The U.S. FDA is poised to publish their final Unique Device Identification (UDI) rule any day now. The publication was due earlier in the summer but has apparently been held up in the review by the Office of Management and Budget (OMB) without any kind of accurate timeline. The organizers of this year’s UDI Conference are hoping the FDA will be able to announce its publication at their event this Thursday and Friday in Baltimore. I understand that not everyone is looking forward to its publication, but some are kind of tired of waiting for it. I’ll bet Jay Crowley and his team Continue reading What The UDI Date Format Says About FDA’s Direction
FDA Chooses DUNS For Unique Facility Identifier
Last week the FDA published draft, non-binding guidance for their recommended unique facility identifier (UFI) for use in registering foreign and domestic drug establishments. Last year, Congress passed the FDA Safety and Innovation Act (FDASIA) to address safety concerns induced by inspection gaps of facilities outside the United States and other issues (see “The Supply Chain Provisions Of The FDA Safety & Innovation Act”). In that law, Congress required the FDA to come up with some way of uniquely identifying all foreign and domestic facilities that are involved in the manufacture and importation of drugs. This new guidance is the response. Continue reading FDA Chooses DUNS For Unique Facility Identifier
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
InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013
In August 2010 I started an annual estimate of the rise in the percentage of drugs in the U.S. supply chain that will have serial numbers attached. Click here to read my first essay on the topic which explains the concept. Click here to read my 2011 essay and click here to read my 2012 essay. These are not estimates of the actual percentage today. Rather, it is a prediction of the rise from an immeasurably small percentage in early 2010 to 100% at some time in the future. My plan was to Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013
Federal Pedigree: Caught In A Web Of Politics
Seventeen months ago, the goal of the Pharmaceutical Distribution Security Alliance (PDSA) was to get a nationwide track & trace bill introduced into Congress and then get it attached to some “must-pass” legislation which would pull it through to certain passage. They found sympathetic members of both houses of Congress and they worked together to produce a single bill. Last summer the “must-pass” legislation was the Prescription Drug User Fee Act (PDUFA) which was combined with other bills and was enacted as the FDA Security and Innovation Act (FDASIA). See “What If RxTEC Isn’t Adopted?”, “PDUFA Will Not Include RxTEC” and “The Supply Chain Provisions Of The FDA Safety & Innovation Act”.)
Unfortunately the track & trace Continue reading Federal Pedigree: Caught In A Web Of Politics
