The era of personalized medicines has begun. These are medicines that are tailored specifically for a single patient, using that patient’s specific DNA or other blood characteristic as a guide or actual source component. The new chimeric antigen receptor T-cells (CAR-T) is an exciting example. It results in the conversion of a patient’s own T-cells into cells that are able to recognize the specific type of cancer cells that the patient has, and thus able to attack them in the same way that normal T-cells attack normal infectious cells. In short, it’s a way of manipulating a person’s own immune system to attack cancer cells that it would normally be blind to. When it works, the results can be breathtaking. The question is, how are these drugs treated under today’s serialization and tracing regulations? Let’s take a look. Continue reading Personalized Medicines In A Serialized World
The Healthcare Distribution Alliance (HDA) recently posted their response to the latest draft Drug Supply Chain Security Act (DSCSA) guidance published by the FDA. That draft guidance explains how, when and why companies in the US pharma supply chain can apply for waivers, exemptions and exceptions to provisions in the DSCSA (see “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”). As usual, the HDA took close to the full sixty day comment period to respond. The comment period closed last Monday. Continue reading HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance
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?
There are lots of impactful requirements in the Drug Supply Chain Security Act (DSCSA), but there are two whose impact will likely increase the safety of patients far more than all of the others. That is, they are the most helpful requirements. Do they include serialization? Verification? Transaction documentation? Wholesaler and 3PL licensing? Not even close.
The two requirements that I believe will have the biggest impact on the safety of drugs in the US supply chain are the requirement to only engage in transactions with authorized trading partners, and the lot number being included in the 2D barcode. Let me explain. Continue reading The 2 Most Helpful Requirements In The DSCSA
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
Just after I posted my last FMD essay on RxTrace (see “FMD, One Year Out”) I found out that the European Commission had published version 9 of their “Safety Features for Medicinal Products for Human Use, Questions and Answers”. This is must reading for anyone with questions about how to interpret the most confusing provisions of the Falsified Medicines Directive (FMD) (also known as EU Directive 2011/62 and which amends Directive 2001/83) and the Delegated Regulation (EUDR) (also known as EU Regulation No 2016/161) (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning“).
With each major revision this Q&A document grows. This time it grew substantially with the addition of 21 new questions and answers and updates to four previously posted answers.
But there is one provision of the FMD that defies explanation, even though the Q&A document burns two Q&As to attempt it. That provision in the FMD is Section 1 of Article 45a, which basically says, in part, that you cannot put an anti-tamper device on non-prescription drugs unless the EC or a Member State specifically says you can. What’s going on here? Continue reading The Most Head-Scratching Section Of The FMD
Last month GS1 US published the results of an assessment of the implementation progress by drug manufacturers of the Drug Supply Chain Security Act (DSCSA) serialization requirements. It contains troubling indications of the next problem the industry will face in its quest for DSCSA compliance: too many unusable barcodes.
Big deal, you say? That kind of complacency could come back to haunt you later this year. Now is the time to look at your own packages and address any deficiencies. Here is a look at what GS1 US found in their assessment. Continue reading Wholesalers Find Troubling Results In DSCSA Barcode Assessment
The Drug Quality and Security Act (DQSA) was constructed back in 2013 by Congressional staff, with input from the FDA, members of the industry and who knows who else. There was one bill in the House of Representatives and a different bill in the Senate. Once these bills passed their respective houses, they formed a conference committee who merged the two bills into the final text that we know today as the DQSA (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). Chapter 2 of that act is the Drug Supply Chain Security Act (DSCSA). Most readers of RxTrace haven’t forgotten that history but it is important to look back at that history to explain why most companies can ignore certain requirements in the law. That’s right. There are requirements in the law that you can ignore because they will not be enforced by anyone. They are the result of the disjoint way the DQSA was written. Let me explain. Continue reading 3 DSCSA Requirements You Can Totally Ignore