Back on June 30, 2017, the U.S. FDA extended the product identifier requirements under the Drug Supply Chain Security Act (DSCSA) to November 26, 2018 due to insufficient industry readiness. This gives the industry an extra full year to make sure their solutions are fully integrated and tested. Are you ready? Are you done? Even those who would have been ready this November are likely to have more to do to make sure their start-ups go smoothly. What about your European Falsified Medicines Directive (FMD) strategy? That’s right around the corner too. Continue reading Sponsored: Bio/Pharma Serialization and Traceability Summit 2017
Opioid Epidemic: Root Cause Exposed
The root cause of the US opioid epidemic was made visible on television two Sundays ago. Did you see it? I’m referring to the 60 Minutes/Washington Post expose called “The Whistleblower” that aired on Sunday, October 15. But if you watched that episode with the volume up, odds are you missed the root cause. Let me explain. Continue reading Opioid Epidemic: Root Cause Exposed
Sponsored: FDA DSCSA Public Meeting Q&A
The two days after the next FDA DSCSA Public Meeting, IQPC will hold their Pharmaceutical Traceability Forum | Interactive event in Washington DC. The FDA meeting will be on December 5 and 6, and the IQPC event will be on December 7 and 8. Perfect for attending two vitally important meetings, and only having to travel once. The Pharmaceutical Traceability Forum | Interactive event includes a slate of excellent speakers who will provide you with their immediate impressions of the FDA meeting that will have just occurred, and the one that was held back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”). Continue reading Sponsored: FDA DSCSA Public Meeting Q&A
A US Medicines Verification Organization (USMVO)?
The Drug Supply Chain Security Act (DSCSA) makes it clear that the FDA must work with industry stakeholders to figure out exactly how the US pharma supply chain should meet its requirements after November 27, 2023–see DSCSA Section 582(g). That section specifies “The transaction information and the transaction statements shall be exchanged in a secure, interoperable, electronic manner…”. There is no mention of the creation of an independent third-party to design or coordinate that exchange, and Continue reading A US Medicines Verification Organization (USMVO)?
Why Aren’t Health Insurance Companies Interested In Pharma Traceability in the US?
Except for Medicare/Medicaid, the United States and Australia are the only countries in the world that do not rely primarily on “single-payer healthcare”. The term refers only to who pays for the healthcare of citizens, not how that care is delivered. Those two countries rely primarily on private insurance companies to act as “payers” of healthcare for most citizens and the funds used to pay are Continue reading Why Aren’t Health Insurance Companies Interested In Pharma Traceability in the US?
HDA Schools FDA On DSCSA
Last week the Healthcare Distribution Alliance (HDA) submitted nine pages of comments in response to the FDA’s Request For Comments in docket number FDA-2017-N-3857 (find their submission here). It is worthwhile for you to read because the HDA generally sets the gold standard for detailed analysis of the Drug Supply Chain Security Act (DSCSA), and because this one is particularly pertinent to discussions going on at the FDA and around the industry right now. Continue reading HDA Schools FDA On DSCSA
OPEN-SCS Announces Major Milestone
Today, the Open Serialization Communication Standard (OPEN-SCS) Group, a collection of healthcare sector companies dedicated to standardizing packaging line serialization and aggregation data exchanges, will announce a major milestone in the push to streamline global track & trace processes. At Pack Expo in Las Vegas, the organization will hold a press conference to formally introduce its initial Serialization Standard, the Packaging Serialization Specification (PSS) 1.0. The achievement is to be revealed in Continue reading OPEN-SCS Announces Major Milestone
Does Interoperability Change In 2023?
There are many terms specifically defined within the Drug Supply Chain Security Act (DSCSA) text (see “Don’t Skip The DQSA Definition of Terms Section”). One of the words you should expect to be defined there is “interoperability”, because it plays such a big role in the system(s) that must be used by everyone in the supply chain after November 27, 2023. That is, the “…interoperable, electronic tracing of product at the package level…” that is at the core of the Enhanced Drug Distribution Security (EDDS) phase that is defined in Section 582(g). But surprisingly, the term is not defined in the text.
In fact, it appears to be left up to Continue reading Does Interoperability Change In 2023?
