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Use of Ozone-Depleting Substances - Removal of Essential-Use Designation - Flunisolide, etc. (US Food and Drug Administration Regulation) (FDA) (2018 Edition)

eBook details

Title: Use of Ozone-Depleting Substances - Removal of Essential-Use Designation - Flunisolide, etc. (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
Author : The Law Library
Release Date : January 17, 2018
Genre: Law,Books,Professional & Technical,
Pages : * pages
Size : 274 KB

Description

The Law Library presents the complete text of the Use of Ozone-Depleting Substances - Removal of Essential-Use Designation - Flunisolide, etc. (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 designations for flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil 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 flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil as products that do not release ODSs, and therefore they will no longer be essential uses of ODSs as of the effective dates of this rule. MDIs for these active moieties containing an ODS may not be marketed after the relevant effective date.

This ebook contains:
- The complete text of the Use of Ozone-Depleting Substances - Removal of Essential-Use Designation - Flunisolide, etc. (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure