Archive for the ‘California Pedigree Law’ Category

During the California Board of Pharmacy, Enforcement Subcommittee meeting on Wednesday the members voted unanimously to recommend to the full board the approval of a regulation that would require the use of the Food and Drug Administration’s (FDA) Standardized Numerical Identifier (SNI) as the unique identifier that is required on all drugs packages as part of their pedigree law.  That law currently requires pharmaceutical manufacturers to apply unique identifiers to 50% of all their prescription drug packages by January 1, 2015 and the remainder by January 1, 2016.

The approved text reads as follows: Read the rest of this entry »

The California pedigree law will have a surprising influence on how the pharmaceutical supply chain operates in another state.  I’ll get to that in a minute, but first, the law will change some things about the way the supply chain operates in all states.  Prescription drug manufacturers who want to continue offering their products to patients within California after 2015-2016 must add unique serial numbers to each drug package and start an electronic drug pedigree.

California is the only state that requires both of those things but most manufacturers are forced to treat the California state law as if it applies nationwide.  That’s because most drug manufacturers sell through distributors in the United States and so they have no way of knowing which drug package will end up being shipped into California and which ones will not.  Voila!  Pharma manufacturers end up having to serialize and create a pedigree for every single package that enters the U.S. supply chain.

This almost certain outcome will likely affect the full nationwide supply chain in a couple of interesting ways.

AFTER 2015:  ALL DRUGS IN THE U.S. SUPPLY CHAIN ARE SERIALIZED AND PEDIGREED BY THE MANUFACTURER

That will be a big change, even outside of California.  Here are some of the things I think we will see happen: Read the rest of this entry »

For the first time in over two years the topic of pedigree appears on the agenda of the California Board of Pharmacy for their upcoming meeting on September 7.  Earlier this year in a presentation at the FDA Track & Trace Workshop Board Executive Office Virginia Herald mentioned that the Board would take up the topics of inference, drop shipments, decommissioning and linkage between shipping orders and invoices at a future meeting in 2011.  It’s hard to tell if those will be the actual topics discussed in next week’s meeting because they aren’t called out explicitly.  Here is the item as it actually appears on the agenda: Read the rest of this entry »

“…[C]ommencing on July 1, 2016, a wholesaler or repackager may not sell, trade, or transfer a [prescription] drug at wholesale without providing a pedigree.

…[C]ommencing on July 1, 2016, a wholesaler or repackager may not acquire a [prescription] drug without receiving a pedigree.

…[C]ommencing on July 1, 2017, a pharmacy may not sell, trade, or transfer a [prescription] drug at wholesale without providing a pedigree.

…[C]ommencing on July 1, 2017, a pharmacy may not acquire a [prescription] drug without receiving a pedigree.”

With these words the State of California introduced a significant change to the way the pharmaceutical supply chain works (see section 4163 of the California Business and Professions Code) and has written a new page in the history of commerce.  It brings pharmaceutical commerce fully into the computer age.  Adam Smith would not recognize it.  Today, and up to the effective dates of these provisions, the value of a legitimate pharmaceutical in the legitimate U.S. supply chain is determined by the physical condition of the product and its package.  After July 1, 2016, the value of a legitimate pharmaceutical in the supply chain in California will be determined by the combination of the physical condition of the product and its package, and the sellers ability to provide the buyer with an electronic pedigree. 

The intended effect of this new regulatory requirement is to place a significant roadblock in front of counterfeiters, diverters and others who would try to scam patients and the legitimate participants in the supply chain.  This is a noble cause.  By requiring sellers to provide buyers with a pedigree at each change in ownership in the supply chain, illegitimate parties will find it very hard to inject illegitimate drugs without exposing their actions and, at the same time, creating evidence that can be used against them in their own prosecution.  By providing a pedigree at each change in ownership, supply chain buyers will be able to check the authenticity of the full supply chain transaction history provided by the seller, maximizing the likelihood that any suspicious activity would be detected long before a patient would receive the drugs.

But I’m more interested today in exploring a surprising unintended effect of these requirements.  I’ve touched on this briefly in past essays but I’ve recently concluded that the implications of these requirements are much more significant than I realized before.  This may be the first time in the history of commerce that Read the rest of this entry »

Right now there is only one industry standard that can be used to comply with the various drug pedigree laws in the United States. That’s the GS1 Drug Pedigree Messaging Standard (DPMS), which was created in 2006 by a group of technology experts and participants from nearly all segments of the U.S. supply chain culminating in GS1 ratification in January 2007. Many of those companies began using DPMS even before it was ratified because the Florida Pedigree Law went into effect in July 2006. Since then, companies are using it to comply with other state pedigree laws as well as for the pedigree provisions of the federal government’s Prescription Drug Marketing Act (PDMA) of 1988 (stayed until December 2006). Interestingly, a few companies have chosen to require DPMS pedigrees today for trading partner risk mitigation even where there is no existing regulatory requirement to do so.

A few months after GS1 ratified the DPMS standard, they ratified the Electronic Product Code Information Services (EPCIS) standard. This is a more general purpose standard intended for use in all supply chains that have a need to track and trace serialized products. Everyone acknowledges that it doesn’t make sense to try to use it for compliance with PDMA, Florida or other state pedigree laws because they do not require serialization, but in 2015 the California Pedigree Law will go into effect and one of its unique provisions requires item-level serialization.  Some see this as an ideal place to apply EPCIS.

There are lots of ways to contrast these two standards and their use for pedigree law compliance, but probably the most striking difference is how they each treat Supply Chain Master Data (SCMD). I defined SCMD in a previous post as “…that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the supply chain.”

GLN as SCMD

Addresses are an example of a “business entity” that can be treated as SCMD. GS1 defines a location identifier they call a Global Location Number (GLN) that can be used to refer to an address. A GLN is a structured series of digits that can be assigned to refer to a single address (among other things). Refer to the GS1 General Specification for the details. Read the rest of this entry »