Category Archives: DSCSA

FDA Hammer Comes Down On McKesson For DSCSA Violations

The internet lit up last week on the publication of an official warning letter from Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, to John H. Hammergren, CEO of McKesson Corporation, for violations of the Drug Supply Chain Security Act (DSCSA).  I’ve written about this situation before, back when the original FDA 483, notice of “inspectional observations”, was originally published (see “McKesson’s DSCSA 483 Explained”), but this new letter provides many more details of the incidents that led to that original notice, including some details of McKesson’s follow-up communications regarding the situation. 

Continue reading FDA Hammer Comes Down On McKesson For DSCSA Violations

HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems

Last October the FDA published a draft guidance called “Verification Systems Under the Drug Supply Chain Security Act (DSCSA) for Certain Prescription Drugs” (see “DSCSA: Verification Systems Draft Guidance”).  Near the end of the comment period in December, the Healthcare Distribution Alliance (HDA) submitted comments containing proposed changes.  Like other comments submitted by the HDA for other FDA DSCSA guidance, these are well worth reading.  Once again, the HDA demonstrates their thorough understanding of the DSCSA and their ability to clearly and crisply explain where the FDA’s draft language fails to reflect the language in the original law. 

Continue reading HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems

FDA Announces Start Of DSCSA Voluntary Piloting Program

Starting tomorrow companies in the US supply chain wishing to volunteer to participate in FDA-sanctioned Drug Supply Chain Security Act (DSCSA) pilots will have just 30 days to apply.  Applicants are asked to propose pilots aimed at the goals of the FDA program.  These include:

Continue reading FDA Announces Start Of DSCSA Voluntary Piloting Program

Most Companies Will Do DSCSA Verification Wrong

A lot has been written about the concept of “verification”, here in RxTrace and elsewhere.  It’s all good, but I still don’t think the critical point has been made yet by anyone—including me (see “What’s So Hard About Unique Identifier Verification?”)—and until it is, companies are going to do it wrong.  Less than an hour after I posted my essay last Wednesday (see “GS1’s Messaging Standard For Verification Of Product Identifiers”) I received an email from a subscriber who had questions about it, the essay was referenced in a post on LinkedIn by a reader in Europe, and I found a great link to a brand new essay about verification by Scott Pugh that had just been posted about the same time.  So here is my new take on why most companies are going to get it wrong.

Continue reading Most Companies Will Do DSCSA Verification Wrong

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

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