We reported about the initial FDA announcement;
Changes In Albuterol Delivery System, Albuterol Inhaler With HFA.
Transition to CFC-free Metered Dose Inhalers Moves Forward
Release date: 06/06/2008
Contact Information: Cathy Milbourn, (202) 564-4355 / milbourn.cathy@epa.gov
(Washington, D.C. - June 6, 2008) 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 importation 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 inhalers 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 Dec. 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 Dec. 31, 2008.
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