Last week the FDA published a notice of a public hearing and request for comments regarding the impact of any future changes made to the length and format of the National Drug Code (NDC). The current format of the NDC has been around since the early 1970s (see “Anatomy Of The National Drug Code”). It has served the FDA, healthcare professionals and patients well since that time, but it is showing its age. I call its affliction, “Identifier Failure” and I point out all of the symptoms for the aging NDC system in my essay “NDC Nearing Its End, Afflicted by ‘Identifier Failure’”.
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→
I was on vacation last week and only arrived home Sunday evening so I didn’t have time to write an essay for Monday, but this is Tuesday! Near the end of last month there was a spike in the number of things that need to be covered in RxTrace. Two of them are important things from HDA and the Center For Supply Chain Studies. I’ve been waiting for both for months, and here they are. Continue reading Newly Published Material From HDA and C4SCS→
When companies are thinking about merging or acquiring (M&A) other companies, or product lines from other companies, they typically engage in a process known as “due diligence” to discover any hidden risks that might come along with the action. In the pharma industry the risks are huge, so this activity is intense and costly. Discovery of larger risks than expected can result in the abandonment of the M&A plan, or can result in the adjustment of the price—usually downward. Now that pharma supply chain companies in the US are required to retain detailed transaction information about every purchase and sale of prescription drugs for six years, and must respond to verification requests over the life of the product, due diligence is now more complex and risky, and so it is more important than ever. Continue reading DSCSA Makes M&A More Complex/Risky/Costly→
There are a lot of discussions going on in the industry right now, over which approach and which technologies the US pharma supply chain should select to meet the 2023 requirements of the Drug Supply Chain Security Act (DSCSA). People are understandably confused over these discussions. Why should we guess what the FDA will accept in 2023? Blockchain? EPCIS? Aren’t these debates and discussions just a waste of our time? Why doesn’t the FDA just tell us which technology they will accept for the DSCSA in 2023? In fact, these questions have become so common lately that I think it is time to examine what is going on. There are definitive answers to these questions, and they are contained within the DSCSA itself. Continue reading DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology→
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.