Tag Archives: FDA

DSCSA

FDA’s Firm Stance on DSCSA Compliance: No More Delays

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The FDA recently emphasized the urgent need for compliance with the Drug Supply Chain Security Act (DSCSA), impacting the pharmaceutical industry significantly. At the 2024 FDLI Annual Conference, Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research (CDER), confirmed that there will be no further extensions to the compliance deadline. This announcement marks a critical step in the FDA’s ongoing efforts to secure the pharmaceutical supply chain.

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DSCSA, FDA

FDA Official Will not extend the 2023 deadline

Deadline will not be extended

As reported by the Regulatory Focus, the FDA will not delay the interoperability deadline for the DSCSA 2023 deadline. You can for sure group the saleable returns requirements as well. The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to have a full interoperable electronic track and trace system in place by 2023.

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DSCSA, FDA

The FDA’s New Guidance for 2021 Explained

As the premier regulatory body for ingestible products in the United States, the FDA (Food and Drug Administration) is responsible for safeguarding public health through safety measures, guidance, and regulations. The importance of the FDA’s job cannot be stressed enough, and in the current global health crisis we find ourselves in, this responsibility is even more critical.

The FDA’s annual guidance schedule is often more aspirational than strictly practical, but it does a good job in providing useful insights into what areas the FDA’s CDER (Center for Drug Evaluation and Research) has given priority for that particular year. 

You can find updated lists for the FDA’s guidance for 2021 here. In this article, we’ll focus on the guidance as it relates to the DSCSA (Drug Supply Chain Security Act).

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DSCSA

FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE

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FDA explains EUAs under a PHE

Last week the FDA posted new guidance called “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency” that directly addresses everything I talked about in my last essay, “DSCSA Exemption For Public Health Emergencies” and more.  This new guidance was “fast-tracked” and went direct to “final” status, skipping the “draft” stage used for most guidances.  The FDA determined that the “…prior public participation for this guidance is not feasible or appropriate.”  Things are moving fast at the FDA regarding Covid-19 so if you’re reading this essay more than a week or two after it is published, I suggest you search the FDA website to confirm that its contents are still fully valid.  Make sure you check the links below for more info.

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DSCSA

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

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 →

NDC

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 →

NDC

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

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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

2018 HDA Traceability Seminar Recap

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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 →