(1) APPLICATION.—Each person who is engaged in the wholesale distribution of a prescription drug must, prior to or simultaneous with each wholesale distribution, provide a pedigree paper to the person who receives the drug.
(2) FORMAT.—A pedigree paper must contain the following information:
(a) For the wholesale distribution of a prescription drug within the normal distribution chain:
1. The following statement: “This wholesale distributor purchased the specific unit of the prescription drug directly from the manufacturer.”
2. The manufacturer’s national drug code identifier and the name and address of the wholesale distributor and the purchaser of the prescription drug.
3. The name of the prescription drug as it appears on the label.
4. The quantity, dosage form, and strength of the prescription drug.
The wholesale distributor must also maintain and make available to the department, upon request, the point of origin of the prescription drugs, including intracompany transfers, the date of the shipment from the manufacturer to the wholesale distributor, the lot numbers of such drugs, and the invoice numbers from the manufacturer.
(b) For all other wholesale distributions of prescription drugs:
1. The quantity, dosage form, and strength of the prescription drugs.
2. The lot numbers of the prescription drugs.
3. The name and address of each owner of the prescription drug and his or her signature.
4. Shipping information, including the name and address of each person certifying delivery or receipt of the prescription drug.
5. An invoice number, a shipping document number, or another number uniquely identifying the transaction.
6. A certification that the recipient wholesale distributor has authenticated the pedigree papers.
7. The unique serialization of the prescription drug, if the manufacturer or repackager has uniquely serialized the individual prescription drug unit.
8. The name, address, telephone number, and, if available, e-mail contact information of each wholesale distributor involved in the chain of the prescription drug’s custody.
When an affiliated group member obtains title to a prescription drug before distributing the prescription drug as the manufacturer under s. 499.003(31)(e), information regarding the distribution between those affiliated group members may be omitted from a pedigree paper required under this paragraph for subsequent distributions of that prescription drug.
(3) EXCEPTIONS.—A pedigree paper is not required for:
(a) The wholesale distribution of a prescription drug by the manufacturer or by a third party logistics provider performing a wholesale distribution of a prescription drug for a manufacturer.
(b) The wholesale distribution of a prescription drug by a freight forwarder within the authority of a freight forwarder permit.
(c) The wholesale distribution of a prescription drug by a limited prescription drug veterinary wholesale distributor to a veterinarian.
(d) The wholesale distribution of a compressed medical gas.
(e) The wholesale distribution of a veterinary prescription drug.
(f) A drop shipment, provided:
1. The wholesale distributor delivers to the recipient of the prescription drug, within 14 days after the shipment notification from the manufacturer, an invoice and the following sworn statement: “This wholesale distributor purchased the specific unit of the prescription drug listed on the invoice directly from the manufacturer, and the specific unit of prescription drug was shipped by the manufacturer directly to a person authorized by law to administer or dispense the legend drug, as defined in s. 465.003, Florida Statutes, or a member of an affiliated group, with the exception of a repackager.” The invoice must contain a unique cross-reference to the shipping document sent by the manufacturer to the recipient of the prescription drug.
2. The manufacturer of the prescription drug shipped directly to the recipient provides and the recipient of the prescription drug acquires, within 14 days after receipt of the prescription drug, a shipping document from the manufacturer that contains, at a minimum:
a. The name and address of the manufacturer, including the point of origin of the shipment, and the names and addresses of the wholesale distributor and the purchaser.
b. The name of the prescription drug as it appears on the label.
c. The quantity, dosage form, and strength of the prescription drug.
d. The date of the shipment from the manufacturer.
3. The wholesale distributor maintains and makes available to the department, upon request, the lot number of such drug if not contained in the shipping document acquired by the recipient.
4. The wholesale distributor that takes title to, but not possession of, the prescription drug is not a member of the affiliated group that receives the prescription drug directly from the manufacturer.
Failure of the manufacturer to provide, the recipient to acquire, or the wholesale distributor to deliver the documentation required under this paragraph shall constitute failure to acquire or deliver a pedigree paper under ss. 499.005(28) and 499.0051. Forgery by the manufacturer, the recipient, or the wholesale distributor of the documentation required to be acquired or delivered under this paragraph shall constitute forgery of a pedigree paper under s. 499.0051.
(g) The wholesale distribution of a prescription drug by a warehouse within an affiliated group to a warehouse or retail pharmacy within its affiliated group, provided:
1. Any affiliated group member that purchases or receives a prescription drug from outside the affiliated group must receive a pedigree paper if the prescription drug is distributed in or into this state and a pedigree paper is required under this section and must authenticate the documentation as required in s. 499.0121(4), regardless of whether the affiliated group member is directly subject to regulation under this part; and
2. The affiliated group makes available, within 48 hours, to the department on request to one or more of its members all records related to the purchase or acquisition of prescription drugs by members of the affiliated group, regardless of the location where the records are stored, if the prescription drugs were distributed in or into this state.
(h) The repackaging of prescription drugs by a repackager solely for distribution to its affiliated group members for the exclusive distribution to and among retail pharmacies that are members of the affiliated group to which the repackager is a member.
1. The repackager must:
a. For all repackaged prescription drugs distributed in or into this state, state in writing under oath with each distribution of a repackaged prescription drug to an affiliated group member warehouse or repackager: “All repackaged prescription drugs are purchased by the affiliated group directly from the manufacturer or from a prescription drug wholesale distributor that purchased the prescription drugs directly from the manufacturer.”
b. Purchase all prescription drugs it repackages:
(I) Directly from the manufacturer; or
(II) From a prescription drug wholesale distributor that purchased the prescription drugs directly from the manufacturer.
c. Maintain records in accordance with this section to document that it purchased the prescription drugs directly from the manufacturer or that its prescription drug wholesale supplier purchased the prescription drugs directly from the manufacturer.
2. All members of the affiliated group must provide, within 48 hours, to agents of the department on request to one or more of its members records of purchases by all members of the affiliated group of prescription drugs that have been repackaged, regardless of the location at which the records are stored or at which the repackager is located.
(i) The wholesale distribution of prescription drugs within a medical convenience kit if:
1. The medical convenience kit is assembled in an establishment that is registered with the United States Food and Drug Administration as a medical device manufacturer;
2. The medical convenience kit manufacturer purchased the prescription drug directly from the manufacturer or from a wholesaler that purchased the prescription drug directly from the manufacturer;
3. The medical convenience kit manufacturer complies with federal law for the distribution of the prescription drugs within the kit; and
4. The drugs contained in the medical kit are:
a. Intravenous solutions intended for the replenishment of fluids and electrolytes;
b. Products intended to maintain the equilibrium of water and minerals in the body;
c. Products intended for irrigation or reconstitution;
d. Anesthetics; or
e. Anticoagulants.
This exemption does not apply to a convenience kit containing any controlled substance that appears in a schedule contained in or subject to chapter 893 or the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.
History.—s. 15, ch. 2008-207; s. 4, ch. 2009-221; s. 24, ch. 2010-161.
