Tag Archives: FDA

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

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:

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My Comments Regarding The New NDC Format

Happy New Year!

A few hours before the end of the comment period, I submitted my comments to FDA’s docket on Regulations.gov for the new NDC format. By the time your read this, the docket will be closed. The agency that operates that web site often takes a few days to post submissions, but because of the government shutdown, I doubt if anyone will be working on it until after the government re-opens (assuming the furloughed workers haven’t gotten a better job by then…In that case, it could be even longer).

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DSCSA: Verification Systems Draft Guidance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  Late last week the FDA published new draft guidance describing their current thinking about the “verification systems” that members of the supply chain are required by the DSCSA to have in place.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

Last week the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published their second report on the experience of selected members of the pharma supply chain with the exchange of drug product tracing information as required by the DSCSA.  This one was aimed at dispensers.  The one published last fall was aimed at wholesale distributors.  As you know, starting in January 1, 2015 (delayed until May 1, 2015), pharmaceutical wholesale distributors have been required to pass to their customers for non-exempt prescription drug shipments, and retain for six years, transaction documents (TI, TH and TS).  Since July 1, 2015 (delayed until March 1, 2016), dispensers have been required to receive and store these Continue reading DSCSA: OIG Report Exposes Likely Enforcement Approach

Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again

Grandfather clockThis week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids.  Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA.  Here it is again.

Regulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet.  When allowed, grandfathering allows Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again

How Will The DSCSA Serialization Mandate Be Enforced After 2017?

iStock_38947550_smallerDrug manufacturers, contract manufacturers (CMOs) and contract packagers (CPOs) are all working hard right now preparing to meet the November 27, 2017 deadline when all prescription drugs entering the U.S. market must contain the new machine- and human-readable product identifier defined in the Drug Supply Chain Security Act (DSCSA) (see “The DSCSA Product Identifier On Drug Packages“).  The date for repackagers is one year later (see “Who Is A DSCSA Repackager?”).  From what I hear around the industry, some companies are going to make that date, but some will not.  What will happen next for those how are not ready?  I discussed this from a regulator perspective last year in one of my personal favorite essays, “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?”, but what about from the perspective of those who will be late? Continue reading How Will The DSCSA Serialization Mandate Be Enforced After 2017?

FDA Speaks At GS1 Connect

Jung_ConnieLast week, Connie Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity, & Recalls, U.S. Food and Drug Administration, spoke about the Drug Supply Chain Security Act (DSCSA) at the GS1 US Connect event in Washington DC.  This was our latest opportunity to get a glimpse of what the FDA is thinking and what they are doing.  Dr. Jung spoke for about 50 minutes and then answered questions from the audience. Continue reading FDA Speaks At GS1 Connect