DSCSA, FDA Guidance

InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance

New Regulations comic
(click image to enlarge)

As you are already well aware, the FDA is long overdue to publish four different guidance documents covering various aspects of the Drug Supply Chain Security Act (DSCSA), as mandated by Congress (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”).  At least two of those guidance documents would affect how companies should expect to comply with the serialization deadline on November 27, 2017. 

If the FDA doesn’t publish on or before that date, does that mean you don’t need to comply on time?  Can you just sit back and wait for the FDA to post those guidance documents someday?  I don’t think so.  Here’s why. Continue reading InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance →

DSCSA

In Absence Of FDA Guidance, Follow PDSA Recommendations

PDSA LogoThe Pharmaceutical Distribution Security Alliance (PDSA) is a coalition of companies and organizations dedicated to the safety and integrity of the U.S. pharmaceutical supply chain.  When the Drug Supply Chain Security Act (DSCSA) went into effect on November 27, 2013 the PDSA began to serve as a voice for its members in communications with the U.S. FDA.  Their preferred way of communication is through formal letters signed by their legal advisor, Vince Ventimiglia.  PDSA letters to the FDA are really interesting because they do an excellent job of providing recommendations for the FDA to consider as they prepared to publish the four guidance documents that were due back on November 27, 2015.  The FDA has still not published those documents.  Continue reading In Absence Of FDA Guidance, Follow PDSA Recommendations →

Sad News

Ken Traub (1963 – 2017)

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Photo of Ken Traub
Ken Traub

Like all of you, I was incredibly shocked and sad to hear that my friend and occasional collaborator Ken Traub passed away on Sunday.  My heart and prayers go out to his wife and son.  Ken will be remembered for a long time by people all over the world because of  the depth of his technical knowledge, the clarity of his writing, the impact of his succinct speaking, the creativity of his thinking, the passion he had for solving complex problems, and the love in his heart. 

According to Brezniak-Rodman Funeral Directors, the memorial service will be held at Temple Isaiah, 55 Lincoln Rd., Lexington, on Wednesday, April 5, 2017 at 11:00 am.  Memorial contributions may be made to any cancer charity.

I’ve known Ken for a few Continue reading Ken Traub (1963 – 2017) →

DSCSA

Can Anyone Buy Non-Serialized Drugs After 11-27-2019?

Image of a package of non-serialized drugsWell over a year ago, my good friend Kevan MacKenzie, Director, Serialization Technology with McKesson, pointed out a really interesting discrepancy contained in the Drug Supply Chain Security Act (DSCSA) regarding the sale of non-serialized drugs.  I’ve been meaning to write about it since then.  The topic finally bubbled up to the top on my list.

What Kevan pointed out is that there are two sections of the DSCSA that contain slightly conflicting requirements.  This leaves companies Continue reading Can Anyone Buy Non-Serialized Drugs After 11-27-2019? →

DSCSA, GTIN, NDC

Sponsored: How To Properly Define GTINs For Your NDCs

Image showing relationships of define GTINs
Packaging Hierarchy. Drawing by Omega Design

RxTrace readers are well aware that the deadline is this November 27 for applying unique serial numbers within GS1 DataMatrix 2D barcodes to prescription drugs distributed in the United States under the Drug Supply Chain Security Act (DSCSA).  Once that happens, most prescription drugs entering the U.S. supply chain will be identified by 14-digit GS1 Global Trade Item Numbers (GTIN-14) for the first time (see “Anatomy of a GTIN”).  That’s because, you can’t fit the drug’s National Drug Code (NDC) along with the serial number, lot number and expiration date into a data matrix barcode, as required by the law, without first encoding it into a GTIN-14 (see “Anatomy Of The National Drug Code”, and “Depicting An NDC Within A GTIN”).  This fact forces companies to encode their NDCs into GTIN-14s, many for the first time. Continue reading Sponsored: How To Properly Define GTINs For Your NDCs →

DSCSA

DSCSA Serialization: What Wholesalers Expect

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Image of McKesson's sign on their corporate headquarters building in San Francisco, CARecently, several of the larger U.S. wholesale distributors have sent letters to their suppliers to review what they expect from them relative to the Drug Supply Chain Security Act (DSCSA).  You may recall that these companies have provided requirements in advance of earlier DSCSA deadlines (see “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers“).  These expectations are aimed at the November 27, 2017 serialization requirements and beyond. Continue reading DSCSA Serialization: What Wholesalers Expect →

RxTrace

My Handshake With Germany

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image of my handshake offer to GermanyOur industry is international by nature.  Protecting patients from counterfeit drugs is partly a humanitarian mission and partly a business.  Consequently, I don’t worry much about who is looking for information on RxTrace.  I have happily fielded queries from Russia, China and even Iran, countries who are not always political “friends” of my beloved country. 

But what if a counterfeiter is seeking information Continue reading My Handshake With Germany →

EUDR, Randomization

Pharma Serial Number Randomization Under The Falsified Medicines Directive

Drug companies who serve markets within the European Union (EU) have until February 9, 2019 to add serial numbers within a Data Matrix barcode to their drug packages, among many other specific requirements (see “The ‘Unique Identifier’ in the EU Delegated Act”).  The specific requirements are outlined in the EU Delegated Regulation (EUDR).  I’ve written a lot about the EUDR over the last few years (see RxTrace: Delegated Regulation).  Today I want to highlight and explain a problem that may be brewing in the implementation of the system of repositories as established by the non-profit European Medicines Verification Organization (EMVO).  The potential problem is related to the way the EMVO Continue reading Pharma Serial Number Randomization Under The Falsified Medicines Directive →

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