December 2007               return to newsletter contents page

AVDA Files Comments with California Board of Pharmacy on E-Pedigree Rules

AVDA Executive Director, Jackie King, recently filed comments on behalf of AVDA with the California Board of Pharmacy, E-Pedigree Work Group. In her comments, she requested that veterinary labeled drugs be exempt from definition of dangerous drugs under section 4022 of the California Administrative Code. AVDA seeks an exemption from the pedigree requirements for all veterinary labeled prescription drugs.

California’s pedigree legislation takes its origin from the Prescription Drug Marketing Act (PDMA of 1987). The federal act applies only to human labeled prescription drugs and does not contemplate veterinary label drugs. Although California has broadly defined “dangerous drugs” to include all prescription drugs, AVDA believes that veterinary labeled prescription drugs should be exempt from the pedigree and serialization requirements since these drugs will never end up in the human drug supply chain. AVDA distributors do not distribute to those who are licensed to sell to humans and AVDA manufacturers of veterinary labeled drugs are not licensed to sell these drugs to human drug distributors. Manufacturers and distributors are required to comply with serialization requirements and have an interoperable system in place by January 1, 2009.

To see the complete text of the comments, click here.