#Product lookup by serial number arris code#
That is pretty specific, although they really did not say it had to be the “GS1” version of the data matrix symbology.Īlso be aware that the Healthcare Distribution Management Association’s (HDMA’s) “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain” (see “ Updated HDMA Bar Code Guidance: A Must Read”), from back in 2011 (it is a little dated and I expect an updated version sometime this year) includes the following FAQ: This means that the “machine-readable data carrier” that carries the DSCSA product identifier must be a 2-dimensional “data matrix” (otherwise known as a “GS1 DataMatrix”, see “ GS1 DataMatrix: An Introduction and Implementation Guideline”) barcode. “(ii) shall be included in a linear or 2-dimensional data matrix barcode when affixed to, or imprinted upon, a homogeneous case…” “(i) shall be included in a 2-dimensional data matrix barcode when affixed to, or imprinted upon, a package and
In Section 582(a)(9) of the DSCSA, “PRODUCT IDENTIFIERS”, includes the requirement: That is not a big difference and is probably a good idea anyway. The only difference I can see between the serial number specification that Congress provided and the specification of a GS1 serial number is that GS1 would allow some symbols to be used (see table 7.11 of the latest GS1 General Specification), but Congress does not. From that, we can infer that the most common implementation of the DSCSA product identifier will be a GS1 Global Trade Identification Number (GTIN) (a GTIN-14 to be exact) that encodes an NDC (see “ Depicting An NDC Within A GTIN”) combined with a serial number that conforms to the specification that Congress provided (above) in the format of a GS1 serial number element string that is associated with that GTIN. However, they described it in a way that there really is not any question about which standards development organization will be used: the same widely recognized international standards development organization that is used to barcode drugs in the U.S. “…A MACHINE-READABLE DATA CARRIER THAT CONFORMS TO…”Ĭongress did not want the FDA to go off and create their own machine-readable data carrier, but they also did not want to prescribe exactly which existing standard should be used. So please don’t get confused when you hear people using the terms “serial number” and “serialization” loosely. The serial number is actually just one part of that identifier, but people focus in on that part because that’s the part that is new and hard to implement correctly. So whenever people, including me, talk about “pharma serialization”, or “putting a serial number on a drug package”, or even a “serial number-based repository”, it’s all just shorthand for the DSCSA product identifier. So the DSCSA product identifier is composed of:Īccording to the SNI guidance, the “serial number” portion of the SNI should be up to 20 characters that can be letters and/or numbers.
#Product lookup by serial number arris serial numbers#
Serial numbers should be numeric (numbers) or alphanumeric (include letters and/or numbers) and should have no more than 20 characters (letters and/or numbers).” (See “ FDA Aligns with GS1 SGTIN For SNDC”.) The sNDC is composed of the National Drug Code (NDC) (as set forth in 21 CFR Part 207) that corresponds to the specific drug product (including the particular package configuration) combined with a unique serial number, generated by the manufacturer or repackager for each individual package. “ The SNI for most prescription drug packages should be a serialized National Drug Code (sNDC).
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)īack in March of 2010-3 ½ years before Congress passed the DSCSA-the FDA published final guidance called “ Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages”, which defined the term “standardized numerical identifier (SNI)” this way: The Drug Supply Chain Security Act (DSCSA) defines the term “Product identifier” this way: market must put “serial numbers”, or “serialize” their drug packages and homogeneous cases before November 27, 2017, but what exactly does that mean? I often write about the fact that drug manufacturers and repackagers that sell into the U.S.
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