There are some discontinuities between the needs of the industry for meeting serialization regulations around the world and certain GS1 standards, including their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) standards. I’ve already pointed out the issue of EPCIS expecting everyone who uses it to possess, by default, a GS1 Global Location Number (GLN) (see “GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance”). Here is one more. Continue reading Serial Number Bonding
Today, Peggy Staver will officially retire from Pfizer, after a career of 35 years. Those of us who have worked on figuring out how to implement anti-counterfeiting solutions that work in the U.S. pharma supply chain over the last 15 years or so will miss her friendly, inquisitive and steady voice very much. Continue reading Thank You Peggy Staver!
RxTrace readers are well aware that the deadline is this November 27 for applying unique serial numbers within GS1 DataMatrix 2D barcodes to prescription drugs distributed in the United States under the Drug Supply Chain Security Act (DSCSA). Once that happens, most prescription drugs entering the U.S. supply chain will be identified by 14-digit GS1 Global Trade Item Numbers (GTIN-14) for the first time (see “Anatomy of a GTIN”). That’s because, you can’t fit the drug’s National Drug Code (NDC) along with the serial number, lot number and expiration date into a data matrix barcode, as required by the law, without first encoding it into a GTIN-14 (see “Anatomy Of The National Drug Code”, and “Depicting An NDC Within A GTIN”). This fact forces companies to encode their NDCs into GTIN-14s, many for the first time. Continue reading Sponsored: How To Properly Define GTINs For Your NDCs
Recently, several of the larger U.S. wholesale distributors have sent letters to their suppliers to review what they expect from them relative to the Drug Supply Chain Security Act (DSCSA). You may recall that these companies have provided requirements in advance of earlier DSCSA deadlines (see “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers“). These expectations are aimed at the November 27, 2017 serialization requirements and beyond. Continue reading DSCSA Serialization: What Wholesalers Expect
The Russia Ministry of Health (MoH) is conducting a serialization and tracing pilot with a number of supply chain members between February 1, 2017 and December 31, 2017 (see “Russia Begins Its Pharma Supply Chain Pilot”). The MoH is due to publish an assessment of the pilot by next February 1st.
Two weeks ago the Russian Minister of Health, Veroníka Skvortsova, signed the guidelines document for the pilot. The 42-page document appears to be written as a pilot setup document, as opposed to Continue reading The Russia Serialization Pilot Guideline
This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July. The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website). That is, it is a database of master data wrapped within a cloud-based service.
Origin master data is composed Continue reading Dawn of HDA’s Origin, The Key to DSCSA Compliance
Last week, the National Agency of Sanitary Surveillance (ANVISA), the healthcare regulator in Brazil, published a draft of their proposed pharma serialization regulations aimed at meeting the requirements of the new law number 13.410 of December 28, 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”). The purpose of this new publication is to solicit comments from interested parties. It is called “Public Consultation No. 311 of February 15, 2017”. This is not a final regulation—the public consultation ends on March 17, 2017, after which changes to the text, based on the feedback collected, are likely before it becomes final—but it provides us with a solid view of ANVISA’s thinking, and that amounts to a big win for the industry, and for Brazil. Now is the time to read it over and submit your comments to help make it even better. Continue reading ANVISA Reveals Draft Serialization Regulation and Asks For Comments
Over the last few weeks, the pharma serialization and tracing landscape has begun to shift in China. The China Food and Drug Administration (CFDA) announced a new use for an existing “National Drug Code” in Public Notice 2017-1 that, according to Google Translate (a helpful but very imperfect translator), will be referred to as the “Bit Code”. In addition, a new notice has appeared on the AliHealth-hosted web portal that drug companies have been using for the last seven years or so to obtain serial numbers for their drug packages. Automated translation tools leave too much to speculation so companies should not use them for compliance purposes. However, here are my thoughts/speculation on what is happening. Continue reading The Intrigue Contained In The New China Drug Code