When either the California ePedigree law or the federal law go into full effect, how smooth will that rollout be? While there are big differences between those implementations and the deployment of Healthcare.gov, the U.S. federal government’s new health insurance exchange website that is part of the Patient Protection and Healthcare Affordable Care Act (often referred to as the ACA, or “Obamacare”), I think the troubles it is experiencing may be an example of how the ePedigree system will work on initial rollout. That’s right, I’m predicting a nightmare, especially if it’s the California law that rolls out. Continue reading How Smooth Will Industry Deployment of the ePedigree Laws Be? Take a Good Look At Healthcare.gov
Tag Archives: California Pedigree Law
California, Congress and The Choices We Are Forced To Face
Another week has gone by with no official movement in the Senate on the compromise pharmaceutical compounding and track & trace bill, H.R. 3204, the Drug Quality and Security Act (DQSA) (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”). With the focus of the Congress rightly on reopening the government I think we should expect to wait a little longer. You can bet that the supporters and the opposition are both developing their strategy as time goes by.
I attended the GS1 Global Healthcare Conference in San Francisco last week and it was a great opportunity to reconnect with a lot of people I have worked with over the years on defining workable standards for healthcare supply chain data exchange. Some of us are Continue reading California, Congress and The Choices We Are Forced To Face
InBrief: California Proposes Breakthrough ePedigree Regulation On Drop Shipments
Late last Friday the California Board of Pharmacy published a proposed regulation for pharmaceutical drop shipments under their ePedigree law that is scheduled to go into effect in 2015 through 2017. See the text of the proposed regulation for “Electronic Pedigree Requirements for Drop Shipments” here, the notice of its proposed action here, and their “Initial Statement of Reasons” here. The Board is now seeking public comments on the proposed text through October 28, 2013.
The Board had asked for public input into the operation of drop shipments in the past to assist it with drawing up the regulation, which was mandated by Continue reading InBrief: California Proposes Breakthrough ePedigree Regulation On Drop Shipments
Working With CMOs Under California ePedigree
So far in RxTrace I have explored the possible implications of the California pedigree law on drug repackagers, 3PLs, VMI relationships and, of course wholesale distributors. Now let’s take a closer look at the murky world of the contract manufacturing organization (CMO). I call this world “murky” only because you have to look very carefully at the relationship between a CMO and the contracting manufacturer to fully understand how the pedigree law might be applied. And even then you are going to have to check with the California Board of Pharmacy because the law is so confusing in this area. Continue reading Working With CMOs Under California ePedigree
3PL Operation Under California ePedigree
Another one of the many types of businesses that will need to make changes to their operations in California once the pharmaceutical ePedigree law goes into effect is the third party logistics provider (3PL) business. There are a number of important differences between wholesale distributors and 3PLs, and because there seem to be confusion over the wording of the California law and recent comments made by California Board of Pharmacy officials regarding 3PLs (at least I’m confused), companies should be careful about their implementations. I do not have the answers and this is not legal advice, so please check with the Board and your lawyer to confirm anything you read here, but I will tell you my current thinking on the subject. Continue reading 3PL Operation Under California ePedigree
InBrief: ‘The Smallest Package Or Immediate Container’ In California
The California pedigree law requires manufacturers to serialize the smallest package of drugs that will be bought by a dispenser. For some manufacturers targeting the U.S. market, that may require serialization and e-pedigree at a lower unit of measure than they might have thought. For products that manufacturers package into multi-packs and sell to wholesalers packaged only that way, you might assume that your “smallest package or immediate container” is the multi-pack. Think again.
Continue reading InBrief: ‘The Smallest Package Or Immediate Container’ In California
Vendor Managed Inventory Under California ePedigree
One of the complexities of the modern pharmaceutical supply chain occurs when a pharmaceutical dispensing organization “outsources” the management of their on-premises inventory to their supplier, or “vendor”. This is known as Vendor Managed Inventory, or VMI. There are several good reasons this might be done, including eliminating the need to deal with issues that have more to do with supply chain execution mechanics and fluctuating supply and demand than they do with the core competency of dispensing drugs.
When VMI is used in the pharma supply chain the supplier is typically a wholesaler whose core competency is in dealing with those exact issues. That’s just what they do. The wholesaler benefits from the VMI relationship because they become the exclusive supplier to the VMI customer. VMI can be a “win-win” proposition as long as costs are kept in-check.
But what will happen to VMI relationships in California after the California pedigree law goes into effect?
Continue reading Vendor Managed Inventory Under California ePedigree
Fall Conference Season Preview
I am a fan of attending conferences because, in addition to hearing thought-provoking presentations by knowledgeable speakers, you get to connect with the other attendees to learn what they are doing and thinking. That’s why it is so important to select the right conferences. Your goal should be to find the conferences that attract the best attendees so that you have the opportunity to make new connections and get updates from your existing ones. Of course, the speakers Continue reading Fall Conference Season Preview
