Tag Archives: FDA

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the FDA has received for their ‘Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers’ draft guidance (see “FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document” and “FDA’s Late Recommendation On Human Readable”).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

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

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

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DSCSA: Verification Systems Draft Guidance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  Late last week the FDA published new draft guidance describing their current thinking about the “verification systems” that members of the supply chain are required by the DSCSA to have in place.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

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