HDA Urges FDA…Please Re-Read The DSCSA

April 30, 2018 Dirk Rodgers Leave a comment

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

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

April 23, 2018 Dirk Rodgers Leave a comment

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 →

Verification

What’s So Hard About Unique Identifier Verification?

April 16, 2018 Dirk Rodgers Leave a comment

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? →

DSCSA

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

April 9, 2018 Dirk Rodgers Leave a comment

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? →

Value Beyond Compliance

DSCSA: OIG Report Exposes Likely Enforcement Approach

April 2, 2018 Dirk Rodgers Leave a comment

Last week the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published their second report on the experience of selected members of the pharma supply chain with the exchange of drug product tracing information as required by the DSCSA. This one was aimed at dispensers. The one published last fall was aimed at wholesale distributors. As you know, starting in January 1, 2015 (delayed until May 1, 2015), pharmaceutical wholesale distributors have been required to pass to their customers for non-exempt prescription drug shipments, and retain for six years, transaction documents (TI, TH and TS). Since July 1, 2015 (delayed until March 1, 2016), dispensers have been required to receive and store these Continue reading DSCSA: OIG Report Exposes Likely Enforcement Approach →

DSCSA

The 2 Most Helpful Requirements In The DSCSA

March 26, 2018 Dirk Rodgers Leave a comment

There are lots of impactful requirements in the Drug Supply Chain Security Act (DSCSA), but there are two whose impact will likely increase the safety of patients far more than all of the others. That is, they are the most helpful requirements. Do they include serialization? Verification? Transaction documentation? Wholesaler and 3PL licensing? Not even close.

The two requirements that I believe will have the biggest impact on the safety of drugs in the US supply chain are the requirement to only engage in transactions with authorized trading partners, and the lot number being included in the 2D barcode. Let me explain. Continue reading The 2 Most Helpful Requirements In The DSCSA →

Conferences

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