In keeping with provisions in the Clean Air Act calling for the phase out of all products containing ozone-depleting substances, the Food and Drug Administration (FDA), in consultation with the Environmental Protection Agency, has issued a final rule removing the “essential-use” designation from epinephrine used in oral pressurized metered-dose inhalers (MDIs).

According to the rule, epinephrine delivered via these products will no longer be available after December 31, 2011. This would include Primatene Mist, which is sold over-the-counter for asthma relief. This new ruling would effectively serve as a ban on Primatene, which is not a recommended drug to be used in an asthma exacerbation according to the EPR III Guidelines.

The AARC supported the decision to remove these products from the market in comments made to the FDA in October of last year, agreeing with the FDA that there are “no substantial technical barriers to formulating epinephrine as a product that does not release oxygen depleting substances.”

The removal of epinephrine from the essential-use list follows on the heels of the removal of albuterol, which beginning in 2009 will no longer be available in inhalers using chlorofluorocarbon (CFC) propellants.

In all cases, the AARC has emphasized in its comments to the government the need for adequate education for patients who must transition to new, CFC-free products to manage their respiratory conditions, urging federal officials to take the need for this education into account as the new rules go into effect.