Tag Archives: TI

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 →

Aggregation

When Will The DSCSA Ever Require Investments In Aggregation?

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Packaging Hierarchy. Drawing by Omega Design
Packaging Hierarchy. Drawing by Omega Design

I have been outspoken on the question of whether or not the Drug Supply Chain Security Act (DSCSA) requires companies in the supply chain to provide their customers with serial number-based aggregation data prior to 2023.  In my view, it does not, but others disagree, saying that there are requirements in the law that lead to the need for aggregation data during that time.  I do not agree with that either.  If you would like to review those arguments and find out exactly what “aggregation data” is, here is a list of RxTrace essays you should read:

Date Published Title/link
March 26th, 2012 Pharma Aggregation: How Companies Are Achieving Perfection Today
November 22nd, 2013 DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?
February 10th, 2014 Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…
June 9th, 2014 The Aggregation Hoax and PIA

BUT WHAT ABOUT AFTER 2023?

The DSCSA requires the FDA to conduct at least 5 topical public meetings between now and Continue reading When Will The DSCSA Ever Require Investments In Aggregation? →

Transaction Data Exchange

Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?

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??????????????We are now more than six weeks past the date that the DSCSA originally mandated drug manufacturers, repackagers and wholesale distributors to pass Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) to their customers in the U.S. and save a copy for six years (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”).  Of course, just before Christmas, the FDA pushed out that part of the requirement until May 1, 2015 to ensure that the requirement did not induce or exacerbate drug shortages (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).

Despite the delay, many companies are already passing the required data to their trading partners through Electronic Data Interchange (EDI) Advance Shipment Notices (ASNs) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).  In fact, the vast majority of companies have Continue reading Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data? →

Exception Handling

DSCSA Exception Handling: A Preview of Your Next Surprise Headache

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HDMA ASN Exception GuidelinesCompanies that participate in the U.S. pharma supply chain and are subject to the U.S. Drug Supply Chain Security Act (DSCSA) are preparing to meet the FDA’s 2015 deadlines for exchanging Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for every shipment.  Those preparations include integrating the generation, transmission, confirmation, storage and retrieval (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”) of these documents into their existing supply chain and regulatory compliance processes.  It is a big deal and it affects a large number of companies. Continue reading DSCSA Exception Handling: A Preview of Your Next Surprise Headache →

Decommissioning

The Coming Battle Over Decommissioning At The Pharmacy

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Certificate of Serial Number Death
Certificate of Serial Number Death

The U.S. pharma supply chain will operate under two major phases as dictated by the Drug Supply Chain Security Act (DSCSA).  We are now operating under the first major phase.  Well, OK, it won’t be fully operational until July 1st when dispensers (see “Who Is A DSCSA Dispenser?”) are required to begin receiving, saving and retrieving Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for each shipment they receive.  Drug manufacturers, repackagers and wholesale distributors were supposed to begin exchanging those documents on January 1st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).  But be aware that according to the DSCSA, as of January 1st, all trading partners must be properly licensed and everyone may only buy and sell drugs legally from/to companies who hold a valid State or Federal license.  Those and other requirements of the DSCSA were not delayed by the FDA.

The second major phase of the DSCSA will not occur until November 27, 2023 when the law transforms into something that is fairly nebulous right now.  That is, between now and Continue reading The Coming Battle Over Decommissioning At The Pharmacy →

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 →

DSCSA Web Portals

A Closer Look At Web Portals for DSCSA Transaction Data Exchange

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???????????????These are the last few days of 2014.  During the rush up to Christmas, the FDA gave the industry a gift by announcing that they will not enforce the transaction data exchange requirements of the Drug Supply Chain Security Act (DSCSA) until May 1, 2015—a four month delay (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1” for details).  So things are likely to be quieter this week than they otherwise might have been.  And if you are one of those who are working this week, why not fill out the 2015 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz?  It will be closed soon so make sure you click here to fill it out now.

One of the approaches that the FDA mentioned in their data exchange guidance, published on November 26, is the use of secure web portals (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”).  Some companies are Continue reading A Closer Look At Web Portals for DSCSA Transaction Data Exchange →