September 2009              return to newsletter contents page

AVDA State Monitor Service

In today’s regulatory environment, pharmaceutical, distribution and healthcare companies are faced with constant changes in federal and state legislation and regulations that affect everyday business. Although no common governance exists among the states, the states do maintain similarities in the way they define and regulate key areas of pharmaceutical marketing practices as well as licensing and distribution activities. To better understand the impact of these state-by‐state regulations, Cegedim Dendrite’s State Monitor Service offers surveys to assist the industry in monitoring these emerging issues.

AVDA members may now subscribe to the State Monitor Service, an online tool that provides legislative and regulatory updates on Drug Distribution and Drug Pedigree laws on the Federal level and in all 50 states and the District of Columbia. Subscribing members have 24/7 access to the service and receive e-mail notification when updates are available. The annual subscription fee for AVDA members is $750. Companies subscribing to this service would individually pay in excess of $25,000 per year.

Drug Pedigree
Provides current state laws and regulations regarding drug pedigree papers. Drug Pedigree requirements aim to safeguard the prescription drug supply--preventing counterfeit, diverted, or adulterated substances from being dispensed to patients. The survey includes states with pending legislation and regulations.

Drug Distributor Licensing Requirements
Provides and monitors a comprehensive picture of wholesale distributor licensing requirements for all 50 states and for the District of Columbia. It includes an overview chart of who must be licensed or registered, the types of licenses / registrations available, and a listing of statutes and regulations used as authority; a chart that gives a snapshot view of particular requirements; and a more comprehensive jurisdictional summary sheet. State Monitor has committed to making improvements to the State Monitor Drug Distributor survey for AVDA members this year. The AVDA State Monitor Drug Distribution survey will now include information on licensing requirements for prescription veterinary drugs for veterinary use. In addition, there is a chart that encompasses the following requirements for legend drugs and controlled substances for both in-state and out-of-state

• Registration / licensure;
• Surety bond or its equivalent;
• Authorized distributors of record;
• Designated representative;
• Pedigree;
• Background check to be done by the licensing authority;
• Submission of fingerprinting;
• Submission of photograph; and
• Allowance for VAWD certification.