Medical Gases Manufacturer

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.

What is a "manufacturing"? In this context, the term includes preparing, deriving, compounding, propagating, processing, producing or fabricating any compressed medical gas.

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 manufacturer may not manufacture or possess any prescription drug other than compressed medical gases - unless, of course, the person has other legal authorization appropriate for such activity.

FDA Establishment Registration. The applicant must have an FDA establishment registration number, or provide documentation supporting an exemption from FDA registration.

APPLICATION: Please select below to apply via the online or paper application.

Inspection: Passing an onsite inspection is a prerequisite to issuance of this permit, unless the applicant holds a Prescription Drug Manufacturer Permit at that address.

License Term: Prescription Drug Manufacturer 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 $1,000 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 does not apply to applicants holding a Prescription Drug Manufacturer Permit at that address.

Product Registration: Florida law requires that all prescription drugs manufactured in this state must be registered with the department before sale. Product registration is NOT a prerequisite to issuance of this permit.