Part 1 of this essay provided a wealth of hyperlinks into the Code of Federal Regulations (CFR) and FDA guidance documents with content related to placing the National Drug Code in human- and machine-readable form onto drug packages prior to November 27, 2017 (see “Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1”). In Part 2, we will look at how the Drug Supply Chain Security Act (DSCSA) will change, or add-to, the requirements found in those earlier specifications. And finally, we will be able to answer the question in the essay title.
HOW THE DSCSA CHANGES THE NDC AND BARCODE REQUIREMENTS FOR DRUG PACKAGES
First of all, the DSCSA does not change anything Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2
After November 27, 2017 the U.S. Drug Supply Chain Security Act (DSCSA) requires drug manufacturers (2018 for repackagers) to affix a DSCSA “product identifier” to all drug packages entering the supply chain (see “The DSCSA Product Identifier On Drug Packages”). According to the DSCSA, that product identifier must be present in both human-readable and 2D Data Matrix barcode forms. Part of that product identifier is what is known as a Standardized Numerical Identifier (SNI). The SNI is composed of the drug’s National Drug Code (NDC) and a serial number (see “DSCSA ‘Serial Numbers’”) that is unique on every individual package of that drug (see “FDA Aligns with GS1 SGTIN For SNDC” and “Anatomy Of An FDA SNI”).
Lately, I’ve heard people in the industry claim that it is acceptable to use a GS1 Global Trade Item Number (GTIN) that encapsulates an NDC (see “Depicting An NDC Within A GTIN”) to satisfy the NDC part of this DSCSA requirement to affix the product identifier on a drug package. I’m not so sure about that. Let me explain. Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1
I was initially disappointed in the FDA Drug Supply Chain Security Act (DSCSA) Pilots Workshop that was held at FDA headquarters last week, but in the end, the outcome appeared to fit the need. Going in, I knew not to expect the FDA to convey any information to the attendees, so that is not why I was disappointed. I attended the public DSCSA workshop they held back in May of 2014 so I already knew their typical approach for workshops like these (see “The 2014 FDA DSCSA Workshop”). I knew that the purpose of the workshop was to inform the FDA, not to inform the attendees. I would estimate that about one out of every four attendees were expecting the opposite, and I would bet a significant percentage of those had not even read the DSCSA once. But that’s not why I was disappointed.
I was initially disappointed because Continue reading The 2016 FDA Pilots Workshop
Medical device manufacturers have a choice of standards to use when identifying their products for the U.S. market. The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose. So far, three organizations have been FDA-accredited: HIBCC, ICCBBA and GS1.
ICCBBA has a lock on the identification of Continue reading GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care
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
This morning the FDA is due to publish an announcement for an opportunity to comment on their proposed collection of certain information as part of ongoing requests for exemptions from the linear “barcode rule” that has been in effect since April 26, 2006. The FDA is soliciting comments on the barcode label requirements for Continue reading FDA Still Receives Requests For Exemptions From 2006 Barcode Rule
That’s right, I now recommend that you follow GS1’s Human Readable Interpretation (HRI) specification for drug labeling, even when under a serialization regulation. Previously I recommended against it (see “The DSCSA Product Identifier On Drug Packages”, and “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”). Why have I changed my mind? GS1 modified their specification to accommodate most of the objections I had over it. Let me explain.
The new specification for HRI is in the latest version of Continue reading I’ve Changed My Mind, Follow GS1’s HRI Specification
It is pretty clear that there is not much interest in the use of Radio Frequency IDentification (RFID) in the pharmaceutical supply chain because every time I publish an essay in RxTrace about some aspect of it, there is a drop in readership. So at the risk of taking another hit in readership, let’s take a look at the case against the use of RFID in the pharma supply chain.
Back in 2010 I published an essay that really rattled my friends in the RFID vendor community (see “RFID is DEAD…at Unit-Level in Pharma”). Since that essay was published, the two or three drug companies that were previously shipping drugs with package-level RFID tags on them have ended that practice, replacing the RFID tags with 2D barcodes. This includes Purdue Pharma and Pfizer, the two flag carriers for RFID in pharma back in the late 2000s Continue reading The Case Against RFID In Pharma