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

The Food and Drug Administration (FDA) has granted 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 amends 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.