Last week I wrote about the debate over the number of possible responses to verification requests in any potential solution the industry might adopt to meet the Drug Supply Chain Security Act (DSCSA) (see “DSCSA Red Light Green Light: Verification Responses”). Today I want to take a closer look at a related issue: the relationship between verification and suspect product. Most specifically, does a failed verification automatically force a product into the suspect product category? The answer might surprise you. Continue reading DSCSA Verification and Suspect Product
On August 21st, large portions of the United States and other places will experience a total eclipse of the sun by the moon. On November 27th, the serialization and verification delay of the Drug Supply Chain Security Act (DSCSA) contained within the FDA’s recent draft compliance policy (see “FDA Delays Enforcement of DSCSA November Deadline: What It Means”) will eclipse the grandfathering guidance that hasn’t even been published yet. In fact, the overdue grandfathering guidance should be easy for the FDA to write now (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”). Grandfathering probably just won’t exist. Here’s why. Continue reading DSCSA Serialization Delay Eclipses Grandfathering
The final report of the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz is now available. Download the full free report here. With this year’s survey we attempted to get a glimpse of the progress toward the next deadlines of the Drug Supply Chain Security Act (DSCSA) from drug manufacturers, repackagers, wholesale distributors, 3PLs and dispensers. Each of those different types of respondents were asked a different set of questions that were pertinent to their segment and their regulatory requirements under the DSCSA.
Congress set the calendar for many different kinds of requirements when it adopted the Drug Supply Chain Security Act, signed by the President back on November 27, 2013. One of those dates was last November 27, 2015, two years after enactment, when the FDA was required to publish four new draft guidances. So far, none of them have appeared (see “FDA DSCSA Deadline Passes Quietly”). Continue reading Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?
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.
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?
In less than one month the Drug Supply Chain Security Act (DSCSA) will require all sales of drugs in the U.S. pharma supply chain to be accompanied by some very specific data (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”). The law requires companies to begin exchanging data on January 1 in either paper or electronic form, but because it would be virtually impossible for the big 3 wholesale distributors to accept even a single piece of paper for even a single shipment, the bulk of the U.S. sales by pharma manufacturers will be documented electronically from day-one. It turns out, the vast majority of that electronic documentation will be passed in the form of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) (see “DQSA: Getting To Electronic Transaction Data Exchange”, “Just Released – The HDMA EDI ASN Guidance For DSCSA”, “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again” and “The HDMA Supply Chain Product Transaction Scenarios For DSCSA”).
But the vast majority of those EDI ASN documents are not likely to Continue reading The Coming Transition To Serialized Data
Back in the middle of the summer the Healthcare Distribution Management Association (HDMA), the industry association for the primary healthcare distributors in the United States, published on their website a very valuable resource for companies that must meet the U.S. Drug Supply Chain Security Act (DSCSA) beginning in January. This new resource is tucked away in the HDMA’s “Issues in Distribution”, “Pharmaceutical Traceability” page under the “Technical/Standards” heading [look for “Supply Chain Product Transaction Scenarios: Drug Supply Chain Security Act Implementation (2014)”]. It is free for anyone to download and I highly recommend that you do. (And while you’re at it, check out some of the other resources available on that page.)
HDMA has been a leader in developing high quality guidance documents that aim to help Continue reading The HDMA Supply Chain Product Transaction Scenarios For DSCSA