California BofP Further Defines Pedigree Regulation As National Law Pends
Published: June 24th, 2013
Experts addressed the supply chain’s readiness for California’s e-pedigree law and the likelihood of a national standard for drug tracing at Pharmapack NA last week in Philadelphia.
With the state’s law set to go into effect in 18 months, the California State Board of Pharmacy is completing the regulations on issues including inference, inspection, certification, drop shipments, and grandfathering. Those items are on the agenda for a Board e-pedigree committee public hearing scheduled today, June 24, in Sacramento, Virginia Herold, executive officer, California State Board of Pharmacy advised the Pharmapack audience.
“We are still trying to define the language on the front end; the committee will be talking further about inference; we are working on drop shipments, and closure of the pedigree at the end of the life of the product,” Herold said.
The committee is moving ahead with the regulations to avoid the risk of an unregulated supply chain. Should the state’s law be preempted by federal legislation, the board would discontinue the process, she said in response to an audience question. “At this point, we do not have any intent to push the law (deadlines) back any farther,” Herold said.
“The pharmacy board is not looking to actively leverage fines, or for all manufacturers to reach 50% of product by 2015 or reach 100% of compliance by the deadline as long as manufacturers progress with serialization. They want an earnest and honest effort with a plan in place to meet the goals to get serialized product into the system and begin to engage with the wholesalers,” said Michael Stewart, vp, track & trace projects, PharmTech, Inc.
Also on the agenda, GS1 Healthcare US will ask the committee if the board will accept the GS1 EPCIS (Electronic Product Code Information Services) standard for meeting the pedigree requirement, said Bob Celeste, director of healthcare, GS1-US.
The board has accepted GS1’s Drug Pedigree Messaging Standard (DPMS) as suitable for the e-pedigree law. The “Russian Doll”-like system provides a locked chain of custody with digital signatures applied and passed forward upon each change of ownership.
With EPCIS, parties would pass along a minimum of data, retrieving other data to assemble a full-blown product trail when called for. “EPCIS cuts down on the data moving through the supply chain. We meet the intent of the law—if you take a bottle off the shelf, I can tell you where it has been in the supply chain,” Celeste said.
The House and Senate bills build upon and advance beyond last year’s RxTEC Act, developed by a supply-chain-spanning coalition intent on securing a uniform national standard for traceability. While the House bill is being opposed by some stakeholders as too weak, a national regulation--should Congress come to a consensus—would lack the benefits envisioned by California, panelists at Pharmapack said.
Ron Guido, vp of global brand protection & supply chain integrity, Johnson & Johnson, described business and patient safety advantages accruing from serialization. On the business side, serialization brings visibility and control that is currently lacking in the supply chain network. “There are business value opportunities we can all enjoy if we take this serialization to the next level as a strategy to reform the pharmaceutical supply chain, Guido said.
“The number one reason we are doing this is for patient safety, and I don’t think we need a business case for that. This isn’t about brand integrity; it’s about patient safety. Even with no laws, we should be doing this on our own. That is the message at the corporate level.”
“(The proposed federal regulation) is very disappointing. They took a great concept and watered it down,” said Guido.