In a Federal Register Notice (FRN) published on October 26, 2016 the United States Food and Drug Administration (FDA) announced an amendment to its regulations regarding the uses of certain ozone-depleting substances (ODSs).

In the current regulations, “essential use” products are exempt from the ban on ODSs under the Clean Air Act and the Environmental Protection Agency (EPA). This final rule will remove the designation for certain “essential use” products. According to the notice, “The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation.”

This FDA direct final rule regarding ODSs will go into effect on February 23, 2017. Comments may be submitted until December 27, 2016.

The notice can be accessed here

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