On May 22nd, 2015, India’s Directorate General of Foreign Trade (DGFT) quietly published Public Notice #13 with the subject “Implementation of the Track and Trace system export of drug formulations”. It was an amended version of Public Notice #4, dated April 1, 2015 with a similar subject. Get it? April Fools!
I have to admit, I fell for it. Did you? Continue reading India’s Pharma Export Serialization Deadlines: April Fools!
I was poking around on the FDA website yesterday to find out if any new DSCSA documents had been released recently. I just returned from a near three-week trip to Western Europe and wanted to see if perhaps I missed something. No. Nothing released recently. You can find a list of DSCSA documents released by the FDA on their website and the most recent one was published on December 31, 2014.
Back in January of this year the FDA published their annual list of guidance titles that they think they will publish in the coming year (updated in April). That list included six titles of guidance documents related to the DSCSA that they expect to either publish in draft form, or finalize. These include: Continue reading FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015
The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers). These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).
A common question is, what is the smallest level of packaging that must be serialized?. The DSCSA text provides the answer. Continue reading InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA
Another type of business affected by the U.S. Drug Supply Chain Security Act (DSCSA) is the third party logistics provider (3PL) business.
I wrote an RxTrace essay about the impact of the California pedigree law on 3PLs back in 2013 (see “3PL Operation Under California ePedigree“). This is an update of that essay to address the impacts of the new DSCSA on 3PLs since the California pedigree law is now obsolete.
There are a number of important differences between wholesale distributors and 3PLs as defined in the DSCSA. Continue reading 3PL Operation Under The DSCSA
I 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
Each 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
In 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?
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
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