California Adopts ePedigree Regulations as 2015 Deadline Looms

The California Board of Pharmacy recently adopted regulations detailing what drugmakers, distributors and other stakeholders must do to meet a 2015 deadline under the state’s electronic pedigree law.

However, the state board is still considering several regulations that could help stakeholders once the law goes into effect.

By January 2015, 50 percent of each drugmaker’s total product entering the state’s market must be serialized. Pharma companies have until 2016 to serialize the other half.

Manufacturers are required to submit to the board by no later than Dec. 31, 2014, a list and quantity of products by name and product package type that will be ready for ePedigree’s initial implementation. Other items to be included in the submission include:

  • A statement identifying one of the following methods was used to measure the percentage of drugs ready to be serialized: unit volume, product package type or drug product family;
  • A statement describing the calculations used to arrive at the percentage figure of products ready for serialized pedigree requirements; and
  • A statement specifying the technology employed to meet the pedigree requirements.

(full story at Drug Industry Daily; paid subscription required)