Division of Drugs, Devices and Cosmetics – Medical Gas Wholesale Distributor

A medical gas wholesale distributor permit is required for wholesale distribution of medical gas, whether within or into this state.

Requirements:

• What is a “Medical Gas”? “Medical gas” means any liquefied or vaporized gas that is a prescription drug, including, without limitation, prescription medical oxygen (oxygen USP), whether it is alone or in combination with other gases.

• Repackaging Medical Gas = Manufacturing. Repackaging medical gases requires a manufacturer permit, as this permit is limited to the wholesale distribution of medical gas in the original sealed container that was purchased by that wholesale distributor.

• What is “repackaging”? The term includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the medical gas.  In this context, transferring or trans-filling medical gas from one container for another is also “repackaging”.

• Other Prescription Drug Activity Prohibited. A medical gas wholesale distributor may not possess any prescription drug other than medical gases – unless, of course, the person has other legal authorization appropriate for such activity.

• Fire Inspection. If the applicant intends to take physical possession of medical gases at the establishment, then the application must attach proof that the establishment has passed a fire inspection by the applicable state or local authorities.

Application: Businesses seeking this permit must complete the Department’s application.  Mail or deliver the application and all required attachments to:

Florida Department of Business and Professional Regulation Drugs, Devices and Cosmetics Program 2601 Blair Stone Road Tallahassee, FL 32399-1047

Department Inspection: Passing an onsite inspection by the Department is a prerequisite to issuance of this permit, unless the applicant holds a Medical Gas Manufacturer permit for the establishment.

License Term: Medical Gas Wholesale Distributor permits are valid through the last day of the initial issuance month in the second year of licensure.  Example:  A permit issued on September 12, 2011 would be valid through September 30, 2013. Fee: The application and permitting fee is $600 for a two-year permit, plus a one-time pre-permit inspection fee of $150. Make checks payable to DBPR. The inspection fee applies only to new permits, and will not be assessed the applicant holds a Medical Gas Manufacturer permit for the establishment.