If you are a manufacturing medical gases you are required to electronically register your locations with the FDA. This was done on paper until about 2009 when the FDA started using a WebTrader portal. The electronic registration for each location needs to be completed annually. The FDA now allows you to register for the next year between Oct through Dec of the previous year. So, in order to register for 2017, you can complete that Oct-Dec 2016.
The FDA also requires each location that manufacturers medical gases to submit, and keep current, drug listings for each medical gas. Once the drug listings are submitted, they only need to be submitted again if there is a change in your drug listing, such as a new label or new cylinder size.
The FDA developed a process to allow us the remove the "unapproved medical gas" status from certain drug listings. Congress designated the core medical gases (and their "medically appropriate" mixtures) to have status similar to "approved" drugs. This is done by submitting an NDA (human) and an NADA (animal) drug listing to the FDA.
To check your establishment registrations: Go HERE, and search by your company name.
To review your drug listings: Go HERE, and search by your labeler code.
AsteRisk has been involved with the FDA electronic submission system since its inception. We are very familiar with how to manage the system and accurately help forms flow through properly. We can take care of all of your electronic registering and drug listings. Please contact us for more information.