The DSCSA Product Identifier On Drug Packages

May 4, 2015 Dirk Rodgers 1 Comment

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 →

SSCC

Identification Of Pharma Cases In The U.S.

April 27, 2015 Dirk Rodgers

Last 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. →

RxTrace

The Future Of RxTrace

April 22, 2015 Dirk Rodgers 9 Comments

When I created RxTrace almost six years ago my goal was to introduce and explore new ideas and opinions I had about technology issues related to regulatory compliance within the pharmaceutical supply chain. (see my first essay that explains this purpose: “Welcome to rxTrace”). Hopefully my loyal readers will agree that I have accomplished exactly that, many times. Later, when I struck out on my own as an independent consultant, RxTrace also generated leads which led to new consulting engagements. It served to Continue reading The Future Of RxTrace →

ANVISA, SSCC

ANVISA And The SSCC Controversy

April 20, 2015 Dirk Rodgers 1 Comment

GS1’s Serial Shipping Container Code, or SSCC, has been around a long time, but the logistics identifier has recently taken center-stage in a number of controversies related to meeting several country-specific pharma traceability regulations. I’ll cover these controversies in multiple essays—in this one, Brazil.

This controversy started when ANVISA, the pharma regulator in Brazil, indicated in their regulations that they expected companies to mark every “transport package” entering their supply chain with a unique identification code so that each serialized unit inside can be associated with it (the aggregation requirement).

The problem is, a homogeneous case of product can Continue reading ANVISA And The SSCC Controversy →

News

India’s Pharma Export Regulations Update And The NECC Story

April 17, 2015 Dirk Rodgers 1 Comment

I 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 →

Thank You!

Thank You Ron Bone!

April 13, 2015 Dirk Rodgers 1 Comment

Well over 18 months ago I learned that Ron Bone was stepping down as SVP of Distribution Support at McKesson. He immediately became a solo consultant and was engaged directly with McKesson again, but this time he filled a part-time role. This was Ron’s way of staying connected with the activities at McKesson related to meeting the federal Drug Supply Chain Security Act (DSCSA) which was on its journey toward enactment, and it was McKesson’s way of maintaining continuity in those efforts. Win-win.

Ron originally intended to fully retire last July…then December…and now, someday. Does anyone think it will happen this time? Frankly, I hope not. I think Ron is having too much fun, and everyone in the industry who knows him enjoys having Ron engaged as much as he is willing. So take your time Ron. No need to rush.

Like Bob Celeste, who departed GS1 US last month after serving as the lead traceability facilitator and motivator for the U.S. pharma supply chain (see “Thank You Bob Celeste!”), Ron was Continue reading Thank You Ron Bone! →

Data Exchange

Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?

April 8, 2015 Dirk Rodgers 1 Comment

The 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

April 6, 2015 Dirk Rodgers

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 →

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