Product Identifier Authentication, Saleable Returns Verification

DSCSA: Saleable Returns Verification

The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future.  Today I want to take a closer look at the results of the Saleable Returns Pilots conducted by the HDA last year to figure out the most efficient way to verify saleable returns.  I discussed the overall project in my report of the Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”) but today I want to focus in on just two of the approaches piloted.  These are:

  • Manufacturer sends to wholesale distributor product identifiers for only the units purchased by that wholesale distributor, and,
  • Verification Router Service (VRS).

Continue reading DSCSA: Saleable Returns Verification →

ANVISA

Brazil Gets Rational With Their New Pharma Traceability Law

Last week, Brazil President Michel Temer signed law number 13,410, which amends law number 11,903 from 2009, their original pharma serialization and tracing law.  The effect of the new law on the old can be seen here.  The problem for me is that I don’t read Portuguese, so I must rely on Google Translate to translate these texts.  This results in an unofficial translation that has a few imperfections that are obvious, even to non-Portuguese readers, but it appears to be not bad. Continue reading Brazil Gets Rational With Their New Pharma Traceability Law →

NDC

NDC Nearing Its End, Afflicted by ‘Identifier Failure’

business-executive-and-his-energy-level-concept-vector-cartoon-i-507717540_4911x3472Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing.  My mother and my mother-in-law both suffered from heart failure during their decline.  Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”.  At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect.  Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition.  The NDC won’t last long now, and there is no longer any excuse for inaction.  The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’ →

FDA Guidance

FDA Finalizes Guidance On Suspect Product

suspect-product-final-guidanceHere we are, waiting for the FDA to publish new draft guidance related to the Drug Supply Chain Security Act (DSCSA) after a deadline that passed more than a year ago, and what do we get?  A final version of a guidance document that was originally published in draft form two and a half years ago:  “Identification of Suspect Product and Notification”.  Well, OK, thanks. 

I have to say, this is important guidance.  In fact, it is probably the most important DSCSA guidance that the FDA has published yet, whether in draft or final forms.  And, unfortunately, Continue reading FDA Finalizes Guidance On Suspect Product →

Anti-counterfeiting

Sponsored: Will Global Serialization Mandates Result In Less Counterfeiting?

iqpc-acf-sidebar-banner-1One of the focuses of RxTrace is to explore global pharma serialization and tracing regulations in an attempt to discover some of their implications.  Some implications turn out to be obvious, but some turn out to be surprising.  Identifying the implications early provides us with a better understanding of what to expect from our investments in time to fine-tune those investments.  If company leaders have a realistic understanding of what to expect from different investments, they will make better decisions for their stakeholders.  Can they expect to be fully compliant?  Only partly compliant, thus needing to spend more down the road?  Will they be fully compliant with the law, but disappoint their primary customers and thus find that their business takes a hit?  If they have a good idea of what to expect before they Continue reading Sponsored: Will Global Serialization Mandates Result In Less Counterfeiting? →

Center For Supply Chain Studies, DSCSA

Could Blockchain Technology Be Used For DSCSA Compliance?

c4scs-logoIf your email inbox is anything like mine it has recently been swamped with articles and webinar notices about the possible use of blockchain technology to solve multiple challenges in healthcare.  I recently attended a very interesting day-long workshop on that very topic. 

So is blockchain a real solution, or is it just the latest over-hyped buzzword that is being promoted by people who don’t understand the real needs of healthcare companies?  I’ll tell you what I think.  But first, a little background.

Blockchain technology is a way of encapsulating information within a layer of structured data that multiple parties can use as the basis for trust in the accuracy of the source of that information.  It’s all about adding trust to information that is shared between parties.  Trust is just one of the many Continue reading Could Blockchain Technology Be Used For DSCSA Compliance? →

Samples

Drug Samples Under Global Serialization and Tracing Regulations

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istock-526070305-smallerSome pharma manufacturers make special packages of certain drugs that they give away to certain medical practitioners as a way of promoting the product and introducing the practitioner and their patients to it.  The method of distribution is usually through field sales people employed directly by the drug manufacturer, and the drug samples are delivered by them directly to the practitioner.

What could go wrong with that?  Probably diversion of the product contained within the “free sample” packaging back into the supply chain, but without the “free sample” indicator on the package.  Should these special packages be tracked?  Should they be serialized?  Continue reading Drug Samples Under Global Serialization and Tracing Regulations →

EPCIS, GS1 U.S.

The New GS1 US DSCSA Implementation Guidance Suite

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A few weeks ago, GS1 US published version 1.2 of the DSCSA implementation guidance that documents how to apply GS1 standards when meeting the U.S. Drug Supply Chain Security Act (DSCSA).  GS1 US is the GS1 Member Organization (MO) in the United States, of GS1, the global supply chain standards organization.  Companies who market drugs in the U.S. pharma supply chain and their solution providers will find this new version to be an indispensable resource that will Continue reading The New GS1 US DSCSA Implementation Guidance Suite →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance

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