Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:
- In the U.S.:
- In the E.U.:
Many RxTrace readers probably saw the FDA press release last week that included the timeline chart called “Summary of Planned Implementation Timeframes for the Drug Supply Chain Security Act”. If you did not see it, here is the link. I found the text to be too small so I reproduced the chart using a larger font size. See that version below. Click on it to enlarge the image. You might find this version better for inclusion in Powerpoint slides.
This is the FDA’s interpretation of their obligations under the Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA) that was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). There really are not any surprises in their interpretation, but there are a few interesting things to notice in this timeline and the associated table of target dates that accompanied it. I have also reproduced the FDA’s deliverable table, but my version is sorted by the estimated target date column to make it easier to see what they plan to do in time sequence.
The first thing to notice about the timeline is Read the rest of this essay »
The U.S. FDA just published a docket asking for public input into standards for the interoperable exchange of information for tracing of human, finished, prescription drugs in paper or electronic format. Ironically, they will accept responses to the docket in either paper or electronic format. Comments should be submitted to the FDA within 60 days. If my calculation is correct, you have until April 21st to submit your comments.
This docket was expected because the Drug Supply Chain Security Act (DSCSA), enacted last November, gives the FDA one year to publish a draft guidance document that establishes standards for the interoperable exchange of that type of information, and they are required to consult with the industry and other interested parties [see Section 582(a)(2)]. I have written about this requirement and the short time after the guidance is published before the members of the supply chain must make use of those standards (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act” and “DQSA: Getting To Electronic Transaction Data Exchange“). This docket fulfills the first of many mandates that the FDA is facing in
There is an interesting dialog going on in the Food and Drug Serialization Professionals group in LinkedIn that was kicked off by a recent RxTrace essay. Click here to see the conversation. It got real interesting when Marc Rosenblatt, Director of Sales at Veracity Network, related an experience his company had in a recent pilot. He said:
“…An unsettling example occurred during one of our distributor pilot programs. Our system detected a number of counterfeit products (9% of the total sample to be exact) that were sent back as returns. This means that the molecular structure or product signature didn’t match up with the legitimate product standard. Upon further examination, it was discovered that the sealed bottles contained counterfeit replacements for the valid product. What makes this even a more difficult pill to swallow (pun intended) is the fact that these products would in most cases be restocked and sold again. The returns areas are the most overlooked link in the supply chain and from reading the DSCSA text, it continues to be (at least for the next 4 years).”
The California Board of Pharmacy made it official late this afternoon. As required by Section 4034.1 of the California Business and Professions Code (CB&PC), the Board posted a public notice late yesterday indicating that sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 of the CB&PC became inoperative due to the enactment of the Federal Drug Quality and Security Act (DQSA) on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“). These specific sections of the CB&PC comprise what has been referred to in the industry as “the California Pedigree Law”.
The public notice was mandated by California law within 90 days of federal preemption because Read the rest of this essay »
One of the most intense questions about any serialization mandate is whether or not manufacturers would be required to pass “aggregation data” to their customers. “Aggregation data” is the serial number-based packaging hierarchy of the shipment. That is, a list of the package-level serial numbers that are contained in each serialized bundle, and then which bundles are contained within which serialized cases and then which cases are contained on which serialized pallet, etc.
You can’t expect to give a couple of workers a handheld barcode reader and expect them to produce six sigma aggregation data. It is possible to collected highly accurate aggregation data (see “Pharma Aggregation: How Companies Are Achieving Perfection Today”), but it requires systems specifically designed to do so. The now obsolete California pedigree law did not Read the rest of this essay »
In the last update by the California Legislature, the timeline for the rollout of the California pedigree law was spread out so that it was to take 2 ½ years from the first manufacturer deadline for serialization of 50% of their product until everything was serialized, pedigreed and wholesalers and pharmacies were making use of the serial numbers and pedigrees. Of course, everyone should be aware by now that the U.S. Drug Quality and Security Act (DQSA) preempted that law and all State and Federal pharma serialization and pedigree laws, and replaced them with new Federal requirements that have a different rollout timeline.
The track and trace provisions of the DQSA are defined within Title II of that act, known as the Drug Supply Chain Security Act (DSCSA). Some of its provisions begin next January. Some start in November of 2017 and some start in 2023. Read the rest of this essay »
Last week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain. Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now. Part 1 took another look at a number of supply chain crimes that have occurred over the last 5 to 6 years and attempted to determine how the new Drug Supply Chain Security Act (DSCSA) that is contained within the DQSA will add new protections that will or won’t help prevent crimes like them in the future.
In this Part 2 essay I want to look at the issue in a different way. I’d like to compare the approach that Read the rest of this essay »