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, they 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, AVDA partnered with Cegedim Dendrite’s State Monitor Service. The State Monitor service tracks emerging issues in the animal health industry.

AVDA began a partnership with Cegedim Dendrite in 2007 to give members access to a service 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 around-the-clock access to the service and receive e-mail notification when updates are available. Companies subscribing to this type of service individually pay in excess of $20,000 per year. AVDA members may subscribe to the service for a small annual subscription rate.

The State Monitor Service is provided by a centralized, on-demand Web-based tool that provides access to the most comprehensive pharmaceutical regulatory and legislative surveys available on the Federal and state level. The State Monitor Service has user-friendly querying that will enable members to search specific regulations or legislation for relevant information that impacts their business without the burden of manually searching lengthy paper-based documents. Subscribing members will also receive regular e-mail alerts regarding emerging federal and state legislative and regulatory issues, to assist them in their efforts to stay up-to-date and comply with ever-changing laws and regulations.

To educate AVDA members, Cegedim Dendrite has hosted several Webinars over the past two years. Webinars are also hosted periodically to inform members of new features and updates with the service.

AVDA member companies are eligible to subscribe to the following surveys:

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. The AVDA State Monitor Drug Distribution survey now includes 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:

• 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
• Allowance for VAWD certification.