DSCSA: Will 2020 Be FDA’s Year To Leap Forward?

November 11, 2019 Dirk Rodgers

When it comes to the Drug Supply Chain Security Act (DSCSA), the FDA seems to alternate between hibernating, and leaping forward. 2017 through mid-2018 was a leap forward period with the publication of 8 draft or final guidance documents and 3 public meetings. Then in 2019, hibernation. Yes, FDA’s list of DSCSA guidance and policy documents has two entries for 2019 so far, but one is simply a notice reopening the comment period on the DSCSA Pilots request for information that was originally opened in 2016 and 2017. The other is the compliance policy that provides one year of enforcement discretion for the 2019 wholesaler saleable returns requirement (see “No Surprise: DSCSA Verification Delay”). Neither were very taxing on the FDA to prepare. What should the FDA do next? What should they be doing right now?

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Russia

Russia: Rationality Makes An Appearance at the 11th Hour. Will It Matter?

November 4, 2019 Dirk Rodgers

Flag by Zscout370 – Государственный флаг Российской Федерации. Цвета флага: (Blue – Pantone 286 C, Red – Pantone 485 C) взяты из [1][2][3][4], Public Domain, https://en.wikipedia.org/w/index.php?curid=33285605

We’ve seen this sequence of events before in China, Brazil, and India, and now they may be happening in the Russian Federation. The government issues regulatory requirements mandating pharma serialization and tracing with crazy-aggressive deadlines and with confusing, sometimes illogical requirements. Amendments are issued, sometimes helping, sometimes making things worse. Then just before (or just after) the deadline, when confusion reigns, someone else in the government issues calls for rationality, and the government quickly folds their requirements, rethinks and retrenches. In China and Brazil it resulted in a full withdrawal and total redesign of their entire approach…and much more reasonable deadlines. So far in India it has mostly just resulted in pushing the deadline out, again and again, but even there, there are signs that some are proposing a complete withdrawal and redesign. So far in the Russian Federation, all we have is the posting of a set of very rational recommendations by a group of participants in parliamentary hearings of the State Duma Committee on Health Protection. Their hearings were apparently related to the spotty readiness of the government and industry and their report comes less than 3 months from the deadline for serialization and tracing of all drugs.

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DSCSA

2019 GS1 US Barcode Assessment, Extrapolated

October 29, 2019 Dirk Rodgers

Last week GS1 US published their “2019 Update: Barcode Readability for DSCSA 2023 Interoperability” in conjunction with the Big 3 wholesale distributors, AmerisourceBergen, McKesson and Cardinal Health. You’ve probably already seen it, but probably not like this. Keep reading.

This year there was a significant jump in the percentage of drug products containing the 2D barcode mandated by the Drug Supply Chain Security Act (DSCSA). The problem is, for the last three years they have published their data four to five months after they collected the data (see also “Wholesalers Find Troubling Results In DSCSA Barcode Assessment“). What everyone really wants to know is, what percentage of drugs would have been marked with the 2D barcode in November of 2018 and today, not back in June of those years. And with three years’ worth of data, you can make a reasonable extrapolation of the data for the November dates, if you just apply a little spreadsheet and graphics skills. Let’s try it.

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China

China Inches Closer To Another Pharma Serialization Mandate

October 21, 2019 Dirk Rodgers

In late August, the China National Medical Products Administration (NMPA) issued three new drug and vaccine traceability guidance documents. Then in mid-September, they issued five draft documents for comment related to the data exchange protocol for drug traceability. Based on those publications, it appears that China really is accelerating their move toward traceability of drugs (see “China Commits To The Digital Future In Healthcare, Including Pharma Traceability”).

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DSCSA

Next Week’s HDA Traceability Seminar

October 14, 2019 Dirk Rodgers

Every year I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar. It’s the one event in the US that is attended by everyone connected with pharma serialization and traceability, including those from manufacturers, 3PLs, repackagers, wholesale distributors, dispensers and solution providers. In that one time and place I can get answers to burning questions about what is going on in the industry and a sense for what people are thinking about a wide range of issues that appear here in RxTrace. The sessions are helpful, but the real goldmine are the hallway conversations. Of course, I’ve written about this before (see “2014 Fall Conference Season Preview” and “Terminology: Track and Trace, and Pedigree”).

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NDC

FDA Inaction On Fixing The NDC Indicates Why They Should Get Out Of The Numbering Business

October 7, 2019 Dirk Rodgers 1 Comment

It’s been eleven months since the FDA held their public hearing to collect ideas for fixing the National Drug Code (NDC) system (see “FDA Seeks Input On The Future Format of the National Drug Code” and “FDA New NDC Format Public Meeting”). The FDA, themselves, estimated that they may have as little as 10 years before they run out of Labeler Codes, and that was over a year ago. So now we have less than nine years? My friends, it’s almost time to panic because the FDA seems to have dropped the ball after hearing from the industry that they would need at least ten years to prepare for any changes that the FDA may make (see “FDA New NDC Format Public Meeting”).

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DSCSA

No Surprise: DSCSA Verification Delay

September 30, 2019 Dirk Rodgers 2 Comments

It was fairly easy to predict the FDA would invoke enforcement discretion for the wholesale distributor’s saleable returns requirement of the Drug Supply Chain Security Act (DSCSA), as they announced last Tuesday (see “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”). The deadline for the mandate was originally this November 27, but with the announcement, will not be enforced until November 27, 2020.

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Counterfeit Drugs

Pharma Counterfeiter Strategies In a Track & Trace World

September 23, 2019 Dirk Rodgers

What is a counterfeiter to do today? Governments around the world are moving toward standardized serialization and track & trace requirements aimed directly at their bottom line. It’s getting harder to fake your way past supply chain workers who are increasingly educated on what to look for and how to raise their suspicions to the authorities. Or is it? Let’s take a closer look.

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