Government Affairs & Legislative Issues

When necessary, AVDA works with the government to represent our member's interests and keep our members informed on legislative issues impacting the animal health industry. AVDA members have access to a regulations and legislative database that tracks federal and state changes called the State Monitor Service. To view information on the State Monitor Service, click here.

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 $1000 and $500 for additional users at member companies. Companies subscribing to this service would individually pay in excess of $25,000 per year.

AVDA Members who have logged on to the State Monitor Service find it easy to use and check it regularly for updates. Periodic tutorials are presented by State Monitor and AVDA staff and AVDA members are welcome to ask questions during and after the webinars. Contact Jackie King at AVDA Headquarters with questions or to subscribe at 443-640-1040 x 105 or by email at jackie@ksgroup.org.

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. State Monitor has made improvements to the State Monitor Drug Distributor and Drug Pedigree survey for AVDA members this year. Both surveys will now include information on licensing and pedigree 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; and
• Allowance for VAWD certification.

AVDA's State Monitor Has Changed
Participate in Webinar on October 13 or October 25 to Learn More
…a new name, enhanced functionality, and a community-like web platform.

In an effort to further enhance the utility and usability of their State Monitor product, Cegedim Dendrite recently launched a totally revamped and graphically driven website, eRegMonitor, to host their powerful legislative research product. The new site will contain all the same great federal and state legislative research you are used to, but will feature an easier to navigate user interface that takes full advantage of state of the art social media and social networking tools - such as blogs and forums. AVDA currently subscribes to the drug pedigree and drug distribution surveys of federal and state legislative and regulatory activities on eRegMonitor.

eRegMonitor will be hosting a series of webinars to help update current AVDA State Monitor subscribers on the new service and to educate other AVDA members about how the service can help them keep up-to-date with the legislative and regulatory changes on the federal and state levels.

Webinars will be held on Thursday, October 13 at 1:00 PM Eastern Time and on Tuesday, October 25 at 11:00 am Eastern Time. Contact Casey Joseph at AVDA headquarters to sign up for a session by calling 443-640-1040x116 or by emailing her at casey@ksgroup.org and we will send you the WebEx invitation and dial-in instructions. If you can't make either one of these sessions, let us know so we can schedule another session for you.

Revised Veterinary Compounding Brochure Now Available to AVDA Members

Representatives from the Animal Health Institute (AHI), American Veterinary Distributors Association (AVDA) and American Veterinary Medical Association (AVMA) have been working closely over the past year to revise the informational brochure on veterinary compounding that was originally published in 2005. The Compounding Brochure working group recommended revising the brochure because since the last publication date, changes had occurred in the regulatory arena regarding compounding, and there is a continued need for clarifying federal rules and differences between FDA-approved and unapproved drugs.

The purpose of the brochure is to better familiarize veterinarians and others in the veterinary supply channel (distributors, sales representatives, etc.) with regulations that apply to compounding. The brochure also differentiates between FDA approved drugs and compounded drugs; explains the specific circumstances under which veterinarians are legally permitted to utilize compounded drug products; and explains what practices are not permitted according to federal guidelines. Manufacturer and distributor sales representatives will be able to use this brochure as a detail piece for veterinarians.

To download a PDF of the revised compounding brochure, click here. AVDA members may order printed copies of the brochures; click here to download the order form.