Tag Archives: DQSA

DSCSA Product Identifier

The DSCSA Product Identifier On Drug Packages

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DSCSA Product IdentifierAccording 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 →

SSCC

Identification Of Pharma Cases In The U.S.

5 BoxesLast week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA.  But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use.

A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box.  A “homogenous case” is a case that Continue reading Identification Of Pharma Cases In The U.S. →

News

India’s Pharma Export Regulations Update And The NECC Story

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ReporterI was more than a little disappointed when I saw that SecuringIndustry.com had beaten me in a race to publish an essay/article about the new crazy serialization and traceability requirements published last week by the government of India.  That was to be my topic for next Monday.  But after reading their excellent coverage—received just as I was sitting down to begin writing—I felt better.  At least I had not yet started writing!  Don’t miss Phil Taylor’s excellent coverage and his link to the source regulation.  See if you agree how crazy it is.  The deadlines are now Continue reading India’s Pharma Export Regulations Update And The NECC Story →

Data Exchange

Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?

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SteadyState.2015.to.2023The use of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) in the U.S. pharmaceutical supply chain has expanded over the last year, due entirely to its recognition by the FDA as a valid method for passing the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) as required by the Drug Supply Chain Security Act (DSCSA).  The Healthcare Distribution Management Association (HDMA) has encouraged that expansion by publishing a “how-to” guide for meeting the requirements of the DSCSA using an ASN (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).

Although not everything has worked out Continue reading Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday? →

GDSN, SCMD

DSCSA Deadline Represents A Crossed Threshold Into The SCMD Era

iStock_000055622022_SmallerThere 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 →

HDMA

InBrief: HDMA Updates DSCSA Q&A

HDMA LogoThe Healthcare Distribution Management Association (HDMA) recently updated their “HDMA Qs and As on the Drug Supply Chain Security Act (DSCSA)” to version 2.0.  This is a very well thought through document that will help companies understand how wholesale distributors are interpreting confusing or ambiguous sections of the law.  The document leans heavily toward questions about how wholesale distributors will need to react in various situations, but it will also be a resource that manufacturers, repackagers and dispensers will want to obtain and review.  What is really needed is for someone to do the same kind of analysis for questions that mainly affect those other supply chain entities.   Continue reading InBrief: HDMA Updates DSCSA Q&A →

serialization

Progress Toward Serialization!?

2014 enough time graph.zoomLast week I announced the availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results that are sponsored by Frequentz.  You should download a free copy of the report here.  This week I want to look at another interesting finding taken directly from the report.  It shows that progress is being made by drug manufacturers, repackagers and CMO/CPOs toward meeting the 2017 (2018 for repackagers) deadline for adding serial numbers to the drug packages they produce for the U.S. market.  That requirement comes from the Drug Supply Chain Security Act (DSCSA) enacted in November of 2013.

One of the many questions we asked Continue reading Progress Toward Serialization!? →

RxTrace Traceability Survey

2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available!

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graphI am proud to announce the free availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results, sponsored by Frequentz.  You can download the new free report here.

This year’s results were very interesting because most of the responses came in during the critical time just before the 2015 DSCSA requirements were to go into effect.  The questions asked were designed to elicit opinions on a wide range of topics, including the respondent company’s ability to meet the regulations on time, their technology choices and practices.  This year Continue reading 2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available! →