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Use of Ozone-Depleting Substances - Removal of Essential-Use Designation (Epinephrine) - Notice of Final Rule (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library

Use of Ozone-Depleting Substances - Removal of Essential-Use Designation (Epinephrine) - Notice of Final Rule (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Use of Ozone-Depleting Substances - Removal of Essential-Use Designation (Epinephrine) - Notice of Final Rule (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designation for epinephrine used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs as of December 31, 2011. Epinephrine MDIs containing an ODS cannot be marketed after this date. This book contains: - The complete text of the Use of Ozone-Depleting Substances - Removal of Essential-Use Designation (Epinephrine) - Notice of Final Rule (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section