Tag Archives: DSCSA Product Identifier

What’s So Hard About Unique Identifier Verification?

Both, the Drug Supply Chain Security Act (DSCSA) in the US and the Falsified Medicines Directive (FMD) in the EU make use of unique identifier verification in one way or another.  Under the FMD, verification is the centerpiece of patient protection.  Under the DSCSA, verification is used as a tool to help resolve higher risk use cases, like saleable returns to wholesale distributors, and anytime someone becomes “suspicious” about a collection of drug packages.  On the surface, verification of unique identifiers seems simple, but there are some sticky problems that make it complex in some circumstances (see also “Drug Verification: EU Vs US”). Continue reading What’s So Hard About Unique Identifier Verification?

The 2 Most Helpful Requirements In The DSCSA

There are lots of impactful requirements in the Drug Supply Chain Security Act (DSCSA), but there are two whose impact will likely increase the safety of patients far more than all of the others.  That is, they are the most helpful requirements.  Do they include serialization?  Verification?  Transaction documentation?  Wholesaler and 3PL licensing?  Not even close.

The two requirements that I believe will have the biggest impact on the safety of drugs in the US supply chain are the requirement to only engage in transactions with authorized trading partners, and the lot number being included in the 2D barcode.  Let me explain. Continue reading The 2 Most Helpful Requirements In The DSCSA

Wholesalers Find Troubling Results In DSCSA Barcode Assessment

Last month GS1 US published the results of an assessment of the implementation progress by drug manufacturers of the Drug Supply Chain Security Act (DSCSA) serialization requirements.  It contains troubling indications of the next problem the industry will face in its quest for DSCSA compliance:  too many unusable barcodes.

Big deal, you say?  That kind of complacency could come back to haunt you later this year.  Now is the time to look at your own packages and address any deficiencies.  Here is a look at what GS1 US found in their assessment. Continue reading Wholesalers Find Troubling Results In DSCSA Barcode Assessment

3 DSCSA Requirements You Can Totally Ignore

The Drug Quality and Security Act (DQSA) was constructed back in 2013 by Congressional staff, with input from the FDA, members of the industry and who knows who else.  There was one bill in the House of Representatives and a different bill in the Senate.  Once these bills passed their respective houses, they formed a conference committee who merged the two bills into the final text that we know today as the DQSA (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  Chapter 2 of that act is the Drug Supply Chain Security Act (DSCSA).  Most readers of RxTrace haven’t forgotten that history but it is important to look back at that history to explain why most companies can ignore certain requirements in the law.  That’s right.  There are requirements in the law that you can ignore because they will not be enforced by anyone.  They are the result of the disjoint way the DQSA was written.  Let me explain. Continue reading 3 DSCSA Requirements You Can Totally Ignore

FDA Delays Enforcement of DSCSA November Deadline: What It Means

Business man trying to stop the clockAs you have read, the FDA has let it slip, with a draft guidance document, that they have decided not to enforce the DSCSA’s November 27, 2017 deadline for manufacturers to apply the new serialized product identifier on drug packages and verification requirements for one year, but it also contains cascading enforcement delays (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”).  This is a major move by the FDA and it will have important consequences for the industry.  Let’s break it down. Continue reading FDA Delays Enforcement of DSCSA November Deadline: What It Means

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?

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

Who Will Enforce The DSCSA 2017 Serialization Mandate?

Last week I listened in on a Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 U.S. wholesale distributors.  It was a well-run call that included several presentations and a Q&A session.  Several times the question was discussed about whether or not the wholesale distributor would accept non-serialized product in the time between November 27, 2017 and November 27, 2019. Continue reading Who Will Enforce The DSCSA 2017 Serialization Mandate?