# Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
> **Food and Drug Administration** · Final rule. · Published 2008-11-19 · Effective 2011-12-31 · 73 FR 69532
## Document
- **Document number:** E8-27436
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 73 FR 69532
- **CFR reference:** 21 CFR 2
- **Publication date:** 2008-11-19
- **Effective date:** 2011-12-31
- **HHS docket:** Docket No. FDA-2007-N-0314
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2008/11/19/E8-27436/use-of-ozone-depleting-substances-removal-of-essential-use-designation-epinephrine)
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