# Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
> **Food and Drug Administration** · Final rule. · Published 2005-04-04 · Effective 2008-12-31 · 70 FR 17168
## Document
- **Document number:** 05-6599
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 70 FR 17168
- **CFR reference:** 21 CFR 2
- **Publication date:** 2005-04-04
- **Effective date:** 2008-12-31
- **HHS docket:** Docket No. 2003P-0029
## Abstract

The Food and Drug Administration (FDA) is amending its regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designations for albuterol used in oral pressurized metered-dose inhalers (MDIs). Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDA- regulated product that releases an ODS is an essential use of the ODS. Two albuterol MDIs that do not use an ODS have been marketed for more than 3 years. FDA has determined that the two non-ODS MDIs will be satisfactory alternatives to albuterol MDIs containing ODSs and is removing the essential-use designation for albuterol MDIs as of December 31, 2008. Albuterol MDIs containing an ODS cannot be marketed after this date.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2005/04/04/05-6599/use-of-ozone-depleting-substances-removal-of-essential-use-designations)
---
*AI Analytics · CC0 1.0*