Tag Archives: serialization

serialization

Pharma Industry Attention Returns to Serialization

FDA sNDC example plus lot and expiry as a GS1 DataMatrix symbolBefore the passage of the Drug Supply Chain Security Act (DSCSA) on November 27, 2013, the pharma industry was focused pretty well on getting the California-mandated serial numbers on 50% of their drug packages by last Thursday (January 1, 2015), and the remainder of their products by next January.  But that mandate evaporated by federal preemption as soon as the Federal bill was signed into law.  From that moment on, everyone turned their sights toward meeting the data exchange requirements of the DSCSA by last Thursday (see “DQSA: How Should Transaction Data Be Exchanged?”).  Of course, just before Christmas, the FDA pushed that effective date out to May 1, 2015 (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).

That extension in enforcement is a blessing to a few Continue reading Pharma Industry Attention Returns to Serialization →

Data Exchange, DSCSA

The Coming Transition To Serialized Data

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???????????In less than one month the Drug Supply Chain Security Act (DSCSA) will require all sales of drugs in the U.S. pharma supply chain to be accompanied by some very specific data (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”).  The law requires companies to begin exchanging data on January 1 in either paper or electronic form, but because it would be virtually impossible for the big 3 wholesale distributors to accept even a single piece of paper for even a single shipment, the bulk of the U.S. sales by pharma manufacturers will be documented electronically from day-one.  It turns out, the vast majority of that electronic documentation will be passed in the form of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) (see “DQSA: Getting To Electronic Transaction Data Exchange”, “Just Released – The HDMA EDI ASN Guidance For DSCSA”, “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again” and “The HDMA Supply Chain Product Transaction Scenarios For DSCSA”).

But the vast majority of those EDI ASN documents are not likely to Continue reading The Coming Transition To Serialized Data →

DSCSA, NDC

The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys

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Thanksgiving is my favorite holiday!
Giving thanks!  It is my favorite holiday and I have a lot to be thankful for.

Until the Drug Supply Chain Security Act (DSCSA) was passed as part of the Drug Quality and Security Act (DQSA) last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), companies could use whatever code they wanted to refer to the prescription drug products in supply chain operations and for their own inventory management.  Some probably chose the 10-digit National Drug Code (NDC), some probably chose the 11-digit reimbursement code that is based on the 10-digit NDC, and some probably chose to use a 12- or 14-digit GS1 Global Trade Item Number (GTIN) as a reference code for their inventory data.  But now that the DSCSA mandates the use of the 10-digit NDC when exchanging transaction data on January 1, companies using the other codes that are based on the NDC might need to Continue reading The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys →

Global Alignment

Global Traceability Data Exchange: Troubled Waters Ahead

iStock_000008540261SmallerAs we near the end of 2014, several important pharma traceability deadlines around the world are approaching.  Besides the U.S. Drug Supply Chain Security Act (DSCSA), these include deadlines in Brazil and South Korea.  Of course, each regulation is different.  Now that the initial implementation of the exchange of transaction data in the U.S. is widely being implemented in Electronic Data Exchange (EDI) Advance Ship Notices (ASNs), the next hurdle for drug manufacturers will be to deploy serialization technologies on their U.S. and Korea market packaging lines.  The data exchange technology problem will shift to Brazil, and that’s where I see trouble. Continue reading Global Traceability Data Exchange: Troubled Waters Ahead →

EPCIS

Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange?

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????????????????????????????????????????I am confident that GS1’s Electronic Product Code Information Services (EPCIS) standard will take center stage in 2023 when the U.S. Drug Supply Chain Security Act (DSCSA) transitions into what that law calls the “Enhanced Drug Distribution System”, or EDDS.  That’s when the DSCSA mandates that supply chain changes of ownership of prescription drugs must be documented in an interoperable electronic system based on their unique serial numbers.

Each of the steps that must be implemented by the industry between now and Continue reading Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange? →

DSCSA

Should You Off-Load Your DSCSA Obligations To Your Contract Partners?

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??????????????????????Manufacturers who make use of third-party contract manufacturers, contract packagers and/or third-party logistics providers (3PLs) may wish to off-load their 2015 and 2017 obligations under the U.S. Drug Supply Chain Security Act (DSCSA) to those contract organizations.  These obligations include providing Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), and collecting and holding that data in case of future investigations starting this coming January; and applying the necessary 2D barcode with serial numbers starting in November of 2017.

This may seem perfectly logical.  After all, absorbing responsibilities is one of the big benefits that contract organizations offer their customers.  But by passing on certain obligations under the law, DSCSA manufacturers may end up with higher risks in the future. Continue reading Should You Off-Load Your DSCSA Obligations To Your Contract Partners? →

Global Alignment

Pharma Serialization: Going Totally Global Soon

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World map.iStock.smallerOne of the best sessions during last week’s LogiPharma conference held in Princeton, NJ was called “Staging Your Implementation To Meet The 2017 Deadline”.  The “deadline” refers to the November 27, 2017 deadline for drug manufacturers to apply unique serial numbers to all drug packages and cases shipped into the U.S. market as required in the Drug Supply Chain Security Act (DSCSA), but it can also refer to similar deadlines with similar requirements in a number of other regions of the world.  The panel included knowledgeable representatives from two of the largest global pharma manufacturers selling into the U.S. market.  Both manufacturers are facing serialization mandates in the E.U., Brazil, Turkey, South Korea, China, India, Argentina and a few countries in Africa as well as the U.S.

As they spoke about their respective programs for meeting the requirements, one of the speakers mentioned that roughly 90% Continue reading Pharma Serialization: Going Totally Global Soon →

Conferences

2014 Fall Conference Season Preview

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ConferenceIt is time to look at the better healthcare supply chain conferences coming up this fall.  This year the focus will be on the Drug Supply Chain Security Act (DSCSA) and the Unique Device Identification (UDI) final rule implementations.  For the DSCSA I think we will see presentations aimed at both the immediate 2015 data exchange requirements and those aimed at the 2017 serialization requirements, but I also expect to see presentations aimed at “second generation” data exchange—those based on GS1’s recently updated Electronic Product Code Information Services (EPCIS) standard.  After meeting the initial data exchange requirements for Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) in January, companies will need to begin preparing for the second generation using EPCIS (see “DQSA: Getting To Electronic Transaction Data Exchange”).  That transition will likely occur over the next three years. Continue reading 2014 Fall Conference Season Preview →