Tag Archives: free

Barcodes

Will The FDA Eliminate The Linear Barcode On Drugs?

3 Comments

OLYMPUS DIGITAL CAMERADuring last week’s FDA DQSA supply chain stakeholder’s conference call I was heartened by Ilisa Bernstein’s comments about the linear barcode rule (she says the FDA just calls it “the barcode rule”).  The question was asked by a caller whether or not the linear barcode requirement might be dropped in light of the 2D barcode requirement contained in the Drug Quality and Security Act (DQSA) since some drug packages are too small to accommodate both barcodes.  This is an excellent question and I was happy the caller asked it so directly.

In her response, Dr. Bernstein pointed out that Continue reading Will The FDA Eliminate The Linear Barcode On Drugs? →

DQSA of 2013

FDA: Ready, Set, Hike!

1 Comment

FDALogoTuesday’s FDA stakeholder call with Dr. Ilisa Bernstein, deputy director in the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance, was helpful if only to let us know that the FDA has begun to mobilize immediately after the Drug Quality and Security Act (DQSA) was signed into law by President Obama last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law” and “InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13”).  The call was very thin on what their plan is, but that was the point.  Dr. Bernstein wanted everyone to know Continue reading FDA: Ready, Set, Hike! →

RxTrace, RxTrace Traceability Survey

Announcing The 2014 RxTrace U.S. Pharma Traceability Survey

iStock_000028920134XSmallWith the enactment of the Drug Supply Chain Security Act of 2013 (DSCSA) last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“) I have decided to conduct an annual survey of U.S. pharma traceability preparedness.  You can fill out the survey by clicking on this link:  Take the 2014 RxTrace U.S. Pharma Traceability Survey Now.

The answers you provide anonymously will be aggregated to provide a view of the thinking of the industry, solution providers, regulators, academics and more, in addition to a view of the preparedness of the industry to meet the new federal pharmaceutical traceability law.  Please make sure your company is represented in the data that is collected.  The survey is Continue reading Announcing The 2014 RxTrace U.S. Pharma Traceability Survey →

Pharma Manufacturers

Working With CMOs Under California ePedigree

5 Comments

CMO ZoomImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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 →

California Pedigree Law

3PL Operation Under California ePedigree

2 Comments
Distribution_centre
Photo from Wikipedia

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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 →

California Pedigree Law

InBrief: ‘The Smallest Package Or Immediate Container’ In California

4 Comments
Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.
Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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 →

California Pedigree Law

Vendor Managed Inventory Under California ePedigree

9 Comments

At the counterImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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 →

Uncategorized

InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013

1 Comment

RxTrace.com Serialization Estimate 2013Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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 →