other · Food and Drug Administration · Rule · Published 2016-10-26 · Effective 2017-02-23 · 81 FR 74298
Document
Document number
2016-25851
Federal Register citation
81 FR 74298
CFR reference
21 CFR 2
Type
Rule
Action
Direct final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-10-26
Effective date
2017-02-23
HHS docket
Docket No. FDA-2015-N-1355
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as "essential uses" under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. FDA is taking this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs.