In a long awaited and much anticipated move the Healthcare Distribution Management Association (HDMA) published updated guidance for the formatting, encoding and placement of barcodes in the U.S. pharmaceutical supply chain. The document is called “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain 2011”. The guidance is aimed mostly at pharma manufacturers and … Continue reading Updated HDMA Bar Code Guidance: A Must Read
The U.S. Food and Drug Administration (FDA) created the concept of the National Drug Code (NDC) in 1969 to “…provide an identification system in computer language to permit automated processing of drug data by Government agencies, drug manufacturers and distributors, hospitals, and insurance companies” (from 34 FR 11157, July 2, 1969). (I can’t find a … Continue reading Anatomy Of The National Drug Code
In a recent essay I discussed GS1 Healthcare’s proposed Network Centric ePedigree (NCeP) models that are currently available for review and discussion by the industry. By the way, GS1 is giving everyone until December 15 to respond to a survey to provide them with your thoughts on the various NCeP models. To review the videos … Continue reading Could This Be Your Future Track & Trace/ePedigree Exchange Solution?
In the U.S. pharmaceutical supply chain this question becomes, should regulators—state legislatures, state Boards of Pharmacies, Congress or the FDA—mandate specific technology for serialization, ePedigree and other regulations? This question arises whenever a new regulation is considered by any of these bodies or agencies. It’s an important question now that the FDA is considering standards … Continue reading Should Regulations Dictate Technology?
Within conversations held during the development of standards for electronic pedigrees it is sometimes common to hear people apply the following test to any pedigree proposal: “A state inspector arrives at your facility without prior warning, enters the warehouse, picks up any random package of drugs and asks to see ‘the pedigree’ for this package.” … Continue reading Inspecting An Electronic Pedigree
For the first time in over two years the topic of pedigree appears on the agenda of the California Board of Pharmacy for their upcoming meeting on September 7. Earlier this year in a presentation at the FDA Track & Trace Workshop Board Executive Office Virginia Herald mentioned that the Board would take up the … Continue reading California Board of Pharmacy Re-awaken
Last week the Pew Prescription Project, an arm of the Pew Charitable Trust, released a report on the risks of substandard and counterfeit drugs. This is a meticulously researched report that will likely be used by legislators and regulators to better understand the problems and potential solutions of U.S. pharmaceutical supply chain security. For this reason it is … Continue reading Pew Prescription Project: After Heparin
RxTrace just completed its second year of publication. In the last 12 months there have been a total of 28 new essays that attempted to shed light on issues and ideas that fall within the intersection of the pharmaceutical supply chain, track and trace technology, standards and regulator compliance. Here is the complete list ordered by … Continue reading RxTrace: Sophomore Effort
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of RxTrace. The material contained in RxTrace is not legal advice. The writers of RxTrace are not lawyers.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than RxTrace.
RxTrace, a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance.
Contact Us | Privacy Statement
Copyright © 2009-2021 TrackTraceRx, Inc. All Rights Reserved.
RxTrace is a registered trademark of TrackTraceRx, Inc
