FDA to Host Public Meeting on Medical Gas Regulations

FDA will hold a public meeting to obtain feedback on whether any changes to regulations concerning medical gas are needed. The meeting will take place on December 6, 2013, from 9 AM to 5 PM and will also be streamed online. FDA is using the public meeting as part of a review process initiated by the FDASIA of 2012. The law requires the agency to obtain input from medical gas manufacturers and other interested parties to determine if changes to federal drug regulations are necessary, and to submit a report no later than 18 months after the law’s enactment.

NABP submitted comments (PDF) regarding the regulation of medical gas to FDA in May 2013. In the comments, the Association noted January 2012 changes to the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) which added separate rules for the licensure of medical gas and medical gas related equipment wholesale distributors. NABP also reiterated its belief that separate federal regulations pertaining to the wholesale distribution of medical gases are necessary because existing regulations, in many instances, do not apply to medical gases. More information about the upcoming FDA meeting and a link to the Federal Register notice are available in an announcement on FDA’s Web site.