Permits.

(1) A person or entity that intends to distribute medical gas within or into this state, unless exempted under this part, must obtain the applicable permit before operating as:

(a) A medical gas wholesale distributor;

(b) A medical gas manufacturer; or

(c) A medical oxygen retail establishment.

(2) The following permits are established:

(a) Medical gas wholesale distributor permit.—A medical gas wholesale distributor permit is required for wholesale distribution, whether within or into this state. A medical gas must remain in the original container obtained by the wholesale distributor and the wholesale distributor may not engage in further manufacturing operations unless it possesses a medical gas manufacturer permit. A medical gas wholesale distributor may not possess or engage in the wholesale distribution of a prescription drug that is not a medical gas or distribute a medical gas other than by wholesale distribution unless otherwise authorized under this chapter.

(b) Medical gas manufacturer permit.—A medical gas manufacturer permit is required for a person or entity located in this state which engages in the manufacture of medical gases by physical air separation, chemical action, purification, or filling containers by a liquid-to-liquid, liquid-to-gas, or gas-to-gas process and distributes those medical gases within this state.

1. A permitted medical gas manufacturer may not manufacture or possess a prescription drug other than a medical gas, unless otherwise authorized under this chapter.

2. A permitted medical gas manufacturer may not distribute a medical gas without obtaining the applicable permit, except that it may engage in wholesale distribution of medical gases that it manufactured without obtaining a medical gas wholesale distributor permit if it complies with this part and the rules adopted under this part that apply to a wholesale distributor.

3. A permitted medical gas manufacturer shall comply with all of the requirements applicable to a wholesale distributor under this part and all appropriate state and federal good manufacturing practices.

(c) Medical oxygen retail establishment permit.—A medical oxygen retail establishment permit is required for an entity that is located in the state and that sells or delivers medical oxygen directly to patients in this state. The sale and delivery must be based on a prescription or an order from a practitioner authorized by law to prescribe. A pharmacy licensed under chapter 465 does not require a permit as a medical oxygen retail establishment.

1. A medical oxygen retail establishment may not possess, purchase, sell, or trade a medical gas other than medical oxygen, unless otherwise authorized under this chapter.

2. A medical oxygen retail establishment may fill and deliver medical oxygen to an individual patient based on an order from a practitioner authorized by law to prescribe. The medical oxygen retail establishment must comply with all appropriate state and federal good manufacturing practices. Medical oxygen sold or delivered by a medical oxygen retail establishment pursuant to an order from a practitioner may not be returned into the retail establishment’s inventory.

3. A medical oxygen retail establishment shall comply with all of the requirements applicable to a wholesale distributor under this part, except for those requirements that pertain solely to nitrous oxide.

(3) An out-of-state wholesale distributor that engages in wholesale distribution into this state must be legally authorized to engage in the wholesale distribution of medical gases as a wholesale distributor in the state in which it resides and provide proof of registration as set forth in s. 499.93(3), if required.

(4) A wholesale distributor may not operate from a place of residence, and a place of residence may not be granted a permit or operate under this part, except for the on-call delivery of home care oxygen for wholesale distributors that also maintain a medical oxygen retail establishment permit.

(5) If wholesale distribution is conducted at more than one location within this state or more than one location distributing into this state, each location must be permitted by the department.

(6) A hospice licensed by the Agency for Health Care Administration pursuant to part IV of chapter 400 is not required to obtain a medical oxygen retail establishment permit to purchase on behalf of and sell medical oxygen to its hospice patients if the hospice contracts for the purchase and delivery of medical oxygen from an establishment permitted pursuant to this part. Sale and delivery to patients by hospices pursuant to this subsection must be based upon a prescription or an order from a practitioner authorized by law to prescribe medical oxygen. For sales to hospices pursuant to this subsection, the medical gas wholesale distributor or the medical gas manufacturer selling medical oxygen to a hospice shall reflect on its invoice the hospice license number provided by the Agency for Health Care Administration and shall maintain such record pursuant to s. 499.89. Both the hospice and the medical oxygen retailer delivering medical oxygen to the patient must maintain a copy of a valid order or prescription for medical oxygen in accordance with s. 499.89 and department rule, which copy must be readily available for inspection.