FDA Seeks to Repeal Pre-approval Requirements for Drugs Sterilized by Irradiation
Posted 11 September 2018 | By
The US Food and Drug Administration (FDA) proposed a rule on Tuesday that would nix pre-approval requirements for over-the-counter (OTC) drugs sterilized by irradiation.
The agency is looking to take the “deregulatory action” because it has determined that the irradiation regulation is “out of date and unnecessary,” according to the proposed rule.
The decision comes as part of FDA’s implementation of orders
under the Trump administration to scale back regulatory burden. It also seeks to fulfill a 2014 citizen petition from Illinois-based law firm The Wood Burditt Group to revoke the irradiation regulation.
If finalized, approval of a new drug application or an abbreviated new drug application would no longer be required to legally market OTC drugs sterilized by irradiation in the US. This exemption would stand as long as the drugs products have been “generally recognized as safe and effective,” and comply with FDA requirements on current good manufacturing practices.
FDA’s interpretation on the sterilization of drugs by irradiation was set forth in 1955 as one of the areas that had been previously identified in a list
of new drugs under federal regulations.
But the technology used in controlled nuclear radiation for drug sterilization has “become well understood,” FDA said, citing standards developed by the Association for the Advancement of Medical Instrumentation and the International Organization for Standardization, among others.