DIVISION OF DRUGS, DEVICES AND COSMETICS
MEDICAL GAS WHOLESALE distributor
A medical gas wholesale distributor is a wholesale distributor that is limited to the wholesale distribution of medical gases to other than the consumer or patient.
- 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 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:
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.
If you have any questions or need assistance completing these forms, please call the Drugs, Devices and Cosmetics Program at (850) 717-1800.
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