Happy New Year, 2018 is here! Last year, the FDA announced a series of three Drug Supply Chain Security Act (DSCSA) Public Meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). So far they have held two (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “FDA DSCSA Public Meeting #2, Still A Gulf”). One more is left in that series, to be held on February 28, 2018. Continue reading 2018: The Year of FDA DSCSA Public Meetings
Category Archives: DSCSA
A US Medicines Verification Organization (USMVO)? Again
If you’re like me, you are doing at least some work this week. I usually do some work work during this quiet time when I am not interrupted. It’s usually things I need to do to wrap up the year, but also includes planning for the new year. In case you are working this week but you need a little diversion, here is something to think about for 2018.
It has become increasingly clear that what the US pharma supply chain needs is for some organization to step up and take responsibility for the decisions and actions that are needed to ensure successful development and operation of the Enhanced Drug Distribution Security phase of the Drug Supply Chain Security Act (DSCSA). There are less than six years before that phase is supposed to begin. But with no one clearly specified as the organization responsible, odds are, it isn’t going to happen. This was the topic I covered two months ago when I originally published “A US Medicines Verification Organization (USMVO)?”. With the end of the year and the holidays coming up, I’ve been too busy to write a new essay this week, so take another look at this idea. Continue reading A US Medicines Verification Organization (USMVO)? Again
FDA DSCSA Public Meeting #2, Still A Gulf
The gulf in expectations and goals exposed in the first FDA Drug Supply Chain Security Act (DSCSA) Public Meeting back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “HDA Schools FDA On DSCSA”) was still visible in the second meeting last week. There is still one more announced meeting scheduled for February 28, 2018 for the FDA and the industry to align (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). Based on my observations at these first two meetings, I’m not going to hold my breath. The FDA is likely to announce more meetings in 2018.
The FDA did adjust their position on at least one thing after the August meeting. Continue reading FDA DSCSA Public Meeting #2, Still A Gulf
HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain
It has been six years since the Healthcare Distribution Alliance (HDA) updated their full barcode guidelines (see “Updated HDMA Bar Code Guidance: A Must Read”). They just updated it again with major changes over the 2011 version. The new document is called “HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain” and it is available on HDA’s website here. With the passage of the Drug Supply Chain Security Act (DSCSA) in November of 2013, an update was long overdue.
You are forgiven if you thought the HDA updated the barcode guidelines only one year ago Continue reading HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain
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
