FDA to study OTC ozone-depleting asthma inhalers
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A joint FDA advisory panel this month will discuss essential use determinations for OTC epinephrine metered-dose asthma inhalers that contain ozone-depleting substances (ODSs). According to the agency's notice of the Jan. 24 meeting of the joint Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees, there are some marketed drug products containing epinephrine in a metered-dose inhaler (MDI) form. Under section 610 of the Clean Air Act, MDIs that are not the subject of an essential-use designation cannot be legally distributed. The panelists will discuss the continued need for the essential-use designation for these products. For more information, visit http://www.fda.gov/oc/advisory/accalendar/2006/cder12541d012406.html.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
