Allocation of Essential Use Allowances for Calendar Year 2008
Transition to CFC-Free Metered Dose Inhalers Moves Forward
For the 2008 calendar year, EPA has allocated 27.0 metric tons of CFC-114 for the manufacture of epinephrine metered dose inhalers (inhalers). In accordance with the Montreal Protocol on Substances that Deplete the Ozone Layer and the Clean Air Act, EPA phased out chlorofluorocarbons (CFCs) in 1996, with limited exemptions. One of those exemptions is production and import of CFCs for use in essential use inhalers to treat asthma and chronic obstructive pulmonary disease.
Each year, in coordination with the U.S. Food and Drug Administration (FDA), EPA allocates essential use allowances to pharmaceutical companies to manufacture essential use inhalers that use CFCs as a propellant. Essential use allowances permit the production and import of CFCs after the 1996 phaseout solely for manufacturing essential use inhalers. FDA’s determination is based on the amount of CFC inhalers necessary to protect public health.
The transition to CFC-free MDIs is well underway and is part of a larger transition that has affected many other consumer and industrial products and sectors over the last several decades. Since 1996, EPA has significantly reduced the amount of CFCs allocated to pharmaceutical companies to manufacture essential use inhalers. In 1998, EPA allocated 4,365 metric tons, and in 2007, allocated 167.0 metric tons.
An important factor in the transition to CFC-free inhalers - although separate from today’s CFC allocation rule – is an upcoming prohibition on the sale and distribution of CFC-propelled inhalers containing albuterol. After December 31, 2008, EPA regulations will prohibit the sale and distribution of CFC-albuterol metered dose inhalers. There are now four albuterol inhalers available propelled by ozone-safe hydrofluoroalkanes (HFAs), rather than CFCs.
To foster coordination and education between patients and health-care providers, on May 30, 2008, FDA issued a public health advisory to alert patients, caregivers, and health care professionals that CFC-propelled albuterol inhalers will not be available after December 31, 2008. More information on the transition for albuterol inhalers is available at FDA’s web site.