Albuterol HFA Multidose Inhalers (MDI)

Albuterol multidose inhalers have been available for many years. Due to the Clean Air Act, substances that deplete the ozone layer, such as chlorofluorocarbons (CFCs) are no longer used in most products.  For pharmaceutical products such as inhalers, there is an exception to the clean air act, allowing some medications with “essential use” to continue to be produced.  In March 2005, the FDA issued a ruling concerning the use of chlorofluorocarbons (CFCs) which stated that the use of CFCs in albuterol inhalers only, may no longer be produced or sold after December 2008.   

To ensure compliance, manufacturers of inhaled albuterol have begun to produce inhalers with a hydrofluoroalkane (HFA) propellant before the mandated December 2008 date.  The “HFA” inhalers are not considered AB rated to the CFC inhalers according to the FDA. 

What this means for physicians is that your patients who require albuterol inhalers currently manufactured with a CFC propellant, need to be switched to an inhaler with an HFA propellant.  The pharmacy can not automatically substitute these, a prescription is required.  HNE has placed ProAir HFA on tier 2 as our preferred albuterol HFA inhaler.  Proventil HFA and Ventolin HFA are available as tier 3 alternatives.  As you begin to transition your patients, please write prescriptions for ProAir HFA or albuterol HFA. 

What this means for patients is that although the effects of the two medications should be the same, there may be differences in the feel of the drug during delivery and the taste of the medication. It is also important to note that while all CFC albuterols contain the same inactive ingredients; this is not true of the albuterol HFA products. 

This rule only affects albuterol CFC MDIs. It does not affect other currently marketed asthma or COPD CFC inhalers, which will be evaluated separately as to whether and when they are no longer essential under the FDA regulation. Notably, this action does not affect Combivent MDI, a combination product that contains albuterol as well as ipratropium, since HHS/FDA has designated it as an essential-use product distinct from the single-ingredient albuterol MDIs.