FDA Proposes Removing New Drug Approval Step for Irradiated OTC Drugs

The FDA proposed a rule to allow over-the-counter drugs sterilized by irradiation to be marketed legally without an agency-approved NDA or ANDA.

If finalized, the rule will remove the new drug approval requirement for irradiated OTCs as long as they comply with other regulatory requirements and are generally considered safe and effective.

The FDA said it no longer considers products that undergo irradiation sterilization to necessarily be new drugs. “The technology of controlled nuclear radiation for sterilization of drugs is now well understood, and sterilization is a manufacturing process that is adequately addressed by the regulations governing the OTC drug monograph system and CGMPs,” the agency said, noting that current CGMP regulations have provisions to ensure that sterilization processes including irradiation do not impact a drug’s attributes.