Back in September, the Office of Inspector General (OIG) published a report on Distributor Readiness for DSCSA.  We discussed the findings in a blog post on our site a couple of weeks ago.  At this time, we wanted to take a deeper dive into another interesting area that was mentioned in the report, which was a statement about the difficulty of identifying the products that were excluded from DSCSA.  The criteria for exclusion after parsing through the regulation is broadly written but includes:

  • Blood or blood components intended for transfusion
  • Compounded drugs
  • Imaging drugs
  • Medical Gases
  • Radioactive drugs / radiopharmaceuticals
  • OTC drugs
  • Veterinary drug product
  • Intravenous products used for electrolyte replenishment

To solve this issue, we have developed an algorithm that flags potential transactions for exclusion within the RXTransparent platform using our CorPharma™ database.  Our CorPharma™ database integrates data from the NIH national library of medicine, the FDA Orange book of therapeutic equivalents and the FDA Purple book of biosimilar equivalents.  Our DSCSA exclusion methodology is summarized below:

Step 1 NDC Validation.  NDC is one of the key data attributes driving DSCSA.  NDC numbers are not assigned for blood products or human drugs that are not in final marketed form, such as active pharmaceutical ingredients, or drugs that are marketed solely as part of a kit or combination product or inner layer of a multi-level packaged product. This first step in our validation methodology eliminates most exclusion categories in DSCSA including compounded drugs, veterinary drugs, blood and most radiopharmaceuticals.

Step 2 Is the drug designated as a prescription drug?  This next filter removes drugs that are either discontinued by the manufacturer or designated as over the counter (OTC) drug products. This impacts the list of excluded products the most.

Step 3 Is the product a medical gas?  There are approximately 1,700 products that are defined as medical gasses.

Step 4 Is the product a Radiopharmaceutical?  There are less than 100 substances that are defined as radiopharmaceuticals and many of these products do not have a designated NDC.

 

Once these exclusion definitions have been defined, we were able to generate a list over 60 thousand NDCs.  This represents less than half of one percent of all drugs currently defined in the NIH national library of medicine.  The list of excluded NDC products are available click below:

 

On October 25th , we will be reviewing this exclusion methodology in our next webinar:  DSCSA Step By Step.  The details and how to register for this event are listed below:

DSCSA Step By Step

Wednesday, October 25, 2017

2 PM Eastern Time

 

 

Dwight deVera, CEO – President