Tag Archives: free

Aggregation, serialization

Aggregation –> Chargeback Accuracy –> ROI

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Last week I attended my favorite annual conference on pharma serialization and tracing in the U.S.:  The Healthcare Distribution Management Association’s (HDMA) Traceability Seminar.  They call it a “seminar” because the subject of the sessions are generally the same every year, but it is better than any other third-party conference, primarily because the right people attend it:  lots of people from drug manufacturers, wholesale distributors and some dispensers.  With this ideal spectrum of attendees, it is very easy to get your questions answered, in the hallway between sessions if not in the sessions themselves.

Of course, every year the folks from the FDA who are directly responsible for writing regulations related to the Drug Supply Chain Security Act (DSCSA) provide Continue reading Aggregation –> Chargeback Accuracy –> ROI →

ANVISA, FDA

More Thoughts On FDA and ANVISA

More ThoughtsOne of the problems with trying to respond overnight to big announcements made by regulators is that it’s easy to leave something significant out.  And in the ensuing days you find out what you should have included in those original essays.  That’s what happened with my two essays from last week:  “Brazil Suspends Pharma Serialization And Tracing Requirements” and “FDA Posts Wholesale Distributor and 3PL License Database“.

So let me add a few more thoughts and observations regarding Continue reading More Thoughts On FDA and ANVISA →

DSCSA, FDA

FDA Posts Wholesale Distributor and 3PL License Database

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FDALogoYesterday the U.S. FDA posted the first issue of the wholesale distributor and third-party logistics provider (3PL) database as mandated by the Drug Supply Chain Security Act (DSCSA).  Through this webpage, you can either download the entire database (in .XLS form), or enter a specific query and then download that result set if desired.  I couldn’t get the result set download to work, so there are obviously some bugs that need to get worked out, but this is still an important step in the implementation of the DSCSA.

With this posting, anyone who buys drugs Continue reading FDA Posts Wholesale Distributor and 3PL License Database →

ANVISA

Brazil Suspends Pharma Serialization And Tracing Requirements

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ANVISA logoLast week, Brazil’s pharma industry regulatory agency, the National Agency of Sanitary Surveillance (ANVISA), announced that they were “suspending” at least part of RDC-54/2013, the declaration that mandated drug serialization and tracing, until further notice.  Thank you to all who forwarded the link to the official announcement.  I was able to translate and read it on Thursday, and I submitted a comment on my own last essay, “Pharma Serialization Deadlines In Flux“, to include the link.  Apparently shortly after that essay was published, ANVISA  Continue reading Brazil Suspends Pharma Serialization And Tracing Requirements →

Deadlines

Sponsored: Pharma Serialization Deadlines In Flux

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iqpc.zoomThe industry is rife with rumors that Brazil’s ANVISA has made the decision to push out their serialization deadline for multiple years—and perhaps redefine the requirements.  I cannot confirm any of these rumors at this point and I do not recommend acting on rumors.  I suggest you continue down the path of meeting the existing, known regulation until—if ever—you get the official word from an official publication of ANVISA.  Who knows when that might occur.  If/when you see something official, let me know. Continue reading Sponsored: Pharma Serialization Deadlines In Flux →

DSCSA, Grandfathering

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

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Grandfather clockRegulations 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 a company to continue doing something after a regulatory deadline that mandates a change, as long as one or more pre-conditions apply.  For example, Section 582(a)(5)(B) of the Drug Supply Chain Security Act (DSCSA) allows wholesale distributors, and repackagers to sell drugs that were already within the supply chain on January 1, 2015 without passing the necessary transaction data.  This makes sense because companies were not obligated to supply that data before that date and so some of the assertions required in the Transaction Statement would not be true (among other problems that grandfathering eliminates).  [Of course, Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? →

SAP

SAP Makes Bold Move Into Pharma Traceability

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sap-erp-graphicLast week SAP announced the availability of their brand new software module they are calling “SAP Advanced Track and Trace for Pharmaceuticals”, or ATTP.  Pharmaceutical Commerce magazine published an article about it recently that provides the details of what is contained in this new module.  The same issue contained a sponsored article from SAP about the module.  As long-term readers of RxTrace know, I do not endorse specific products and I rarely even write about specific products.  This essay is not an endorsement— Continue reading SAP Makes Bold Move Into Pharma Traceability →

Record-keeping

Again, A Closer Look At The Six-Year Record-Keeping Requirement

I sat on my back porch gazing at this amazing sky all afternoon Sunday.
I sat on my back porch gazing at this amazing sky all afternoon Sunday.

It was a very beautiful weekend here in the Chicago area, and consequently I could not bring myself to spend any part of it sitting in front of a computer hammering out a new essay, so for the second week in a row (sorry), here is a re-run of a popular essay from July 14, 2014.  I promise to return next week with a brand new essay.

??????????The Drug Supply Chain Security Act (DSCSA) contains record-keeping requirements for drug manufacturers, wholesale distributors, repackagers and dispensers that begin on January 1st, 2015,  All companies must keep a copy of the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) they receive and those they send for at least six years.  In addition, manufacturers and repackagers must also retain Continue reading Again, A Closer Look At The Six-Year Record-Keeping Requirement →