed legally without an NDA or ANDA, even if they are sterilized by irradiation. FDA is proposing to take this action because the irradiation regulation is out of date and unnecessary. The technology of controlled nuclear radiation for sterilization of drugs is now well understood, and our regulations require that OTC drugs be manufactured in compliance with current good manufacturing practices (CGMPs). Appropriate and effective sterilization of drugs, including by irradiation, is adequately addressed by the CGMP requirements. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.

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