This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow. The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers. In fact, if they had failed to meet their late May deadline for publication of this particular draft guidance Continue reading FDA To Publish Key Draft Guidance Tomorrow
Dear Blockchain Vendors,
It was good to see all of you at last week’s Drug Supply Chain Security Act (DSCSA) and Blockchain proof of concepts pilots review held by the Center For Supply Chain Studies (C4SCS) in Rockville, MD. I hope your travel home was uneventful. Let me say right at the top, I was in the audience representing Systech International. My co-worker, Joe Lipari partnered with Dwight deVere of RxTransparent as the Green Team. RxTrace is independent of Systech International. That said, as the author of RxTrace, I have some helpful advice for you. Continue reading An Open Letter To Blockchain Vendors: Please Pay More Attention
Normally drugs dispensed by American pharmacies are repackaged into the “standard” amber vial. The pharmacy places their own label on that bottle so the patient normally doesn’t receive the manufacturer’s package that would have the new 2D barcode mandated by the Drug Supply Chain Security Act (DSCSA). There are a few drugs that are not repackaged by US pharmacies, like most things in an inhaler and drugs in “compliance packaging” like birth control pills. But even then, the pharmacy puts their label on the package
One of the few drugs I take daily is a statin, which has always been put into an amber bottle by my pharmacy. A few months ago I received a three months supply, and to my surprise, the pharmacy dispensed the prescription in the manufacturer’s original 90-count bottle, and there was the DSCSA 2D barcode on the label. The pharmacy label was positioned so that it formed a “flag” and did not cover the 2D barcode, and the pharmacy label was easily removed to expose the entire manufacturer’s label. This drug was made by Lupin Pharmaceuticals, a generic drug manufacturer base in India. How did they do? Continue reading I Receive My First Serialized Drug From My Pharmacy: Is It Right?
Companies are spending hundreds of millions of dollars, euros, rupees and rubles getting ready to comply with serialization regulatory mandates around the world. Deadlines are fast approaching in the US and the EU and they are already passed in India, South Korea, Argentina and Turkey. What companies are looking for next is how to extract some value beyond just complying with government mandates. Just about every solution provider offering serialization components and solutions out there has at least one product or service that is aimed squarely at this type of need. What we need to do is get these people together: those who are looking, and those who have the solutions.
Cognizant, a management consulting company, has written a very nice 11-page white paper exploring value beyond compliance. Continue reading Sponsored: Extracting Value Beyond Compliance From Serialization
I just helped IQPC update their printable global pharma serialization regulation map. Get a copy here. Things change around the world pretty often so it’s important to update resources like this frequently. The information for most of the existing countries was updated and I added a few new countries. It’s a great resource to print and pin up on your office wall, or the company bulletin board to keep everyone focused on the approaching deadlines around the world. And it looks great too! Continue reading Sponsored: Newly Updated Global Serialization Regulation Map
The second—and longer—draft guidance document the FDA published on the day of the third DSCSA public meeting is a “catch-all” (see also “DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations” and “FDA DSCSA Public Meeting #3: A Difference?”). It contains lots of diverse recommendations, all related to the standardization of data contained in the DSCSA transaction information (TI), transaction history (TH), and transaction statement (TS). This draft guidance applies to every member of the supply chain, including drug manufacturers, CMOs, 3PLs, wholesale distributors, repackagers and dispensers of all kinds. Everyone should read it and submit comments to the FDA when something isn’t clear enough. Continue reading DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing
The IQPC PharmaTrace Summit will be held on June 4-6 in Princeton, NJ. In preparation for the event, IQPC asked four industry veterans to respond to a set of forward-looking questions to get a glimpse of the future of serialization and track & trace in the US pharma supply chain. The four include: Continue reading Sponsored: Interview With Four Pharma Supply Chain Thought Leaders
As I mentioned last week, the FDA published two new draft DSCSA guidance documents on the day of the recent FDA DSCSA Public Meeting (see “FDA DSCSA Public Meeting #3: A Difference?”). Let’s take a closer look at what’s in them and their significance to companies facing the Drug Supply Chain Security Act (DSCSA). I’ll cover one of the two in this essay and cover the other document in the next essay. Continue reading DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations