Tag Archives: pharmaceutical serialization

FDA DSCSA Public Meeting #2, Still A Gulf

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The gulf in expectations and goals exposed in the first FDA Drug Supply Chain Security Act (DSCSA) Public Meeting back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “HDA Schools FDA On DSCSA”) was still visible in the second meeting last week.  There is still one more announced meeting scheduled for February 28, 2018 for the FDA and the industry to align (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).  Based on my observations at these first two meetings, I’m not going to hold my breath.  The FDA is likely to announce more meetings in 2018.

The FDA did adjust their position on at least one thing after the August meeting. Continue reading FDA DSCSA Public Meeting #2, Still A Gulf

DSCSA: Saleable Returns Verification

The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future.  Today I want to take a closer look at the results of the Saleable Returns Pilots conducted by the HDA last year to figure out the most efficient way to verify saleable returns.  I discussed the overall project in my report of the Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”) but today I want to focus in on just two of the approaches piloted.  These are:

  • Manufacturer sends to wholesale distributor product identifiers for only the units purchased by that wholesale distributor, and,
  • Verification Router Service (VRS).

Continue reading DSCSA: Saleable Returns Verification

‘An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?’, Again

Dear FriendI hope your holidays were filled with love and cheer.  Mine were.  It was great.  So great, in fact, that I did not have time to write a brand new essay for today.  Not much has happened lately since we are still awaiting publications from the FDA, the EC and ANVISA (and others),  Instead, here is one of my best essays from 2015, reposted as it appeared on August 31, 2015 without modification (see “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?“).  I’m even leaving in the off-season references.  If you read this essay back then, you might enjoy it again.  If you did not read it back then, I recommend that you read it now.  Let me know what you think.

Before we begin, if you have not yet responded to the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz, please to so now.  It is open to everyone and the survey will be closed soon.

And now Continue reading ‘An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?’, Again

An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?

Dear FriendDear FDA, EMA and ANVISA,

How are you?  I’m sure your summer has been busy, just like mine.  Hope you were able to get at least some time away.  I’ve taken most Saturdays off, but the other days of the week have been very full with consulting, and then writing RxTrace essays every Sunday.  You know, the wife is not very happy about that!

The reason I am writing directly to you at this time is to ask a question that I hope you are asking yourselves and planning ahead for. Continue reading An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?

Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015

RxTrace.com Serialization Estimate 2014.zoomIt’s August and that means it is time to check in on the progress toward full serialization of drugs in the U.S. supply chain.  This is an annual look I’ve been doing for five years now.  For my previous essays, see:

In each essay I produced a graph of my own personal estimate Continue reading Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015

India’s Pharma Export Serialization Deadlines: April Fools!

animated ashok chakraOn May 22nd, 2015, India’s Directorate General of Foreign Trade (DGFT) quietly published Public Notice #13 with the subject “Implementation of the Track and Trace system export of drug formulations”.  It was an amended version of Public Notice #4, dated April 1, 2015 with a similar subject.   Get it?  April Fools!

I have to admit, I fell for it.  Did you? Continue reading India’s Pharma Export Serialization Deadlines: April Fools!

The Coming Battle Over Decommissioning At The Pharmacy

Certificate of Serial Number Death
Certificate of Serial Number Death

The U.S. pharma supply chain will operate under two major phases as dictated by the Drug Supply Chain Security Act (DSCSA).  We are now operating under the first major phase.  Well, OK, it won’t be fully operational until July 1st when dispensers (see “Who Is A DSCSA Dispenser?”) are required to begin receiving, saving and retrieving Transaction Information (TI)Transaction History (TH), and Transaction Statements (TS) for each shipment they receive.  Drug manufacturers, repackagers and wholesale distributors were supposed to begin exchanging those documents on January 1st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).  But be aware that according to the DSCSA, as of January 1st, all trading partners must be properly licensed and everyone may only buy and sell drugs legally from/to companies who hold a valid State or Federal license.  Those and other requirements of the DSCSA were not delayed by the FDA.

The second major phase of the DSCSA will not occur until November 27, 2023 when the law transforms into something that is fairly nebulous right now.  That is, between now and Continue reading The Coming Battle Over Decommissioning At The Pharmacy

InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014

RxTrace.com Serialization Estimate 2014.zoomIt is time for the RxTrace look at the estimated rise in the percentage of drugs in the U.S. supply chain that are serialized.  Every year we take a look at this topic while longingly wishing that someone would perform a real study and publish the numbers.  However, it may not make much difference from here on out because it will be impossible for drugs without serial numbers to exist in the U.S. supply chain in just a few years.  So let’s take a look. Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014