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

   1. (a) "Wholesale distribution" means distribution of prescription drugs to persons other than a consumer or patient, but does not include:

      1. The purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a prescription drug for its own use from the group purchasing organization or from other hospitals or health care entities that are members of that organization;

      2. The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug by a charitable organization described in s. 501(c)(3) of the Internal Revenue Code of 1986, as amended and revised, to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

      3. The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug among hospitals or other health care entities that are under common control. For purposes of this section, "common control" means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, by voting rights, by contract, or otherwise.

      4. The sale, purchase, or trade of a prescription drug among federal, state, or local government health care entities that are under common control and are authorized to purchase such prescription drug.

      5. The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug for emergency medical reasons; for purposes of this subparagraph, the term "emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;

      6. The purchase or acquisition of a prescription drug by an emergency medical services medical director for use by emergency medical services providers acting within the scope of their professional practice pursuant to chapter 401.

      7. The dispensing of a prescription drug pursuant to a prescription;

      8. The distribution of prescription drug samples by manufacturers' representatives or distributors' representatives; or

      9. The sale, purchase, or trade of blood and blood components intended for transfusion. As used in this section, the term "blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing, and the term "blood components" means that part of the blood separated by physical or mechanical means.

   2. (b) "Wholesale distributor" means any person engaged in wholesale distribution of prescription drugs in or into this state, including, but not limited to, manufacturers; repackers; own-label distributors; jobbers; private-label distributors; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; exporters; retail pharmacies; and the agents thereof that conduct wholesale distributions.
   3. (c) "Retail pharmacy" means a community pharmacy licensed under chapter 465 that purchases prescription drugs at fair market prices and provides prescription services to the public.

2. (2) The following types of wholesaler permits are established:

   1. (a) A prescription drug wholesaler's permit. A prescription drug wholesaler is a wholesale distributor that may engage in the wholesale distribution of prescription drugs. A prescription drug wholesaler that applies to the department after January 1, 1993, must submit a bond of $200, payable to the Florida Drug, Device, and Cosmetic Trust Fund. This bond will be refunded to the permittee when the permit is returned to the department and the permittee ceases to function as a business. A permittee that fails to notify the department before changing the address of the business, fails to notify the department before closing the business, or fails to notify the department before a change of ownership forfeits its bond.
   2. (b) A compressed medical gas wholesaler's permit. A compressed medical gas wholesaler is a wholesale distributor that is limited to the wholesale distribution of compressed medical gases to other than the consumer or patient. The compressed medical gas must be in the original sealed container that was purchased by that wholesaler. A compressed medical gas wholesaler may not possess or engage in the wholesale distribution of any prescription drug other than compressed medical gases. The department shall adopt rules that govern the wholesale distribution of prescription medical oxygen for emergency use. With respect to the emergency use of prescription medical oxygen, those rules may not be inconsistent with rules and regulations of federal agencies unless the Legislature specifically directs otherwise.

   3. (c) An out-of-state prescription drug wholesaler's permit. An out-of-state prescription drug wholesaler is a wholesale distributor located outside this state which engages in the wholesale distribution of prescription drugs into this state and which must be permitted by the department and comply with all the provisions required of a wholesale distributor under ss. 499.001-499.081.

      1. The out-of-state drug wholesaler must maintain at all times a license or permit to engage in the wholesale distribution of prescription drugs in compliance with laws of the state in which it is a resident.

      2. An out-of-state prescription drug wholesaler's permit is not required for an intracompany sale or transfer of a prescription drug from an out-of-state establishment that is duly licensed as a prescription drug wholesaler, in its state of residence, to a licensed prescription drug wholesaler in this state, if both wholesalers are under common control. The recordkeeping requirements of s. 499.0121(6) must be followed for this transaction.

      3. The department may adopt rules that allow out-of-state drug wholesalers to obtain a drug wholesale permit on the basis of reciprocity to the extent that an out-of-state drug wholesaler:

      a. Possesses a valid permit granted by another state that has requirements comparable to those that a drug wholesaler in this state must meet as prerequisites to obtaining a permit under the laws of this state.

      b. Can show that the other state from which the wholesaler holds a permit would extend reciprocal treatment under its own laws to a drug wholesaler of this state.

   4. (d) A retail pharmacy wholesaler's permit. A retail pharmacy wholesaler is a retail pharmacy engaged in wholesale distribution of prescription drugs within this state under the following conditions:

      1. The pharmacy must obtain a retail pharmacy wholesaler's permit pursuant to ss. 499.001-499.081 and the rules adopted under those sections.

      2. The wholesale distribution activity does not exceed 30 percent of the total annual purchases of prescription drugs. If the wholesale distribution activity exceeds the 30-percent maximum, the pharmacy must obtain a prescription drug wholesaler's permit.

      3. The transfer of prescription drugs that appear in any schedule contained in chapter 893 is subject to chapter 893 and the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.

      4. The transfer is between a retail pharmacy and another retail pharmacy or a health care practitioner licensed in this state and authorized by law to dispense or prescribe prescription drugs.

      5. All records of sales of prescription drugs subject to this section must be maintained separate and distinct from other records and comply with the recordkeeping requirements of ss. 499.001-499.081.

3. (3) A person that engages in wholesale distribution of prescription drugs in this state must have a wholesale distributor's permit issued by the department, except as noted in this section. Each establishment must be separately permitted except as noted in this subsection.

   1. (a) A separate establishment permit is not required when a permitted prescription drug wholesaler consigns a prescription drug to a pharmacy that is permitted under chapter 465 and located in this state, provided that:

      1. The consignor wholesaler notifies the department in writing of the contract to consign prescription drugs to a pharmacy along with the identity and location of each consignee pharmacy;

      2. The pharmacy maintains its permit under chapter 465;

      3. The consignor wholesaler, which has no legal authority to dispense prescription drugs, complies with all wholesale distribution requirements of s. 499.0121 with respect to the consigned drugs and maintains records documenting the transfer of title or other completion of the wholesale distribution of the consigned prescription drugs;

      4. The distribution of the prescription drug is otherwise lawful under this chapter and other applicable law;

      5. Open packages containing prescription drugs within a pharmacy are the responsibility of the pharmacy, regardless of how the drugs are titled; and

      6. The pharmacy dispenses the consigned prescription drug in accordance with the limitations of its permit under chapter 465 or returns the consigned prescription drug to the consignor wholesaler. In addition, a person who holds title to prescription drugs may transfer the drugs to a person permitted or licensed to handle the reverse distribution or destruction of drugs. Any other distribution by and means of the consigned prescription drug by any person, not limited to the consignor wholesaler or consignee pharmacy, to any other person is prohibited.

   2. (b) A wholesale distributor's permit is not required for the one-time transfer of title of a pharmacy's lawfully acquired prescription drug inventory by a pharmacy with a valid permit issued under chapter 465 to a consignor prescription drug wholesaler, permitted under this chapter, in accordance with a written consignment agreement between the pharmacy and that wholesaler if: the permitted pharmacy and the permitted prescription drug wholesaler comply with all of the provisions of paragraph (a) and the prescription drugs continue to be within the permitted pharmacy's inventory for dispensing in accordance with the limitations of the pharmacy permit under chapter 465. A consignor drug wholesaler may not use the pharmacy as a wholesale distributor through which it distributes the legend drugs to other pharmacies. Nothing in this section is intended to prevent a wholesale drug distributor from obtaining this inventory in the event of nonpayment by the pharmacy.
   3. (c) The department shall require information from each wholesale distributor as part of the permit and renewal of such permit, as required under s. 499.01.
4. (4) Personnel employed in wholesale distribution must have appropriate education and experience to enable them to perform their duties in compliance with state permitting requirements.

History.--s. 15, ch. 92-69; s. 187, ch. 97-264.