What is happening with CFC-albuterol MDIs?
EPA coordinates with the United States Food and Drug Administration (FDA) to determine which CFC MDIs continue to be essential for public health as alternatives penetrate the market. In 2005, FDA removed the essential use designation for albuterol used in oral pressurized MDIs as of December 31, 2008 FDA rulemaking (PDF) (26, pp., 212 kb, About PDF). Therefore, after December 31, 2008, CFC-albuterol MDIs cannot be sold, distributed or offered for sale or distribution in interstate commerce pursuant to Section 610 of the Clean Air Act (information on nonessential products ban). The term “interstate commerce” refers to the product’s entire distribution chain up to, and including, the point of sale to the ultimate consumer. Will I still be able to purchase an albuterol MDI after December 31, 2008? Yes. Only CFC-albuterol MDIs are being phased out. CFC-free albuterol MDIs (i.e. HFA MDIs) are available. There are currently four HFA MDIs available to patients – three that contain albuterol a
