Florida Governor Jeb Bush signed the Prescription Drug Protection Act or Pedigree Paper law on June 3, 2003. Many provisions of the act became law on July 1, 2003. Some portions phase in on October 1, 2003, January 1, 2004 or later. To link to a schedule of effective dates for the act, also known as SB 2312, click on the following: http://www.doh.state.fl.us/pharmacy/drugs/news/SB2312Effdates.pdf

To link to the full text of the bill, click on http://election.dos.state.fl.us/laws/03laws/ch_2003-155.pdf

Here is a recap of the legislation as it pertains to veterinary distributors.

1) Sect. 11, pg 16 - Wholesaler Permits will be issued on an annual basis, rather than multiyear.

2) Sect. 13, pg 33 - An application for a wholesaler permit or renewal of a permit will now require a $100,000 bond, in a form that the applicant cannot revoke, cancel, or otherwise reduce.

3) Sect. 13, pg 34 - An out-of-state wholesaler permit is required for intra-company transfers if the out-of-state wholesaler does business under a different business name. An example is given using a stock transfer from company A in Texas to company B in Florida where both companies are owned by the same company.

4) Sect. 14, pg 35 - Effective January 1, 2004, freight forwarders located in Florida are required to obtain a permit to possess prescription drugs intended for exportation. If you are exporting you must assure that the freight forwarder is permitted.

5) Sect. 14, pg 43 - Effective January 1, 2004, each (meaning each co. name) prescription drug wholesaler or out-of-state wholesaler must have a designated representative. The representative must be certified by Florida Department of Health. A test will be developed in the future and the designated representative must have a passing score of at least 75.

6) Sect. 15, pg 45 - Wholesalers must review records related to the acquisition of prescription drugs for accuracy and completeness and authenticate each transaction listed on a pedigree paper. In addition to administrative penalties for failure to do this, criminal penalties apply. (Sect 5-8, pgs 10-13)

7) Sect. 15, pg 46 - A manufacturer must file with the Florida Department of Health a list of authorized distributors and Florida will publish the list on its website. After July 1, 2006 full implementation of the pedigree will go into effect for all prescription drugs. This means that every wholesale distribution of a unit of a prescription drug must be accompanied by a pedigree paper. Prior to July 1, 2006 if a prescription drug is on a specified list of 30 drugs (such as Procrit, Epogen, and Neupogen given to strengthen patients with AIDS or cancer) the wholesaler must either provide a pedigree paper or state the unit was purchased directly from the manufacturer by the seller or a member of its affiliated group. If a prescription drug is not on the list then a wholesaler who is an authorized distributor of record for the manufacturer, whether or not the wholesaler purchased that unit from the manufacturer, does not have to pass on any documentation related to the source of the drug. If a wholesaler is not an authorized distributor the wholesaler must pass on a pedigree paper. In either situation the pedigree paper is required to be passed on only to another wholesale distributor and not to end-users.

8) Sect. 15, pgs 46-47 - If a manufacturer does not submit a listing of authorized distributors, or the list does not include at least 10 wholesalers permitted in FL, a wholesaler can still be designated as an authorized distributor of record for a manufacturer if the wholesaler has annual prescription drug sales of $100 million or more, has a verifiable account number issued by the manufacturer, and the wholesaler made at least 12 purchases directly from the manufacturer in the past 12 months using that account.