Welcome To A Monthly Slice of RxTrace
A Monthly Slice of RxTrace is a place where I will try to start a conversation each month on topics that will closely resemble those on RxTrace.com. Why replicate here? I don’t plan to replicate the same essays you will find on RxTrace. What I mean is, I plan to write on the same kind of topics that you find there. RxTrace is ‘a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance’, and that’s what A Monthly Slice of RxTrace will be too. If you follow RxTrace.com, you will want to follow a Monthly Slice of RxTrace on the Center For Supply Chain Studies MemberSpace as well, because I will treat this outlet as an extension to it.
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That’s the plan. So what about this month? I don’t have a full essay for this month, but there are quite a few things on my mind right now. Here is a list. Some of these will become RxTrace or Monthly Slice of RxTrace essays. Others may not.
- The future format of the National Drug Code (NDC)
The FDA recognizes that the 10-digit NDC won’t last much longer. They project 10-15 years before the current 5-digit Labeler Codes are used up. The Labeler Code is one of the three components of the NDC. FDA’s current idea is to start issuing 6-digit Labeler Codes once the supply of 5-digit codes runs dry, which would cause the NDC to become a variable length identifier: either 10-digits, or 11-digits. And the 11-digit version will NOT match the 11-digit NDC-based reimbursement code that pharma dispensers use today as their “NDC”. So that’s a problem. The FDA has announced a public hearing to discuss the issue and potential solutions. (For more on this issue, see “Anatomy Of The National Drug Code”, “UDI And The Approaching End Of The NDC”, “An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon”, “NDC Nearing Its End, Afflicted by ‘Identifier Failure’” and “FDA Seeks Input On The Future Format of the National Drug Code”.)
- Russia’s pharma serialization regulatory plan
Russia has been conducting a pilot for the last 18 months or so and they have posted some information about their requirements, but some is contradictory, or just plain hard to figure out. I expect more information to come out soon and I look forward to dissecting it. (For more on the Russian pilot and regulations, see “Russia Begins Its Pharma Supply Chain Pilot”, “The Russia Serialization Pilot Guideline” and “New Direction For Pharma Serialization In The Russian Federation”.)
- China’s pharma serialization plans
China recently published some guidance on serializing pharmaceuticals there. Unfortunately, there are very few hard, well understood facts that can be extracted from those documents. More has to be coming, or nothing is going to work right there. (For more on the China regulations, see “The Intrigue Contained In The New China Drug Code” and “China Posts New Draft Pharma Serialization Guidelines”.)
- Brazil’s pharma serialization plans
Brazil has been quietly piloting some draft requirements for the last 18 months or so. Given their earlier timeline, I think we are likely to hear more from them in the next few months. (For more on what has been happening in Brazil, see “Brazil Gets Rational With Their New Pharma Traceability Law”, and “Brazil Publishes RDC-157 To Regulate 2017 3-Lot Pilot”.)
- FMD and DSCSA industry readiness
No list would be complete without recognition of the facts that the DSCSA manufacturer serialization and verification requirements are due to go into effect in just a few months, and the FMD “Big Bang” effective date is only five months away. Based on industry readiness, there is no way the FMD will be able to be operational on time without significant (temporary?) waivers. The DSCSA date—already a delay of one year—might stick, but it’s at least possible that it will be pushed out again. I’m watching. Are you? (For more on industry readiness in the US, see “HDA’s 2017 Manufacturer Serialization Readiness Survey Results”.)
- The Enhanced Drug Distribution Security (EDDS) design
The DSCSA mandates the FDA to work with industry stakeholders to design the operation of the EDDS. How’s that going? Slow. A lot of decisions need to be made final well before November 27, 2023 so that industry has time to develop, test and deploy the systems necessary to meet it. We’re already laughably too close to that deadline to expect to meet it, but to my surprise, the only decision the FDA has made is to take a gap year in 2018 before they continue the regular DSCSA public meetings…sometime in the future. They’ll get there…someday. And I plan to analyze it all here, and in RxTrace.com. (For more on recent FDA DSCSA activities, see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”, “FDA’s New DSCSA Grandfathering Guidance”, “FDA DSCSA Public Meeting #2, Still A Gulf”, “FDA DSCSA Public Meeting #3: A Difference?” and “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”.)
- Pharma serialization regulations blooming everywhere
It’s not just the big countries. Smaller countries are enacting pharma serialization regulations too. In fact, that’s a response to the problems they face from counterfeiters who target remote areas with smaller populations and less powerful governments. This makes it complex for multi-national drug companies who increasingly face the need to customize packaging and barcoding for smaller markets.
There is so much to keep track of and write about. Stay tuned.
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- Dirk Rodgers
- September 6, 2018
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