October 2007               return to newsletter contents page

Government Affairs Update

Things have been heating up on the state and Federal levels regarding new legislation and regulations.

Florida

AVDA’s lobbyist in Florida, Bonnie Basham of Capital Ideas, continues to work on AVDA’s behalf to persuade Florida regulators not to change the definition of an authorized recipient of prescription drugs to exclude the holder of the premises permit at a veterinary office or hospital. She is also working with the House Health Care staff in the Florida legislature to revise the pedigree law. Staff and the bill sponsors are supportive of correcting the veterinary wholesaler prescription drug permit issues that AVDA members have had in obtaining permits.

Click here for the Florida meetings and activities related to the Department of Health.

Notices of Hearings

The FL Department of Health, Drug Wholesaler Advisory Council, announces a public meeting to be held via conference call, which all persons are invited.

Date and Time: November 8, 2007, 9:30 a.m.
Conference Call Number: 1-888-808-6959, Code 2454292.

Agenda Items: Welcome/Introductions, Approval of Minutes from the September 13, 2007, Meeting; Old Business; New Business; Rule Development Update, Rule Hearing Update, New Council Member Update, Program Office Update, Select Next Meeting Date, and Open Discussion.

The agenda will be sent out electronically to the interested party distribution list and placed on the website two weeks prior to the meeting. Please contact Maxine Wenzinger at 850-245-4292 if you have any questions.

Federal

HR 3580 was recently signed by the president. This omnibus bill replaces many previous bills that would affect pedigree. This is also known as the Food and Drug Administration Amendments Act of 2007.

Key points include:

• Development of a numerical identifier at the package or pallet level starting with the manufacturer.

• Identifier must link repackaged products back to the original product.

• Standards to be developed within 30 months. (9/2010)

• Increased resources and facilities for enforcement.

California

California pedigree requirements effective January 1, 2009 include:

• All dangerous drugs (includes human and animal prescription drugs)

• Originate with manufacturer (no exemptions for ADR)

• Interoperable, electronic, serialized to the unit level

• Includes the state issued license number by the board.

Section 4022 of the California administrative code clearly identifies that this relates to both human and animal products. The California Board of Pharmacy met on September 20, 2007. They stated that the implementation date of January 1, 2009 is a hard deadline. Full compliance will be expected and there will be no phase in period.

“We are a consumer protection agency. We do not protect consumers by changing dates or requirements,” Bill Powers, CA Board of Pharmacy.

The board would require significant evidence that the best interests of the consumer would be served by delaying the implementation date from January 1, 2009 to January 1, 2011. They are requesting hard data from industry, not just cost issues but pilot study results from manufacturers, distributors, and retailers. The board is accepting questions and correspondence at Californiapedigree@dca.ca.gov. The board intends to publish a Q&A sometime in December 2007.

Manufacturers of veterinary prescription products will be impacted by this law because they must conform with the serialization and interoperable system requirements for all animal prescription drugs that they sell in the state. The cost for barcoding alone can range from 20 cents to $2 per tag depending on the technology used.

The next California State Board of Pharmacy enforcement meeting is scheduled for 12/5/07 @ the Red Lion Hotel, 1401 Arden Way, Sacramento, CA 95815 (916) 649-4728.

Here is a link to information about California meetings and events.