FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption

Last week the FDA finally published their draft guidance for submitting a waiver, exception or exemption from certain Drug Supply Chain Security Act (DSCSA) requirements.  Originally, the latest possible date FDA could delay publishing this particular guidance was May 31, 2017.  That is, 180 days before the manufacturer’s serialization and verification requirement was due to go into effect on November 27, 2017.  Once that date passed without publishing this draft, they were forced to delay the start of the serialization/verification deadline, as they did in late June last year (see “FDA Tea Leaves: Are They About To Delay The November Deadline?” and “FDA Delays Enforcement of DSCSA November Deadline: What It Means”).  That bought the FDA another year to publish, with the new publication deadline for the guidance being May 31, 2018, which they have now met (see “FDA To Publish Key Draft Guidance Tomorrow”). Continue reading FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption

FDA To Publish Key Draft Guidance Tomorrow

This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow.  The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers.  In fact, if they had failed to meet their late May deadline for publication of this particular draft guidance Continue reading FDA To Publish Key Draft Guidance Tomorrow

An Open Letter To Blockchain Vendors: Please Pay More Attention

Dear Blockchain Vendors,

It was good to see all of you at last week’s Drug Supply Chain Security Act (DSCSA) and Blockchain proof of concepts pilots review held by the Center For Supply Chain Studies (C4SCS) in Rockville, MD.  I hope your travel home was uneventful.  Let me say right at the top, I was in the audience representing Systech International.  My co-worker, Joe Lipari partnered with Dwight deVere of RxTransparent as the Green Team.  RxTrace is independent of Systech International.  That said, as the author of RxTrace, I have some helpful advice for you. Continue reading An Open Letter To Blockchain Vendors: Please Pay More Attention

HDA Urges FDA…Please Re-Read The DSCSA

Late last month the Healthcare Distribution Alliance (HDA) submitted a letter to the FDA in response to the docket for the DSCSA Public Meeting held on February 28, 2018 (see “FDA DSCSA Public Meeting #3: A Difference?”).  Like everyone who attends these meetings, HDA appreciates the FDA holding them.  HDA recognizes the importance of clear and well-reasoned responses to every important discrepancy in interpretation their members heard during these meetings.  You can tell from this and all previous HDA letters to the FDA regarding the Drug Supply Chain Security Act (DSCSA).  This letter is another masterpiece, following previous HDA masterpieces (see “HDA Schools FDA On DSCSA” and “HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS”).

HDA’s letter about the third FDA DSCSA Public Meeting was a very effective deconstruction of eight of the ten items in FDA’s list of “Enhanced Security Needs” summarized Continue reading HDA Urges FDA…Please Re-Read The DSCSA

Data Ownership In The Track And Trace Cloud, Reprised And Updated

Back in January of 2013 I wrote an important essay called “Data Ownership In The Track And Trace Cloud” which analyzed a potential future where members of the pharma supply chain would need to deposit and maintain track and trace data in a centralized or semi-centralized data repository in the “cloud”.  As the title implies, my main focus was on who would own that data, which was, and continues to be, a hot topic.

But now, five years on, things are getting less “potential” and more real. Continue reading Data Ownership In The Track And Trace Cloud, Reprised And Updated

What’s So Hard About Unique Identifier Verification?

Both, the Drug Supply Chain Security Act (DSCSA) in the US and the Falsified Medicines Directive (FMD) in the EU make use of unique identifier verification in one way or another.  Under the FMD, verification is the centerpiece of patient protection.  Under the DSCSA, verification is used as a tool to help resolve higher risk use cases, like saleable returns to wholesale distributors, and anytime someone becomes “suspicious” about a collection of drug packages.  On the surface, verification of unique identifiers seems simple, but there are some sticky problems that make it complex in some circumstances (see also “Drug Verification: EU Vs US”). Continue reading What’s So Hard About Unique Identifier Verification?

I Receive My First Serialized Drug From My Pharmacy: Is It Right?

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Normally drugs dispensed by American pharmacies are repackaged into the “standard” amber vial.  The pharmacy places their own label on that bottle so the patient normally doesn’t receive the manufacturer’s package that would have the new 2D barcode mandated by the Drug Supply Chain Security Act (DSCSA).  There are a few drugs that are not repackaged by US pharmacies, like most things in an inhaler and drugs in “compliance packaging” like birth control pills.  But even then, the pharmacy puts their label on the package

 

somewhere.

One of the few drugs I take daily is a statin, which has always been put into an amber bottle by my pharmacy.  A few months ago I received a three months supply, and to my surprise, the pharmacy dispensed the prescription in the manufacturer’s original 90-count bottle, and there was the DSCSA 2D barcode on the label.  The pharmacy label was positioned so that it formed a “flag” and did not cover the 2D barcode, and the pharmacy label was easily removed to expose the entire manufacturer’s label.  This drug was made by Lupin Pharmaceuticals, a generic drug manufacturer base in India.  How did they do? Continue reading I Receive My First Serialized Drug From My Pharmacy: Is It Right?

Sponsored: Extracting Value Beyond Compliance From Serialization

Companies are spending hundreds of millions of dollars, euros, rupees and rubles getting ready to comply with serialization regulatory mandates around the world.  Deadlines are fast approaching in the US and the EU and they are already passed in India, South Korea, Argentina and Turkey.  What companies are looking for next is how to extract some value beyond just complying with government mandates.  Just about every solution provider offering serialization components and solutions out there has at least one product or service that is aimed squarely at this type of need.  What we need to do is get these people together:  those who are looking, and those who have the solutions.

Cognizant, a management consulting company, has written a very nice 11-page white paper exploring value beyond compliance. Continue reading Sponsored: Extracting Value Beyond Compliance From Serialization