How To Accept Manual Entry Of Drug Unique Identifiers

Most regulations dictating the application of unique identifiers on drug packages also dictate specific data be encoded into a machine-readable barcode, and human readable text. The purpose of the machine-readable unique identifiers is obvious–to allow computers to read the product’s unique identifier quickly and accurately. The purpose of the human-readable unique identifier is less well-understood. Many believe it is to allow manual entry of the barcode contents when the barcode is unreadable for any reason. Others believe it is Continue reading How To Accept Manual Entry Of Drug Unique Identifiers

FDA New NDC Format Public Meeting

I attended the FDA’s New NDC Format Public Meeting last Monday where I presented my open letter that was last Monday’s RxTrace essay (see “An Open Letter To The FDA: New NDC Format Public Meeting”).  After a welcome from Dr. Janet Woodcock, Director, FDA, Center For Drug Evaluation and Research (CDER) and a brief overview of the purpose of the meeting by Paul Loebach of FDA CDER, there were nine presentations from stakeholders and the public.  After each presentation, the FDA panel Continue reading FDA New NDC Format Public Meeting

An Open Letter To The FDA: New NDC Format Public Meeting

Dear FDA:
Thank you for inviting interested parties like me to provide our thoughts on the new NDC format that you think will be necessary in 10 to 15 years (see “FDA Seeks Input On The Future Format of the National Drug Code”).  I hope you can make it that long, but regardless, now is certainly the time to begin working on a replacement. Continue reading An Open Letter To The FDA: New NDC Format Public Meeting

DSCSA: Verification Systems Draft Guidance

Verification is an important part of the operation of the Drug Supply Chain Security Act (DSCSA), and from my observation, it isn’t understood very well.  People new to the DSCSA always think “verification” means something beyond what the actual definition is in the law.  Late last week the FDA published new draft guidance describing their current thinking about the “verification systems” that members of the supply chain are required by the DSCSA to have in place.  It’s an important draft because I suspect not many companies have “verification systems” that have the kind of capabilities spelled out by the FDA.  Of course, as usual, it’s only a draft, not for implementation but for comment only.  You have until December 24, 2018 to submit comments for consideration by the FDA as they someday make this guidance final. Continue reading DSCSA: Verification Systems Draft Guidance

DSCSA Uniqueness: SNI vs SGTIN

In case you didn’t see my note at the end of my essay a few weeks ago, I am publishing new, free-to-everyone, RxTrace essays, one per month, on the Center For Supply Chain Studies (C4SCS) community website under the “Tune In | Monthly Slice of RxTrace” heading.  In fact, there are now two new essays there.  I’m finding that they are getting little notice there, so I have decided to post short intro essays, like this one, here on RxTrace.com whenever I post a new essay on the C4SCS website.  That way everyone here will get notified and can easily find them with a single click.

October’s essay is quite good.  It discusses the differences between the SGTIN that drug manufacturers put on their packages and the SNI that the DSCSA requires them to put there, and the implications of those differences.  It’s a very timely topic, I think you’ll agree. Continue reading DSCSA Uniqueness: SNI vs SGTIN

2018 HDA Traceability Seminar Recap

Dr. Ilisa Bernstein, PharmD, JD

I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar every year because it is where the a very large number of the key members of the US supply chain meet to discuss implementation of the Drug Supply Chain Security Act (DSCSA).  Organizations like the HDA, GS1 US and the FDA often save up their significant news and publications throughout the fall so they can release them with big fanfare at this event.  This year was no exception.  All three of those organizations made news with their announcements this year. Continue reading 2018 HDA Traceability Seminar Recap

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

Aggregation Under the FMD

Two weeks ago, an EU Member State Expert Group connected to the European Commission (EC) published a paper aimed at explaining what hospitals should do to meet their obligation to verify and decommission drugs after the Falsified Medicines Directive (FMD) Delegated Regulation (EUDR) goes into effect on February 9, 2019.  The new paper is all about aggregation and its use by Continue reading Aggregation Under the FMD

DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
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