Tag Archives: drug supply chain

RxTrace Traceability Survey

Sponsored: The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report

Cover thumbnailThe final report of the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz is now available.  Download the full free report here.  With this year’s survey we attempted to get a glimpse of the progress toward the next deadlines of the Drug Supply Chain Security Act (DSCSA) from drug manufacturers, repackagers, wholesale distributors, 3PLs and dispensers.  Each of those different types of respondents were asked a different set of questions that were pertinent to their segment and their regulatory requirements under the DSCSA.

Frequentz.logoTake a close look at the results.  They reveal that Continue reading Sponsored: The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report →

DSCSA

Pay No Attention To The Enforcement Delay Unless You Are A Dispenser

iStock_000037865140_smallerAs I reported last Thursday, the FDA published new revised guidance that extends their enforcement delay of the Drug Supply Chain Security Act (DSCSA) data exchange requirements for dispensers by an additional 4 months (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  What does this mean for drug manufacturers, wholesale distributors and repackagers? Continue reading Pay No Attention To The Enforcement Delay Unless You Are A Dispenser →

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

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 →

DSCSA

DSCSA: Transaction History

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TH.iStock_000000755934SmallerThis is the second in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January.  Last week’s essay was about DSCSA Transaction Information (TI).  On the surface, Transaction History (TH) looks simple.  The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines TH this way:

“(25) TRANSACTION HISTORY.—

The term ‘transaction history’ means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.”

According to this simple definition, Continue reading DSCSA: Transaction History →