FDA Proposes to End Exemptions for Use of Ozone Depleting Substances in Medical Devices

The Food and Drug Administration is eliminating an exemption to the ban on the use of chlorofluorocarbons (CFCs) and other ozone depleting substances (ODSs) in sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation, it said in an interim final rule (here). The end of the “essential use” exemption will take effect Feb. 23, unless comments opposing the final rule are received by Dec. 27. If that happens, FDA may withdraw its interim rule and consider the changes under an identical proposed rule (here), with comments also due Dec. 27. Separately, FDA is also proposing to eliminate the “essential use” exemption for use of CFCs and other ODSs in anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application. Comments on that proposed rule (here) are due Dec. 27.