NDC

My Comments Regarding The New NDC Format

January 7, 2019 Dirk Rodgers 6 Comments

Happy New Year!

A few hours before the end of the comment period, I submitted my comments to FDA’s docket on Regulations.gov for the new NDC format. By the time your read this, the docket will be closed. The agency that operates that web site often takes a few days to post submissions, but because of the government shutdown, I doubt if anyone will be working on it until after the government re-opens (assuming the furloughed workers haven’t gotten a better job by then…In that case, it could be even longer).

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Russia

More Details On The Russian Crypto-Code

December 17, 2018 Dirk Rodgers Leave a comment

Since my last essay about the Russia Crypto-Code (a.k.a., Crypto-Tail) (see “New Direction For Pharma Serialization In The Russian Federation”), Russia has published little of value in document form about the requirements or the technology. I have heard rumors that the pilots conducted with the Crypto-Code have failed. Interestingly, according to the Center for Research in Perspective Technologies (CRPT), the Russian 50-50 public-private company now under contract with the government there to define and implement the technology, those same pilots were a smashing success. I am skeptical of that reported success, but let’s take a look at some of the details they have provided. Continue reading More Details On The Russian Crypto-Code →

Blockchain

GS1 Blockchain Discussion Group Kickoff Meeting

December 10, 2018 Dirk Rodgers Leave a comment

Stock photo of actors reenacting the GS1 US discussion group meeting.

I attended the GS1 US Blockchain Discussion Group kickoff meeting on November 28-29 out of curiosity. Fortunately it was held in Chicago so I didn’t need to travel very far. Just a simple commuter train ride from home each day. Any farther and I might not have attended, but I was glad I did. It was great to have the opportunity to Continue reading GS1 Blockchain Discussion Group Kickoff Meeting →

DSCSA

FDA Gets Comments On Their Draft Q&A on DSCSA Product Identifiers

December 3, 2018 Dirk Rodgers Leave a comment

Over the weekend I skimmed through the many responses the FDA has received for their ‘Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers’ draft guidance (see “FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document” and “FDA’s Late Recommendation On Human Readable”). As usual, the most specific, most detailed and most interesting response comes from the Healthcare Distribution Alliance (HDA). In fact, a few of the other respondents refer to the HDA’s work in the areas covered by the Q&A. Many of the respondents—even those who did not credit HDA—agreed with the HDA’s positions they covered. There were a few different opinions, however. Let’s take a look. Continue reading FDA Gets Comments On Their Draft Q&A on DSCSA Product Identifiers →

EU FMD

FMD: Your Initial Upload To The EU Hub

November 26, 2018 Dirk Rodgers 1 Comment

Congratulations, you’ve just connected to the EU Hub and you are authorized to begin uploading production data ahead of the February 9, 2019 deadline. It’s been a long road. Most pharma marketing authorisation holders (MAH) report taking six months from initial onboarding application to authorization. Now what? Continue reading FMD: Your Initial Upload To The EU Hub →

Barcodes

How To Accept Manual Entry Of Drug Unique Identifiers

November 19, 2018 Dirk Rodgers Leave a comment

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 →

NDC

FDA New NDC Format Public Meeting

November 12, 2018 Dirk Rodgers Leave a comment

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 →

NDC

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

November 5, 2018 Dirk Rodgers 2 Comments

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 →