There are a number of misconceptions floating around the industry right now about what will happen in November of 2023, when the Enhanced Drug Distribution Security (EDDS) phase mandated by the Drug Supply Chain Security Act (DSCSA) begins. It is surprising where you hear some of these, but they are all based on mis-reads of the DSCSA law itself. I’ll explain the myths, and then I will try to provide extracts from the DSCSA that expose them as myths. Continue reading 5 Myths About The DSCSA In 2023
Right now we are waiting for major new announcements regarding serialization and tracing requirements in the United States (4 overdue FDA guidance documents), the European Union (final publication of the Delegate Act related to the Falsified Medicines Act), Brazil (major redesign of their regulation), and Russia (first official publication of their regulation). But last week, the India Directorate General of Foreign Trade (DGFT) published a new public notice containing details of the “Implementation of the Track and Trace System for Export of Pharmaceuticals and Drug Consignments”. These details are for drugs made in India but exported to other markets. Continue reading India Posts New Deadlines (Again) For Serialization Of Drug Exports
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
Last week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA. But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use.
A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box. A “homogenous case” is a case that Continue reading Identification Of Pharma Cases In The U.S.
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?