Tag Archives: pharmaceuticals

Dispensers, DSCSA

Who Is A DSCSA Dispenser?

???????????????????????????????????When the U.S. Drug Supply Chain Security Act (DSCSA) was signed into law last November, it introduced a new term into the supply chain lexicon:  “Dispenser”.  It is unfortunate that the authors chose not to use a more recognizable word—like “pharmacies”, or “hospitals”, or “physicians”—because, if they had, more organizations in the dispensing sector might have taken more notice of the requirements they are facing.  But, of course, they could not do that because they wanted to refer to all of those organizations using a single term.  All of those types of organizations fall into the DSCSA definition of “dispensers” and the use of that word appears to have led to some confusion, and therefore some amount of complacency.

“Dispenser” is one of the terms the DSCSA defines so that the rest of the text does not need to repeat the full list of organizations the authors are referring to (see “Don’t Skip The DQSA Definition of Terms Section”).  Its definition is only applicable Continue reading Who Is A DSCSA Dispenser? →

Randomization

Randomization—An Interview with Ken Traub—Part 3: Threat Analysis

Hacker typing on a laptopThis is the third of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization.  The full series includes essays covering:

  1. GS1 Serial Number Considerations
  2. Properties of Randomization
  3. Threat Analysis (this essay)
  4. Algorithmic Approach
  5. Other Approaches to Randomization

This week Ken introduces the concept of threat analysis.  – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 3: Threat Analysis →

Randomization

Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization

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iStock_000011797297SmallerThis is the second of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization.  The full series includes essays covering:

  1. GS1 Serial Number Considerations
  2. Properties of Randomization (this essay)
  3. Threat Analysis
  4. Algorithmic Approach
  5. Other Approaches to Randomization

This week Ken introduces three properties of randomization.  — Dirk.

Continue reading Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization →

FDA

Anatomy Of The National Drug Code

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The U.S. Food and Drug Administration (FDA) created the concept of the National Drug Code (NDC) in 1969 to “…provide an identification system in computer language to permit automated processing of drug data by Government agencies, drug manufacturers and distributors, hospitals, and insurance companies” (from 34 FR 11157, July 2, 1969).  (I can’t find a copy online of the original Federal Register article from 1969 so I’m relying on a more recent article that references it.)   Those of us in the U.S. pharma supply chain make use of NDC’s every day, but very few of us know the history of their development, exactly how the numbers are composed and what they mean.  I’ll try to explain all of that and provide sources for further reading.

HISTORY OF THE NDC

The NDC was initially a voluntary identifier (see references at the end of this essay).  We all know how that would have turned out (for more on that thought, see my recent essay “Should Regulations Dictate Technology?“) so in 1972 the FDA made the NDC mandatory for all prescription and over-the-counter (OTC) drugs.  Manufacturers were required to obtain a “Labeler Code” from the FDA, construct their NDC’s using that code as the base and print the NDC number on drug packages.  Barcodes were not required by the FDA back then.

From the quote in the first paragraph above you can see that the FDA intended the NDC to be Continue reading Anatomy Of The National Drug Code →