Tag Archives: wholesale distributor

DSCSA

DSCSA: What Wholesalers Want

Last November pharma manufacturers selling into the U.S. market had to meet a big serialization and verification deadline under the Drug Supply Chain Security Act (DSCSA).  Now, pharma wholesale distributors in the United States are facing their own important deadline this coming November.  Remember how manufacturers had to scramble and go through a lot of pain to achieve compliance in time?  Your friendly neighborhood wholesale distributors—big and small—are going through that now.  And the problem is…they can’t do what they need on their own.  They need all drug manufacturers to do something so that they can be compliant with the DSCSA in November.

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DSCSA

McKesson’s DSCSA 483 Explained

Back on July 3, 2018 the FDA issued a notice of “inspectional observations”—known as an “FDA Form 483”—containing observations that appeared to the inspector to be potential violations of certain sections of the Drug Supply Chain Security Act (DSCSA).  The FDA recently posted the form on their website, but did not post the response from the company.  I assume McKesson would have contested it.  Without knowing what McKesson said to the FDA in response, let’s take a closer look at the FDA’s logic and come up with our own thoughts. Continue reading McKesson’s DSCSA 483 Explained →

DSCSA

DSCSA Verification and Suspect Product

Last week I wrote about the debate over the number of possible responses to verification requests in any potential solution the industry might adopt to meet the Drug Supply Chain Security Act (DSCSA) (see “DSCSA Red Light Green Light: Verification Responses”).  Today I want to take a closer look at a related issue:  the relationship between verification and suspect product.  Most specifically, does a failed verification automatically force a product into the suspect product category?  The answer might surprise you. Continue reading DSCSA Verification and Suspect Product →

DSCSA

DSCSA Serialization Delay Eclipses Grandfathering

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On August 21st, large portions of the United States and other places will experience a total eclipse of the sun by the moon.  On November 27th, the serialization and verification delay of the Drug Supply Chain Security Act (DSCSA) contained within the FDA’s recent draft compliance policy (see “FDA Delays Enforcement of DSCSA November Deadline: What It Means”) will eclipse the grandfathering guidance that hasn’t even been published yet.  In fact, the overdue grandfathering guidance should be easy for the FDA to write now (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”).  Grandfathering probably just won’t exist.  Here’s why. Continue reading DSCSA Serialization Delay Eclipses Grandfathering →

Kits

DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?…Again

iStock_000069076997_smallerI am writing this from Mumbai India where I am scheduled to speak at the Systech Uniquity Conference, but I will be home by the time you read this.  I just won’t have time to publish a new essay this week due to the incredibly long flights I need to get home.  So, here is a re-posting of a great essay from May 9, 2016.

 

DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?

Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA).  But be careful.  Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?…Again →

Kits

DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?

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iStock_000069076997_smallerMedical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA).  But be careful.  Just because you and your customers have called your product “a kit” for years doesn’t mean that Congress and the FDA call it that under the DSCSA.  In fact, many products that have historically been referred to as “medical convenience kits” will be treated under the DSCSA as a repackaged drug, a combination product, or worse, just a collection of device(s) and drug(s).  Let’s take a closer look. Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’? →

EU FMD

EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary

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iStock_000016455220_SmallerEver since the E.U. Falsified Medicines Directive (FMD) was passed in 2011 my European friends have touted the fact that their government mandated solution would take a “bookend” approach.  The implication was always that it would be much less complex than the ePedigree approaches that were being planned by various U.S. states, and then by the U.S. federal government with the passage in 2013 of the Drug Supply Chain Security Act (DSCSA).

My friends always liked to point out how simple Continue reading EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary →

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 →