December 2005                return to newsletter contents page

Pedigree Papers

The Next Step for Compliance with the Prescription Drug Marketing Act  May Be the Most Costly for a Distributor

by Davey Stone, Chairman, AVDA

The Prescription Drug Marketing Act (PDMA) enacted in the 1980s with modifications in the early 1990s required states to pass legislation for the licensing of wholesale distributors. Part of this act included the requirements for a wholesale distributor to provide an “Identifying Statement” to reflect the origin of a prescription drug. The term “Identifying Statement” later became known as Pedigree Papers, but implementation of the Pedigree Paper

requirement has been delayed a number of times by FDA with the latest delaying action in February 2004. As it stands now, the FDA will not address the requirements of “Identifying Statements” until the end of 2006 or the beginning of 2007. As a result, individual states have passed legislation that requires implementation of some form of a Pedigree, either in a paper format or an electronic format, before the Federal legislation becomes effective.

The legislation already passed in 12 states and the proposed legislation in another 18 states reveals that no two state requirements for Pedigree are the same. To complicate matters even more, there has been no representation by the veterinary industry during the legislative process. Legislation passed in the 12 states was highly represented by the National Association of Boards of Pharmacy and the Healthcare Distribution Management Association. As a result of the hodgepodge of laws veterinary distributors must comply with, Pedigree Papers have been formulated for the distribution of human prescription drugs by human wholesale distributors.

As a veterinary wholesale distributor, are you familiar with the new legislation already passed on Pedigree Papers? Do you realize that non-compliance with the Pedigree Paper requirements in most states can consist not only of a monetary penalty but can also result in the drug being declared as adulterated? Can you provide a paper trail to reflect where the drug was obtained and distributors that possessed the drug before your purchase? Do you have plans to implement Pedigree requirements but are hesitant to begin the process? Will your implementation plans coincide with those planned by the veterinary industry?

Although legislation has already been passed in 12 states, it is still not too late for veterinary wholesale distributors to formulate some plans for compliance and to petition a State Board of Pharmacy to accept a guideline for compliance by the veterinary industry. It is still not too late to lobby the remaining 18 states that have proposed legislation and to petition other states that may be entertaining legislation on Pedigree requirements.

As an industry, we must pull our resources together, formulate a plan of action, and have the American Veterinary Distributors Association heard as a representative of our industry. The failure to act now on Pedigree may triple our cost and diminish our returns on the sale of human prescription drugs.

Note: You will receive a survey from AVDA next week to measure your preparedness to deal with Pedigree Paper requirements. Please make sure to provide your input.