FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late

Today is November 27, 2017, the four year anniversary of President Obama signing the Drug Quality and Security Act (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), and it is the two year anniversary of the due date for the FDA to publish four guidance documents—one of the four on grandfathering (see “FDA DSCSA Deadline Passes Quietly”).  And today they have finally met that requirement, for grandfathering at least.  One overdue Drug Supply Chain Security Act (DSCSA) guidance down, three to go (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?“, and “”).  (The DSCSA is Part 2 of the DQSA.)

You can find the new grandfathering guidance here.  As I write this on Sunday I have not yet seen the actual guidance, only the announcement that it will be published sometime on Monday.  I will post my analysis of it later.

Also, the Healthcare Distribution Alliance published their full “HDA Guidelines for Bar Coding in the Pharmaceutical Supply Chain”.  I had intended to post my analysis of it on the day they published, but with the holidays, the timing just didn’t work out, so I will review it next week.  For today, suffice it to say, this is a “must have” document for your technical library.  It’s a free download for HDA members.

Not to be outdone, ANVISA also published their technical implementation guide for their National Drug Control System (SNCM) last week.  It’s a 224 page technical document in Portuguese.  Odds are, someone is going to do an English translation and make it public.  If I can free up enough time before Christmas I might do it.  Either way, I will write about it at some point in the near future.  Watch for that.

Turkey preparation by K. Rodgers. Photo by Bernard Laureus.

I hope your Thanksgiving was as happy as mine was.  I visited lots of relatives and ate lots of great food on my favorite holiday.