Aggregation of saleable drug packages to shipping cases and pallets is not required by the US Drug Supply Chain Security Act (DSCSA) or the EU Falsified Medicines Directive (FMD) or the related Delegated Regulation (EUDR). But certain business processes in the EU under the FMD will be difficult to accomplish without it, and after November 2023, the operation of the supply chain in the US will not be efficient without it (see “Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation”, “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary” and “Pharma Aggregation: How Companies Are Achieving Perfection Today”). Absent a mandate, companies need to recognize, themselves, just how vital aggregation is to their businesses and prepare to generate it and/or make use of it.Continue reading An Aggregation ‘Discussion’
Two weeks ago, an EU Member State Expert Group connected to the European Commission (EC) published a paper aimed at explaining what hospitals should do to meet their obligation to verify and decommission drugs after the Falsified Medicines Directive (FMD) Delegated Regulation (EUDR) goes into effect on February 9, 2019. The new paper is all about aggregation and its use by Continue reading Aggregation Under the FMD
Neither the Drug Supply Chain Security Act (DSCSA) in the United States, nor the Falsified Medicines Directive (FMD) in the European Union explicitly mandates the capture or use of aggregation data (see “Aggregation –> Chargeback Accuracy –> ROI” and “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary“). In this instance, “aggregation data” is data that documents the serialized packaging containment hierarchy of drug products—also known as “parent-child relationships”. It is well established that companies are not required by law to capture it, but for the smooth operation of pharma supply chains under a serialization, tracing and/or verification regulation, high quality aggregation data will be necessary. But there are warning signs that a significant percentage of drug manufacturers are not going to meet that bar by the deadlines. Continue reading Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation
Last week I attended my favorite annual conference on pharma serialization and tracing in the U.S.: The Healthcare Distribution Management Association’s (HDMA) Traceability Seminar. They call it a “seminar” because the subject of the sessions are generally the same every year, but it is better than any other third-party conference, primarily because the right people attend it: lots of people from drug manufacturers, wholesale distributors and some dispensers. With this ideal spectrum of attendees, it is very easy to get your questions answered, in the hallway between sessions if not in the sessions themselves.
Of course, every year the folks from the FDA who are directly responsible for writing regulations related to the Drug Supply Chain Security Act (DSCSA) provide Continue reading Aggregation –> Chargeback Accuracy –> ROI
While listening to a monthly Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 wholesale distributors I heard a comment that snapped me out of my conference call-induced stupor. Unfortunately I was in a location where I could not take notes so I don’t remember the exact comments that were made, but I remember what it was that brought me back to full consciousness.
The comment made me realize in a jolt why the Big-3—or at least the one running this monthly call—may be unwilling to give up on their claims that they will need aggregation data to accompany shipments of prescription drugs from manufacturers as early as November 2019. It may have to do with a mis-interpretation of their handling of saleable returned product within the DSCSA. Let me explain. Continue reading Wholesaler Confusion Over DSCSA Aggregation Explained
I have been outspoken on the question of whether or not the Drug Supply Chain Security Act (DSCSA) requires companies in the supply chain to provide their customers with serial number-based aggregation data prior to 2023. In my view, it does not, but others disagree, saying that there are requirements in the law that lead to the need for aggregation data during that time. I do not agree with that either. If you would like to review those arguments and find out exactly what “aggregation data” is, here is a list of RxTrace essays you should read:
|March 26th, 2012||Pharma Aggregation: How Companies Are Achieving Perfection Today|
|November 22nd, 2013||DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?|
|February 10th, 2014||Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…|
|June 9th, 2014||The Aggregation Hoax and PIA|
BUT WHAT ABOUT AFTER 2023?
The DSCSA requires the FDA to conduct at least 5 topical public meetings between now and Continue reading When Will The DSCSA Ever Require Investments In Aggregation?
In my last essay I touched on the use of Product Identifier Authentication, or PIA, as an alternative to the collection and distribution of aggregation data to allow wholesale distributors and repackagers to meet the verification requirements of the Drug Supply Chain Security Act (DSCSA). Starting in November of 2018 for repackagers and in November of 2019 for wholesalers, the DSCSA will require these companies to verify that the standardized numerical identifier (SNI)—commonly referred to as “the serial number”—corresponds with one that the manufacturer originally applied to drugs that are found to be suspect, and for any returned drug that will be resold.
As I pointed out in my previous essay (see “The Aggregation Hoax and PIA”), manufacturers and repackagers may be able to choose to pass on aggregation information that would allow wholesale distributors to meet their requirements, or they might choose to offer a PIA service that would allow these companies to check the authenticity of one or more SNIs via a web service. Continue reading Product Identifier Authentication (PIA)
Pharmaceutical manufacturers should be aware that there is a lot of uninformed misinformation going around out there lately about the need for them to supply aggregation data to their trading partners to meet the Drug Supply Chain Security Act (DSCSA) (for more on aggregation, see “Pharma Aggregation: How Companies Are Achieving Perfection Today”, “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”, and “Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…”). In my view, prior to 2023 you can collect aggregation data if you want to, but don’t let anyone tell you that the DSCSA requires you to. It doesn’t. And I also encourage you to be skeptical of any claims that wholesale distributors will not accept your product anytime soon unless you provide them with aggregation data. Feel free to Continue reading The Aggregation Hoax and PIA