Category Archives: DSCSA

Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance

FDA official, Connie Jung PhD, Senior Advisor for Policy, spoke at the International Society of Pharmaceutical Engineering (ISPE) Serialization Workshops event yesterday to provide background on the Drug Supply Chain Security Act (DSCSA).  I used the opportunity to ask her a number of questions regarding some of the things I based my prediction in Monday’s essay that the FDA will announce a delay in the DSCSA in the next three weeks (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”).  The timing was perfect, and when I registered for the event, I didn’t even know the FDA was on the agenda.

Here’s the backstory. Continue reading Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance

FDA Tea Leaves: Are They About To Delay The November Deadline?

Drawing of tea leaves to be read
Can you read these?

I don’t have any hard evidence, but there are some interesting things out there that just might point to a coming delay in the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for drug manufacturer serialization and electronic transaction data exchange.  Let’s call them “tea leaves”, and let me attempt to “read” them.  They might turn out to be meaningless, so don’t take any action based on such speculation.  And if you know something more, or interpret something differently, leave a message.

During the Cold War the U.S. government and the press attempted to figure out what was going on in the Soviet Union by paying attention to who was standing next to whom during military parades.  Our exercise might see a little like that. Continue reading FDA Tea Leaves: Are They About To Delay The November Deadline?

Will Manufacturers Have Trouble Verifying Some Drugs Next Year?

I recently wrote about several letters sent to the FDA by the Pharmaceutical Distribution Security Alliance (PDSA) regarding the overdue guidance documents (see “In Absence Of FDA Guidance, Follow PDSA Recommendations”).  I highly recommend that you read those letters.  But there was one letter from the PDSA to the FDA that I did not reference in that essay because it is not related to missing guidance.  Instead, it’s about PDSA’s fear about the potential inability of some manufacturers to verify, in the DSCSA sense, certain drugs between now and November of 2019.  To be exact, the type of verification they are worried about is the kind that will be based on a drug’s Standardized Numerical Identifier (SNI). Continue reading Will Manufacturers Have Trouble Verifying Some Drugs Next Year?

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

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

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?

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 Serialization: What Wholesalers Expect

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