Category Archives: 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the FDA has received for their ‘Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers’ draft guidance (see “FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document” and “FDA’s Late Recommendation On Human Readable”).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

DSCSA: Verification Systems Draft Guidance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  Late last week the FDA published new draft guidance describing their current thinking about the “verification systems” that members of the supply chain are required by the DSCSA to have in place.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  Of course, as usual, it’s only a draft, not for implementation but for comment only.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 Continue reading DSCSA: Verification Systems Draft Guidance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

FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document

Last week the FDA posted final versions of two DSCSA guidance documents, and, a new draft Product Identifier Q&A document.  The two final guidance documents include the grandfathering policy and the product identifier compliance policy that delayed enforcement of the product identifier and verification requirements until November 27, 2018.  These documents are companions to each other, which is to say that they are pretty tightly related, and that’s why FDA Continue reading FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document

Does the DSCSA Have A ‘Spirit’

I was on an industry call a few weeks ago when someone from a technology vendor suggested that the industry should take some particular action because, it was aligned with “the spirit of the Drug Supply Chain Security Act (DSCSA)”.  That got me to thinking… Continue reading Does the DSCSA Have A ‘Spirit’

HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

Unlike the implication of this drawing, FDA does hear and care about submitted comments.

The Healthcare Distribution Alliance (HDA) recently posted their response to the latest draft Drug Supply Chain Security Act (DSCSA) guidance published by the FDA.  That draft guidance explains how, when and why companies in the US pharma supply chain can apply for waivers, exemptions and exceptions to provisions in the DSCSA (see “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”).  As usual, the HDA took close to the full sixty day comment period to respond.  The comment period closed last Monday. Continue reading HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance