May 2003                             return to newsletter contents page

Florida Prescription Drug Pedigree Law Update

The Florida Legislature unanimously passed Senate Bill 2312 – the Prescription Drug Protection Act.  This bill revises the Florida Drug and Cosmetic Act to impose more stringent regulations on prescription drug wholesalers. The list of prohibited acts relating to drugs, devices and cosmetics is expanded to include additional prohibitions relating to prescription drugs.  

The bill creates criminal offenses relating to illicit activities involving diversion from the wholesale distribution of prescription drugs. Effective January 1, 2004, the permitting requirements for drug wholesalers are overhauled to require extensive 

information upon application for a permit including a criminal history background check, and to require that permits expire annually rather than biennially.

Reciprocity for out-of-state drug wholesalers who are already licensed in another jurisdiction is eliminated and such establishments must seek a Florida permit. The bill distinguishes “primary drug wholesalers” from “secondary drug wholesalers.”  The bill specifies factors that the Department of Health must consider in reviewing the qualifications of persons seeking a permit to engage in prescription drug wholesale activities in Florida. The department is authorized to adopt rules for the annual renewal of permits of prescription drug wholesalers.

The recordkeeping requirements for prescription drug wholesalers are revised for a wholesaler that is an authorized distributor of record (ADR) of a drug manufacturer.  Each person who is engaged in wholesale drug distribution and who is not an ADR must provide to each wholesale drug distributor of such drug, before the sale is made, a written statement under oath identifying each previous sale of the drug back to the last ADR, the lot number of the drug, and the sales invoice number of the invoice evidencing the sale of the drug.  The written statement must accompany the drug to the next wholesale distributor and no longer needs to identify all sales of such drug in the “pedigree papers.”

If this law is approved by the Governor, it becomes effective on July 1,2003.  To read the summary of the bill prepared by the Senate Committee on Health, Aging and Long-Term Care, click here.

Scroll down in the PDF report until you get to SB 2312.