Chlorofluorocarbon Propellants in Self-Pressurized Containers; Addition to List of Essential Uses

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The Food and Drug Administration (FDA) is proposing to grant the petition of Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), to add metered-dose albuterol sulfate and ipratropium bromide in combination for oral inhalation to the list of products containing a chlorofluorocarbon (CFC) propellant for an essential use. Essential use products are exempt from FDA's ban on the use of CFC propellants in FDA-regulated products and the Environmental Protection Agency's (EPA's) ban on the use of CFC's in pressurized dispensers. This document proposes to amend FDA's regulations governing use of CFC's to include metered-dose albuterol sulfate and ipratropium bromide in combination for oral inhalation as an essential use.