FDA Issues Final Rule on CFC-based Inhalers

Remaining Chlorofluorocarbon Products to Be Off Market by End of 2013

April 14, 2010 04:30 pm News Staff

Nearly three years after the FDA proposed that ozone-depleting chlorofluorocarbon-based inhalers be eliminated, a final rule(edocket.access.gpo.gov) affecting the last seven such products was published April 14 in the Federal Register.

[Front page of FDA publication on CFC-based inhalers being phased out]

In an April 13 FDA news release(www.fda.gov), agency officials said that three chlorofluorocarbon, or CFC, inhalers will be phased out during the next three years. Specifically,

  • flunisolide, which is marketed as Aerobid Inhaler System, will not be available for sale after June 30, 2011;
  • the combination of albuterol and ipratropium, which is marketed as Combivent Inhalation Aerosol, will not be available for sale after Dec. 31, 2013; and
  • pirbuterol, which is marketed as Maxair Autohaler, will not be available for sale after Dec. 31, 2013.

The phase-out period is intended to give patients time to change their therapeutic regimens. The FDA said patients should continue using their CFC inhalers until they have talked with their physicians about switching to a medication that does not use chlorofluorocarbons as a propellant(www.fda.gov).

Alternative medications include inhalers that use the propellant hydrofluoroalkane, or HFA, instead of CFCs. Other options include dry powder inhalers that don't use propellants and liquids that are used with a nebulizer machine.

Agency officials also said physicians should talk with their patients about how to use their new medications correctly.

Manufacturers already have ceased production of four CFC inhalers that are being phased out of the market by the end of this year. Specifically,

  • nedocromil, which is marketed as Tilade Inhaler, will not be available for sale after June 14, 2010;
  • metaproterenol, which is marketed as Alupent Inhalation Aerosol, will not be available for sale after June 14, 2010;
  • triamcinolone, which is marketed as Azmacort Inhalation Aerosol, will not be available for sale after Dec. 31, 2010; and
  • cromolyn, which is marketed as Intal Inhaler, will not be available for sale after Dec. 31, 2010.

The CFC phase-out is part of an international agreement to ban substances that deplete the Earth's ozone layer. The United States eliminated production of CFCs in 1996, except for certain limited uses, including CFC-based metered-dose inhalers. Such products were granted "essential-use designation" exemptions until appropriate substitutes could be formulated and widely disseminated.


please wait Processing