DSCSA Red Light Green Light: Verification Responses

There is an important debate going on over the last 9 months regarding exactly how many different answers companies should prepare to provide in response to a DSCSA verification request.  Some say two:  “Red light” or “Green light”.  And others say three:  “Yes”, “No”, or “It’s Complicated”.  This might seem like a minor question, but … Continue reading DSCSA Red Light Green Light: Verification Responses

DSCSA Serialization: What Wholesalers Expect

Recently, 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 … Continue reading DSCSA Serialization: What Wholesalers Expect

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 … Continue reading DSCSA: Saleable Returns Verification

Drug Verification: EU Vs US

Drug 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 … Continue reading Drug Verification: EU Vs US

Wholesaler Confusion Over DSCSA Aggregation Explained

While listening to a monthly Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 wholesale distributors I heard a comment that snapped me out of my conference call-induced stupor.  Unfortunately I was in a location where I could not take notes so I don’t remember the exact comments that were made, … Continue reading Wholesaler Confusion Over DSCSA Aggregation Explained