Brazil Suspends Pharma Serialization And Tracing Requirements | RxTrace

"Last week, Brazil’s pharma industry regulatory agency, the National Agency of Sanitary Surveillance (ANVISA), announced that they were “suspending” at least part of RDC-54/2013, the declaration that mandated drug serialization and tracing, until further notice.  Thank you to all who forwarded the link to the official announcement.  I was able to translate and read it on Thursday, and I submitted a comment on my own last essay, “Pharma Serialization Deadlines In Flux“, to include the link.  Apparently shortly after that essay was published, ANVISA  publicly announced the suspension." Dirk Rodgers - Read the full article from Dirk here.

RxTrace.com: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015

Dirk Rodgers of rxtrace.com writes "It’s August and that means it is time to check in on the progress toward full serialization of drugs in the U.S. supply chain.  This is an annual look I’ve been doing for five years now.  For my previous essays, see:

• “Estimated Rise In Serialized Drugs In The U.S. Supply Chain”;
• “Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014”.

In each essay I produced a graph of my own personal estimate of the likely rise in the percentage of drugs that I thought would result, based on the deadlines that were in place at the time.  Of course, things changed last year because the Drug Supply Chain Security Act had preempted the California Pedigree law the previous November, so last year I made a new estimate that took into consideration the DSCSA dates.

Why serialization is vital for pharmaceutical product integrity in the cold chain

Read entire article at the Cold Chain View blog.

More than ever before, drug security is an important issue in ensuring the integrity of medicines and vaccines reaching patients. The industry needs to demonstrate that we care for patients, and are putting all necessary measures in place to ensure that medicines are safe to be taken.

That means knowing the entire journey of a medicine through the supply chain, and having fully automated documentation about the conditions on its journey. One of the ways in which this can be addressed in the cold supply chain is through serialization. A key driver for implementing serialization will be global compliance requirements coming into play. The USA introduced the Drug Supply Chain Security Act at the end of 2013, which will require the availability of information at individual package level about where a drug has been in the supply chain.

Making the business case for implementing serialization cost-effectively in the supply chain

Read the full article at the Cold Chain View blog.

As part of the implementation of serialization, automation of the process will become law within 10 years. As already highlighted previously, serialization provides accountability and traceability of every item shipped in the supply chain. The need to conform to these new requirements might at first glance look like it would require costly additional investment. But it need not be – and it might even be more cost-effective, once you take into account the additional benefits that could be obtained.

‘The Smallest Individual Saleable Unit’ In The DSCSA - RxTrace

Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.

The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers).  These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).

3PL Operation Under The DSCSA - RxTrace.com paper

Photo from Wikipedia

Dirk Rodgers has written another great article covering the impact on 3PLs when considering the DSCSA - Read the full article on RxTrace.com

Another type of business affected by the U.S. Drug Supply Chain Security Act (DSCSA) is the third party logistics provider (3PL) business.

I wrote an RxTrace essay about the impact of the California pedigree law on 3PLs back in 2013 (see “3PL Operation Under California ePedigree“).  This is an update of that essay to address the impacts of the new DSCSA on 3PLs since the California pedigree law is now obsolete.

There are a number of important differences between wholesale distributors and 3PLs as defined in the DSCSA.

Why Does ANVISA Embrace GS1 Standards, Except The Serial Number? - By Dirk Rodgers

Dirk Rodgers of RxTrace.com has written another great article on ANVISA... Read below for an excerpt  or read the full article here. Serialization is a challenge and with this interpretation from the Brazilian authorities it certainly complicates matters for manufacturers if their goods land up in Brazil...

"In Brazil, the National Agency of Sanitary Surveillance (ANVISA) has built their pharma serialization regulation around GS1 standards. They embrace the GS1 Datamatrix and GS1-128, both encoded with GS1 Application Identifiers (AI) and using GS1 Human Readable Interpretation (HRI) (see my previous essay, “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”, for my thoughts on HRI), the GS1 Global Trade Item Number (GTIN) and the GS1 Serial Shipping Container Code (SSCC) to be specific. But there is one GS1 standard they steer clear of: the GS1 serial number. Why is that?

The ANVISA Unique Medicine Identifier (IUM) on Drug Packages - Dirk Rodgers

Last week Dirk wrote about the DSCSA Product Identifier on Drug Packages in the United States.  Last month he wrote about shipping container/transport package identification under the Brazil National Medicine Control System (SNCM) (see “ANVISA And The SSCC Controversy”).  In this article Dirk takes a look at drug package identifiers under the SNCM as regulated by the National Agency of Sanitary Surveillance (ANVISA).  Dirk is a member of the GS1 Healthcare group - Contact GS1 Healthcare for more information.

An excerpt from Dirk's article:

"Under the SNCM, manufacturers must apply a Unique Medicine Identifier (IUM) to all drug packages imported or sold into the Brazilian supply chain and trace them through the supply chain by December 11, 2016.  By December 11 of 2015, manufacturers must apply the IUM to the packages of at least three lots of drugs and trace them to the dispensing points.  And you thought compliance with the DSCSA was going to be hard to achieve!

The DSCSA Product Identifier On Drug Packages - Dirk Rodgers

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])

Frequentz Inc's Track and Trace Solution news

PALO ALTO, Calif., April 28, 2015 - As the counterfeit drug market grows and the pharmaceutical supply chain becomes more complex, Frequentz Inc., a global leader and champion of end-to-end visibility, is proud to announce they are validating medications flowing through two-thirds of the 67,000 U.S. pharmacies. Frequentz's track and trace system is utilized by two of the top three global distributors of pharmaceuticals, increasing Frequentz's ability to help keep consumers safe. With such broad reach, Frequentz gives consumers the confidence they can trust the medications coming from the majority of pharmacies and contract manufacturers.

Read full article at PR Newswire

5th Traceability and the Drug Quality and Security Act - ExL Events

5th Traceability and the Drug Quality and Security Act - An ExL Event

5th Traceability and the Drug Quality and Security Act– 5th Traceability and the Drug Quality and Security Act

Join us in Morristown, New Jersey at the 5th Traceability and the Drug Quality and Security Act conference to learn from leading supply chain experts about they have managed to provide business value through serialization and pedigree beyond regulatory compliance. Make sure you have everything in place to be able to respond to FDA inquiries within 48 hours to avoid high fines and work effectively together with your wholesalers and dispensers. This interactive forum discusses best practices for track and trace and lessons learned from implementing an integrated global supply chain security program that improves transparency, secures your supply chain and protects your brand, all while leveraging business benefits.

California Board of Pharmacy Issues Licensing Guidance for 3PLs

The California Board of Pharmacy issued guidance this week outlining the process for obtaining the licensing as third-party logistics providers or non-resident third-party logistics providers in the state. This requirement extends to all 3PLs that ship pharmaceuticals to or from California.
Prior to the Drug Supply Chain Security Act (DSCSA), 3PLs were required to obtain licensing as a wholesaler—now 3PLs and wholesalers are separate entities under California law.
Read the full story at IWLA

Pharma Serialization Update - April

Bill Fletcher highlights a few key deadlines looming for Pharma Serialization:

1. The FDA enforcement discretion not to enforce the transaction document aspects of the Drug Supply Chain Security Act (DSCSA) ends May 1. Companies who may have chosen to spend more time working out kinks in their transaction document (TD) may be running out of time.  
2. There is controversy with the way shipper cases are tracked in Brazil.
3. Companies selling into Brazil will now need to collect traceability data from 3 LOTs by December of this year. 
4. Chinese traceability is fully effective this December.  
5. New requirements in India for primary packages are creating very onerous designs on manufacturers
6. EU delegated acts for Falsified Medicines is expected in the next couple of months. Encoding will include GTIN, country reimbursement code, LOT expiration date and serial number in human readable and encoded in a GS1 DataMatrix symbol

Bill Fletcher - Pharma-Logic

ANVISA And The SSCC Controversy - By Dirk Rodgers

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 be both a “standard grouping” of the product and a transport package. GS1 recommends that “standard groupings” of product be marked with its own GS1 Global Trade Item Number, or GTIN. Read the full article at RxTrace.com - Author Dirk Rodgers

India’s Pharma Export Regulations Update And The NECC Story

India’s Pharma Export Regulations Update And The NECC Story - By Dirk Rodgers of RxTrace.com
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. View full article here

Serialization to cover three major aspect of 1) emerging regulatory compliance, 2) empowering consumer via SMS authentication and 3) supply chain visibility through product traceability

An era of pharmaceutical serialization has begun. Around the world, countries are beginning to mandate the bar coding of pharmaceuticals to defend supply chain from counterfeits. Serialization is a strategic decision for companies. Serialization planning by companies should cover all three aspects though different, yet intertwined, in their serialization program i.e. regulatory compliance, Brand protection […]


https://icondeepali.wordpress.com/2015/03/02/serialization-to-cover-three-major-aspect-of-1-emerging-regulatory-compliance-2-empowering-consumer-via-sms-authentication-and-3-supply-chain-visibility-through-product-traceability/

Top five trends move the cold chain industry to the next level:capacity, last mile, and security become important

by Rene Tjong Tjin Tai, CEO, Dyzle There is now a good deal of awareness of the need for proper cold chain management in the storage and transportation of temperature-sensitive products in the pharmaceutical and food industry. In particular, there is now increasing pressure on manufacturers and logistics providers alike to ensure that regulatory requirements […]


https://dyzle.wordpress.com/2015/03/03/top-five-trends-move-the-cold-chain-industry-to-the-next-level-capacity-last-mile-and-security-become-important/

Progress Toward Serialization!

"Frequentz has published the 2015 RxTrace U.S. Pharma Traceability Survey Results and Dirk Rodgers, of rxtrace.com, reviews some interesting findings taken directly from the report. Dirk talks about how the report 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." Read Dirk's full blog at Progress Toward Serialization!?.