DIVISION OF DRUGS, DEVICES AND COSMETICS
MEDICAL OXYGEN RETAIL ESTABLISHMENT
A medical oxygen retail establishment permit is required for any person that sells medical oxygen to patients only.
What is “Medical Oxygen”? The term refers to oxygen USP, a compressed medical gas prescription drug under Florida law.
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.
Prescription Required. The sale of medical oxygen to the patient under this permit must be based on an order from a practitioner authorized by law to prescribe.
Patient-Specific Refilling Authorized. A medical oxygen retail establishment may refill medical oxygen for an individual patient based on an order from a practitioner authorized by law to prescribe.
Patients Only – Wholesale Activity Prohibited. This permit does not authorize the sale or other distribution of medical oxygen to any person other than the patient. The wholesale distribution of compressed medical gases, including medical oxygen, requires a compressed medical gas wholesale distributor.
Other Prescription Drug Activity Prohibited. A medical oxygen retail establishment 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.
Application: Businesses seeking this permit must complete the Department’s application. Mail or deliver the application and all required attachments to:
Fire Inspection. If the applicant intends to take physical possession of compressed medical gases at the establishment, the application must attach proof that the establishment has passed a fire inspection by the applicable state or local authorities.
Department Inspection: Passing an onsite inspection is a prerequisite to issuance of this permit, unless the applicant holds a Compressed Medical Gas Manufacturer and/or Compressed Medical Oxygen Wholesale Distributor permit for the establishment.
License Term: Medical Oxygen Retail Establishment 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 if the applicant holds a Compressed Medical Gas Manufacturer and/or Compressed Medical Oxygen Wholesale Distributor 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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