Monthly Archives: May 2015

DSCSA

Vendor Managed Inventory Under the DSCSA

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At the counterI wrote this essay on Vendor Managed Inventory (VMI) back in 2013 which was aimed at what would likely happen to VMI under the California pedigree law (see “Vendor Managed Inventory Under California ePedigree”).  But even though that law is now obsolete (see “The California Pedigree Law Is Now Officially Inoperative“), surprise, some of the same issues crop up when VMI is performed under the DSCSA.  So I converted the original essay to speak to VMI under the DSCSA.  I think you will agree, it is still pertinent…

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 Continue reading Vendor Managed Inventory Under the DSCSA →

UDI

Sponsored: The Best Source Of UDI Guidance

1573-125x125_June_aniEach year on September 24 the FDA Unique Device Identification (UDI) final rule applies to another set of medical devices in the United States.  That is the anniversary of the publication of the UDI final rule in 2013 (see “InBrief: FDA Publishes Final UDI Rule”).  This year on that date, the set of devices that must comply with the rule includes implantable, life-supporting and life-sustaining devices for the first time.  Manufacturers of those devices should be in the process of making the changes necessary to comply.  And so, it is time again for the best source of Continue reading Sponsored: The Best Source Of UDI Guidance →

ANVISA

Why Does ANVISA Embrace GS1 Standards, Except The Serial Number?

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Brazil Ministry of Health logoIn Brazil, the National Agency of Sanitary Surveillance (ANVISA) has built their pharma serialization regulation around GS1 standards.  They embrace the GS1 Datamatrix and GS1-128, both encoded with GS1 Application Identifiers (AI) and using GS1 Human Readable Interpretation (HRI) (see my previous essay, “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”, for my thoughts on HRI), the GS1 Global Trade Item Number (GTIN) and the GS1 Serial Shipping Container Code (SSCC) to be specific.  But there is one GS1 standard they steer clear of:  the GS1 serial number.  Why is that? Continue reading Why Does ANVISA Embrace GS1 Standards, Except The Serial Number? →

ANVISA

The ANVISA Unique Medicine Identifier (IUM) on Drug Packages

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Idea for a barcode that might meet ANVISA requirements
Idea for a barcode that might meet ANVISA requirements

Last week I wrote about the DSCSA Product Identifier on Drug Packages in the United States.  Last month I wrote about shipping container/transport package identification under the Brazil National Medicine Control System (SNCM) (see “ANVISA And The SSCC Controversy”).  Today I will take a look at drug package identifiers under the SNCM as regulated there by the National Agency of Sanitary Surveillance (ANVISA).  Most of the factual information included here is based on Continue reading The ANVISA Unique Medicine Identifier (IUM) on Drug Packages →

DSCSA Product Identifier

The DSCSA Product Identifier On Drug Packages

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DSCSA Product IdentifierAccording to the Drug Supply Chain Security Act (DSCSA), manufacturers must apply a new “Product Identifier” on all of their prescription drug products by November 27, 2017 (Repackagers by that date in 2018).  The DSCSA Product Identifier is defined this way:

“PRODUCT IDENTIFIER.—

The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”  (Section 581[14])

Continue reading The DSCSA Product Identifier On Drug Packages →