DIVISION OF DRUGS, DEVICES AND COSMETICS

COMPRESSED MEDICAL GAS WHOLESALE distributor

A compressed medical gas wholesale distributor is a wholesale distributor that is limited to the wholesale distribution of compressed medical gases to other than the consumer or patient.

Requirements:

• What is a “Compressed Medical Gas”? “Compressed 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 Compressed Medical Gas = Manufacturing. Repackaging compressed medical gases requires a manufacturer permit, as this permit is limited to the wholesale distribution of compressed 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 compressed medical gas.  In this context, transferring or trans-filling compressed medical gas from one container for another is also “repackaging”. 

• Other Prescription Drug Activity Prohibited. A compressed medical gas wholesale distributor possess any prescription drug other than compressed 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 compressed 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

1940 North Monroe Street

Tallahassee, FL  32399-0783

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

License Term: Compressed 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 Compressed Medical Gas Manufacturer permit for the establishment.

If you have any questions or need assistance completing these forms, please call the Drugs, Devices and Cosmetics Program at (850) 717-1800.