The Florida Senate

499.0122  Medical oxygen and veterinary legend drug retail establishments; definitions, permits, general requirements.--

(1)  As used in this section, the term:

(a)  "Medical oxygen retail establishment" means a person licensed to sell medical oxygen to patients only. The sale must be based on an order from a practitioner authorized by law to prescribe. The term does not include a pharmacy licensed under chapter 465.

1.  A medical oxygen retail establishment may not possess, purchase, sell, or trade any legend drug other than medical oxygen.

2.  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. A medical oxygen retail establishment that refills medical oxygen must comply with all appropriate state and federal good manufacturing practices.

(b)  "Prescription medical oxygen" means oxygen USP that is a compressed medical gas and which can only be sold on the order or prescription of a practitioner authorized by law to prescribe. The label of prescription medical oxygen must comply with current labeling requirements for oxygen under the Federal Food, Drug, and Cosmetic Act.

(c)  "Veterinary legend drug" means a legend drug intended solely for veterinary use. The label of the drug must bear the statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

(d)  "Veterinary legend drug retail establishment" means a person permitted to sell veterinary legend drugs to the public or to veterinarians, but does not include a pharmacy licensed under chapter 465.

1.  The sale to the public must be based on a valid written order from a veterinarian licensed in this state who has a valid client-veterinarian relationship with the purchaser's animal.

2.  Veterinary legend drugs may not be sold in excess of the amount clearly indicated on the order or beyond the date indicated on the order.

3.  An order may not be valid for more than 1 year.

4.  A veterinary legend drug retail establishment may not purchase, sell, trade, or possess human prescription drugs or any controlled substance as defined in chapter 893.

5.  A veterinary legend drug retail establishment must sell a veterinary legend drug in the original, sealed manufacturer's container with all labeling intact and legible. The department may adopt by rule additional labeling requirements for the sale of a veterinary legend drug.

(2)(a)  A person that engages in the retail sale of medical oxygen or veterinary legend drugs in this state must have a retail establishment permit issued by the department.

(b)  The department shall adopt rules relating to information required from each retail establishment pursuant to s. 499.01(4), including requirements for prescriptions or orders.

(c)  A retail establishment must comply with all of the wholesale distribution requirements of s. 499.0121 except those set forth in s. 499.0121(6)(d).

(d)  Legend drugs sold by a retail establishment pursuant to a practitioner's order may not be returned into the retail establishment's inventory.

History.--s. 17, ch. 92-69; s. 33, ch. 98-151; s. 39, ch. 2000-242; s. 87, ch. 2004-5.