Tag Archives: DSCSA

RFID

The Case Against RFID In Pharma

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iStock_000001225482SmallerIt is pretty clear that there is not much interest in the use of Radio Frequency IDentification (RFID) in the pharmaceutical supply chain because every time I publish an essay in RxTrace about some aspect of it, there is a drop in readership.  So at the risk of taking another hit in readership, let’s take a look at the case against the use of RFID in the pharma supply chain.

Back in 2010 I published an essay that really rattled my friends in the RFID vendor community (see “RFID is DEAD…at Unit-Level in Pharma”).  Since that essay was published, the two or three drug companies that were previously shipping drugs with package-level RFID tags on them have ended that practice, replacing the RFID tags with 2D barcodes.  This includes Purdue Pharma and Pfizer, the two flag carriers for RFID in pharma back in the late 2000s Continue reading The Case Against RFID In Pharma →

serialization

InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014

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RxTrace.com Serialization Estimate 2014.zoomIt is time for the RxTrace look at the estimated rise in the percentage of drugs in the U.S. supply chain that are serialized.  Every year we take a look at this topic while longingly wishing that someone would perform a real study and publish the numbers.  However, it may not make much difference from here on out because it will be impossible for drugs without serial numbers to exist in the U.S. supply chain in just a few years.  So let’s take a look. Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014 →

DSCSA

DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 3

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AB ZoomIn Part 2 of this series I explained exactly what the “special privileges” are in the Drug Supply Chain Security Act (DSCSA) for wholesale distributors who purchase directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager who buys directly from the manufacturer (see “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 1”, and “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2”).  In this third part, I will explain why all of this matters to drug manufacturers and how, in some situations, the “Big-3” wholesale distributors may not want to handle your product after the end of this year. Continue reading DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 3 →

DSCSA

DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2

iStock_000001015002SmallerIn Part 1 of this series I explained how the “Big-3” wholesale distributors in the U.S. changed their buying practices back in the mid-2000s so now they only buy their inventory directly from each drug manufacturer.  But in a small number of cases, that isn’t possible.  In those cases, they are forced to buy from an exclusive distributor, or from a company who buys pre-packaged drugs from the NDA- or ANDA-holder.  (See “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 1”.)  And I pointed out that the DSCSA contains “special privileges” for any wholesale distributor who can buy direct from the manufacturer.  In this second part, I will explain exactly what these “special privileges” are in the Drug Supply Chain Security Act (DSCSA). Continue reading DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2 →

DSCSA, HDMA

HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again

The Healthcare Distribution Management Association (HDMA) had just published another update to their guidance for meeting the U.S. Drug Supply Chain Security Act (DSCSA) using Electronic Data Interchange (EDI) 856 Advance Ship Notice (ASN).  In case you thought they already did that a few months ago, you are right.  This is an update (July) to the earlier update, and this one is important, so make sure you replace your old copy with this one.

The previous guidance document (see “Just Released – The HDMA EDI ASN Guidance For DSCSA”) was pulled together very quickly to meet the demands of everyone in the supply chain.  However, it missed a few critical characteristics, like how to document:

  • the identity of the buyer and seller when either differs from the ship-to or ship-from locations;
  • when the drugs were originally purchased directly from the manufacturer or exclusive distributor;
  • when the seller received a direct purchase statement from their supplier.

Continue reading HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again →

DSCSA

DSCSA: Special Privileges For The “Big-3” Wholesale Distributors, Part 1

iStock_000011736093SmallerAre you a pharmaceutical manufacturer who is acting as a wholesale distributor, as defined by the U.S. Drug Supply Chain Security Act (DSCSA), for some of your products?  This might occur if you are buying pre-packaged drugs from the New Drug Application (NDA)-holder or Abbreviated New Drug Application (ANDA)-holder and offering them for sale to U.S. wholesale distributors.  If you cannot justifiably fit into the DSCSA definitions of either a “co-licensed partner”, or an “exclusive distributor” for those drugs, you might as well remove them from your catalog because the “Big-3” wholesale distributors—AmerisourceBergen, Cardinal Health and McKesson—probably will not be willing to buy them anymore as of next January.

That’s because the DSCSA, which begins to take effect at that time, will most likely consider you as a Continue reading DSCSA: Special Privileges For The “Big-3” Wholesale Distributors, Part 1 →

Record-keeping

DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement

??????????The Drug Supply Chain Security Act (DSCSA) contains record-keeping requirements for drug manufacturers, wholesale distributors, repackagers and dispensers that begin on January 1st.  All companies must keep a copy of the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) they receive and those they send for at least six years.  In addition, manufacturers and repackagers must also retain knowledge about the “product identifier” on each unit they sell into the supply chain for a period of six years after the date it was sold.  Companies who perform investigations into suspect product must also keep records of their process and the outcome for six years.

There are a few implications of these record-keeping requirements.  Let’s take a look at some of them.  Continue reading DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement →

PIA, POD, Randomization

DSCSA: Congress Should Have Mandated Randomization

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iStock_000015967853SmallerCongress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain.  Let me explain.

The text of the Drug Supply Chain Security Act (DSCSA) was developed last year by Congressional staff in consultation/negotiation with various lobbying organizations—primarily the Prescription Drug Security Alliance (PDSA).  The effect of the legislation is to create a way of protecting the U.S. pharmaceutical supply chain that relies primarily on product identifier authentication (PIA) (see “Product Identifier Authentication” and “The Aggregation Hoax and PIA”) for at least the first 10 years and possibly beyond. Continue reading DSCSA: Congress Should Have Mandated Randomization →