The Governor has signed HB 371 which includes significant changes in Florida’s pedigree papers statute. This bill did not directly affect the AVDA legislation creating the Limited Veterinary Drug Wholesale Distributor’s license.

AVDA members will want to take note of these changes:

The concept of an Authorized Distributor of Record is no longer used in Florida because all human drugs purchased from a source other than a manufacturer must have a pedigree paper – either in electronic or hard copy – “attached” to the drug.

Authentication of the pedigree paper is required before the wholesaler can take possession of the drug.

The definition of a pedigree paper was amended to make provisions for the use of a statement by the drug wholesaler that they purchase a drug directly from the manufacturer. This follows the same concept as was already in the law for the “specified list” of drugs.

Implications for AVDA members:

AVDA members who purchase (human) prescription drugs from human drug wholesalers, and who are not licensed under the new licensing provisions of the veterinary wholesale permit allowed in our Senate Bill 1540, will now be required to receive a pedigree paper for those drugs purchased from human drug wholesalers.

The only exception to this requirement is when human drugs are purchased directly from a drug manufacturer.

A drug manufacturer includes any contract manufacturer who may also be a distributor for that manufacturer.

Here is the exact language from the legislation:

2. A statement, under oath, in written or electronic form, confirming that a wholesale distributor purchases and receives the specific unit of the prescription drug directly from the manufacturer of the prescription drug and distributes the prescription drug directly, or through an intracompany transfer, to a chain pharmacy warehouse or a person authorized by law to purchase prescription drugs for the purpose of
administering or dispensing the drug, as defined in s. 465.003.

a. The information required to be included pursuant to this subparagraph must include:

(I) The following statement: "This wholesale distributor purchased the specific unit of the prescription drug directly from the manufacturer."

(II) The manufacturers' national drug code identifier and the name and address of the wholesaler and the purchaser of the prescription drug.

(III) The name of the prescription drug as it appears on the label.

(IV) The quantity, dosage form, and strength of the prescription drug.

b. 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.

The practice of using a “drop shipment” of drugs directly from the manufacturer to the pharmacy remains in effect. The wholesaler must follow the following procedure in order to continue drop shipments. This provision does not apply to repackagers.

Within 14 days of the date of shipment, the distributor must deliver to the pharmacy/recipient an invoice with 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, as described in s. 499.0121(6)(h), Florida Statutes, 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.

The manufacturer must provide to the pharmacy a shipping document which contains the following information – at a minimum:

(I) The name and address of the manufacturer, including the point of origin of the shipment, and the names and addresses of the wholesaler and the purchaser.

(II) The name of the prescription drug as it appears on the label.

(III) The quantity, dosage form, and strength of the prescription drug.

(IV) The date of the shipment from the manufacturer.

The wholesale distributor must maintain and make available to the Department the lot number of the drug(s) listed on the shipping documents.

If the manufacturer fails to provide, the pharmacy fails to acquire or the distributor fails to deliver the documentation described above, the “failure” shall be considered a “failure to deliver a pedigree paper” which is a felony.

Forgery by the manufacturer, pharmacy or distributor of this documentation is also a forgery and thus, a felony.

A complete set of frequently asked questions and answers can be found on the Department of Health’s web site: www.doh.state.fl.us/pharmacy/drugs.