FDA Proposes to End Drug Approval Requirement for Irradiated OTC Drugs

The Food and Drug Administration is proposing to eliminate drug approval requirements for pharmaceuticals sterilized by irradiation. Currently, any irradiated drug is considered a new drug by the agency. But under the proposal, over-the-counter drugs that are marketed pursuant to the OTC Drug Review and that are generally recognized as safe and effective could be marketed legally without an FDA-approved new drug application or abbreviated new drug application, even if they are sterilized by irradiation, FDA said. Now that the technology of controlled nuclear radiation for sterilization of drugs is well understood, “repealing the irradiation regulation would eliminate a requirement that is no longer necessary, and will not diminish public health protections,” FDA said.