Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing. My mother and my mother-in-law both suffered from heart failure during their decline. Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”. At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect. Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition. The NDC won’t last long now, and there is no longer any excuse for inaction. The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’
Tag Archives: GS1
The Open Serialization Communication Standard (Open-SCS)
Most RxTrace readers are at least aware of GS1 standards. GS1 is an international non-profit membership organization that facilitates the development and maintenance of technical standards that are intended for use within supply chain operations and interactions. GS1 standards are used in many supply chains including pharma. GS1 standards are playing an indispensable role in the implementation of pharma serialization, including their GTIN, GLN, SSCC, Datamatrix, application identifier and EPCIS standards. I have written frequently about GS1 and these specific standards (see “GS1”).
But today I want to draw your attention to a different standards development organization Continue reading The Open Serialization Communication Standard (Open-SCS)
The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations
The Healthcare Distribution Alliance (HDA) (formerly HDMA) published their highly anticipated “Guidelines for Bar Coding in the Pharmaceutical Supply Chain, Quick Start Guide” a few weeks ago. Do yourself a favor and stop reading this essay right now, click on the link and download your copy and read it. It is free, and it is essential reading for manufacturers and solution providers who expect to develop and deploy solutions that ship serialized units and cases of prescription drugs to U.S. wholesale distributors. This includes solutions that Continue reading The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations
Product Identification And National Registration Codes
There is a long-running tug-of-war going on between GS1 and national governments around the world over how exactly to identify medical products, whether devices or pharmaceuticals. National governments regulate those products to maximize the health of their citizens and so they take a natural interest in how they are identified. They want to eliminate all ambiguity between products within their market. They need to be able to tightly grant market authorization, revoke it and oversee recalls when warranted. To do that effectively, they need a way of clearly and concisely referencing a given product. That same way of referencing the product should also be used for patient education and for healthcare professional prescribing. Bad things happen when mistakes are made in the identification of healthcare products.
GS1 offers a global standard way of identifying Continue reading Product Identification And National Registration Codes
Decommissioning Under the FMD/EUDR
It is a little surprising that the European Union Delegated Regulation (EUDR) uses a form of the word “decommission” 67 times, but not even once uses the opposite term, “commission”. Article 3.2(c) of the EUDR defines the term ‘decommissioning of a unique identifier’ as:
“… the operation changing the active status of a unique identifier stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful verification of the authenticity of that unique identifier;”
It is a striking omission to define how to change the active status of a drug to impede successful verification, but to fail to define the opposite operation that sets the active status to enable successful verification in the first place. Continue reading Decommissioning Under the FMD/EUDR
Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2
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
The DSCSA Product Identifier On Drug Packages
According to the Drug Supply Chain Security Act (DSCSA), manufacturers must apply a new “Product Identifier” on all of their prescription drug products by November 27, 2017 (Repackagers by that date in 2018). The DSCSA Product Identifier is defined this way:
“PRODUCT IDENTIFIER.—
The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.” (Section 581[14])
Continue reading The DSCSA Product Identifier On Drug Packages
DSCSA Deadline Represents A Crossed Threshold Into The SCMD Era
There is a not-so-secret situation that has been festering for years in the internal IT systems of many companies in the U.S. pharma supply chain. In the past, nobody liked to admit it, but most would, because the full extent of the problem was hidden away from public view. It was an internal problem mostly affecting only internal systems.
The problem was that the quality of the local master data was poor. Master data is the data that companies hold in internal databases to describe their trading partners (customers and suppliers), products (their own and those of other companies), contract parameters (pricing, authorization, terms and conditions, etc.), and facilities, etc.
Companies get lulled into thinking this data Continue reading DSCSA Deadline Represents A Crossed Threshold Into The SCMD Era
