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Epinephrine bronchodilators retain FDA essential-use designation allowing CFCs -- ANPR.

This article was originally published in The Tan Sheet

Executive Summary

EPINEPHRINE BRONCHODILATOR PRODUCTS RETAIN ESSENTIAL-USE DESIGNATION because epinephrine is the "only active moiety" used in OTC drug products containing chlorofluorocarbon propellants, FDA observes in a March 6 advance notice of proposed rulemaking on CFCs in self-pressurized container whose uses are no longer essential. "These OTC drug products are available to patients who may not have access to prescription drugs. Therefore," the ANPR states, "FDA has tentatively determined that prescription drugs should not be considered as alternatives to drug products containing epinephrine."
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