Tag Archives: Verification

Verification

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? →

DSCSA

DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations

As I mentioned last week, the FDA published two new draft DSCSA guidance documents on the day of the recent FDA DSCSA Public Meeting (see “FDA DSCSA Public Meeting #3: A Difference?”).  Let’s take a closer look at what’s in them and their significance to companies facing the Drug Supply Chain Security Act (DSCSA).  I’ll cover one of the two in this essay and cover the other document in the next essay. Continue reading DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations →

HDA

HDA’s 2017 Manufacturer Serialization Readiness Survey Results

There is a reason so many RxTrace essays have something to do with the Healthcare Distribution Alliance (HDA) (I won’t list them all, but here are two recent ones:  “HDA Traceability Seminar: RxTrace Future Topic List Explodes” and “HDA Schools FDA On DSCSA”).  It’s because they have their fingers in just about everything related to the US pharma supply chain’s preparation for compliance with the Drug Supply Chain Security Act (DSCSA).  HDA members are literally in the “center” of the supply chain, and the organization is at the center of many of the most important initiatives related to meeting the DSCSA, including their Origin master data sharing service (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”), their future Verification Router Service (VRS) (see “First Meeting of the HDA Verification Router Service Task Force”), and they hold the most important DSCSA conference every year (see “FDA Speaks About DSCSA At HDA”).  And their HDA Research Foundation now conducts the most important manufacturer DSCSA serialization readiness survey.  They just published the latest one.  Let’s take a look at it. Continue reading HDA’s 2017 Manufacturer Serialization Readiness Survey Results →

DSCSA

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? →

HDA

First Meeting of the HDA Verification Router Service Task Force

Happy Martin Luther King Jr. Day!

As someone who often attempts to explain truth and reality through writing, I can really appreciate the writing skill of Rev. Dr. Martin Luther King Jr. (see “Celebrating Martin Luther King Jr.”).  I’ve learned that the best writing has to come from your heart just as much as it does from your head, but I still make mistakes that I don’t expect to see in Dr. King’s writing.  Last week is an example.  By attending the Healthcare Distribution Alliance’s (HDA’s) Verification Router Services (VRS) Task Force meeting in Crystal City, Virginia, I learned more about HDA’s intentions for the design of the VRS. Continue reading First Meeting of the HDA Verification Router Service Task Force →

Product Identifier Authentication, Saleable Returns Verification

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 →

DSCSA, FDA Guidance

FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected

FDALogoLast week the US FDA Center for Drug Evaluation and Research (CDER) published an update to their guidance agenda for calendar 2016.  Originally published in January, this is the mid-year update, when the CDER has a shorter window to think about and, presumably, can be more accurate.  What has changed since January?  The number of Drug Supply Chain Security Act (DSCSA)-related draft guidance they expect to publish by year end remains the same, as reported by our friends at the Regulatory Affairs Professionals Society (RAPS).

In fact, according to RAPS, those same six draft guidances were Continue reading FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected →

DSCSA, EUDR

Drug Verification: EU Vs US

USvsEU flagsDrug verification is at the heart of most pharma serialization regulations.  It is the point at which someone in the supply chain or a patient uses the unique identifier on the drug package to determine that the drug is probably authentic, or definitely is not.  We can tell a lot about the intent of a given serialization regulation by looking at the specific language that determines by whom and when a unique identifier must be verified. Continue reading Drug Verification: EU Vs US →