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Metered Dose Inhalers
The Transition to Ozone-Safe Propellants

U.S. Food and Drug Administration (FDA) Resources

Press Release: FDA Advises Patients to Switch to HFA-Propelled Albbuterol Inhalers Now (5/30/08)

Public Health Advisory (5/30/08)

FDA Fact Sheet (1p, 188kb, About PDF)

Full Coverage

This page contains information on the transition to ozone-safe MDIs. Click on the links below to learn more about the transition and get answers to many frequently asked questions.

Why are MDIs propelled by CFCs being phased out?

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 an estimated 6.3 million 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.

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Why do MDIs contain propellants?

MDIs use a chemical propellant to push medication out of the inhaler. Two common propellants are CFCs and HFAs (hydrofloroalkanes). HFAs are ozone-safe propellants and are replacements for ozone-depleting CFCs in many sectors. Neither CFCs nor HFAs are medications; they serve only as the propellant that pushes the medication out of the inhaler. There are a variety of active medications that can be contained within MDIs, such as albuterol, flunisolide, cromolyn, and epinephrine.

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What is happening with CFC-albuterol MDIs?

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 FDA rulemaking (PDF) (26, pp., 212 kb, About PDF). Therefore, after 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.

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.

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, pubic health departments, or any other entity provide CFC-albuteral MDIs to patients free of charge after Devember 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 Exit EPA Disclaimer:

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When will other inhalers that contain CFCs be affected?

Eventually, all CFC-MDIs are planned to be phased out. Through the public rulemaking process, the FDA will determine when the remaining CFC-MDIs are no longer an essential use of ODSs.

FDA has proposed the schedule listed below. On the date that the essential use designation is removed for a particular moiety, that CFC-MDI may not be sold, distributed, or offered for sale or distribution in interstate commerce.

CFC MDI moiety Proposed date for removing the "essential use" designation
Flunisolide, Triamcinolone, Metaproterenol, Pirbuterol, Cromolyn, Nedocomil, and Albuterol and Iratropium (in combination)
Information on FDA rulemaking (PDF) (20 pp., 145kb, About PDF) 		December 31, 2009
Epinephrine
Information on FDA rulemaking (PDF) (23 pp., 144kb, About PDF) 		December 31, 2010

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Where can I get more information on the transition?

Additional information on the transition to ozone-safe inhalers is available from the following websites:

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