Medical Gas Manufacturer

A medical gas manufacturer permit is required for any person that engages in the manufacture of medical gases or repackages medical gases from one container to another.

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.

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

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 manufacturer may not manufacture or possess any prescription drug other than 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.

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:

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.

Form Assistance

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

Need Help?

All requests for publications, documents, forms, applications for licenses, permits and other similar certifications can be obtained by contacting the Customer Contact Center.

Walter Copeland, Division Director

Division of Drugs, Devices and Cosmetics
2601 Blair Stone Road
Tallahassee, FL 32399-1047

Telephone: 850.717.1800