California Needs Stakeholder Input in Order to Permit Inference

With several drug manufacturers already employing 2-D bar coding as they prepare to meet California’s electronic pedigree rule, inference will be key to achieving both supply-chain efficiency and regulatory compliance.

Inference refers to inferring “the contents of a case, pallet, or other aggregate of individual units, packages, or containers of dangerous drugs, from a unique identifier associated with the case, pallet, or other aggregate, without opening each case, pallet, or other aggregate or otherwise individually validating each unit,” according to the California State Board of Pharmacy (CA BoP).

But in order for inference to be allowed officially under California’s law, the CA BoP must issue rulemaking on its use. To prepare for such possible rulemaking, the CA BoP is asking pharma supply-chain participants to submit detailed information on how the use of inference will not increase risk.

In a notice issued on July 23, the CA BoP stated that California's e-pedigree law is required to ensure that “all participants in the dangerous drug supply chain will ‘verify and validate the delivery and receipt of dangerous drugs against [electronic] pedigrees at the unit level, in a manner that maintains the integrity of the pedigree system without an unacceptable increase in the risk of diversion or counterfeiting.’ ”

The CA BoP must define the “circumstances under which it would be permissible to substitute an inference as to the contents of an aggregate container for verification and validation of that container’s individual unit contents.”

Supply-chain participants include manufacturers, wholesalers, or pharmacies furnishing, administering, or dispensing dangerous drugs, and the CA BoP wants to hear from all of them, explained Virginia Herold, CA BoP’s executive officer, told PMP News.

“We would like to hear members of the supply chain detail the types of anticipated problems that inference would solve,” she said.

Written submissions must be received by mail or personal delivery at the Board offices by no later than September 1, 2012 and must contain the following information outlined in the CA BoP’s July 23 notice:

1. Identifying and contact information for the submitting person or entity.
2. A description of the submitting party’s interest in this subject, including the submitting party’s role, if any, in the supply chain (e.g., manufacturer, repackager, distributor, or dispenser) or other basis for interest (e.g., vendor, consultant, standards body) and a brief description of the person, company, or other entity responsible for the submission.
3. If the submitting party is a supply chain participant, a detailed description of the means and methodology, including hardware and software specifications, processes, and data carrier(s), that the submitting party has deployed or intends to deploy to “verify and validate the delivery and receipt of dangerous drugs against [electronic] pedigrees at the unit level,” including specification of the means and methodology for certification.
4. If the submitting party is seeking a regulatory allowance for inference, a specific request for same along with a detailed description of the particular circumstance(s) and/or those transaction(s) under which or pursuant to which there is a perceived need for inference. Define the requested inference(s) as specifically as possible, and where possible provide a limiting descriptor for such transaction(s) that could be used in regulatory language. In addition, provide as much data as possible regarding the factual circumstance(s) and/or transaction(s) in question, including the number and percentage of transaction(s) to which such an inference might apply, both with regard to the submitting party and in the supply chain as a whole, and any trading partners that will be involved in the inference(s).
5. If the submitting party is opposed to a regulatory allowance for inference, either generally or with regard to particular circumstances/transactions, a detailed description of same that as closely as possible meets the requirements of item 4., above.
6. The detailed reason(s) that such an inference is necessary and/or advantageous, and either decreases risk(s) of diversion or counterfeiting (or other risk(s) in the supply chain), holds risk(s) constant, or does not unacceptably increase such risk(s). Or the detailed reason(s) any inference(s) is/are unnecessary, disadvantageous, or unacceptably increase(s) risk(s).
7. Proposed SOPs that incorporate and explain the use of the inference(s), and describe the proposed process for statistical sampling to ensure the accuracy of pedigree information.
8. A proposal for the allocation of any liability that may be incurred due to use of inference.

The CA BoP will discuss all submissions received on or before September 1 at its Enforcement Committee meeting on September 11, 2012, and/or at the full Board meeting on October 25-26, 2012.

All written submissions should be mailed or delivered to Executive Officer Virginia Herold, Board of Pharmacy, 1625 N. Market Blvd., Suite N219, Sacramento, CA 95834.
 

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