Metered Dose Inhalers
The Transition to Ozone-Safe Propellants
U.S. Food and Drug Administration (FDA) Resources
This page contains information on the transition to ozone-safe Metered Dose Inhalers (MDIs). A one-page, printable fact sheet on the transition is also available for downloading (1 p., 88 kb, About PDF).
Chlorofluorocarbons (CFCs) deplete the stratospheric ozone layer. A thinner ozone layer allows more harmful ultraviolet (UV) radiation to reach the Earth’s surface. Overexposure to UV radiation can lead to serious health effects, such as skin cancer, cataracts, and immune suppression, as well serious ecological impacts.
The Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol) is a landmark international agreement designed to protect the ozone layer. As a Party to the Montreal Protocol, the United States has committed to phasing out and eventually eliminating substances that deplete the ozone layer, including CFCs. It is estimated that actions to protect and restore the ozone layer will save millions of U.S. lives that would have otherwise been lost to skin cancer.
The shift to CFC-free MDIs is part of a larger transition that has affected many consumer and industrial products and sectors over the last several decades. In 1996, the United States prohibited the production and import of CFCs except for certain essential uses. In fact, MDIs used for the treatment of asthma and chronic obstructive pulmonary disease are among the last uses to switch to ozone-safe alternatives.
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. As of 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.
- A copy of FDA's Albuterol CFC-MDI rule can be found here (25, pp., 278 kb, About PDF).
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 and one that contains levalbuterol.
- Proventil HFA (albuterol sulfate) Inhalation Aerosol
- Ventolin HFA (albuterol sulfate) Inhalation Aerosol
- ProAir HFA (albuterol sulfate) Inhalation Aerosol
- Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol
Will I be able to purchase CFC-albuterol MDIs after December 31, 2008?
No. Under the Nonessential Products Ban, CFC-albuterol inhalers cannot be sold at pharmacies, from online distributors, or from any other sources after December 31, 2008.
Can free health clinics, public health departments, or any other entity provide CFC-albuterol MDIs to patients free of charge after December 31, 2008?
No. No person or entity may sell or distribute CFC-albuteral MDIs after December 31, 2008. This includes the distribution of free CFC-albuterol MDIs by free health clinics, public health departments, or any other entity.
Will I be able to use my CFC-albuterol MDI after December 31, 2008?
Yes. You will not be able to purchase a CFC-albuterol inhaler after December 31, 2008, but you may continue personal use of any CFC-albuterol inhalers purchased prior to this date.
Why is my HFA-albuterol MDI more expensive than my CFC-albuterol MDI?
Your HFA-albuterol MDI may be more expensive than your CFC-albuterol MDI because HFA-MDIs are not currently available in generic form. To assist patients with the higher costs of the HFA-albuterol MDIs, all four HFA-albuterol MDI manufacturers have instituted programs to assist patients with the increased out-of-pocket costs of making the transition. For low-income patients, each manufacturer has eased the income restrictions to receive free and discounted medicines and has streamlined the procedures for applying for assistance. To assist patients who may face a higher co-pay, coupons for free and discounted HFA albuterol MDIs are available through physicians, at pharmacies, and for download from individual manufacturer websites. For more information about financial assistance programs, please visit :
Epinephrine metered dose inhalers that contain chlorofluorocarbons are being phased out and cannot be sold in the United States after December 31, 2011. Patients who use epinephrine CFC inhalers need to talk to their health care professionals and switch to another medicine before that date.
- A copy of FDA's Epinephrine CFC MDI final rule can be found here (21 pp, 260 KB, About PDF)
- Questions and answers about the Epinephrine phaseout is available from FDA
When will other inhalers that contain CFCs be affected?
On April 14, 2010, FDA announced that seven metered dose inhalers that contain CFCs are being phased out in the United States.
- A copy of this rule can be found here (29 pp, 256 KB).
- Questions and answers about the phaseout of these 7 MDIs is available from FDA
Dates for the phase-out of each CFC inhaler have been set. After those dates, these CFC inhalers cannot be made, dispensed, or sold in the United States. The seven CFC inhalers are listed here by their brand names, along with their manufacturers and the last date they can be sold in the United States. The generic names for the medicines appear in parentheses.
- Tilade Inhaler (nedocromil), made by King Pharmaceuticals, last date for sale: June 14, 2010
- Alupent Inhalation Aerosol (metaproterenol), made by Boehringer Ingelheim Pharmaceuticals, last date for sale: June 14, 2010
- Azmacort Inhalation Aerosol (triamcinolone), made by Abbott Laboratories, last date for sale: Dec. 31, 2010
- Intal Inhaler (cromolyn), made by King Pharmaceuticals, last date for sale: Dec. 31, 2010
- Aerobid Inhaler System (flunisolide), made by Forest Laboratories, last date for sale: June 30, 2011
- Combivent Inhalation Aerosol (albuterol and ipratropium in combination), made by Boehringer Ingelheim Pharmaceuticals, last date for sale: Dec. 31, 2013
- Maxair Autohaler (pirbuterol), made by Graceway Pharmaceuticals, last date for sale: Dec. 31, 2013
Four of the seven CFC inhalers are no longer being made. Three CFC inhalers currently in use—Aerobid, Combivent, and Maxair—will be phased out over the next one to three years. These later phase-out dates give patients time to talk with their health care professionals and switch to another medicine.
Additional information on the transition to ozone-safe inhalers is available from the following websites: